2012 drug packaging review: many dangerous, reportable flaws.

PubMed

2013-05-01

Drug packaging plays an important role in protecting and providing information to patients. The packaging examined by Prescrire in 2012, on the whole, still fails to perform all of these functions effectively. Two issues are especially worrisome. First, packaging too often poses a danger to children. In addition, too many patient leaflets provide incomplete information about adverse effects, thus failing to properly protect the most vulnerable patients. Yet, the method Prescrire used to analyse drug packaging shows that it is not difficult to detect and anticipate risks. It is up to healthcare professionals to take advantage of the method, to protect patients from, and report, dangerous packaging.

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

21 CFR 355.20 - Packaging conditions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.20 Packaging conditions. (a) Package size limitation. Due to the toxicity associated with fluoride active ingredients, the... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Packaging conditions. 355.20 Section 355.20 Food...

Application of Quality by Design (QbD) Principles to Extractables/Leachables Assessment. Establishing a Design Space for Terminally Sterilized Aqueous Drug Products Stored in a Plastic Packaging System.

PubMed

Jenke, Dennis

2010-01-01

The concept of quality by design (QbD) reflects the current global regulatory thinking related to pharmaceutical products. A cornerstone of the QbD paradigm is the concept of a design space, where the design space is a multidimensional combination of input variables and process parameters that have been demonstrated to provide the assurance of product quality. If a design space can be established for a pharmaceutical process or product, then operation within the design space confirms that the product or process output possesses the required quality attributes. This concept of design space can be applied to the safety (leachables) assessment of drug products manufactured and stored in packaging systems. Critical variables in such a design space would include those variables that affect the interaction of the drug product and its packaging, including (a) composition of the drug product, (b) composition of the packaging system, (c) configuration of the packaging system, and (d) the conditions of contact. This paper proposes and justifies such a leachables design space for aqueous drug products packaged in a specific plastic packaging system. Such a design space has the following boundaries:Aqueous drug products with a pH in the range of 2 to 8 and that contain no polarity-impacting agents such as organic solubilizers and stabilizers (addressing variable a). Packaging systems manufactured from materials that meet the system's existing material specifications (addressing variable b). Nominal fill volumes from 50 to 1000 mL (addressing variable c). Products subjected to terminal sterilization and then stored at room temperature for a period of up to 24 months (addressing variable d). The ramification of such a design space is that any drug product that falls within these boundaries is deemed to be compatible with the packaging system, from the perspective of safety, without the requirement of supporting drug product testing. When drug products are packaged in plastic container systems, substances may leach from the container and accumulate in the product. It is necessary that the drug product's vendor demonstrate that any such leaching does not occur to the extent that the leached substances adversely affect the product's safety and/or efficacy. One method for accomplishing this objective is via analysis of the drug product to identify and quantify the leached substances. When a particular packaging system is utilized for multiple drug products, one reaches the point, after testing numerous drug products, where the leaching properties of the packaging system are well known and readily predictable. In such a case, testing of additional products in the same packaging system produces no new information and thus becomes redundant and unnecessary. The quality by design (QbD) principle can be simply stated as follows: once a system has been tested to the extent that the test results are predictable, further testing can be replaced by establishing that the system was operating within a defined design space. The purpose of this paper is to demonstrate the application of QbD principles to a packaging system that has been utilized with over 12 parenteral drug products. The paper concludes that the leachables profile of all drug products that fit a certain description (the design space) is known and predicable.

Drug packaging in 2013: small changes would reap big benefits.

PubMed

2014-05-01

Drug packaging is important both in protecting and informing patients. Some improvements were made in 2013, but many of the products examined by Prescrire still had poor-quality or even dangerous packaging. Problem packaging is a major concern for patients who are more vulnerable to adverse effects, particularly children and pregnant women. Several problems were noted with products intended for self-medication (umbrella brands), oral solutions sold with dosing devices, and injectable drugs. Looking back at 20 years of Red Cards that Prescrire has issued to products with dangerous packaging reveals several improvements, but too many dangers persist. Urgent action needs to be taken by regulatory agencies and drug companies: patient leaflets must be more explicit with regard to adverse effects, especially those of nonsteroidal anti-inflammatory drugs during pregnancy; accidental ingestion by children must be prevented; and companies must design safer dosing devices. Healthcare professionals and patients must remain vigilant and report all packaging issues to the relevant authorities.

39 CFR 233.8 - Expedited forfeiture proceedings for property seized for administrative forfeiture involving...

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Evidence, such as drug scales, drug distribution paraphernalia, drug records, drug packaging material, method of drug packaging, drug “cutting” agents and other equipment, that indicates an intent to process... a controlled substance is presumed to be for personal use when there are no indicia of illicit drug...

39 CFR 233.8 - Expedited forfeiture proceedings for property seized for administrative forfeiture involving...

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Evidence, such as drug scales, drug distribution paraphernalia, drug records, drug packaging material, method of drug packaging, drug “cutting” agents and other equipment, that indicates an intent to process... a controlled substance is presumed to be for personal use when there are no indicia of illicit drug...

21 CFR 500.23 - Thermally processed low-acid foods packaged in hermetically sealed containers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Thermally processed low-acid foods packaged in hermetically sealed containers. 500.23 Section 500.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Administrative Rulings and Decisions § 500.23 Thermally processed low-acid foods packaged in hermetically sealed...

21 CFR 500.23 - Thermally processed low-acid foods packaged in hermetically sealed containers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Thermally processed low-acid foods packaged in hermetically sealed containers. 500.23 Section 500.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Administrative Rulings and Decisions § 500.23 Thermally processed low-acid foods packaged in hermetically sealed...

21 CFR 500.23 - Thermally processed low-acid foods packaged in hermetically sealed containers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Thermally processed low-acid foods packaged in hermetically sealed containers. 500.23 Section 500.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Administrative Rulings and Decisions § 500.23 Thermally processed low-acid foods packaged in hermetically sealed...

21 CFR 500.23 - Thermally processed low-acid foods packaged in hermetically sealed containers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Thermally processed low-acid foods packaged in hermetically sealed containers. 500.23 Section 500.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Administrative Rulings and Decisions § 500.23 Thermally processed low-acid foods packaged in hermetically sealed...

21 CFR 181.22 - Certain substances employed in the manufacture of food-packaging materials.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Certain substances employed in the manufacture of food-packaging materials. 181.22 Section 181.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Food Ingredients § 181.22 Certain substances employed in the manufacture of food-packaging materials...

21 CFR 500.23 - Thermally processed low-acid foods packaged in hermetically sealed containers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Thermally processed low-acid foods packaged in hermetically sealed containers. 500.23 Section 500.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Administrative Rulings and Decisions § 500.23 Thermally processed low-acid foods packaged in hermetically sealed...

21 CFR 70.20 - Packaging requirements for straight colors (other than hair dyes).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Packaging requirements for straight colors (other than hair dyes). 70.20 Section 70.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... straight colors (other than hair dyes). Straight colors shall be packaged in containers which prevent...

21 CFR 70.20 - Packaging requirements for straight colors (other than hair dyes).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Packaging requirements for straight colors (other than hair dyes). 70.20 Section 70.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... straight colors (other than hair dyes). Straight colors shall be packaged in containers which prevent...

21 CFR 70.20 - Packaging requirements for straight colors (other than hair dyes).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Packaging requirements for straight colors (other than hair dyes). 70.20 Section 70.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... straight colors (other than hair dyes). Straight colors shall be packaged in containers which prevent...

21 CFR 70.20 - Packaging requirements for straight colors (other than hair dyes).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Packaging requirements for straight colors (other than hair dyes). 70.20 Section 70.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... straight colors (other than hair dyes). Straight colors shall be packaged in containers which prevent...

21 CFR 181.22 - Certain substances employed in the manufacture of food-packaging materials.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food-packaging materials. 181.22 Section 181.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... of food-packaging materials. Prior to the enactment of the food additives amendment to the Federal... manufacturing practice for food-packaging materials includes the restriction that the quantity of any of these...

21 CFR 310.515 - Patient package inserts for estrogens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Patient package inserts for estrogens. 310.515 Section 310.515 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.515 Patient...

21 CFR 310.509 - Parenteral drug products in plastic containers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

21 CFR 310.509 - Parenteral drug products in plastic containers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

21 CFR 310.509 - Parenteral drug products in plastic containers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

21 CFR 310.509 - Parenteral drug products in plastic containers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

21 CFR 310.509 - Parenteral drug products in plastic containers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

Death by heroin intoxication in a body pusher with an innovative packaging technique: case report and review of the literature.

PubMed

Visentin, Sindi; Bevilacqua, Greta; Giraudo, Chiara; Dengo, Caterina; Nalesso, Alessandro; Montisci, Massimo

2017-11-01

Death due to mechanical or chemical intoxication of heroin body packers, thanks to the continuous improvement in packaging techniques, are increasingly rare, and almost all the cases reported in the literature refer to drug swallowers. A case of fatal acute heroin intoxication in a body pusher with an unreported packaging technique is presented, and previous deaths due to heroin body packing are reviewed, taking into consideration imaging techniques performed, cause of death, toxicological analysis on biological and non-biological samples, as well as number, position and type of drug packages identified at the dissection of the body. The innovative packaging technique found in the present case, constituted by an external multilayer cellophane casing containing 16 smaller packages of hardened heroin powder, each one covered with cigarette paper and multiple layers of heat-sealed cellophane, was probably used to avoid both chemical complications of package rupture and to create a package with morphological and radiological features different from those reported by previous studies. Drug dealers, in fact, are continually looking for packaging methods that, besides being safer, minimize the risk of detection at the radiological examinations performed, thus increasing the number of false negative findings. The identification of new types of package is therefore important, in order to identify packages that do not have the typical radiological signs, both in order to protect the patient's health and to avoid the non-recognition of a drug carrier. Despite the presence of multilayer composition of both the smaller and the bigger external coverage, these new types of package did not guarantee the greater safety of the drug dealer. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 570.13 - Indirect food additives resulting from packaging materials prior sanctioned for animal feed and...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.13 Section 570.13 Food and Drugs FOOD AND DRUG... FOOD ADDITIVES General Provisions § 570.13 Indirect food additives resulting from packaging materials...

21 CFR 570.13 - Indirect food additives resulting from packaging materials prior sanctioned for animal feed and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.13 Section 570.13 Food and Drugs FOOD AND DRUG... FOOD ADDITIVES General Provisions § 570.13 Indirect food additives resulting from packaging materials...

21 CFR 570.13 - Indirect food additives resulting from packaging materials prior sanctioned for animal feed and...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.13 Section 570.13 Food and Drugs FOOD AND DRUG... FOOD ADDITIVES General Provisions § 570.13 Indirect food additives resulting from packaging materials...

21 CFR 570.13 - Indirect food additives resulting from packaging materials prior sanctioned for animal feed and...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.13 Section 570.13 Food and Drugs FOOD AND DRUG... FOOD ADDITIVES General Provisions § 570.13 Indirect food additives resulting from packaging materials...

21 CFR 570.13 - Indirect food additives resulting from packaging materials prior sanctioned for animal feed and...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.13 Section 570.13 Food and Drugs FOOD AND DRUG... FOOD ADDITIVES General Provisions § 570.13 Indirect food additives resulting from packaging materials...

21 CFR 501.2 - Information panel of package for animal food.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

21 CFR 501.2 - Information panel of package for animal food.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

21 CFR 501.2 - Information panel of package for animal food.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

21 CFR 501.2 - Information panel of package for animal food.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

21 CFR 501.2 - Information panel of package for animal food.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

[The development and operation of a package inserts service system for electronic medical records].

PubMed

Yamada, Hidetoshi; Nishimura, Sachiho; Shimamori, Yoshimitsu; Sato, Seiji; Hayase, Yukitoshi

2003-03-01

To promote the appropriate use of pharmaceuticals and to prevent side effects, physicians need package inserts on medicinal drugs as soon as possible. A medicinal drug information service system was established for electronic medical records to speed up and increase the efficiency of package insert communications within a medical institution. Development of this system facilitates access to package inserts by, for example, physicians. The time required to maintain files of package inserts was shortened, and the efficiency of the drug information service increased. As a source of package inserts for this system, package inserts using a standard generalized markup language (SGML) form were used, which are accessible to the public on the homepage of the Organization for Pharmaceutical Safety and Research (OPSR). This study found that a delay occurred in communicating revised package inserts from pharmaceutical companies to the OPSR. Therefore a pharmaceutical department page was set up as part of the homepage of the medical institution for electronic medical records to shorten the delay in the revision of package inserts posted on the medicinal drug information service homepage of the OPSR. The usefulness of this package insert service system for electronic medical records is clear. For more effective use of this system based on the OPSR homepage pharmaceutical companies have been requested to provide quicker updating of package inserts.

Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

PubMed Central

2011-01-01

Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

Packaging and labeling of pharmaceutical products obtained from the internet.

PubMed

Veronin, Michael

2011-02-15

For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

Development of Potent Antiviral Drugs Inspired by Viral Hexameric DNA-Packaging Motors with Revolving Mechanism

PubMed Central

Pi, Fengmei; Zhao, Zhengyi; Chelikani, Venkata; Yoder, Kristine; Kvaratskhelia, Mamuka

2016-01-01

The intracellular parasitic nature of viruses and the emergence of antiviral drug resistance necessitate the development of new potent antiviral drugs. Recently, a method for developing potent inhibitory drugs by targeting biological machines with high stoichiometry and a sequential-action mechanism was described. Inspired by this finding, we reviewed the development of antiviral drugs targeting viral DNA-packaging motors. Inhibiting multisubunit targets with sequential actions resembles breaking one bulb in a series of Christmas lights, which turns off the entire string. Indeed, studies on viral DNA packaging might lead to the development of new antiviral drugs. Recent elucidation of the mechanism of the viral double-stranded DNA (dsDNA)-packaging motor with sequential one-way revolving motion will promote the development of potent antiviral drugs with high specificity and efficiency. Traditionally, biomotors have been classified into two categories: linear and rotation motors. Recently discovered was a third type of biomotor, including the viral DNA-packaging motor, beside the bacterial DNA translocases, that uses a revolving mechanism without rotation. By analogy, rotation resembles the Earth's rotation on its own axis, while revolving resembles the Earth's revolving around the Sun (see animations at http://rnanano.osu.edu/movie.html). Herein, we review the structures of viral dsDNA-packaging motors, the stoichiometries of motor components, and the motion mechanisms of the motors. All viral dsDNA-packaging motors, including those of dsDNA/dsRNA bacteriophages, adenoviruses, poxviruses, herpesviruses, mimiviruses, megaviruses, pandoraviruses, and pithoviruses, contain a high-stoichiometry machine composed of multiple components that work cooperatively and sequentially. Thus, it is an ideal target for potent drug development based on the power function of the stoichiometries of target complexes that work sequentially. PMID:27356896

Prediction of drug-packaging interactions via molecular dynamics (MD) simulations.

PubMed

Feenstra, Peter; Brunsteiner, Michael; Khinast, Johannes

2012-07-15

The interaction between packaging materials and drug products is an important issue for the pharmaceutical industry, since during manufacturing, processing and storage a drug product is continuously exposed to various packaging materials. The experimental investigation of a great variety of different packaging material-drug product combinations in terms of efficacy and safety can be a costly and time-consuming task. In our work we used molecular dynamics (MD) simulations in order to evaluate the applicability of such methods to pre-screening of the packaging material-solute compatibility. The solvation free energy and the free energy of adsorption of diverse solute/solvent/solid systems were estimated. The results of our simulations agree with experimental values previously published in the literature, which indicates that the methods in question can be used to semi-quantitatively reproduce the solid-liquid interactions of the investigated systems. Copyright © 2012 Elsevier B.V. All rights reserved.

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2012 CFR

2012-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2013 CFR

2013-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 101.2 - Information panel of package form food.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

21 CFR 101.2 - Information panel of package form food.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

21 CFR 101.2 - Information panel of package form food.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

21 CFR 101.2 - Information panel of package form food.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

21 CFR 109.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... establishments manufacturing food-packaging materials. 109.15 Section 109.15 Food and Drugs FOOD AND DRUG... polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. (a) Polychlorinated...). These accidents in turn caused the contamination of food products intended for human consumption (meat...

21 CFR 509.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... establishments manufacturing food-packaging materials. 509.15 Section 509.15 Food and Drugs FOOD AND DRUG... polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. (a) Polychlorinated...). These accidents in turn caused the contamination of food products intended for human consumption (meat...

21 CFR 501.1 - Principal display panel of package form animal food.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Principal display panel of package form animal food. 501.1 Section 501.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions...

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 226.80 - Packaging and labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 226.80 - Packaging and labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 226.80 - Packaging and labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

21 CFR 226.80 - Packaging and labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

21 CFR 226.80 - Packaging and labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Patient package inserts for oral contraceptives. 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Patient package inserts for oral contraceptives. 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and...

16 CFR 1702.16 - Petitions requesting an exemption for a drug or a new drug.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Petitions requesting an exemption for a drug or a new drug. 1702.16 Section 1702.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT...

16 CFR 1702.16 - Petitions requesting an exemption for a drug or a new drug.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Petitions requesting an exemption for a drug or a new drug. 1702.16 Section 1702.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT...

16 CFR 1702.16 - Petitions requesting an exemption for a drug or a new drug.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Petitions requesting an exemption for a drug or a new drug. 1702.16 Section 1702.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT...

16 CFR 1702.16 - Petitions requesting an exemption for a drug or a new drug.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Petitions requesting an exemption for a drug or a new drug. 1702.16 Section 1702.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT...

16 CFR 500.2 - Terms defined.

Code of Federal Regulations, 2013 CFR

2013-01-01

... food, drug, device or cosmetic as defined by section 201 of the Federal Food, Drug, and Cosmetic Act... for use in the delivery or display of that commodity to retail purchasers. For purposes of the... package means a package which is one of a lot, shipment, or delivery of packages of the same consumer...

16 CFR 500.2 - Terms defined.

Code of Federal Regulations, 2012 CFR

2012-01-01

... food, drug, device or cosmetic as defined by section 201 of the Federal Food, Drug, and Cosmetic Act... for use in the delivery or display of that commodity to retail purchasers. For purposes of the... package means a package which is one of a lot, shipment, or delivery of packages of the same consumer...

16 CFR 500.2 - Terms defined.

Code of Federal Regulations, 2014 CFR

2014-01-01

... food, drug, device or cosmetic as defined by section 201 of the Federal Food, Drug, and Cosmetic Act... for use in the delivery or display of that commodity to retail purchasers. For purposes of the... package means a package which is one of a lot, shipment, or delivery of packages of the same consumer...

Interventions to improve the use of antimalarials in south-east Asia: an overview.

PubMed Central

Gomes, M.; Wayling, S.; Pang, L.

1998-01-01

There are few drugs for malaria, and those which are available for use are subject to rapid development of resistance. Curiously, little effort has been made to improve drug use in malaria-endemic countries and to assess the benefits of such improvements. Advances can be made in public understanding of the value of ingesting a full regimen of antimalarials, in order to achieve complete cure, and in improving simple technologies (blister packaging) to achieve the same result. Better efforts can be made to reduce the availability of fake or substandard drugs in the marketplace. In this article, we describe the outcome of a concerted effort to improve drug compliance and drug quality in an area of multidrug resistance for malaria. These research efforts, guided by the Task Force for Improved Use of Antimalarials, characterized the problems in drug compliance in South-East Asia, and developed interventions to improve drug use in the various countries. Interventions involved drug packaging, public information campaigns, and assessments of drug quality. Results show that blister packaging worked best to improve drug compliance and that the increased cost of packaged medication did not limit its use. Drug quality was a major problem in unregulated countries and should be improved. PMID:9763718

Interventions to improve the use of antimalarials in south-east Asia: an overview.

PubMed

Gomes, M; Wayling, S; Pang, L

1998-01-01

There are few drugs for malaria, and those which are available for use are subject to rapid development of resistance. Curiously, little effort has been made to improve drug use in malaria-endemic countries and to assess the benefits of such improvements. Advances can be made in public understanding of the value of ingesting a full regimen of antimalarials, in order to achieve complete cure, and in improving simple technologies (blister packaging) to achieve the same result. Better efforts can be made to reduce the availability of fake or substandard drugs in the marketplace. In this article, we describe the outcome of a concerted effort to improve drug compliance and drug quality in an area of multidrug resistance for malaria. These research efforts, guided by the Task Force for Improved Use of Antimalarials, characterized the problems in drug compliance in South-East Asia, and developed interventions to improve drug use in the various countries. Interventions involved drug packaging, public information campaigns, and assessments of drug quality. Results show that blister packaging worked best to improve drug compliance and that the increased cost of packaged medication did not limit its use. Drug quality was a major problem in unregulated countries and should be improved.

21 CFR 108.35 - Thermal processing of low-acid foods packaged in hermetically sealed containers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... authorized employee of the Food and Drug Administration to inspect the commercial processor's manufacturing... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Thermal processing of low-acid foods packaged in hermetically sealed containers. 108.35 Section 108.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2011 CFR

2011-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2013 CFR

2013-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2012 CFR

2012-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 1.20 - Presence of mandatory label information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... information. The term package means any container or wrapping in which any food, drug, device, or cosmetic is...) of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387(13)) defining “package,” the term package means any container or wrapping in which any food, drug, device, or cosmetic is enclosed...

16 CFR 1701.1 - Special packaging for substances subject to a standard that are distributed to pharmacies to be...

Code of Federal Regulations, 2012 CFR

2012-01-01

... whether it is intended that the pharmacist will repackage the drug before it is dispensed to the consumer... repackaged by the pharmacist, the manufacturer need not utilize special packaging. However, the Commission... to insure that the pharmacist will actually dispense the drug in the proper package. If the...

16 CFR 1701.1 - Special packaging for substances subject to a standard that are distributed to pharmacies to be...

Code of Federal Regulations, 2010 CFR

2010-01-01

... whether it is intended that the pharmacist will repackage the drug before it is dispensed to the consumer... repackaged by the pharmacist, the manufacturer need not utilize special packaging. However, the Commission... to insure that the pharmacist will actually dispense the drug in the proper package. If the...

16 CFR 1701.1 - Special packaging for substances subject to a standard that are distributed to pharmacies to be...

Code of Federal Regulations, 2014 CFR

2014-01-01

... whether it is intended that the pharmacist will repackage the drug before it is dispensed to the consumer... repackaged by the pharmacist, the manufacturer need not utilize special packaging. However, the Commission... to insure that the pharmacist will actually dispense the drug in the proper package. If the...

16 CFR 1701.1 - Special packaging for substances subject to a standard that are distributed to pharmacies to be...

Code of Federal Regulations, 2011 CFR

2011-01-01

... whether it is intended that the pharmacist will repackage the drug before it is dispensed to the consumer... repackaged by the pharmacist, the manufacturer need not utilize special packaging. However, the Commission... to insure that the pharmacist will actually dispense the drug in the proper package. If the...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2010 CFR

2010-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 201.307 - Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sodium phosphates; package size limitation... Requirements for Specific Drug Products § 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale. (a) Reports in the medical literature and data accumulated by the Food...

21 CFR 570.14 - Indirect food additives resulting from packaging materials for animal feed and pet food.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Indirect food additives resulting from packaging..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.14 Indirect food additives resulting from packaging materials for animal feed and...

21 CFR 570.14 - Indirect food additives resulting from packaging materials for animal feed and pet food.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Indirect food additives resulting from packaging..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.14 Indirect food additives resulting from packaging materials for animal feed and...

21 CFR 570.14 - Indirect food additives resulting from packaging materials for animal feed and pet food.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Indirect food additives resulting from packaging..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.14 Indirect food additives resulting from packaging materials for animal feed and...

21 CFR 570.14 - Indirect food additives resulting from packaging materials for animal feed and pet food.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Indirect food additives resulting from packaging..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.14 Indirect food additives resulting from packaging materials for animal feed and...

21 CFR 570.14 - Indirect food additives resulting from packaging materials for animal feed and pet food.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Indirect food additives resulting from packaging..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.14 Indirect food additives resulting from packaging materials for animal feed and...

Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa.

PubMed

Nayyar, Gaurvika M L; Breman, Joel G; Newton, Paul N; Herrington, James

2012-06-01

Poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardise progress and investments in combating malaria. Emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand-Cambodia border makes protection of the effectiveness of the drug supply imperative. We reviewed published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs. Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified. In 21 surveys of drugs from six classes from 21 countries in sub-Saharan Africa, 796 (35%) of 2297 failed chemical analysis, 28 (36%) of 77 failed packaging analysis, and 79 (20%) of 389 were classified as falsified. Data were insufficient to identify the frequency of substandard (products resulting from poor manufacturing) antimalarial drugs, and packaging analysis data were scarce. Concurrent interventions and a multifaceted approach are needed to define and eliminate criminal production, distribution, and poor manufacturing of antimalarial drugs. Empowering of national medicine regulatory authorities to protect the global drug supply is more important than ever. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effect of drug reminder packaging on medication adherence: a systematic review revealing research gaps

PubMed Central

2014-01-01

Background This was a systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Evidence mapping was used to reveal the effect of drug reminder packaging on medication adherence, to identify research gaps and to make suggestions for future research. Methods PubMed, Embase, CINAHL and PsycINFO were searched with an end date of September 2013 using the Medical Subject Headings (MeSH) term ‘medication adherence’ and 20 different search terms for ‘drug reminder packaging’, limited to the English and German languages. Additional references were identified through cross-referencing. All prospective controlled trials with an intervention using drug reminder packaging for patients taking at least one medication without the assistance of a health-care professional were included in the evidence mapping of the effect of drug reminder packaging on adherence and outcomes according to the Economic, Clinical and Humanistic Outcomes (ECHO) model. Results A total of 30 studies met the inclusion criteria: 10 randomized controlled trials, 19 controlled clinical trials and 1 cohort study. Drug reminder packaging had a significant effect on at least one adherence parameter in 17 studies (57%). The methodological quality was strong in five studies. Two studies provided complete information. Clear research gaps emerged. Conclusions Overall, the studies showed a positive effect of drug reminder packaging on adherence and clinical outcomes. However, poor reporting and important gaps like missing humanistic and economic outcomes and neglected safety issues limit the drawing of firm conclusions. Suggestions are made for future research. PMID:24661495

The challenges of packaging combination devices.

PubMed

Mankel, George

2008-01-01

This article focuses on the development of a packaging format for drug eluting stents where the package not only has to meet the needs of the stent, but also the needs of the drug incorporated into its polymer coating. The package has to allow the transfer of ethylene oxide gas for sterilisation, but when in storage, must provide a barrier to keep out moisture and oxygen. A pouch and commercial scale manufacturing process were developed to incorporate this dual function into one item.

PharmacoGx: an R package for analysis of large pharmacogenomic datasets.

PubMed

Smirnov, Petr; Safikhani, Zhaleh; El-Hachem, Nehme; Wang, Dong; She, Adrian; Olsen, Catharina; Freeman, Mark; Selby, Heather; Gendoo, Deena M A; Grossmann, Patrick; Beck, Andrew H; Aerts, Hugo J W L; Lupien, Mathieu; Goldenberg, Anna; Haibe-Kains, Benjamin

2016-04-15

Pharmacogenomics holds great promise for the development of biomarkers of drug response and the design of new therapeutic options, which are key challenges in precision medicine. However, such data are scattered and lack standards for efficient access and analysis, consequently preventing the realization of the full potential of pharmacogenomics. To address these issues, we implemented PharmacoGx, an easy-to-use, open source package for integrative analysis of multiple pharmacogenomic datasets. We demonstrate the utility of our package in comparing large drug sensitivity datasets, such as the Genomics of Drug Sensitivity in Cancer and the Cancer Cell Line Encyclopedia. Moreover, we show how to use our package to easily perform Connectivity Map analysis. With increasing availability of drug-related data, our package will open new avenues of research for meta-analysis of pharmacogenomic data. PharmacoGx is implemented in R and can be easily installed on any system. The package is available from CRAN and its source code is available from GitHub. bhaibeka@uhnresearch.ca or benjamin.haibe.kains@utoronto.ca Supplementary data are available at Bioinformatics online. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

21 CFR 111.415 - What requirements apply to filling, assembling, packaging, labeling, and related operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to filling, assembling, packaging, labeling, and related operations? 111.415 Section 111.415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to holding components, dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to packaging and labels received? 111.160 Section 111.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review.

PubMed

Jenke, Dennis R; Stults, Cheryl L M; Paskiet, Diane M; Ball, Douglas J; Nagao, Lee M

Elemental impurities in drug products can arise from a number of different sources and via a number of different means, including the active pharmaceutical ingredient, excipients, the vehicle, and leaching of elemental entities that are present in the drug product's manufacturing or packaging systems. Thus, knowledge about the presence, level, and likelihood of leaching of elemental entities in manufacturing and packaging systems is relevant to understanding how these systems contribute to a drug product's total elemental impurity burden. To that end, a joint team from the Extractables and Leachables Safety Information Exchange (ELSIE) Consortium and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) has conducted a review of the available literature on elemental entities in pharmaceutically relevant polymers and the presence of these elemental entities in material extracts and/or drug products. This review article contains the information compiled from the available body of literature and considers two questions: (1) What elemental entities are present in the relevant polymers and materials and at what levels are they present? (2) To what extent are these elemental entities leached from these materials under conditions relevant to the manufacturing and storage/distribution of solution drug products? Conclusions drawn from the compiled data are as follows: (1) Elemental entities are present in the materials used to construct packaging and manufacturing systems as these materials either contain these elemental entities as additives or are exposed to elemental entities during their production. (2) Unless the elemental entities are parts of the materials themselves (for example, SiO 2 in glass) or intentionally added to the materials (for example, metal stearates in polymers), their incidental amounts in the materials are generally low. (3) When elemental entities are present in materials and systems, generally only a very small fraction of the total available amount of the entity can be leached under conditions that are relevant to packaged drug products. Thus, while sources of certain elemental impurities may be ubiquitous in the natural environment, they are not ubiquitous in materials used in pharmaceutical packaging and manufacturing systems and when they are present, they are not extensively leached under relevant conditions. The information summarized here can be utilized to aid the elemental impurity risk assessment process by providing the identities of commonly reported elements and data to support probability estimates of those becoming elemental impurities in the drug product. Furthermore, recommendations are made related to establishing elements of potential product impact for individual materials. Extraneous impurities in drug products provide no therapeutic benefit and thus should be known and controlled. Elemental impurities can arise from a number of sources and by a number of means, including the leaching of elemental entities from drug product packaging and manufacturing systems. To understand the extent to which materials used in packaging systems contain elemental entities and the extent to which those entities leach into drug products to become elemental impurities, the Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Consortia have jointly performed a literature review on this subject. Using the compiled information, it was concluded that while packaging materials may contain elemental entities, unless those entities are intentional parts of the materials, the amounts of those elemental entities are generally low. Furthermore, generally only a very small fraction of the total available amount of the entity can be leached under conditions that are relevant to packaged drug products. Thus, risk assessment of sources of elemental impurities in drug products that may be related to materials used in pharmaceutical packaging and manufacturing systems can utilize the information and recommendations presented here. © PDA, Inc. 2015.

Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-the-counter medicines by laypeople.

PubMed

Hellier, Elizabeth; Tucker, Mike; Kenny, Natalie; Rowntree, Anna; Edworthy, Judy

2010-09-01

This study aimed to examine the utility of using color and shape to differentiate drug strength information on over-the-counter medicine packages. Medication errors are an important threat to patient safety, and confusions between drug strengths are a significant source of medication error. A visual search paradigm required laypeople to search for medicine packages of a particular strength from among distracter packages of different strengths, and measures of reaction time and error were recorded. Using color to differentiate drug strength information conferred an advantage on search times and accuracy. Shape differentiation did not improve search times and had only a weak effect on search accuracy. Using color to differentiate drug strength information improves drug strength identification performance. Color differentiation of drug strength information may be a useful way of reducing medication errors and improving patient safety.

21 CFR 310.518 - Drug products containing iron or iron salts.

Code of Federal Regulations, 2011 CFR

2011-04-01

... an active ingredient in solid oral dosage form, e.g., tablets or capsules shall meet the following.... (ii) If a drug product is packaged in unit-dose packaging, and if the immediate container bears...

21 CFR 310.518 - Drug products containing iron or iron salts.

Code of Federal Regulations, 2010 CFR

2010-04-01

... an active ingredient in solid oral dosage form, e.g., tablets or capsules shall meet the following.... (ii) If a drug product is packaged in unit-dose packaging, and if the immediate container bears...

Electro-Microfluidic Packaging

NASA Astrophysics Data System (ADS)

Benavides, G. L.; Galambos, P. C.

2002-06-01

There are many examples of electro-microfluidic products that require cost effective packaging solutions. Industry has responded to a demand for products such as drop ejectors, chemical sensors, and biological sensors. Drop ejectors have consumer applications such as ink jet printing and scientific applications such as patterning self-assembled monolayers or ejecting picoliters of expensive analytes/reagents for chemical analysis. Drop ejectors can be used to perform chemical analysis, combinatorial chemistry, drug manufacture, drug discovery, drug delivery, and DNA sequencing. Chemical and biological micro-sensors can sniff the ambient environment for traces of dangerous materials such as explosives, toxins, or pathogens. Other biological sensors can be used to improve world health by providing timely diagnostics and applying corrective measures to the human body. Electro-microfluidic packaging can easily represent over fifty percent of the product cost and, as with Integrated Circuits (IC), the industry should evolve to standard packaging solutions. Standard packaging schemes will minimize cost and bring products to market sooner.

21 CFR 610.62 - Proper name; package label; legible type.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Proper name; package label; legible type. 610.62 Section 610.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... contrast in color value between the proper name and the background shall be at least as great as the color...

21 CFR 111.127 - What quality control operations are required for packaging and labeling operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for packaging and labeling operations? 111.127 Section 111.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING...

21 CFR 181.22 - Certain substances employed in the manufacture of food-packaging materials.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Certain substances employed in the manufacture of food-packaging materials. 181.22 Section 181.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... INGREDIENTS Specific Prior-Sanctioned Food Ingredients § 181.22 Certain substances employed in the manufacture...

21 CFR 181.22 - Certain substances employed in the manufacture of food-packaging materials.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Certain substances employed in the manufacture of food-packaging materials. 181.22 Section 181.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... INGREDIENTS Specific Prior-Sanctioned Food Ingredients § 181.22 Certain substances employed in the manufacture...

21 CFR 1302.01 - Scope of part 1302.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Scope of part 1302. 1302.01 Section 1302.01 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS... packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d...

21 CFR 1302.01 - Scope of part 1302.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Scope of part 1302. 1302.01 Section 1302.01 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS... packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d...

21 CFR 101.1 - Principal display panel of package form food.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Principal display panel of package form food. 101.1 Section 101.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.1 Principal display panel of...

21 CFR 101.3 - Identity labeling of food in packaged form.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Identity labeling of food in packaged form. 101.3 Section 101.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.3 Identity labeling of food in...

21 CFR 101.3 - Identity labeling of food in packaged form.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Identity labeling of food in packaged form. 101.3 Section 101.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.3 Identity labeling of food in...

21 CFR 1302.01 - Scope of part 1302.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Scope of part 1302. 1302.01 Section 1302.01 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS... packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d...

21 CFR 1302.01 - Scope of part 1302.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Scope of part 1302. 1302.01 Section 1302.01 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS... packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d...

21 CFR 820.130 - Device packaging.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device packaging. 820.130 Section 820.130 Food and... QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the...

SynergyFinder: a web application for analyzing drug combination dose-response matrix data.

PubMed

Ianevski, Aleksandr; He, Liye; Aittokallio, Tero; Tang, Jing

2017-08-01

Rational design of drug combinations has become a promising strategy to tackle the drug sensitivity and resistance problem in cancer treatment. To systematically evaluate the pre-clinical significance of pairwise drug combinations, functional screening assays that probe combination effects in a dose-response matrix assay are commonly used. To facilitate the analysis of such drug combination experiments, we implemented a web application that uses key functions of R-package SynergyFinder, and provides not only the flexibility of using multiple synergy scoring models, but also a user-friendly interface for visualizing the drug combination landscapes in an interactive manner. The SynergyFinder web application is freely accessible at https://synergyfinder.fimm.fi ; The R-package and its source-code are freely available at http://bioconductor.org/packages/release/bioc/html/synergyfinder.html . jing.tang@helsinki.fi. © The Author(s) 2017. Published by Oxford University Press.

21 CFR 179.21 - Sources of radiation used for inspection of food, for inspection of packaged food, and for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing. 179.21 Section 179.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) IRRADIATION IN...

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control § 211.130 Packaging and labeling operations. There shall be written procedures designed to... manufacture and control of the batch. (d) Examination of packaging and labeling materials for suitability and...

21 CFR 800.12 - Contact lens solutions and tablets; tamper-resistant packaging.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-resistant retail packages, there is the opportunity for the malicious adulteration of these products with... confidence in the security of the packages of over-the-counter (OTC) health care products. The Food and Drug... used to make such a solution for retail sale that is not packaged in a tamper-resistant package and...

21 CFR 800.12 - Contact lens solutions and tablets; tamper-resistant packaging.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-resistant retail packages, there is the opportunity for the malicious adulteration of these products with... confidence in the security of the packages of over-the-counter (OTC) health care products. The Food and Drug... used to make such a solution for retail sale that is not packaged in a tamper-resistant package and...

21 CFR 800.12 - Contact lens solutions and tablets; tamper-resistant packaging.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-resistant retail packages, there is the opportunity for the malicious adulteration of these products with... confidence in the security of the packages of over-the-counter (OTC) health care products. The Food and Drug... used to make such a solution for retail sale that is not packaged in a tamper-resistant package and...

21 CFR 800.12 - Contact lens solutions and tablets; tamper-resistant packaging.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-resistant retail packages, there is the opportunity for the malicious adulteration of these products with... confidence in the security of the packages of over-the-counter (OTC) health care products. The Food and Drug... used to make such a solution for retail sale that is not packaged in a tamper-resistant package and...

21 CFR 800.12 - Contact lens solutions and tablets; tamper-resistant packaging.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-resistant retail packages, there is the opportunity for the malicious adulteration of these products with... confidence in the security of the packages of over-the-counter (OTC) health care products. The Food and Drug... used to make such a solution for retail sale that is not packaged in a tamper-resistant package and...

21 CFR 700.25 - Tamper-resistant packaging requirements for cosmetic products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... cosmetic products. 700.25 Section 700.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS GENERAL Requirements for Specific Cosmetic Products § 700.25 Tamper-resistant packaging requirements for cosmetic products. (a) General. Because most cosmetic liquid...

21 CFR 700.25 - Tamper-resistant packaging requirements for cosmetic products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... cosmetic products. 700.25 Section 700.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS GENERAL Requirements for Specific Cosmetic Products § 700.25 Tamper-resistant packaging requirements for cosmetic products. (a) General. Because most cosmetic liquid...

21 CFR 700.25 - Tamper-resistant packaging requirements for cosmetic products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cosmetic products. 700.25 Section 700.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS GENERAL Requirements for Specific Cosmetic Products § 700.25 Tamper-resistant packaging requirements for cosmetic products. (a) General. Because most cosmetic liquid...

21 CFR 700.25 - Tamper-resistant packaging requirements for cosmetic products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cosmetic products. 700.25 Section 700.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS GENERAL Requirements for Specific Cosmetic Products § 700.25 Tamper-resistant packaging requirements for cosmetic products. (a) General. Because most cosmetic liquid...

21 CFR 179.21 - Sources of radiation used for inspection of food, for inspection of packaged food, and for...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing. 179.21 Section 179.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) IRRADIATION IN THE...

21 CFR 701.10 - Principal display panel.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.10 Principal display panel. The term principal display panel as it applies to cosmetics in package form and as used in this part, means the part of a label that is most...

21 CFR 1141.10 - Required warnings.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Required warnings. 1141.10 Section 1141.10 Food... PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS Cigarette Package and Advertising Warnings § 1141.10 Required warnings. (a) Packages. (1) It shall be unlawful for any person to manufacture, package, sell...

Obstruction of critical information on over-the-counter medication packages by external tags.

PubMed

Sansgiry, Sujit S; Pawaskar, Manjiri D

2005-02-01

Over-the-counter (OTC) medication packages are important sources of information for consumers during product selection and use. Consumers may not be able to access information from OTC packages if external tags, namely price or anti-theft tags, are improperly placed. To determine the amount and type of information concealed by anti-theft tags and price tags affixed on OTC drug packages. A field study was performed by evaluating packages containing acetaminophen and combinations of acetaminophen in stores located in Houston. Five packages for 4 products selected from each store after an initial survey for presence of an external tag were examined. A data collection sheet was prepared that extracted the type and amount of information concealed by these tags. Data were analyzed by performing descriptive analyses to provide an understanding of the information obscured. A total of 24 stores were considered in the study, and 67 products and 285 packages were evaluated. External tags, both anti-theft and price tags, obscured significant amounts of information on the principal display panel (53.4%) and the Drug Facts panel (47.7%) of OTC packages. These tags concealed crucial information on various aspects of labels such as brand names (42.3%), product description (36.3%), warnings (51.5%), uses (10.4%), and purposes (7.2%). Results suggest that improper use of external tags clearly obscured important information on OTC medication packages necessary for consumers to make informed decisions regarding product selection and use. Tagging practices should be altered to allow consumers full access to drug information on the product.

21 CFR 201.62 - Declaration of net quantity of contents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... generally parallel to the base on which the package rests as it is designed to be displayed: Provided, That...: Provided, That in the case of drugs packed in containers designed to deliver the drug under pressure, the... contrast (by typography, layout, color, embossing, or molding) to other matter on the package; except that...

21 CFR 201.62 - Declaration of net quantity of contents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... generally parallel to the base on which the package rests as it is designed to be displayed: Provided, That...: Provided, That in the case of drugs packed in containers designed to deliver the drug under pressure, the... contrast (by typography, layout, color, embossing, or molding) to other matter on the package; except that...

Drug packaging. A key factor to be taken into account when choosing a treatment.

PubMed

2011-10-01

A drug's packaging contributes to its harm-benefit balance. Highlighting the key practical information and identifying potential sources of error or mix-ups is part and parcel of the correct use of medicines. Select labelling that clearly and prominently displays the important information, including the international nonproprietary name (INN).

[Repackaging drugs in pill-box in France: an illegal activity for pharmacists?].

PubMed

Hallouard, F; Bourdelin, M; Fessi, H; Bontemps, H

2011-07-01

Drug repackaging in pill-box by pharmacists is booming since few years. However, repackaging processes needed to open the industrially primary packaging will be found illegal in France. Thus, in this country drug repacking remains legal only by overwrapping medicines. Now, this solution is not applicable for example, with divisible or liquid forms. Therefore, packaging recommendations must be taken immediately in order to preserve the quality of drugs dispensed and to obtain a legalization of this activity. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Effect assessment of "film coating and packaging" on the photo-stability of highly photo-labile antihypertensive products.

PubMed

Mukharya, Amit; Patel, Paresh U; Chaudhary, Shivang

2013-04-01

Lacidipine (LCDP) is chemically a "1, 4-dihydropyridine derivative" Ca+(2) channel blocker used as an antihypertensive. Type and extent of packaging have a strong influence on the photo-stability of the 1,4-dihydropyridine derivatives. In standard, light protection of drug substance/drug product can be obtained either by use of an opaque additive in the formulation that competitively absorbs or reflects light reaching the sample and/or by blocking the access of light to the drug through external protection by packaging. External protection by covering tablets with an opaque film coating involving a light-reflecting inorganic pigment such as titanium dioxide and/or by using an opaque impermeable packaging material was an appropriate suitable option for establishing photo-stability. Thus, the main objective of the present study was to optimize the % level of film coating in LCDP core tablets, and selection of a final packaging material and its respective extent, that is, primary, secondary and/or tertiary packaging, for LCDP tablets. The main objective (% level of film coating) was optimized by directly exposing core tablets, 1% w/w, 2% w/w and 3% w/w film-coated tablets, to a light source as per Option-2 of ICH Q1B and its comparative analysis at the end of light exposure testing. The other objective (extent of drug product packaging) was established successfully by assessing whether or not an acceptable change has occurred at the end of the light exposure testing of the LCDP film-coated tablets in a direct exposure study or a primary immediate pack and/or secondary marketing pack.

21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper..., dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident...

21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper..., dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident...

21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper..., dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident...

21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper..., dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident...

21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper..., dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident...

ChemoPy: freely available python package for computational biology and chemoinformatics.

PubMed

Cao, Dong-Sheng; Xu, Qing-Song; Hu, Qian-Nan; Liang, Yi-Zeng

2013-04-15

Molecular representation for small molecules has been routinely used in QSAR/SAR, virtual screening, database search, ranking, drug ADME/T prediction and other drug discovery processes. To facilitate extensive studies of drug molecules, we developed a freely available, open-source python package called chemoinformatics in python (ChemoPy) for calculating the commonly used structural and physicochemical features. It computes 16 drug feature groups composed of 19 descriptors that include 1135 descriptor values. In addition, it provides seven types of molecular fingerprint systems for drug molecules, including topological fingerprints, electro-topological state (E-state) fingerprints, MACCS keys, FP4 keys, atom pairs fingerprints, topological torsion fingerprints and Morgan/circular fingerprints. By applying a semi-empirical quantum chemistry program MOPAC, ChemoPy can also compute a large number of 3D molecular descriptors conveniently. The python package, ChemoPy, is freely available via http://code.google.com/p/pychem/downloads/list, and it runs on Linux and MS-Windows. Supplementary data are available at Bioinformatics online.

Evaluating Documents: The Case of Patient Package Inserts. Technical Report No. 2.

ERIC Educational Resources Information Center

Krug, Robert E.

To illustrate the types of factors that must be considered in evaluating public documents, this paper analyzes a number of possible outcomes resulting from one type of document, the patient package insert (PPI) designed to provide consumers of prescription drugs with information about the drugs. It first outlines the intended sequence for a PPI:…

21 CFR 1310.06 - Content of records and reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... exempted from §§ 1300.02(b)(28)(i)(D) or 1300.02(b)(28)(i)(E) during the preceding calendar year. (6) Data shall identify the specific isomer, salt or ester when applicable but quantitative data shall be....). (9) Number of dosage units (if drug product) (100 doses per package). (10) Package type (if drug...

Delivery of chemotherapeutic drugs in tumour cell-derived microparticles.

PubMed

Tang, Ke; Zhang, Yi; Zhang, Huafeng; Xu, Pingwei; Liu, Jing; Ma, Jingwei; Lv, Meng; Li, Dapeng; Katirai, Foad; Shen, Guan-Xin; Zhang, Guimei; Feng, Zuo-Hua; Ye, Duyun; Huang, Bo

2012-01-01

Cellular microparticles are vesicular plasma membrane fragments with a diameter of 100-1,000 nanometres that are shed by cells in response to various physiological and artificial stimuli. Here we demonstrate that tumour cell-derived microparticles can be used as vectors to deliver chemotherapeutic drugs. We show that tumour cells incubated with chemotherapeutic drugs package these drugs into microparticles, which can be collected and used to effectively kill tumour cells in murine tumour models without typical side effects. We describe several mechanisms involved in this process, including uptake of drug-containing microparticles by tumour cells, synthesis of additional drug-packaging microparticles by these cells that contribute to the cytotoxic effect and the inhibition of drug efflux from tumour cells. This study highlights a novel drug delivery strategy with potential clinical application.

[The body packer syndrome].

PubMed

Clément, R; Fornes, P; Lecomte, D

2001-02-17

Ingestion of illicit drug packages is a well known method for transportation. These packages are prone to rupture causing overdose. The body packer syndrome may be overlooked in medical practice as illustrated by the following case report. A 19-year old male had convulsions followed by cardiac arrest during a flight. He was resuscitated in the plane, but he died a few hours after admission in intensive care unit. Chest and abdominal X-rays were considered normal. Cocaïne métabolites were found in his urine. The death was considered suspicious. X-rays performed before medicolegal autopsy showed numerous packages in his digestive tract. Thirty-six packages were found in the stomach and intestine. Two were ruptured in the stomach. The cause of death was cocaïne overdose caused by package rupture. The packages are usually visible on an standard abdomen X-ray. The drug is often wrapped in latex membranes or condoms. The air is trapped between the condoms by the nodes, forming two crescents visible on the X-ray. Surgery is preferred to laxatives when the packages are fragile with a high risk of rupture.

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

16 CFR 1702.15 - Petitions alleging the incompatiability of child resistant packaging with the particular...

Code of Federal Regulations, 2010 CFR

2010-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR 1702.15 - Petitions alleging the incompatiability of child resistant packaging with the particular...

Code of Federal Regulations, 2011 CFR

2011-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance...

Code of Federal Regulations, 2012 CFR

2012-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance...

Code of Federal Regulations, 2014 CFR

2014-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR § 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance...

Code of Federal Regulations, 2013 CFR

2013-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

Unit-dose packaged drugs for treating malaria.

PubMed

Orton, L; Barnish, G

2005-04-18

Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria. We searched the Cochrane Infectious Diseases Group Specialized Register (November 2004), CENTRAL (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), LILACS (November 2004), conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field. Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria. We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information. Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants). There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.

21 CFR 310.3 - Definitions and interpretations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of any substance which composes such drug, in whole or in part, whether it be an active substance or... the liability of similar side effects and contraindications. (l) Special packaging as defined in section 2(4) of the Poison Prevention Packaging Act of 1970 means packaging that is designed or...

21 CFR 310.3 - Definitions and interpretations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of any substance which composes such drug, in whole or in part, whether it be an active substance or... the liability of similar side effects and contraindications. (l) Special packaging as defined in section 2(4) of the Poison Prevention Packaging Act of 1970 means packaging that is designed or...

21 CFR 1141.10 - Required warnings.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Required warnings. 1141.10 Section 1141.10 Food... PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS Cigarette Package and Advertising Warnings § 1141.10 Required warnings. (a) Packages—(1) It shall be unlawful for any person to manufacture, package, sell...

21 CFR 205.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., compounding, processing, packaging, repackaging, or labeling of a prescription drug. (e) Prescription drug..., including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug...

21 CFR 205.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., compounding, processing, packaging, repackaging, or labeling of a prescription drug. (e) Prescription drug..., including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug...

Surface contamination of hazardous drug pharmacy storage bins and pharmacy distributor shipping containers.

PubMed

Redic, Kimberly A; Fang, Kayleen; Christen, Catherine; Chaffee, Bruce W

2018-03-01

Purpose This study was conducted to determine whether there is contamination on exterior drug packaging using shipping totes from the distributor and carousel storage bins as surrogate markers of external packaging contamination. Methods A two-part study was conducted to measure the presence of 5-fluorouracil, ifosfamide, cyclophosphamide, docetaxel and paclitaxel using surrogate markers for external drug packaging. In Part I, 10 drug distributor shipping totes designated for transport of hazardous drugs provided a snapshot view of contamination from regular use and transit in and out of the pharmacy. An additional two totes designated for transport of non-hazardous drugs served as controls. In Part II, old carousel storage bins (i.e. those in use pre-study) were wiped for snapshot view of hazardous drug contamination on storage bins. New carousel storage bins were then put into use for storage of the five tested drugs and used for routine storage and inventory maintenance activities. Carousel bins were wiped at time intervals 0, 8, 16 and 52 weeks to measure surface contamination. Results Two of the 10 hazardous shipping totes were contaminated. Three of the five-old carousel bins were contaminated with cyclophosphamide. One of the old carousel bins was also contaminated with ifosfamide. There were no detectable levels of hazardous drugs on any of the new storage bins at time 0, 8 or 16 weeks. However, at the Week 52, there was a detectable level of 5-FU present in the 5-FU carousel bin. Conclusions Contamination of the surrogate markers suggests that external packaging for hazardous drugs is contaminated, either during the manufacturing process or during routine chain of custody activities. These results demonstrate that occupational exposure may occur due to contamination from shipping totes and storage bins, and that handling practices including use of personal protective equipment is warranted.

Death by 'ice': fatal methamphetamine intoxication of a body packer case detected by postmortem computed tomography (PMCT) and validated by autopsy.

PubMed

Bin Abdul Rashid, Saiful Nizam; Rahim, Amir Saad Abdul; Thali, Michael J; Flach, Patricia M

2013-03-01

Fatal acute methamphetamine (MA) poisoning in cases of internal drug trafficking is rarely described in the literature. This case study reports an MA 'body packer' who died from fatal methamphetamine intoxication due to leaking drug packages in the alimentary tract. The deceased was examined by postmortem computed tomography (PMCT), and the results were correlated to subsequent autopsy and toxicological findings. The deceased was arrested by the police when he was found disoriented in the city of Kuala Lumpur. He was transferred to the emergency department on suspicion of drug abuse. The initial drug screening was reactive for amphetamines. Shortly after admission to the hospital, he died despite rigorous resuscitation attempts. The postmortem plain chest and abdominal radiographs revealed multiple suspicious opacities in the gastrointestinal tract attributable to body packages. An unenhanced whole body PMCT revealed twenty-five drug packages, twenty-four in the stomach and one in the transverse colon. At least two were disintegrating, and therefore leaking. The autopsy findings were consistent with the PMCT results. Toxicology confirmed the diagnosis of fatal methamphetamine intoxication.

Effect assessment of “film coating and packaging” on the photo-stability of highly photo-labile antihypertensive products

PubMed Central

Mukharya, Amit; Patel, Paresh U; Chaudhary, Shivang

2013-01-01

Introduction: Lacidipine (LCDP) is chemically a “1, 4-dihydropyridine derivative” Ca+2 channel blocker used as an antihypertensive. Type and extent of packaging have a strong influence on the photo-stability of the 1,4-dihydropyridine derivatives. In standard, light protection of drug substance/drug product can be obtained either by use of an opaque additive in the formulation that competitively absorbs or reflects light reaching the sample and/or by blocking the access of light to the drug through external protection by packaging. Materials and Methods: External protection by covering tablets with an opaque film coating involving a light-reflecting inorganic pigment such as titanium dioxide and/or by using an opaque impermeable packaging material was an appropriate suitable option for establishing photo-stability. Thus, the main objective of the present study was to optimize the % level of film coating in LCDP core tablets, and selection of a final packaging material and its respective extent, that is, primary, secondary and/or tertiary packaging, for LCDP tablets. Results and Conclusion: The main objective (% level of film coating) was optimized by directly exposing core tablets, 1% w/w, 2% w/w and 3% w/w film-coated tablets, to a light source as per Option-2 of ICH Q1B and its comparative analysis at the end of light exposure testing. The other objective (extent of drug product packaging) was established successfully by assessing whether or not an acceptable change has occurred at the end of the light exposure testing of the LCDP film-coated tablets in a direct exposure study or a primary immediate pack and/or secondary marketing pack. PMID:24015379

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during finishing...

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during finishing...

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during finishing...

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during finishing...

Packaging of pharmaceuticals: still too many dangers but several encouraging initiatives.

PubMed

2007-06-01

(1) In 2006 in France, several drugs sold in poorly designed packaging exposed patients to a risk of serious adverse effects. (2) In 2006, Prescrire used a standardised methodology to examine the packaging of all new pharmaceutical products (656 different boxes) assessed in the New Products section of our French edition, la revue Prescrire. About 75% of these boxes contained tablets or capsules, mostly in blister packs. (3) Poor labelling remains a major problem. The international nonproprietary names (INN) is hard to spot on most boxes of patented brand-name drugs and is often overshadowed by the brand name. The primary packaging of many products does not even include the INN. (4) Two particularly ambiguous types of labelling are becoming more common on blister packs: pre-cut multiple-unit blister packs on which the labelling is truncated when a unit blister is removed; and blister packs on which the labelling spans two blisters, creating a risk of overdose. (5) The use of colours is frequently inappropriate. In particular, irrelevant information is often highlighted unnecessarily, while other, important information is barely visible. (6) Too many devices for oral administration create a risk of misuse. Very few are graduated in units of weight. Most are graduated in millilitres, obliging caregivers to use conversion charts and thus creating a risk of dosing errors. Devices graduated in kg bodyweight can also lead to dosing errors. (7) The labelling of some injectable drugs is barely legible. The various models of plastic ampoules, that are gradually replacing glass ampoules, can represent a danger because they resemble other plastic ampoules containing products administered by different routes. Packaging that does not provide a syringe or needle can cause problems for caregivers and represents another potential source of error. (8) Many of the patient information leaflets examined in 2006 had the same flaws as previously observed, i.e. uneven information quality, discrepancies between different sections, and out-of-date information. More and more French leaflets now include insets offering "Health Advice". There are better and worse examples, but there is no guarantee that they have been properly reviewed by the regulatory agency. (9) Increasingly drug boxes include pictograms, even though several studies have shown they are often difficult to interpret. And most boxes of generics also now include standard dosing schedules that are not always appropriate and may create a risk of dosing errors with potentially serious consequences. (10) 67 multidose bottles examined in 2006 had no childproof safety cap. Some contained psychotropics, which can have life-threatening effects if accidentally consumed in large amounts. (11) Some manufacturers have adopted realistic solutions to these problems. In particular, generics manufacturers again improved product labelling in 2006 (emphasis on the INN), appropriate use of colours for dose differentiation, and, encouragingly, far more Braille labels. (12) In 2006, the French regulatory agency introduced several measures aimed at improving the labelling of ampoules containing some injectable drugs. The impact of these measures was visible on several products marketed in 2006, including plastic vials of solutions for nebulization. (13) Several other examples of well-designed packaging were seen: safety devices on prefilled syringes; a childproof safety device; a tamperproof ring; unit-dose blister packs; clearly written patient leaflets; and the use of clear and appropriate symbols and pictograms. (14) In practice, in view of the large number of incidents recorded in 2006, and the plethora of packaging designs, caregivers should take time to analyse and discuss drug packaging. In this way, they will be in a position to distinguish between good and bad drug packaging, and to anticipate the risks associated with poorly designed packaging. (15) There are many ways in which drug regulatory authorities can help to ensure that drugs are sold in safe packaging. The French regulatory agency's work on the labelling of injectable drugs is an encouraging step. European Directive 2004/27/EC on medicines for human use provides for improvements in labelling (e.g. Braille) and patient information leaflets. Transposition of these measures into French law should lead to a number of improvements, provided the relevant regulations and guidelines place patients' interests first.

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 210.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... holding of a drug product includes packaging and labeling operations, testing, and quality control of drug... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Definitions. 210.3 Section 210.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...

21 CFR 210.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... holding of a drug product includes packaging and labeling operations, testing, and quality control of drug... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Definitions. 210.3 Section 210.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...

21 CFR 210.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... holding of a drug product includes packaging and labeling operations, testing, and quality control of drug... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Definitions. 210.3 Section 210.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...

21 CFR 210.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... holding of a drug product includes packaging and labeling operations, testing, and quality control of drug... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Definitions. 210.3 Section 210.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...

21 CFR 179.45 - Packaging materials for use during the irradiation of prepackaged foods.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Packaging materials for use during the irradiation... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) IRRADIATION IN THE... materials for use during the irradiation of prepackaged foods. The packaging materials identified in this...

21 CFR 179.45 - Packaging materials for use during the irradiation of prepackaged foods.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Packaging materials for use during the irradiation... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) IRRADIATION IN THE... materials for use during the irradiation of prepackaged foods. The packaging materials identified in this...

21 CFR 179.45 - Packaging materials for use during the irradiation of prepackaged foods.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Packaging materials for use during the irradiation... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) IRRADIATION IN THE... materials for use during the irradiation of prepackaged foods. The packaging materials identified in this...

21 CFR 179.45 - Packaging materials for use during the irradiation of prepackaged foods.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Packaging materials for use during the irradiation... OF HEALTH AND HUMAN SERVICES (CONTINUED) IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF... irradiation of prepackaged foods. The packaging materials identified in this section may be safely subjected...

21 CFR 179.45 - Packaging materials for use during the irradiation of prepackaged foods.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Packaging materials for use during the irradiation... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) IRRADIATION IN THE... materials for use during the irradiation of prepackaged foods. The packaging materials identified in this...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

16 CFR 1702.3 - Substantive requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1702.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES... (IND) or a New Drug Application (NDA). ...

Profiling of metal ions leached from pharmaceutical packaging materials.

PubMed

Fliszar, Kyle A; Walker, David; Allain, Leonardo

2006-01-01

Metal leachables from packaging components can affect the safety and efficacy of a pharmaceutical formulation. As liquid formulations continue to contain surfactants, salts, and chelating agents coupled with lower drug levels, the interaction between the formulation and the packaging material becomes more important. This study examines the interaction of commonly used packaging materials with extraction solvents representative of liquid formulations found in the pharmaceutical industry stressed under conditions encountered during accelerated stability studies.

75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

...] Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical... industry entitled ``Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for... the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.'' In the...

21 CFR 182.70 - Substances migrating from cotton and cotton fabrics used in dry food packaging.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Substances migrating from cotton and cotton... Provisions § 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging. Substances migrating to food from cotton and cotton fabrics used in dry food packaging that are generally...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in... affect the required declarations of identity under definitions and standards for foods promulgated...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in... affect the required declarations of identity under definitions and standards for foods promulgated...

The role of radiology in diagnosis and management of drug mules: an update with new challenges and new diagnostic tools

PubMed Central

Cengel, Ferhat

2016-01-01

Emergency physicians and radiologists have been increasingly encountering internal concealment of illegal drugs. The packages commonly contain powdered solid drugs such as cocaine, heroin, methamphetamine and hashish, but they may also contain cocaine in the liquid form. The second type of package has recently been more commonly encountered, and poses a greater diagnostic challenge. As clinical evaluation and laboratory tests frequently fail to make the correct diagnosis, imaging examination is typically required. Imaging methods assume a vital role in the diagnosis, follow-up and management. Abdominal X-ray, ultrasonography, CT and MRI are used for the imaging purposes. Among the aforementioned methods, low-dose CT is state-of-the-art in these cases. It is of paramount importance that radiologists have a full knowledge of the imaging characteristics of these packages and accurately guide physicians and security officials. PMID:26867003

76 FR 81363 - Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... Foods Packaged in Hermetically Sealed Containers; Correction AGENCY: Food and Drug Administration, HHS... containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass...

78 FR 72838 - Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-04

... represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include...

Use of Activated Carbon in Packaging to Attenuate Formaldehyde-Induced and Formic Acid-Induced Degradation and Reduce Gelatin Cross-Linking in Solid Dosage Forms.

PubMed

Colgan, Stephen T; Zelesky, Todd C; Chen, Raymond; Likar, Michael D; MacDonald, Bruce C; Hawkins, Joel M; Carroll, Sophia C; Johnson, Gail M; Space, J Sean; Jensen, James F; DeMatteo, Vincent A

2016-07-01

Formaldehyde and formic acid are reactive impurities found in commonly used excipients and can be responsible for limiting drug product shelf-life. Described here is the use of activated carbon in drug product packaging to attenuate formaldehyde-induced and formic acid-induced drug degradation in tablets and cross-linking in hard gelatin capsules. Several pharmaceutical products with known or potential vulnerabilities to formaldehyde-induced or formic acid-induced degradation or gelatin cross-linking were subjected to accelerated stability challenges in the presence and absence of activated carbon. The effects of time and storage conditions were determined. For all of the products studied, activated carbon attenuated drug degradation or gelatin cross-linking. This novel use of activated carbon in pharmaceutical packaging may be useful for enhancing the chemical stability of drug products or the dissolution stability of gelatin-containing dosage forms and may allow for the 1) extension of a drug product's shelf-life when the limiting attribute is a degradation product induced by a reactive impurity, 2) marketing of a drug product in hotter and more humid climatic zones than currently supported without the use of activated carbon, and 3) enhanced dissolution stability of products that are vulnerable to gelatin cross-linking. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 509.7 - Unavoidability.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Unavoidability. 509.7 Section 509.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General...

21 CFR 509.7 - Unavoidability.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Unavoidability. 509.7 Section 509.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General...

21 CFR 509.7 - Unavoidability.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Unavoidability. 509.7 Section 509.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General...

21 CFR 509.7 - Unavoidability.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Unavoidability. 509.7 Section 509.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General...

A strategy for the prevention of protein oxidation by drug product in polymer-based syringes.

PubMed

Nakamura, Koji; Abe, Yoshihiko; Kiminami, Hideaki; Yamashita, Arisa; Iwasaki, Kazuhiro; Suzuki, Shigeru; Yoshino, Keisuke; Dierick, William; Constable, Kevin

2015-01-01

Recently, new and advanced ideas have been presented on the value of polymer-based syringes for improved safety, better strength, reduced aggregation, and the prevention of drug degradation. In this report, our findings on drug degradation from protein oxidation will be presented and discussed. Commonly, dissolved oxygen is one of the factors for causing protein degradation. Due to the nature of higher gas permeability in polymer-based syringes, it was thought to be difficult to control the oxygen level during storage. However, this report demonstrates the appropriateness of combining the use of an oxygen absorber within the secondary packaging as a deoxygenated packaging system. In addition, this report suggests that another factor to enhance protein oxidization is related to radicals on the syringe barrel from sterilization by irradiation. We demonstrate that steam sterilization can minimize protein oxidization, as the protein filled in steam sterilized syringe is much more stable. In conclusion, the main oxidation pathway of a protein has been identified as dissolved oxygen and radical generation within a polymer container. Possible solutions are herewith presented for controlling oxidation by means of applying a deoxygenated packaging system as well as utilizing steam sterilization as a method of sterilization for prefillable polymer syringes. There have been many presentations and discussions about the risks associated with glass prefilled syringes. Advanced ideas are being presented on the value of polymer-based syringes for improved safety, better strength, reduced protein aggregation, and the prevention of drug degradation. Drug degradation based on protein oxidation is discussed in this report. Identification of the main factors causing this degradation and possible solutions available by using polymer-based syringes will be presented. The causes of protein oxidation have been identified as dissolved oxygen and radicals generated by the applied method of sterilization. The oxidation reaction created by dissolved oxygen within the drug product can be effectively inhibited by controlling the removal of the oxygen through the use of a deoxygenated packaging system. This packaging system can control the level or complete removal of oxygen from the primary container and the secondary packaging system. Protein oxidation induced by the formation of radicals from sterilization by irradiation is another critical aspect where it was thought that various sterilization methods were acceptable without loosing drug product quality. However, this report is first to demonstrate that gamma sterilized polymer-based syringes accelerated protein oxidation by radical generation; this effect can be prevented by means of steam sterilization. © PDA, Inc. 2015.

Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products.

PubMed

Jenke, Dennis; Castner, James; Egert, Thomas; Feinberg, Tom; Hendricker, Alan; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Shaw, Arthur; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank

2013-01-01

Polymeric and elastomeric materials are commonly encountered in medical devices and packaging systems used to manufacture, store, deliver, and/or administer drug products. Characterizing extractables from such materials is a necessary step in establishing their suitability for use in these applications. In this study, five individual materials representative of polymers and elastomers commonly used in packaging systems and devices were extracted under conditions and with solvents that are relevant to parenteral and ophthalmic drug products (PODPs). Extraction methods included elevated temperature sealed vessel extraction, sonication, refluxing, and Soxhlet extraction. Extraction solvents included a low-pH (pH = 2.5) salt mixture, a high-pH (pH = 9.5) phosphate buffer, a 1/1 isopropanol/water mixture, isopropanol, and hexane. The resulting extracts were chemically characterized via spectroscopic and chromatographic means to establish the metal/trace element and organic extractables profiles. Additionally, the test articles themselves were tested for volatile organic substances. The results of this testing established the extractables profiles of the test articles, which are reported herein. Trends in the extractables, and their estimated concentrations, as a function of the extraction and testing methodologies are considered in the context of the use of the test article in medical applications and with respect to establishing best demonstrated practices for extractables profiling of materials used in PODP-related packaging systems and devices. Plastic and rubber materials are commonly encountered in medical devices and packaging/delivery systems for drug products. Characterizing the extractables from these materials is an important part of determining that they are suitable for use. In this study, five materials representative of plastics and rubbers used in packaging and medical devices were extracted by several means, and the extracts were analytically characterized to establish each material's profile of extracted organic compounds and trace element/metals. This information was utilized to make generalizations about the appropriateness of the test methods and the appropriate use of the test materials.

21 CFR 509.3 - Definitions and interpretations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Definitions and interpretations. 509.3 Section 509.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING...

21 CFR 509.3 - Definitions and interpretations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Definitions and interpretations. 509.3 Section 509.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING...

21 CFR 509.3 - Definitions and interpretations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Definitions and interpretations. 509.3 Section 509.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING...

21 CFR 509.3 - Definitions and interpretations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Definitions and interpretations. 509.3 Section 509.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING...

An explanation for the physical instability of a marketed fixed dose combination (FDC) formulation containing isoniazid and ethambutol and proposed solutions.

PubMed

Bhutani, Hemant; Mariappan, T T; Singh, Saranjit

2004-07-01

An investigation was carried out to explore the possible reason for the physical instability of a marketed strip packaged anti-TB fixed dose combination (FDC) tablet containing 300 mg of isoniazid (H) and 800 mg of ethambutol hydrochloride (E). The instability was in the form of distribution of white powder inside the strip pockets. High-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS-MS) studies confirmed that both H and E were present in the powder. The same was also confirmed through Fourier-transform infrared (FTIR) spectroscopy, which also indicated absence of interaction between the two drugs. No sublimation of the drugs was observed up to 110 degrees C, indicating that the observed instability was not due to this reason. Subsequently, attention was paid to the possibility of moisture gain by the tablets through defective packaging (which was established) due to hygroscopicity of E. To understand the phenomenon further, pure drugs and their mixtures were stored under accelerated conditions of temperature and humidity [40 degrees C/75% relative humidity (RH)] and both increase in weight and physical changes were recorded periodically. The mixtures gained moisture at a higher rate than pure E and those with higher content of E became liquid, which on withdrawal from the chambers, became crystallized. The drug mixture containing H:E at a ratio of 30:70 w/w, which was similar to the ratio of the drugs in the tablets (27:73 w/w), crystallized fastest, indicating formation of a rapid crystallizing saturated system at this ratio of the drugs. It is postulated that the problem of instability arises because of the formation of a saturated layer of drugs upon moisture gain through the defective packaging material and drying of this layer with time. The study suggests that barrier packaging free from defects and alternatively (or in combination) film coating of the tablets with water-resistant polymers are essential for this formulation.

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and...

45 CFR 156.122 - Prescription drug benefits.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Prescription drug benefits. 156.122 Section 156... Essential Health Benefits Package § 156.122 Prescription drug benefits. (a) A health plan does not provide... at least the greater of: (i) One drug in every United States Pharmacopeia (USP) category and class...

45 CFR 156.122 - Prescription drug benefits.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Prescription drug benefits. 156.122 Section 156... Essential Health Benefits Package § 156.122 Prescription drug benefits. (a) A health plan does not provide... at least the greater of: (i) One drug in every United States Pharmacopeia (USP) category and class...

21 CFR 201.310 - Phenindione; labeling of drug preparations intended for use by man.

Code of Federal Regulations, 2014 CFR

2014-04-01

... in the medical literature and data accumulated by the Food and Drug Administration indicate that... label and labeling on or within the package from which the drug is to be dispensed, and any other...

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

PubMed

2012-03-20

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

Sensitivity and specificity of CT scanning for determining the number of internally concealed packages in 'body-packers'.

PubMed

Asha, Stephen Edward; Higham, Matthew; Child, Peter

2015-05-01

If package counts on abdominal CTs of body-packers were known to be accurate, follow-up CTs could be avoided. The objective was to determine the accuracy of CT for the number of concealed packages in body-packers, and the reliability of package counts reported by body-packers who admit to concealing drugs. Suspected body-packers were identified from the emergency departments (ED) database. The medical record and radiology reports were reviewed for package counts determined by CT, patient-reported and physically retrieved. The last method was used as the reference standard. Sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) were calculated for CT package count accuracy. Reliability of patient-reported package counts was assessed using Pearson's correlation coefficient. There were 50 confirmed body-packers on whom 104 CT scans were performed. Data for the index and reference tests were available for 84 scans. The sensitivity, specificity, PPV and NPV for CT package count were 63% (95% CI 46% to 77%), 82% (95% CI 67% to 92%), 76% (95% CI 58% to 89%) and 71% (95% CI 56% to 83%) respectively. For CTs with a package count<15, the sensitivity, specificity, PPV and NPV for CT package count were 96% (95% CI 80% to 99%), 95% (95% CI 82% to 99%), 93% (95% CI 76% to 99%) and 97% (95% CI 86% to 100%), respectively. Correlation between patient-reported package counts and the number of packages retrieved was high (r=0.90, p<0.001, R2=81%). The accuracy of CT for determining the number of concealed packages is poor, although when applied to patients with few concealed packages accuracy is high and is useful as a rule-out test. Among patients who have admitted to drug concealment, the number of packages reported to be concealed is reliable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

PubMed

Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

2017-08-23

The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

Party package travel: alcohol use and related problems in a holiday resort: a mixed methods study.

PubMed

Hesse, Morten; Tutenges, Sébastien; Schliewe, Sanna; Reinholdt, Tine

2008-10-07

People travelling abroad tend to increase their use of alcohol and other drugs. In the present study we describe organized party activities in connection with young tourists' drinking, and the differences between young people travelling with and without organized party activities. We conducted ethnographic observations and a cross-sectional survey in Sunny Beach, Bulgaria. The behaviour of the guides from two travel agencies strongly promoted heavy drinking, but discouraged illicit drug use. Even after controlling for several potential confounders, young people who travelled with such "party package travel agencies" were more likely to drink 12 or more units when going out. In univariate analyses, they were also more likely to get into fights, but were not more likely to seek medical assistance or medical assistance for an accident or an alcohol-related problem. After controlling for confounders, the association between type of travel agency and getting into fights was no longer significant. Short-term consequences of drinking in the holiday resort did not differ between party package travellers and ordinary package travellers. There may be a small impact of party package travels on young people's drinking. Strategies could be developed used to minimise the harm associated with both party package travel and other kinds of travel where heavy substance use is likely to occur.

Is the test of senior friendly/child resistant packaging ethical?

PubMed

Bix, Laura; de la Fuente, Javier; Pimple, Kenneth D; Kou, Eric

2009-12-01

Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the 'senior friendliness' of CR designs that are used throughout the world disallow people with 'overt or obvious' disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision.

21 CFR 201.51 - Declaration of net quantity of contents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

21 CFR 201.51 - Declaration of net quantity of contents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

21 CFR 201.51 - Declaration of net quantity of contents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

21 CFR 201.51 - Declaration of net quantity of contents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

21 CFR 201.51 - Declaration of net quantity of contents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

21 CFR 201.122 - Drugs for processing, repacking, or manufacturing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs for processing, repacking, or manufacturing... for processing, repacking, or manufacturing. A drug in a bulk package, except tablets, capsules, or... manufacturing, processing, or repacking”; and if in substantially all dosage forms in which it may be dispensed...

Combining Internet monitoring processes, packaging and isotopic analyses to determine the market structure: example of Gamma Butyrolactone.

PubMed

Pazos, Diego; Giannasi, Pauline; Rossy, Quentin; Esseiva, Pierre

2013-07-10

The Internet is becoming more and more popular among drug users. The use of websites and forums to obtain illicit drugs and relevant information about the means of consumption is a growing phenomenon mainly for new synthetic drugs. Gamma Butyrolactone (GBL), a chemical precursor of Gamma Hydroxy Butyric acid (GHB), is used as a "club drug" and also in drug facilitated sexual assaults. Its market takes place mainly on the Internet through online websites but the structure of the market remains unknown. This research aims to combine digital, physical and chemical information to help understand the distribution routes and the structure of the GBL market. Based on an Internet monitoring process, thirty-nine websites selling GBL, mainly in the Netherlands, were detected between January 2010 and December 2011. Seventeen websites were categorized into six groups based on digital traces (e.g. IP addresses and contact information). In parallel, twenty-five bulk GBL specimens were purchased from sixteen websites for packaging comparisons and carbon isotopic measurements. Packaging information showed a high correlation with digital data confirming the links previously established whereas chemical information revealed undetected links and provided complementary information. Indeed, while digital and packaging data give relevant information about the retailers, the supply routes and the distribution close to the consumer, the carbon isotopic data provides upstream information about the production level and in particular the synthesis pathways and the chemical precursors. A three-level structured market has been thereby identified with a production level mainly located in China and in Germany, an online distribution level mainly hosted in the Netherlands and the customers who order on the Internet. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Primary packaging considerations in developing medicines for children: oral liquid and powder for constitution.

PubMed

Campbell, Gossett A; Vallejo, Erick

2015-01-01

The packaging presentation of oral liquid pediatric medicines is a critical step in maintaining chemical and physical stability, compliance, adherence, and proper handling by the target patient population, guardians, caregivers, and health-care professionals. The common packaging presentations for commercial oral liquid pediatric drug products are glass bottle, plastic bottle, sachet, and stick pack configurations. The type of pack presentation selected is driven by the quality target product profile (QTPP) that is designed around the physicochemical properties of the drug substance and the desired drug product suitability for the target population. The QTPP defines the intended use of the drug product, drug product quality criteria, dose strength, dosage form, container closure system, storage conditions, stability criteria, dosing device, shelf life, and attributes affecting the pharmacokinetic characteristics. Oral liquid pediatric formulations are typically prepared from a powder that is constituted at the time of use as a suspension or a solution for single or multiple use depending on the stability of the constituted formulation. Active ingredients with high aqueous solubility can be developed as a powder for oral solution and presented in a bottle for multiple use product and a stick pack, packet, or sachet for single-use product. Active ingredients with low aqueous solubility can be developed as a powder for oral suspension and presented in a bottle for multiple use product and a stick pack or sachet for single-use product. A secondary package may be used in cases where the primary pack failed to provide adequate protection against light degradation. This work will help formulation scientists select the most appropriate pack presentation in the early stages of pediatric clinical development. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Deficiencies of product labeling directions for the preparation of radiopharmaceuticals.

PubMed

Hung, Joseph C; Ponto, James A; Gadient, Katie R; Frie, Julia A; Aksamit, Carolyn M; Enquist, Cassandra L; Carrels, Katie E

2004-01-01

To identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals. Preparation instructions, which include both reconstitution and quality control (QC) directions, as stated in the package inserts were evaluated for all commercially available reconstituted radiopharmaceuticals. Reviews of the package inserts were initially performed by each author, and then all identified deficiencies were compiled and evaluated by all authors. The preparation scenario for each package insert evaluated was based on a centralized nuclear pharmacy operation assuming typical support personnel, standard operating equipment, and workload. The instructions as stated in each package insert for the preparation (including QC) were rated as inadequate if a satisfactory preparation could not be prepared by a nuclear pharmacist or physician when instructions were followed exactly. Identified deficiencies in package insert instructions for the preparation of radiopharmaceuticals fell into the following five categories: (1) absent or incomplete directions (especially with regard to QC procedures); (2) restrictive directions (e.g., specific requirement to use designated needles, chromatography solvents, counting devices), (3) inconsistent directions (e.g., different reconstituted volumes for the same final drug product, unworkable expiration times); (4) impractical directions (e.g., unrealistically low reconstituted activity limits, dangerously high number of radiolabeled particles); and (5) vague directions (e.g., use of the words "should," "may," "recommend"). Manufacturers' directions for the preparation of radiopharmaceuticals often contain deficiencies and should be viewed as standard guidance rather than as requirements. Just as physicians are permitted to use U.S. Food and Drug Administration (FDA)-approved drugs for off-label indications, nuclear pharmacists should be allowed to use alternative methods for preparing radiopharmaceuticals, provided those methods have been validated to be as good as the stated directions and that the nuclear pharmacists do not engage in activities that fall outside the normal practice of pharmacy. Manufacturers, FDA, nuclear pharmacists, and nuclear physicians should work together to address identified deficiencies in package insert directions.

21 CFR 177.1420 - Isobutylene polymers.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following... polyisobutylene used in food-packaging adhesives complying with § 175.105 of this chapter. ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Isobutylene polymers. 177.1420 Section 177.1420...

21 CFR 120.6 - Sanitation standard operating procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... garments; (3) Prevention of cross contamination from insanitary objects to food, food packaging material... health conditions that could result in the microbiological contamination of food, food packaging... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Sanitation standard operating procedures. 120.6...

A new glass option for parenteral packaging.

PubMed

Schaut, Robert A; Peanasky, John S; DeMartino, Steven E; Schiefelbein, Susan L

2014-01-01

Glass is the ideal material for parenteral packaging because of its chemical durability, hermeticity, strength, cleanliness, and transparency. Alkali borosilicate glasses have been used successfully for a long time, but they do have some issues relating to breakage, delamination, and variation in hydrolytic performance. In this paper, alkali aluminosilicate glasses are introduced as a possible alternative to alkali borosilicate glasses. An example alkali aluminosilicate glass is shown to meet the compendial requirements, and to have similar thermal, optical, and mechanical attributes as the current alkali borosilicate glasses. In addition, the alkali aluminosilicate performed as well or better than the current alkali borosilicates in extractables tests and stability studies, which suggests that it would be suitable for use with the studied liquid product formulation. The physical, mechanical, and optical properties of glass make it an ideal material for packaging injectable drugs and biologics. Alkali borosilicate glasses have been used successfully for a long time for these applications, but there are some issues. In this paper, alkali aluminosilicate glasses are introduced as a possible alternative to alkali borosilicate glasses. An example alkali aluminosilicate glass is shown to meet the requirements for packaging injectable drugs and biologics, and to be suitable for use with a particular liquid drug. © PDA, Inc. 2014.

Drug Treatment Centers in Afghanistan: Creating a Participatory Approach to Tackling the Drug Trade

DTIC Science & Technology

2012-12-01

Anti-Government Forces AIDS: Acquired Immunodeficiency Syndrome ANP: Afghan National Police ART: Anti-Retroviral Treatment BPHS: Basic Package of...treatment centers do performance reviews, corruption within the drug treatment clinics, and how management monitor staff burnout . While clinical governance

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2011 CFR

2011-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

21 CFR 181.23 - Antimycotics.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Antimycotics. Substances classified as antimycotics, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Antimycotics. 181.23 Section 181.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.24 - Antioxidants.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Antioxidants. Substances classified as antioxidants, when migrating from food-packaging material (limit of... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Antioxidants. 181.24 Section 181.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.23 - Antimycotics.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Antimycotics. Substances classified as antimycotics, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Antimycotics. 181.23 Section 181.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.24 - Antioxidants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Antioxidants. Substances classified as antioxidants, when migrating from food-packaging material (limit of... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Antioxidants. 181.24 Section 181.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2010 CFR

2010-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

21 CFR 181.25 - Driers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Driers. Substances classified as driers, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Driers. 181.25 Section 181.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.25 - Driers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Driers. Substances classified as driers, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Driers. 181.25 Section 181.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 109.7 - Unavoidability.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Unavoidability. 109.7 Section 109.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General...

21 CFR 113.81 - Product preparation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Product preparation. 113.81 Section 113.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS...

21 CFR 181.24 - Antioxidants.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Antioxidants. Substances classified as antioxidants, when migrating from food-packaging material (limit of... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Antioxidants. 181.24 Section 181.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 109.7 - Unavoidability.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Unavoidability. 109.7 Section 109.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General...

21 CFR 181.23 - Antimycotics.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Antimycotics. Substances classified as antimycotics, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Antimycotics. 181.23 Section 181.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 109.7 - Unavoidability.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Unavoidability. 109.7 Section 109.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General...

21 CFR 181.25 - Driers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... migrating from food-packaging material shall include: Cobalt caprylate. Cobalt linoleate. Cobalt naphthenate... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Driers. 181.25 Section 181.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PRIOR-SANCTIONED FOOD...

21 CFR 109.7 - Unavoidability.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Unavoidability. 109.7 Section 109.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General...

21 CFR 181.23 - Antimycotics.

Code of Federal Regulations, 2014 CFR

2014-04-01

... antimycotics, when migrating from food-packaging material shall include: Calcium propionate. Methylparaben... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Antimycotics. 181.23 Section 181.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PRIOR-SANCTIONED FOOD...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2012 CFR

2012-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

21 CFR 181.23 - Antimycotics.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Antimycotics. Substances classified as antimycotics, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Antimycotics. 181.23 Section 181.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.25 - Driers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Driers. Substances classified as driers, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Driers. 181.25 Section 181.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.25 - Driers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Driers. Substances classified as driers, when migrating from food-packaging material shall include... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Driers. 181.25 Section 181.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.24 - Antioxidants.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Antioxidants. Substances classified as antioxidants, when migrating from food-packaging material (limit of... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Antioxidants. 181.24 Section 181.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2013 CFR

2013-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

21 CFR 864.7490 - Sulfhemoglobin assay.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490 Sulfhemoglobin...

21 CFR 864.7490 - Sulfhemoglobin assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490 Sulfhemoglobin...

21 CFR 864.7425 - Carboxyhemoglobin assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Carboxyhemoglobin assay. 864.7425 Section 864.7425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7425 Carboxyhemoglobin...

21 CFR 864.7490 - Sulfhemoglobin assay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490 Sulfhemoglobin...

21 CFR 864.7425 - Carboxyhemoglobin assay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Carboxyhemoglobin assay. 864.7425 Section 864.7425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7425 Carboxyhemoglobin...

21 CFR 864.7490 - Sulfhemoglobin assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490 Sulfhemoglobin...

21 CFR 864.7425 - Carboxyhemoglobin assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Carboxyhemoglobin assay. 864.7425 Section 864.7425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7425 Carboxyhemoglobin...

21 CFR 864.7490 - Sulfhemoglobin assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490 Sulfhemoglobin...

21 CFR 864.7425 - Carboxyhemoglobin assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carboxyhemoglobin assay. 864.7425 Section 864.7425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7425 Carboxyhemoglobin...

Low molecular weight components of polymers used in packaging.

PubMed Central

Gilbert, S G

1975-01-01

The increasing use of polymers in packaging of foods and drugs focuses attention on the possible chronic toxicity relations of migrants from these polymers to the contents. Such migrants can arise from residues and additives in the polymers from manufacturing processes used in fabrication of packages. The origin and chemical nature of potential migrants, the methods of transfer, and principles involved in development of safety criteria for their regulation are discussed. PMID:1236793

21 CFR 110.37 - Sanitary facilities and controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food-packaging materials, or for employee sanitary facilities. (b) Plumbing. Plumbing shall be of... understandable signs directing employees handling unproteced food, unprotected food-packaging materials, of food... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Sanitary facilities and controls. 110.37 Section...

21 CFR 1141.12 - Incorporation by reference of required warnings.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Incorporation by reference of required warnings... SERVICES (CONTINUED) TOBACCO PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS Cigarette Package and Advertising Warnings § 1141.12 Incorporation by reference of required warnings. “Cigarette Required Warnings...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2013 CFR

2013-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2014 CFR

2014-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2012 CFR

2012-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 1302.02 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Definitions. 1302.02 Section 1302.02 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.02 Definitions. Any term contained in this part shall have the definition set...

21 CFR 1302.03 - Symbol required; exceptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Symbol required; exceptions. 1302.03 Section 1302.03 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.03 Symbol required; exceptions. (a) Each commercial container of...

21 CFR 109.3 - Definitions and interpretations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Definitions and interpretations. 109.3 Section 109.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING...

21 CFR 1302.03 - Symbol required; exceptions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Symbol required; exceptions. 1302.03 Section 1302.03 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.03 Symbol required; exceptions. (a) Each commercial container of...

21 CFR 1302.02 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Definitions. 1302.02 Section 1302.02 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.02 Definitions. Any term contained in this part shall have the definition set...

21 CFR 1302.02 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Definitions. 1302.02 Section 1302.02 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.02 Definitions. Any term contained in this part shall have the definition set...

21 CFR 109.3 - Definitions and interpretations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Definitions and interpretations. 109.3 Section 109.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING...

21 CFR 1302.02 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Definitions. 1302.02 Section 1302.02 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.02 Definitions. Any term contained in this part shall have the definition set...

21 CFR 181.28 - Release agents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... classified as release agents, when migrating from food-packaging material shall include: Dimethylpolysiloxane... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Release agents. 181.28 Section 181.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PRIOR-SANCTIONED...

21 CFR 1302.03 - Symbol required; exceptions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Symbol required; exceptions. 1302.03 Section 1302.03 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.03 Symbol required; exceptions. (a) Each commercial container of...

21 CFR 186.1673 - Pulp.

Code of Federal Regulations, 2014 CFR

2014-04-01

... food packaging containers. (c) The ingredient is used in paper and paperboard made by conventional... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Pulp. 186.1673 Section 186.1673 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) INDIRECT FOOD...

21 CFR 1302.03 - Symbol required; exceptions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Symbol required; exceptions. 1302.03 Section 1302.03 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.03 Symbol required; exceptions. (a) Each commercial container of...

21 CFR 109.3 - Definitions and interpretations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Definitions and interpretations. 109.3 Section 109.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING...

21 CFR 820.120 - Device labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device labeling. 820.120 Section 820.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.120 Device labeling. Each manufacturer...

21 CFR 109.3 - Definitions and interpretations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Definitions and interpretations. 109.3 Section 109.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING...

21 CFR 864.7720 - Prothrombin consumption test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720 Prothrombin...

21 CFR 864.7415 - Abnormal hemoglobin assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864.7415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7415 Abnormal...

21 CFR 864.7375 - Glutathione reductase assay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375 Glutathione...

21 CFR 864.7720 - Prothrombin consumption test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720 Prothrombin...

21 CFR 864.7900 - Thromboplastin generation test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7900...

21 CFR 864.7900 - Thromboplastin generation test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7900...

21 CFR 864.7720 - Prothrombin consumption test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720 Prothrombin...

21 CFR 864.7375 - Glutathione reductase assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375 Glutathione...

21 CFR 864.7720 - Prothrombin consumption test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720 Prothrombin...

21 CFR 864.7720 - Prothrombin consumption test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720 Prothrombin...

21 CFR 864.7375 - Glutathione reductase assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375 Glutathione...

21 CFR 864.7415 - Abnormal hemoglobin assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864.7415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7415 Abnormal...

21 CFR 864.7900 - Thromboplastin generation test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7900...

21 CFR 864.7900 - Thromboplastin generation test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7900...

21 CFR 864.7900 - Thromboplastin generation test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7900...

21 CFR 864.7375 - Glutathione reductase assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375 Glutathione...

21 CFR 864.7375 - Glutathione reductase assay.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375 Glutathione...

21 CFR 864.7415 - Abnormal hemoglobin assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864.7415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7415 Abnormal...

16 CFR § 1702.16 - Petitions requesting an exemption for a drug or a new drug.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Petitions requesting an exemption for a drug or a new drug. § 1702.16 Section § 1702.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION...

[Good morning, Mr. Representative. Anything new to tell us about? Analysis of the pharmacological products introduced by the drugs industry into a health district].

PubMed

Baena Díez, J M; López Mompó, C; López Gosp, D; Martínez Martínez, J L; Ellacuría Torres, A; Fuentes Rodríguez, S

2003-12-01

To study whether the visits of technical health representatives (ITS) mean that new drugs are introduced. Design. Prospective, descriptive study. Urban health centre. The products presented by 137 ITS from 83 drug laboratories in weekly sessions for a year were studied. The products presented, the year they were first marketed, intrinsic value (IV), newness and use potential, cost per package and defined daily dose and material handed over were studied. 472 drug products were introduced. The most common ones belonged to the cardiovascular group (27.3%), digestion and metabolism (14.8%) and anti-infection drugs (13.3%). 65.5% had been on the market for <5 years. 84.3% had a high IV. Only 31 products (6.6%) were new (95% CI, 4.5-9.2). 71% of these supposed no or very slight therapeutic improvement, 25.8% a modest improvement and 3.2% a major improvement. Mean cost was 19.3 euros per package and 2 euros per DDD, with significant differences found (P<.006) on stratifying by date of marketing (more recently marketed products cost more). 61% of the products were presented with additional material (leaflets, monographs, journals), 21.6% with gifts of symbolic value, and 19.9% with samples of the product. There were significant differences (P<.03) between the new drugs and the normal prescriptions issued at the centre. In the new drugs, there were fewer products with high IV and cost per package and per DDD was higher. The products introduced by the reps do not include any important new drugs. They are presented with abundant back-up and are more expensive than those normally prescribed.

Mental models in risk assessment: informing people about drugs.

PubMed

Jungermann, H; Schütz, H; Thüring, M

1988-03-01

One way to communicate about the risks of drugs is through the use of package inserts. The problems associated with this medium of informing patients have been investigated by several researchers who found that people require information about drugs they are using, including extensive risk information, and that they are willing to take this information into account in their usage of drugs. But empirical results also show that people easily misinterpret the information given. A conceptual framework is proposed that might be used for better understanding the cognitive processes involved in such a type of risk assessment and communication. It is based on the idea that people develop, through experience, a mental model of how a drug works, which effects it might produce, that contraindications have to be considered, etc. This mental model is "run" when a specific package insert has been read and a specific question arises such as, for example, whether certain symptoms can be explained as normal or whether they require special attention and action. We argue that the mental model approach offers a useful perspective for examining how people understand package inserts, and consequently for improving their content and design. The approach promises to be equally useful for other aspects of risk analysis that are dependent upon human judgment and decision making, e.g., threat diagnosis and human reliability analysis.

Is the test of senior friendly/child resistant packaging ethical?

PubMed Central

Bix, Laura; De La Fuente, Javier; Pimple, Kenneth D.; Kou, Eric

2009-01-01

Abstract Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the ‘senior friendliness’ of CR designs that are used throughout the world disallow people with ‘overt or obvious’ disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision. PMID:19650857

78 FR 72841 - List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-04

... manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No... Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to rejected dietary...

21 CFR 1141.14 - Misbranding of cigarettes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Misbranding of cigarettes. 1141.14 Section 1141.14...) TOBACCO PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS; (Eff. 9-22-12) Cigarette Package and Advertising Warnings § 1141.14 Misbranding of cigarettes. (a) A cigarette shall be deemed to be misbranded...

21 CFR 1141.14 - Misbranding of cigarettes.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Misbranding of cigarettes. 1141.14 Section 1141.14...) TOBACCO PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS Cigarette Package and Advertising Warnings § 1141.14 Misbranding of cigarettes. (a) A cigarette shall be deemed to be misbranded under section 903(a...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to rejected dietary...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2014 CFR

2014-04-01

..., packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) The... synthetic paraffin used in food-packaging adhesives complying with § 175.105. [42 FR 14534, Mar. 15, 1977... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food...

21 CFR 1141.14 - Misbranding of cigarettes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Misbranding of cigarettes. 1141.14 Section 1141.14...) TOBACCO PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS Cigarette Package and Advertising Warnings § 1141.14 Misbranding of cigarettes. (a) A cigarette shall be deemed to be misbranded under section 903(a...

21 CFR 1141.10 - Required warnings.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Required warnings. 1141.10 Section 1141.10 Food... PRODUCTS CIGARETTE PACKAGE AND ADVERTISING WARNINGS; (Eff. 9-22-12) Cigarette Package and Advertising Warnings § 1141.10 Required warnings. (a) Packages—(1) It shall be unlawful for any person to manufacture...

21 CFR 113.87 - Operations in the thermal processing room.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Section 113.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED... Food and Drug Administration. (b) A system for product traffic control in the retort room shall be...

75 FR 45769 - Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Ambulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... 2010 OPPS/ASC final rule, we estimated that pass-through spending for both drugs and biologicals and... pass through drugs and non-implantable biologicals, and device categories and the proportion of... and implantable biologicals), ``policy packaged'' drugs (diagnostic radiopharmaceuticals and contrast...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 1140.10 - General responsibilities of manufacturers, distributors, and retailers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false General responsibilities of manufacturers, distributors, and retailers. 1140.10 Section 1140.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... ensuring that the cigarettes or smokeless tobacco it manufactures, labels, advertises, packages...

21 CFR 1140.10 - General responsibilities of manufacturers, distributors, and retailers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false General responsibilities of manufacturers, distributors, and retailers. 1140.10 Section 1140.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... ensuring that the cigarettes or smokeless tobacco it manufactures, labels, advertises, packages...

21 CFR 1140.10 - General responsibilities of manufacturers, distributors, and retailers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false General responsibilities of manufacturers, distributors, and retailers. 1140.10 Section 1140.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... ensuring that the cigarettes or smokeless tobacco it manufactures, labels, advertises, packages...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 1140.10 - General responsibilities of manufacturers, distributors, and retailers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false General responsibilities of manufacturers, distributors, and retailers. 1140.10 Section 1140.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... ensuring that the cigarettes or smokeless tobacco it manufactures, labels, advertises, packages...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 177.1310 - Ethylene-acrylic acid copolymers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... this section are not applicable to ethylene-acrylic acid copolymers used in food-packaging adhesives... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Ethylene-acrylic acid copolymers. 177.1310 Section 177.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 177.1600 - Polyethylene resins, carboxyl modified.

Code of Federal Regulations, 2010 CFR

2010-04-01

... resins used in food-packaging adhesives complying with § 175.105 of this chapter. ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Polyethylene resins, carboxyl modified. 177.1600 Section 177.1600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 181.1 - General.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning... 21 Food and Drugs 3 2011-04-01 2011-04-01 false General. 181.1 Section 181.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.1 - General.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning... 21 Food and Drugs 3 2010-04-01 2009-04-01 true General. 181.1 Section 181.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2010 CFR

2010-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1673 - Pulp.

Code of Federal Regulations, 2011 CFR

2011-04-01

... for use as a constituent of food packaging containers. (c) The ingredient is used in paper and... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Pulp. 186.1673 Section 186.1673 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.28 - Release agents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Release agents. Substances classified as release agents, when migrating from food-packaging material shall... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Release agents. 181.28 Section 181.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 177.1600 - Polyethylene resins, carboxyl modified.

Code of Federal Regulations, 2011 CFR

2011-04-01

... resins used in food-packaging adhesives complying with § 175.105 of this chapter. ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Polyethylene resins, carboxyl modified. 177.1600 Section 177.1600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2010 CFR

2010-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1551 - Hydrogenated fish oil.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used for dry food packaging. (d) The ingredient is used at levels not to exceed good manufacturing... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Hydrogenated fish oil. 186.1551 Section 186.1551 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD...

21 CFR 181.28 - Release agents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Release agents. 181.28 Section 181.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Release agents. Substances classified as release agents, when migrating from food-packaging material shall...

75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0605..., or Holding Operations for Dietary Supplements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

21 CFR 177.1400 - Hydroxyethyl cellulose film, water-insoluble.

Code of Federal Regulations, 2013 CFR

2013-04-01

... packaging food in accordance with the following prescribed conditions: (a) Water-insoluble hydroxyethyl... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Hydroxyethyl cellulose film, water-insoluble. 177.1400 Section 177.1400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1673 - Pulp.

Code of Federal Regulations, 2013 CFR

2013-04-01

... for use as a constituent of food packaging containers. (c) The ingredient is used in paper and... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Pulp. 186.1673 Section 186.1673 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 189.220 - Flectol H.

Code of Federal Regulations, 2014 CFR

2014-04-01

... component of food packaging adhesives. (b) Food containing any added or detectable level of this substance... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Flectol H. 189.220 Section 189.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBSTANCES PROHIBITED...

21 CFR 181.1 - General.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false General. 181.1 Section 181.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PRIOR-SANCTIONED FOOD INGREDIENTS General Provisions § 181.1 General. (a) An ingredient whose use in food or food packaging is...

21 CFR 177.1600 - Polyethylene resins, carboxyl modified.

Code of Federal Regulations, 2012 CFR

2012-04-01

... resins used in food-packaging adhesives complying with § 175.105 of this chapter. ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Polyethylene resins, carboxyl modified. 177.1600 Section 177.1600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 177.1310 - Ethylene-acrylic acid copolymers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... applicable to ethylene-acrylic acid copolymers used in food-packaging adhesives complying with § 175.105 of... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Ethylene-acrylic acid copolymers. 177.1310 Section 177.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 1302.05 - Effective dates of labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Effective dates of labeling requirements. 1302.05 Section 1302.05 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.05 Effective dates of labeling requirements. All...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) The ingredient is used as a constituent of paper and paperboard used for food packaging. (2) The... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) INDIRECT FOOD...

21 CFR 181.1 - General.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning... 21 Food and Drugs 3 2013-04-01 2013-04-01 false General. 181.1 Section 181.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.24 - Antioxidants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... antioxidants, when migrating from food-packaging material (limit of addition to food, 0.005 percent) shall... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Antioxidants. 181.24 Section 181.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PRIOR-SANCTIONED FOOD...

21 CFR 181.1 - General.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning... 21 Food and Drugs 3 2012-04-01 2012-04-01 false General. 181.1 Section 181.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 177.1400 - Hydroxyethyl cellulose film, water-insoluble.

Code of Federal Regulations, 2012 CFR

2012-04-01

... packaging food in accordance with the following prescribed conditions: (a) Water-insoluble hydroxyethyl... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Hydroxyethyl cellulose film, water-insoluble. 177.1400 Section 177.1400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 186.1555 - Japan wax.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging. (2) The... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Japan wax. 186.1555 Section 186.1555 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) INDIRECT FOOD...

21 CFR 186.1316 - Formic acid.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used for food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Formic acid. 186.1316 Section 186.1316 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) INDIRECT FOOD...

21 CFR 177.1310 - Ethylene-acrylic acid copolymers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... this section are not applicable to ethylene-acrylic acid copolymers used in food-packaging adhesives... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Ethylene-acrylic acid copolymers. 177.1310 Section 177.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 181.28 - Release agents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Release agents. Substances classified as release agents, when migrating from food-packaging material shall... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Release agents. 181.28 Section 181.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 177.1310 - Ethylene-acrylic acid copolymers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... this section are not applicable to ethylene-acrylic acid copolymers used in food-packaging adhesives... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Ethylene-acrylic acid copolymers. 177.1310 Section 177.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 1302.06 - Sealing of controlled substances.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Sealing of controlled substances. 1302.06 Section 1302.06 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.06 Sealing of controlled substances. On each bottle, multiple...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) The ingredient is used as a constituent of paper and paperboard used for food packaging. (2) The... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) INDIRECT FOOD...

21 CFR 186.1673 - Pulp.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for use as a constituent of food packaging containers. (c) The ingredient is used in paper and... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Pulp. 186.1673 Section 186.1673 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 181.28 - Release agents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Release agents. Substances classified as release agents, when migrating from food-packaging material shall... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Release agents. 181.28 Section 181.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 177.1600 - Polyethylene resins, carboxyl modified.

Code of Federal Regulations, 2013 CFR

2013-04-01

... resins used in food-packaging adhesives complying with § 175.105 of this chapter. ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Polyethylene resins, carboxyl modified. 177.1600 Section 177.1600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 111.70 - What specifications must you establish?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What specifications must you establish? 111.70 Section 111.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING...

21 CFR 864.7060 - Antithrombin III assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin III...

21 CFR 864.7525 - Heparin assay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification. A...

21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695 Platelet...

21 CFR 864.7400 - Hemoglobin A 2 assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hemoglobin A 2 assay. 864.7400 Section 864.7400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7400 Hemoglobin A 2...

21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prothrombin-proconvertin test and thrombotest. 864.7735 Section 864.7735 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864...

21 CFR 864.7060 - Antithrombin III assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin III...

21 CFR 864.7060 - Antithrombin III assay.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin III...

21 CFR 864.7400 - Hemoglobin A2 assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hemoglobin A2 assay. 864.7400 Section 864.7400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7400 Hemoglobin A2...

21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695 Platelet...

21 CFR 864.7060 - Antithrombin III assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin III...

21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695 Platelet...

21 CFR 864.7750 - Prothrombin time test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prothrombin time test. 864.7750 Section 864.7750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7750 Prothrombin time...

21 CFR 864.7925 - Partial thromboplastin time tests.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Partial thromboplastin time tests. 864.7925 Section 864.7925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7925 Partial...

21 CFR 864.7750 - Prothrombin time test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prothrombin time test. 864.7750 Section 864.7750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7750 Prothrombin time...

21 CFR 864.7750 - Prothrombin time test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prothrombin time test. 864.7750 Section 864.7750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7750 Prothrombin time...

21 CFR 864.7875 - Thrombin time test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test. (a...

21 CFR 864.7290 - Factor deficiency test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Factor deficiency test. 864.7290 Section 864.7290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7290 Factor deficiency...

21 CFR 864.7875 - Thrombin time test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test. (a...

21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695 Platelet...

21 CFR 864.7290 - Factor deficiency test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Factor deficiency test. 864.7290 Section 864.7290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7290 Factor deficiency...

21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prothrombin-proconvertin test and thrombotest. 864.7735 Section 864.7735 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864...

21 CFR 864.7925 - Partial thromboplastin time tests.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Partial thromboplastin time tests. 864.7925 Section 864.7925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7925 Partial...

21 CFR 864.7925 - Partial thromboplastin time tests.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Partial thromboplastin time tests. 864.7925 Section 864.7925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7925 Partial...

21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prothrombin-proconvertin test and thrombotest. 864.7735 Section 864.7735 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864...

21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prothrombin-proconvertin test and thrombotest. 864.7735 Section 864.7735 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864...

21 CFR 864.7925 - Partial thromboplastin time tests.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Partial thromboplastin time tests. 864.7925 Section 864.7925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7925 Partial...

21 CFR 864.7400 - Hemoglobin A 2 assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hemoglobin A 2 assay. 864.7400 Section 864.7400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7400 Hemoglobin A 2...

21 CFR 864.7750 - Prothrombin time test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prothrombin time test. 864.7750 Section 864.7750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7750 Prothrombin time...

21 CFR 864.7455 - Fetal hemoglobin assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Fetal hemoglobin assay. 864.7455 Section 864.7455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7455 Fetal hemoglobin...

21 CFR 864.7060 - Antithrombin III assay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin III...

21 CFR 864.7875 - Thrombin time test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test. (a...

21 CFR 864.7290 - Factor deficiency test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Factor deficiency test. 864.7290 Section 864.7290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7290 Factor deficiency...

21 CFR 864.7875 - Thrombin time test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test. (a...

21 CFR 864.7525 - Heparin assay.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification. A...

21 CFR 864.7925 - Partial thromboplastin time tests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Partial thromboplastin time tests. 864.7925 Section 864.7925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7925 Partial...

21 CFR 864.7455 - Fetal hemoglobin assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Fetal hemoglobin assay. 864.7455 Section 864.7455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7455 Fetal hemoglobin...

21 CFR 864.7290 - Factor deficiency test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Factor deficiency test. 864.7290 Section 864.7290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7290 Factor deficiency...

21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695 Platelet...

21 CFR 864.7525 - Heparin assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification. A...

21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prothrombin-proconvertin test and thrombotest. 864.7735 Section 864.7735 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864...

21 CFR 864.7525 - Heparin assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification. A...

21 CFR 864.7875 - Thrombin time test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test. (a...

21 CFR 864.7455 - Fetal hemoglobin assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fetal hemoglobin assay. 864.7455 Section 864.7455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7455 Fetal hemoglobin...

21 CFR 864.7525 - Heparin assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification. A...

21 CFR 880.2800 - Sterilization process indicator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Sterilization process indicator. 880.2800 Section 880.2800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent...

21 CFR 880.2800 - Sterilization process indicator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Sterilization process indicator. 880.2800 Section 880.2800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent...

Targeted Nanoparticle Tested in Patients with Cancer

Cancer.gov

By packaging molecules of the chemotherapy drug docetaxel in nanoparticles, researchers aim to deliver a high dose directly to tumors and reduce the drug's toxicity. A trial to test the targeted nanoparticle is underway in humans.

Party package travel: alcohol use and related problems in a holiday resort: a mixed methods study

PubMed Central

Hesse, Morten; Tutenges, Sébastien; Schliewe, Sanna; Reinholdt, Tine

2008-01-01

Background People travelling abroad tend to increase their use of alcohol and other drugs. In the present study we describe organized party activities in connection with young tourists' drinking, and the differences between young people travelling with and without organized party activities. Methods We conducted ethnographic observations and a cross-sectional survey in Sunny Beach, Bulgaria. Results The behaviour of the guides from two travel agencies strongly promoted heavy drinking, but discouraged illicit drug use. Even after controlling for several potential confounders, young people who travelled with such "party package travel agencies" were more likely to drink 12 or more units when going out. In univariate analyses, they were also more likely to get into fights, but were not more likely to seek medical assistance or medical assistance for an accident or an alcohol-related problem. After controlling for confounders, the association between type of travel agency and getting into fights was no longer significant. Short-term consequences of drinking in the holiday resort did not differ between party package travellers and ordinary package travellers. Conclusion There may be a small impact of party package travels on young people's drinking. Strategies could be developed used to minimise the harm associated with both party package travel and other kinds of travel where heavy substance use is likely to occur. PMID:18840273

Chromatographic and Spectral Analysis of Two Main Extractable Compounds Present in Aqueous Extracts of Laminated Aluminum Foil Used for Protecting LDPE-Filled Drug Vials

PubMed Central

Akapo, Samuel O.; Syed, Sajid; Mamangun, Anicia; Skinner, Wayne

2009-01-01

Laminated aluminum foils are increasingly being used to protect drug products packaged in semipermeable containers (e.g., low-density polyethylene (LDPE)) from degradation and/or evaporation. The direct contact of such materials with primary packaging containers may potentially lead to adulteration of the drug product by extractable or leachable compounds present in the closure system. In this paper, we described a simple and reliable HPLC method for analysis of an aqueous extract of laminated aluminum foil overwrap used for packaging LDPE vials filled with aqueous pharmaceutical formulations. By means of combined HPLC-UV, GC/MS, LC/MS/MS, and NMR spectroscopy, the two major compounds detected in the aqueous extracts of the representative commercial overwraps were identified as cyclic oligomers with molecular weights of 452 and 472 and are possibly formed from poly-condensation of the adhesive components, namely, isophthalic acid, adipic acid, and diethylene glycol. Lower molecular weight compounds that might be associated with the “building blocks” of these compounds were not detected in the aqueous extracts. PMID:20140083

A comprehensive approach to addiction medicine as an appropriate response to the HIV epidemic among drug users.

PubMed

Gerra, Gilberto

2013-12-01

The services for drug-dependence treatment and care, particularly in low-income countries, should not be fragmented and uncoordinated. A basic package of interventions should be provided in the same place and managed by the same team, with a one-stop shop approach. The services for substance use disorders should be appealing, accessible, voluntary-based, and science-based. They should also, like efforts to fight other diseases, be included in the community and the public health systems; that is, those who are affected by drug use and those who serve them should not face discrimination. The first-line assistance and the second-line essential elements of the comprehensive package will be described. The work of the United Nations Office on Drugs and Crime (UNODC) and World Health Organization (WHO) to promote science-based and voluntary-based ethical treatment in Asia will be illustrated.

21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

Code of Federal Regulations, 2014 CFR

2014-04-01

... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

Code of Federal Regulations, 2013 CFR

2013-04-01

... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

Code of Federal Regulations, 2012 CFR

2012-04-01

... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

Code of Federal Regulations, 2011 CFR

2011-04-01

... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false How must I control the components I use to produce PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD... GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Control of...

Agony of the ecstasy: report of five cases of MDMA smuggling.

PubMed

Low, V H S; Dillon, E K

2005-10-01

The international smuggling of illicit drugs by the ingestion or rectal insertion of drug-filled packages is recognized in the trafficking of heroin and cocaine. Customs authorities, with suspicion of such activities, presented five subjects. The legally allowed radiological examination comprising one supine abdominal radiograph was performed. Radiographic findings demonstrated the presence of multiple enteric oval, capsule-shaped packages of soft tissue density. This was confirmed following supervised evacuation of bowel contents induced by the administration of laxatives. Analysis of the concealed material identified ecstasy (methylenedioxymethamphetamine (MDMA)), a substance not previously reported as transported by this route.

21 CFR 177.1400 - Hydroxyethyl cellulose film, water-insoluble.

Code of Federal Regulations, 2014 CFR

2014-04-01

... hydroxyethyl cellulose film may be safely used for packaging food in accordance with the following prescribed... grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Hydroxyethyl cellulose film, water-insoluble. 177...

21 CFR 113.87 - Operations in the thermal processing room.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Operations in the thermal processing room. 113.87 Section 113.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 4.1 - What is the scope of this subpart?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What is the scope of this subpart? 4.1 Section 4.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL REGULATION... operating system at facilities that manufacture co-packaged or single-entity combination products. ...

21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2011 CFR

2011-04-01

... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 181.26 - Drying oils as components of finished resins.

Code of Federal Regulations, 2011 CFR

2011-04-01

... classified as drying oils, when migrating from food-packaging material (as components of finished resins... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Drying oils as components of finished resins. 181.26 Section 181.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 177.1640 - Polystyrene and rubber-modified polystyrene.

Code of Federal Regulations, 2011 CFR

2011-04-01

... polystyrene and rubber-modified polystyrene used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Polystyrene and rubber-modified polystyrene. 177.1640 Section 177.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 177.1640 - Polystyrene and rubber-modified polystyrene.

Code of Federal Regulations, 2010 CFR

2010-04-01

... polystyrene and rubber-modified polystyrene used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Polystyrene and rubber-modified polystyrene. 177.1640 Section 177.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 509.5 - Petitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.5 Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Petitions. 509.5 Section 509.5 Food and Drugs FOOD...

21 CFR 177.1340 - Ethylene-methyl acrylate copolymer resins.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ethylene-methyl acrylate copolymer resins used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Ethylene-methyl acrylate copolymer resins. 177.1340 Section 177.1340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 186.1316 - Formic acid.

Code of Federal Regulations, 2011 CFR

2011-04-01

... paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Formic acid. 186.1316 Section 186.1316 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1316 - Formic acid.

Code of Federal Regulations, 2010 CFR

2010-04-01

... paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Formic acid. 186.1316 Section 186.1316 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 189.220 - Flectol H.

Code of Federal Regulations, 2011 CFR

2011-04-01

... products, and has been used as a component of food packaging adhesives. (b) Food containing any added or... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Flectol H. 189.220 Section 189.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 1.377 - What definitions apply to this subpart?

Code of Federal Regulations, 2011 CFR

2011-04-01

... substances that migrate into food from food packaging and other articles that contact food, dietary... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What definitions apply to this subpart? 1.377 Section 1.377 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

21 CFR 509.5 - Petitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.5 Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Petitions. 509.5 Section 509.5 Food and Drugs FOOD...

21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 181.26 - Drying oils as components of finished resins.

Code of Federal Regulations, 2010 CFR

2010-04-01

... classified as drying oils, when migrating from food-packaging material (as components of finished resins... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Drying oils as components of finished resins. 181.26 Section 181.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 111.1 - Who is subject to this part?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Who is subject to this part? 111.1 Section 111.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR...

19 CFR 162.65 - Penalties for failure to manifest narcotic drugs or marihuana.

Code of Federal Regulations, 2011 CFR

2011-04-01

... or marihuana. 162.65 Section 162.65 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF... Substances, Narcotics, and Marihuana § 162.65 Penalties for failure to manifest narcotic drugs or marihuana. (a) Cargo or baggage containing unmanifested narcotic drugs or marihuana. When a package of regular...

19 CFR 162.65 - Penalties for failure to manifest narcotic drugs or marihuana.

Code of Federal Regulations, 2010 CFR

2010-04-01

... or marihuana. 162.65 Section 162.65 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF... Substances, Narcotics, and Marihuana § 162.65 Penalties for failure to manifest narcotic drugs or marihuana. (a) Cargo or baggage containing unmanifested narcotic drugs or marihuana. When a package of regular...

21 CFR 509.5 - Petitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.5 Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Petitions. 509.5 Section 509.5 Food and Drugs FOOD...

21 CFR 189.220 - Flectol H.

Code of Federal Regulations, 2012 CFR

2012-04-01

... products, and has been used as a component of food packaging adhesives. (b) Food containing any added or... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Flectol H. 189.220 Section 189.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 189.220 - Flectol H.

Code of Federal Regulations, 2013 CFR

2013-04-01

... products, and has been used as a component of food packaging adhesives. (b) Food containing any added or... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Flectol H. 189.220 Section 189.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 1.377 - What definitions apply to this subpart?

Code of Federal Regulations, 2014 CFR

2014-04-01

... substances that migrate into food from food packaging and other articles that contact food, dietary... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What definitions apply to this subpart? 1.377 Section 1.377 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

21 CFR 1.377 - What definitions apply to this subpart?

Code of Federal Regulations, 2013 CFR

2013-04-01

... substances that migrate into food from food packaging and other articles that contact food, dietary... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What definitions apply to this subpart? 1.377 Section 1.377 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

21 CFR 186.1316 - Formic acid.

Code of Federal Regulations, 2012 CFR

2012-04-01

... paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Formic acid. 186.1316 Section 186.1316 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 177.1640 - Polystyrene and rubber-modified polystyrene.

Code of Federal Regulations, 2013 CFR

2013-04-01

... polystyrene and rubber-modified polystyrene used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Polystyrene and rubber-modified polystyrene. 177.1640 Section 177.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 178.3750 - Polyethylene glycol (mean molecular weight 200-9,500).

Code of Federal Regulations, 2014 CFR

2014-04-01

... used in food-packaging adhesives complying with § 175.105 of this chapter. ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Polyethylene glycol (mean molecular weight 200-9,500). 178.3750 Section 178.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

21 CFR 178.3450 - Esters of stearic and palmitic acids.

Code of Federal Regulations, 2014 CFR

2014-04-01

... stearate or mixtures thereof may be safely used as adjuvants in food-packaging materials when used in... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Esters of stearic and palmitic acids. 178.3450 Section 178.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 181.26 - Drying oils as components of finished resins.

Code of Federal Regulations, 2013 CFR

2013-04-01

... classified as drying oils, when migrating from food-packaging material (as components of finished resins... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Drying oils as components of finished resins. 181.26 Section 181.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2014 CFR

2014-04-01

... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 186.1316 - Formic acid.

Code of Federal Regulations, 2013 CFR

2013-04-01

... paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Formic acid. 186.1316 Section 186.1316 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2013 CFR

2013-04-01

... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 177.1340 - Ethylene-methyl acrylate copolymer resins.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ethylene-methyl acrylate copolymer resins used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Ethylene-methyl acrylate copolymer resins. 177.1340 Section 177.1340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2012 CFR

2012-04-01

... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 181.26 - Drying oils as components of finished resins.

Code of Federal Regulations, 2014 CFR

2014-04-01

... food-packaging material (as components of finished resins) shall include: Chinawood oil (tung oil... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Drying oils as components of finished resins. 181.26 Section 181.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 177.1640 - Polystyrene and rubber-modified polystyrene.

Code of Federal Regulations, 2012 CFR

2012-04-01

... polystyrene and rubber-modified polystyrene used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Polystyrene and rubber-modified polystyrene. 177.1640 Section 177.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 177.1340 - Ethylene-methyl acrylate copolymer resins.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ethylene-methyl acrylate copolymer resins used in food-packaging adhesives complying with § 175.105 of this... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Ethylene-methyl acrylate copolymer resins. 177.1340 Section 177.1340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 509.5 - Petitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.5 Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Petitions. 509.5 Section 509.5 Food and Drugs FOOD...

21 CFR 509.5 - Petitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... RELATED PRODUCTS UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.5 Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Petitions. 509.5 Section 509.5 Food and Drugs FOOD...

21 CFR 181.26 - Drying oils as components of finished resins.

Code of Federal Regulations, 2012 CFR

2012-04-01

... classified as drying oils, when migrating from food-packaging material (as components of finished resins... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Drying oils as components of finished resins. 181.26 Section 181.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 1.377 - What definitions apply to this subpart?

Code of Federal Regulations, 2012 CFR

2012-04-01

... substances that migrate into food from food packaging and other articles that contact food, dietary... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What definitions apply to this subpart? 1.377 Section 1.377 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...