Role of Compendial Standards and Verification Programs to Safeguard the Global Supply Chain FDLI Conference on Safeguarding the Functional Food and Dietary.

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Presentation transcript:

Role of Compendial Standards and Verification Programs to Safeguard the Global Supply Chain FDLI Conference on Safeguarding the Functional Food and Dietary Ingredient Supply Chain Panel on Meaningful Test Methodologies- Key Challenges September 10, 2013 Ben Firschein, J.D., LL.M. Director, Government Affairs and Policy United States Pharmacopeial Convention (USP)

Topics Key Points FDA/FSMA: Implications USP: How Standards Can Help USP Standards Verification Spectral Libraries Food Fraud Database Conclusion

Key Points Public (compendial) quality standards facilitate trade, help ensure product/ingredient identity, and advance global “safety net” Help prevent adulteration/contamination Help manufacturers source trusted ingredients and comply with FDA requirements Verification programs based on compendial standards are a viable solution to many supply chain concerns for producers and purchasers

FDA: Global Challenges Supply chain increasingly complex FDA-regulated products originate from more than 150 countries Growth in overseas products will continue Distinction between domestic and imported products is obsolete

FDA: Global Strategy Places Greater Responsibility on Manufacturers/Others Allocates resources based on risk Leverages combined efforts of government, industry, and public-private partnerships (third parties) Greater manufacturer accountability Know your supplier Testing of ingredients and finished product to establish safety and quality Manage risk of incidents

FDA: Food Safety Modernization Act Evaluation of hazards/risk-based controls (Sec. 103) Performance standards (Sec. 104) Identify food at highest risk of adulteration/mitigate (Sec. 106) Foreign supplier verification (Sec. 301) Voluntary qualified importer (Sec. 302) Mandatory certification of imported food based on risk (Sec. 303) Accreditation of third-party auditors (Sec. 307)

FDA: Food Safety Modernization Act Proposed rules: Foreign Foreign Supplier Verification Program (certain exemptions for dietary supplements/components) Accreditation of Third Party Auditors Domestic Preventive Controls: may include verification Intentional adulteration- proposed rule forthcoming

FSMA: Legal Implications 1. Expansion of FDA authority/manufacturer requirements Suspension of facility registration (informal hearing) Recall (informal hearing) Increased frequency of inspections (domestic and foreign facilities) Denial of importation (failure to obtain requested certification or revocation of qualified importer status) Recordkeeping and review (manufacturer) 2. More FDA warning letters and enforcement actions 3. “Proof of the pudding” will be in agency regulations, rules, and guidance to implement the Act

Background on USP…and How Standards Can Help Scientific, independent, nonprofit organization Established in 1820 Headquartered in Maryland, USA; Facilities in India, China, Brazil, Switzerland, Ethiopia, and Ghana 900+ employees Mission: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods

Background on USP…and How Standards Can Help Set public quality standards for prescription and over-the-counter medicines, excipients (inactive ingredients), dietary supplements, and food ingredients through volunteer experts Works closely with U.S. FDA >100 years, developing and revising drug quality standards through expert volunteers; strict conflict of interest rules

USP’s Standards The United States Pharmacopeia- National Formulary (USP–NF) Food Chemicals Codex (FCC) USP Dietary Supplements Compendium (DSC) USP Medicines Compendium (MC) USP on Compounding Herbal Medicines Compendium (HMC) Other Resources Pharmacopeial Forum (PF) FCC Forum (FCCF) USP Dictionary Chromatographic Columns

USP Reference Standards More than 3,000 Reference standards that support FDA-enforceable monograph procedures Rigorously tested by USP, industry, and government scientists USP Reference Standards are highly characterized specimens of: drug substances excipients impurities degradation products dietary supplements compendial reagents performance test tablets USP expends ~60% of its resources, mostly in our world-wide laboratories, to bring official USP Reference Standards to the United States and to the world. After intensive work in our laboratories to assess candidate material and determine content, resulting data were considered carefully by the Council of Experts’ Reference Standards Expert Committee. We recently crossed a high water mark—2600 reference materials in commerce throughout the world. And many, many more are needed to undergird all the many public procedures needed to support test procedures for food and drugs moving in national and international commerce.

Role of USP Quality Standards in Law First USP standards 1820; role in Federal law added 1906 (strength, quality, purity), 1938 (identity) Federal Food, Drug, and Cosmetic Act (FDCA) adulteration & misbranding provisions apply to both Public Health Service Act biologics & FDCA drugs Naming/Identity A drug with a name recognized in USP–NF must comply with compendial identity or be deemed adulterated, misbranded, or both Strength, Quality & Purity Must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs

Role of USP Quality Standards in Law For dietary Supplements: misbranded if purports to be “USP” but does not meet compendial standard Food: FCC specifications for food ingredients incorporated by reference in over 200 FDA regulations

How Do Compendial Standards Help? Identity Strength Quality/Purity Set standards for identity, strength, quality and purity Help ensure the right dosage Help prevent economically-motivated adulteration Is the ingredient what it purports to be Is enough of the ingredient present Are levels of impurities, particularly toxic impurities, appropriately controlled

How Do Compendial Standards Help? The requirement to do testing is part of GMPs for dietary supplements USP (and other) standards and Reference Materials can be used to perform the identity testing required under 21 CFR 111.75(h) (1)

How Do Compendial Standards Help? Standards and reference materials can also be used for the testing on the finished batch of dietary supplements to ensure that they meet product specifications for: Identity Purity Strength Composition Limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of dietary supplement (21 CFR 111.75(c))

USP Verification Services USP Dietary Supplement Verification Launched 2002 Dietary Supplements USP Dietary Ingredient Verification Launched 2004 Dietary Ingredients Traditional Chinese Medicine Ingredients Ayurvedic Medicine Ingredients USP Pharmaceutical Ingredient Verification Launched 2006 Drug Substances Excipients Verification programs are based on compendial standards, manufacturer requirements, and GMPs

Key Elements of the Verification Programs 1. Product appropriate for inclusion in program 2. Audit of manufacturing sites for GMP compliance 3. Review of chemistry, manufacturing and controls product documentation 4. Laboratory testing of product samples 5. Review of conformance with mark usage guidelines 6. Continuous surveillance: Surveillance audits Internal audit report, Annual product report Product testing Phase II Phase I Mark Approval

USP Food Fraud Database http://www.foodfraud.org/ Free resource Collection of public reports on foods that have historically been reported adulterated and with what adulterant Useful for assessing risk of fraud, counterfeiting, or economically motivated adulteration Beyond listing ingredients subjected to food fraud, gives easy access to detection methods for adulterants as reported in peer-reviewed scientific journals, which can provide an excellent starting point for mitigation strategies

Conclusion FDA is moving toward verification of food and certification of third party auditors Appropriate standards and testing regimes can reduce risk of exposure/enforcement actions by FDA and other regulatory bodies USP standards and USP verification programs can help