Working with U.S. FDA
For more than a century, the United States Pharmacopeial Convention (USP) and the U.S. Food and Drug Administration (FDA) have worked together to protect the public health and promote the quality and safety of drugs, dietary supplements, and foods.
In November 2010, a collaborative USP–FDA exhibit opened at USP headquarters showcasing the history and success of this private–public partnership.
USP–FDA: Roles & Collaborations
Visit the links below to learn about the distinct roles USP and FDA play and how their work together benefits public health.
- Promotes the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner
- Ensures the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the food supply, cosmetics, dietary supplements, and products that give off radiation
- Regulates tobacco products
- Advances the public health by helping to speed product innovations
- Helps the public to get the accurate, science-based information they need to use medicines and foods to improve their health
- Approves new drugs in interstate commerce for the U.S. market (both prescription and over-the-counter)
- Requires and enforces good manufacturing practices
- Reviews private documents
- Conducts inspections
- Enforces food and drug laws (including those USP standards incorporated in federal law)
- Sets standards for the identity of medicines, food ingredients, and dietary supplements as well as for their quality, purity, and strength
- Provides drug standards (for naming/identity, strength, quality, and purity, as well as packaging and storage) that are enforced by FDA under the Federal Food, Drug, and Cosmetic Act.
- Provides the Reference Standards, carefully measured chemical and physical samples, that are key tools used in the tests and methods to measure conformance to the written standards and quality assurance requirements
- Promotes medication safety via standards for drug naming and cautionary labeling of injectable drug products
- Helps manufacturers to meet good manufacturing practices (GMPs) through voluntary inspections. USP awards a mark to ingredients and products that pass USP's verification requirements: www.usp.org/USPVerified. This mark helps ensure that consumers receive quality products.
- Provides technical assistance to governments around the world through Memoranda of Understanding with many countries and regions, including China, India, and Latin America, and our USAID-sponsored program on Promoting the Quality of Medicines (PQM)
- Promotes greater understanding of USP's standards via sites around the world. Like FDA, in the past few years USP has expanded globally and now has laboratories in India, China, and Brazil, in addition to our headquarters in Rockville, Maryland, and an office in Basel, Switzerland. We have begun working closely with the FDA Office of International Programs, assisting staff at its China and India field offices and U.S. headquarters.
- Sponsors scientific meetings to enhance understanding of standards-related scientific and health issues
- FDA enforces USP–NF standards.
- FDA staff act as liaisons to USP standards committees.
- FDA can request USP to develop or modify standards.
- FDA can comment on USP's proposed standards.
- FDA staff speak at/participate in USP scientific meetings.
- FDA and USP staffs share information about developments (scientific, trends in industry, concerns, etc.).
- USP often comments on FDA proposed actions.
- USP staff have supported FDA, participating as appropriate on FDA Advisory Committees and at other public meetings.
- FDA and USP collaborate through Cooperative Research and Development Agreements (CRADAs).
Drugs and Biologics
- USP has produced standards for the quality and uniformity of drugs and biologics since 1820, starting as recipes for compounding pharmacists and refocusing in the past 100 years on quality standards—chemical formulations, identifications, and assays—for drug ingredients and finished drug products.
- USP was recognized in the 1906 Food & Drugs ("Wiley") Act as an "official compendium," providing the basis for the predecessor of FDA to deem a drug adulterated.
- Expanded role for USP in 1938 Federal Food, Drug, and Cosmetic Act (FDCA) (current law): a drug with a name recognized in USP must comply with compendial identity standards, or be deemed adulterated, or misbranded, or both. To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs. FDCA §§501(b) and 502(e)(3)(b); see also 21 CFR §299.5.
- USP compendial standards also help inform FDA's current GMPs. FDCA §501(a)(2)(B), added in 1962, bolstered FDA's existing 501(b) enforcement authority related to compendial quality standards, requiring conformity with FDA GMP requirements as to safety, and also requiring that a drug "has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; . . . "
Packaging and Labeling
- Under the FDCA, a drug is deemed misbranded "if it purports to be a drug the name of which is recognized in an official compendium [such as USP], unless it is packaged and labeled as prescribed therein." FDCA §502(g). Current example: USP's ongoing effort to revise General Chapter <1> Injections to better protect patients by restricting cap and overseal printing to certain cautionary statements that healthcare practitioners are likely to see and read at the time of administration of high-risk parenterals (such as paralyzing agents).
- USP standards for dietary supplements have less legal recognition than its standards for drugs; a dietary supplement will be considered misbranded only if it is represented as conforming to USP specifications and fails to so conform. FDCA §403(s)(2)(D), as added by Dietary Supplement Health and Education Act (DSHEA).
- When the 1958 Food Additives amendments were added to the FDCA, the National Academy of Sciences (NAS) launched the Food Chemicals Codex (FCC). NAS transferred ownership of the FCC to USP in 2006.
- >There is no general statutory recognition in the FDCA for FCC standards. FCC standards are enforceable under the federal food misbranding provision, FDCA §403(g), only where FCC standards have been incorporated as part of a definition or standard of identity in particular FDA food regulations. There are many such regulatory references to the FCC. Such regulations need to be periodically updated by FDA to ensure incorporation of the latest compendial standards.
- Enforcement of USP standards is the responsibility of FDA and other governmental authorities, in the United States and elsewhere. USP has no role in enforcement.