USP and Regulators

USP has worked closely with the United States government since the early 19th century. That collaboration continues today as USP, a scientific nonprofit organization, allies with the Food and Drug Administration and other regulatory bodies around the world to help ensure the quality, safety, and benefit of medicines and foods. Under the 1938 Food, Drug, and Cosmetic Act, prescription and over-the-counter medicines sold in the United States must comply with quality standards published in the United States Pharmacopeia-National Formulary (USP-NF). USP also publishes widely observed quality standards for food ingredients in the Food Chemicals Codex (FCC); and for dietary supplements in the Dietary Supplements Compendium (DSC).

• General
• Dietary Supplements
• Pharmaceuticals
• Strengthening FDA
• Food Quality
• Developing Countries and Counterfeit Medicines

USP offers a wide range of resources to regulators, including information about new quality standards in development or revisions of existing standards; forums where the science behind standards is discussed; and information about USP's efforts to combat counterfeit and substandard medicines in developing countries.

General

• Overview of USP
• USP's Impact
• USP's Vision
• USP Standards Development
• What is a Pharmacopeia?
• USP Monograph Backgrounder
• USP History
• USP in the News
• USP's Strategic Plan  (1.5MB)

Dietary Supplements

• How USP Verifies Dietary Supplements
• What the USP Verified Mark Means on a Supplement Label
• Choosing a Dietary Supplement video:High Bandwidth (6.0MB) or Low Bandwidth (3.0MB)
• USP Verified Dietary Supplements Backgrounder
• USP Verified Dietary Supplement Ingredients Backgrounder
• New USP Collaboration Helps Health Professionals and Consumers Identify High-Quality Dietary Supplements
• MCMIA and USP Sign Agreement to Promote Dietary Supplement Verification Program in Greater China
• USP Dietary Supplements Compendium
• FDA's Dietary Supplement CGMPs: Standards without Standardization  (543KB)

Pharmaceuticals

• USP to Verify the Quality of Pharmaceutical Ingredients Worldwide
• Import Safety: New Standards for Heparin and Glycerin

Strengthening FDA

• Letter from Secretary Sebelius  (497KB)
• USP Letters to Obama, Torti, and Daschle  (161KB)
• Press Release: USP Applauds President's Budget Support for FDA

Food Quality

• Infant Formula Adulteration with Melamine Underscores Need for Better Detection Methods
• "Provisional Monographs" for Self-Affirmed GRAS Ingredients"
• "USP Food Reference Materials and the FCC: A Service to the Food and Analytical Community"
• New Standard for Popular Stevia–based Sweetener to Assure Manufacturers and Consumers of Product's Quality (01/05/2009)
• U.S. Pharmacopeia Working to Better Detect, Measure Melamine Adulteration in Food
• The FCC Forum—Your Opportunity, Your Responsibility to the Public Standards-Setting Process
• FCC Expert Viewpoint: How Do 'Standards' and FCC Accommodate Innovation?
• The FCC at USP: A New Home for Food Ingredient Standards
• FCC Expert Viewpoint: Why Are "Standards" So Important...Do They Really Relate to Safety?
• USP's Assumption of the Food Chemicals Codex: Risks and Opportunities (2007)  (83KB)
• Published Specifications Strengthen the U.S. Safety Net for Food Ingredients (2008)  (559KB)
• The Scientific Utility of the Food Chemicals Codex for Every Food Scientist: Why the Food Chemicals Codex should be on every food scientist's bookshelf (2008)  (3.9MB)
• The supportive relationship between current Good Manufacturing Practices (cGMPs) and quality specifications for dietary supplements/dietary ingredients (2008)  (432KB)

Developing Countries and Counterfeit Medicines

• Why is drug quality important?
• What is poor drug quality?  (112KB)
• Anti-Counterfeiting Measures and USP Standards
• Counterfeit Medicines in the Mekong Region (video 1) (3.8 MB)
• Counterfeit Medicines in the Mekong Region (video 2) (4.4 MB)
• Excellency Dr. Yim Yann, president of the Pharmacists Association of Cambodia, urges Cambodian citizens to buy their medicines from a legal pharmacy to assure that they are getting a safe, good quality product (video) (15 MB)
• USP Announces New Standards to Protect Patients from Counterfeit and Adulterated Medicines (02/04/2009)
• Counterfeit and Substandard Drugs and the Problem of Antimicrobial Drug Resistance  (84KB)
• Mekong Region Takes Action Against Fake Antimalarials  (114KB)
• Antimalarial Drug Quality in Mekong Countries (poster)  (175KB)
• Identification of Counterfeit and Sub-Standard Fixed-Dose Combination Anti-Tuberculosis Drugs to Prevent the Emergence of Multidrug-Resistant Tuberculosis (poster)  (15.1MB)
• Patrick Lukalay in "Stopping Counterfeits and Substandard Drugs" from pharmamanufacturing.com.
• Patrick Lukalay in "Lessons from Heparin" from pharmamanufacturing.com.