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USP potency limits

This article was originally published in The Tan Sheet

Executive Summary

Subcommittee on Nonprescription Drugs and Nutritional Supplements decides to retain its current official upper potency limits for dietary supplements during a March 3 conference call. The subcommittee discussed whether to keep its lower limits at 90% of the labeled amount at a Dec. 8 meeting (1"The Tan Sheet" Dec. 13, 1999, p. 10). However, since many manufacturers must meet a 100% lower potency limit due to FDA regulations, the USP body proposed to include language in the general notices section of the Pharmacopeial Forum stating companies may exceed the USP upper limit by the same percentage with which they exceed its established lower limit. The proposal will appear in the May/June Pharmacopeial Forum where it will be open to public comment

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USP Supplement Potency Lower Limit Of 90% Retained

The lower potency limit dietary supplements are required to meet for the duration of their shelf life will remain at 90% of the labeled amount, the U.S. Pharmacopeia Subcommittee on Non Prescription Drugs and Nutritional Supplements voted Dec. 8 in Rockville, Md.

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