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Sourcing USP-grade Dietary Supplement Components to Meet the Specification Requirements of 21 CFR§111.70

Josef Brinckmann, Traditional Medicinals, Inc., and Member, USP Dietary Supplements General Chapters Expert Committee

The dietary supplement CGMPs¹ require the establishment of a specification for each component used in a dietary supplement product. The component specification must establish its identity and include other requirements necessary to ensure that specifications for purity, strength, and composition of dietary supplements containing the component are met, as well as limits on contaminants that could adulterate the product. Your QC Unit is also required to determine that the specifications are met.

Utilizing a pharmacopeial quality standards monograph as the basis of your component specification can be one sure way to meet the component specification requirements of the CGMPs. For example, USP monographs provide a specification that consists of tests, procedures, and acceptance criteria that help ensure identity, composition, strength, quality, and purity.²

But this is easier said than done and takes some effort to accomplish. Many American suppliers of botanical raw materials and extracts are not yet accustomed to sorting, grading, testing, and selling their ingredients according to specified pharmacopoeial quality designations (e.g. USP-grade or PhEur-grade). To accomplish this, your QC laboratory will need to collaborate closely with your supplier's QC laboratory in order to establish specifications that conform to the monograph. Experience shows that this will result in higher costs for your supplier (passed on to you) in order to carefully select raw material batches that consistently meet the requirements, subject them to full monograph testing, and issue your QC Unit a valid Certificate of Analysis that demonstrates conformance to all of the specified qualitative and quantitative standards. But paying a premium for pharmacopeial-grade dietary supplement components is certainly worth the price. It not only will e! nable you to meet the specification requirements of the CGMPs but also will lead to consistent and reproducible quality for your finished products, which is integral to reproducible safety and effectiveness.

¹ Food and Drug Administration. 21 CFR Sec. 111.70: What specifications must you establish? In: Code of Federal Regulations. Washington, DC: National Archives and Records Administration. April 1, 2009. Title 21, Volume 2, Pages 239-240. Available at: http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr111.70.pdf.

² United States Pharmacopeial Convention. General Notices. Monographs and General Chapters. In: The United States Phramacopeia, Thirty-Second Revision, and the National Formulary, Twenty-Seventh Edition (USP 32-NF 27). Rockville, MD: United States Pharmacopeial Convention. 2009.