USP 1150.docx

USP 1150 The cGMP Final Rule for Dietary Supplements — Stability Testing The Final Rule (21 CFR Part 111 in 2007) for current good manufacturing practices (cGMP) issued by the FDA has now e effective for panies involved in manufacturing and distributing nutrition supplements. The rule states that all manufacturers of dietary supplements are not required to establish an expiration /shelf-life for their products; however, if they choose to use either an“ Expiration Date ” or“ Best if Used By Date, ” this claim must be supported and substantiated by scientific data (see 68 FR 12157 at 12204). The most relevant scientific data are from stability (shelf-life) studies. Although the FDA does not provide specific guidelines of methodology or procedures for such studies, it mends that manufacturers have a written testing program designed to assess the stability characteristics of the dietary supplement, and to use the results of stability testing to determine appropriate storage conditions and expiration dates. In general, USP <1150> pharmaceutical stability offers definitive stability guidance on how manufacturers can pendial procedures to monitor the stability of their product through product expiry. There are several important considerations when designing and conducting stability studies. 1. Stability Protocols: before each study, a stability protocol should be written. The protocol