Comments RE: Pharmacy Compounding Advisory Committee meeting on bulk drug substances nominated for inclusion on the Section 503A bulk drug substance list

"The Center for Science in the Public Interest, an advocacy group that accepts no funding from industry, opposes the proposed inclusion of the seven bulk peptide drug substances (BPC-157, KPV, TB-500, MOTs-C, emideltide, semax, and epitalon) in the 503A Bulks List, allowing them to be compounded, because this action is inconsistent with the FDA’s own standards for pharmacy compounding, poses dangers to consumers, and removes incentives for developing new pharmaceutical products through the standard drug approval process.  

Agency scientists recently reviewed the available data for these seven bulk drug substances in detail and recommended that all seven “NOT be included in the 503A Bulks List” (emphasis in the original) because of the overall lack of data to characterize the substances’ historical use, physical and chemical properties, safety profile, and effectiveness. We support the career scientists’ determinations and urge the committee and subsequently the agency itself to follow the recommendations of the FDA’s own subject matter experts. "

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