The existence of an FCC monograph for a food ingredient does not provide independent evidence that a particular product can be legally marketed in the United States under the FD&C Act and its implementing regulations. It is the ultimate responsibility of food and ingredient manufacturers and distributors to ensure that their products are legally marketed in the United States. The U.S. Pharmacopeial Convention is a private, non-governmental organization that publishes the United States Pharmacopeia (USP) and the National Formulary (NF) as official compendiums of the United States. Although much of the USP and NF is legally enforceable, the chapters of USP (general information chapters) numbered above are informative and generally do not contain mandatory requirements (see USP 2.10 general notices). General information chapters may include recommendations that can help an organization meet the requirements of the PMMC. USP standards are recognized by law in the United States. and elsewhere and are used in more than 140 countries. USP has laboratories in Brazil, China, India and the United States.
Visit the following categories to learn more about specific laws and regulations: Congress has consistently given USP standards a role in the adulteration and mislabelling provisions of successive federal food and drug laws, beginning with the Pure Food and Drugs Act of 1906 and continuing today with the federal Food Act, Drugs and Cosmetics (FDCA). Under federal law, a drug whose name is recognized in the USP-NF must comply with the current version of the compendial standards deemed official by the USP, otherwise there is a risk of being distorted, mislabelled, or both (FDCA 501(b) and 502(e)(3)(b); FDA Regulation 21 CFR 299.5 (a&b)). Biologics, including those approved by the FDA under the Public Health Service Act (PHS), are also considered drugs subject to FDCA adulteration and mismarking regulations, including USP standards (FDCA 201(g), 301(a-c), and PHS Act 351(j)). Drugs and biologics recognized in the USP must meet the standards of identity. and must also meet standards of strength, quality, and purity, unless the label shows all aspects in which the drug differs (FDCA 501(b); 21 CFR 299.5(c)). In addition, (as illustrated by the labeling standard for ferrules and cap seals), drugs recognized in the USP-NF must also be packaged and labeled in accordance with compendial standards (FDCA 502(g)) to avoid being mislabeled. With respect to dietary supplements (separately regulated in the Health and Dietary Supplement Education Act, DSHEA), a dietary supplement covered by the USP-NF specifications and presented as complying with those specifications is considered mislabelled if it fails to do so. See FDCA Section 403(s(2)(D). The text „If it is intended for use in animals, it is so marked.“ is the official text of the USP-NF. A general chapter numbered less than 1000 (or more than 2000 for dietary supplements) becomes applicable and required with respect to certain elements as follows (an „applicable general chapter“): All written comments must be marked with the file number of this document: FDA-2017-D-6821.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) defines the „official compendium“ as „the official pharmacopoeia of the United States, the official homeopathic pharmacopoeia of the United States, the official national formula, or a supplement to any of them.“ 21 U.S.C. 321(J). Home | General provisions | Buildings and facilities | Facilities | Control of drug components, containers and closures| Production and process controls | Holding and sales | Laboratory controls| Records and reports | Returned and Recovered Drugs The USAN Board began providing ingredient names for drugs before they were marketed in 1961. USP participates in this activity alongside the American Medical Association, the American Pharmacists Association and the FDA. The Board`s question will be included in the USP Dictionary of USAN and International Drug Names (the dictionary) along with other drug names (including generic, proprietary, chemical and code names). Since 1988, this publication has been recognized by federal regulations as a source of established names for drug substances in the United States (except in cases where USP specifies a different nonproprietary name). USP appreciates being informed of missing or incorrect hyperlinks. To report these issues, please email us at uspnf-info@usp.org.
USP will catalog identified hyperlink issues and fix them as soon as possible. In accordance with its mandate and guiding authority, USP establishes standards for articles recognized in the USP-NF, which are expressed in an article`s monograph, applicable general chapters, or general notices (see GN 3.10). With specific reference to labelling, the USP General Notices have a section devoted exclusively to labelling (see GN 10.40 labelling; „The items in these compendiums are subject to compliance with any labelling requirements that may be issued by government agencies in addition to the compendial requirements established for the items.“). Like other officid requirements, labelling requirements may be included in individual monographs or, like these amendments to General Chapter injections, in general chapters that apply to more than one device. It should also be noted that the current labelling and other labelling provisions are dealt with in a new general chapter . We are proud of our organization and proud of all our employees. No half measures, but passionate about challenges. From a compendial point of view, a USP General Chapter of less than 1000 is not applicable or mandatory unless mentioned in a monograph, another applicable General Chapter or General Communications. No, the FDA is the only source of pharmaceutical CGMP and quality guidelines. CGMP requirements can be found in laws and regulations, and current FDA considerations on these requirements are explained in the agency`s guidance documents. USP develops and publishes standards for drug substances, drugs, excipients, and dietary supplements in the United States Pharmacopeia-National Formulary (USP-NF). These standards have been recognized in the Federal Food, Drug and Cosmetic Act (FD&C) since its inception in 1938.
The FD&C Act defines the term „official compendium“ as the official USP, official NF, official homeopathic pharmacopoeia of the United States, or an addition to it. USP-NF standards play a role in the adulteration and mismarking provisions of the FD&C Act (which also apply to biologics, a subset of drugs, under the Public Health Service Act). USP has no role in enforcing these or other regulations that recognize USP-NF standards, which is the responsibility of the FDA and other government agencies in the United States and elsewhere. Manufacturers and potentially affected parties are encouraged to contact the FDA with any questions regarding the specific applicability of USP standards to their products. 1. Are USP General Chapters on considered equivalent to FDA guidelines? What is their purpose and how should manufacturers use these information chapters? USP publishes proposals for chapters or monographs in the Pharmacopeial Forum, a bimonthly publication. SPU subscribers have access to these publications and may submit comments (within 90 days of publication) for review by SPU Final proposals (official revisions, new chapters or monographs) are published in subsequent supplements or editions of the Pharmacopoeia. USP is a non-profit scientific organization that sets public standards for the identity, strength, quality, and purity of medicines.
USP standards are recognized in various provisions of the Federal Food, Drug and Cosmetic Act (FDCA), as well as state laws, regulations, and guidelines. These standards are enforced by the U.S. Food and Drug Administration (FDA), states, and other regulatory agencies. The USP Committee of Nomenclature Experts was established in 1986 to create appropriate established names for dosage forms and drug combinations and to develop naming guidelines. The Nomenclature Expert Committee coordinates its work with the USAN Council and produces the Pronunciation Guide, which is used by the USAN. If you are unable to submit comments online, please send your written comments to: USP reference standards are not intended for use in humans or animals as a drug or medical device. They are intended for testing and testing purposes only according to the USP compendia.
