The United States Pharmacopeial Convention is the organization responsible for producing an annual report known as the United States Pharmacopeia (USP). This report outlines quality guidelines for ingredients of human and animal pharmaceuticals.
The USP creates clinically-backed reference materials for many ingredients common to pharmaceutical drugs in the United States. Any ingredient found within a pharmaceutical product, prescription or over-the-counter, must conform to any USP guidelines regarding its safety.
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The USP is recognized by Congress as the official guidance for process safety related to pharmaceutical formulation. These guidelines establish the following attributes:
- Packaging and Labeling
USP & Dietary Supplements
USP standards do not apply to foods and dietary supplements the same way they apply to pharmaceuticals. The USP does provide verification services for supplements but it’s important to understand how they’re different. The USP provides detailed documents outlining their requirements for a dietary supplement or dietary ingredient certification (free to download, email required.)
- Testing of Product Samples
- Product Categorization
- GMP Inspection & Certification
- Relevant lab testing conducted
- Annual quality systems audit
- Accurate labeling
- Strength, Purity, and Identity Testing
There is a great interview with USP Chief Science Officer and Executive Vice President Jaap Venerma that details the differences in certification processes for supplements when compared to pharmaceuticals. It really helps explain why buying non-certified supplements is a gamble.
The USP website maintains an updated list of all USP-Certified brands, products, and retailers. It’s a useful read for anyone looking to locate USP-certified supplements. Just a head’s up, USP certification is much less prevalent programs offered by other certifying agencies such as the NSF.
The United States Pharmacopeia
The USP was first established in 1820 by a number of scientists with the goal of standardizes medicinal quality. Thie original USP contains formulas for the preparation of 217 drugs. At the time, it was by-and-far the largest such collection of its type.
In 1888, the American Pharmacological Association created a similar such collection known as the National Formulary (NF.) The 1906 passage of the Federal Food & Drug Act gave the USP and NF guidelines official status and recognition. This legislation was succeeded by the 1938 Federal Food, Drug, and Cosmetic Act which expanded the roles of each.
In 1975, the USP “bought out” the NF and combined each into a single entity known as the United States Pharmacopeia–National Formulary (USP–NF). Today, the USP-NF contains more than 4,500 unique definitions for products ranging from medical devices and home products to pharmaceuticals and dietary supplements.
USP Quality Institute
The USP maintains a branch of their organization known as the Quality Institute. This entity works with governments around the world to help fund research programs designed to identify effective ways to provide quality medicines around the globe.
The USP sponsors a Fellowship in Quality of Medical Products program through which they partner with leading academic programs around the world. The purpose of this fellowship program is to help unite medical professionals’ knowledge from around the world.
Generics Access Plan
The USP works to establish new ways to increase patient access to inexpensive generic medications. In the past 10 years, USP estimates its efforts to have saved consumers over $1.5 Trillion dollars.
The USP maintains a collection of monographs for certain industries, including Dietary Supplements. A monograph is a series of guidelines for testing, storing, packaging, labeling, and otherwise preparing a compound for consumers. Check out this sample monograph for Calcium Citrate (PDF) for a better example.
Certain dietary supplements may not bear the formal USP-Certified seal but still contains USP-grade ingredients. This means, for each USP-grade ingredient, the USP monograph for that ingredient was met. This includes production in a cGMP-abiding facility as well. Many of the best vitamin brands on the market have USP-grade ingredients but aren’t officially USP-Certified.
Visit the USP’s Quality Supplements website to learn more about USP certification and dietary supplements. There you’ll find resources on learning about supplement quality, process auditing, GMP guidelines, and the latest USP-related news.