HHS Allows Compounding of 6 Peptides Despite FDA Staff Objections

HHS has announced an interim enforcement-discretion policy allowing state-licensed pharmacies, federal facilities and licensed physicians to compound six previously restricted peptides under specified conditions while FDA considers whether to formally authorize their use under Section 503A of the Federal Food, Drug, and Cosmetic Act.

The 10/28 policy covers BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. FDA's Pharmacy Compounding Advisory Committee voted in July to recommend their inclusion on the agency's list of bulk drug substances eligible for compounding, despite CDER scientific reviewers finding imited clinical evidence supporting the products’ safety and effectiveness (see earlier story).

The policy does not constitute FDA approval of the peptides or formally add them to the Section 503A bulks list. Instead, HHS says it does not intend to take enforcement action against qualifying compounders that comply with the policy's safeguards until the substances are addressed through final rulemaking.

Those conditions include sourcing peptides from FDA-registered manufacturers that comply with GMP requirements, obtaining certificates of analysis documenting identity and quality, reporting serious adverse events and product-quality problems, and limiting compounded products to a single active pharmaceutical ingredient. The policy also restricts permitted routes of administration for each peptide and requires patient-specific prescriptions.

HHS says the interim approach is intended to discourage widespread use of research-use-only peptides supplied by foreign manufacturers by providing patients with a more controlled alternative.

HHS says it may reconsider the policy if safety signals or product-quality problems emerge. The enforcement discretion will remain in place until each peptide is addressed through final rulemaking.

The policy follows substantial internal opposition from FDA scientists, according to an Associated Press report citing six people familiar with its development. AP reported that most FDA scientific staff opposed loosening restrictions on the peptides and had limited input in developing the policy, which was driven largely by HHS.

HHS initially sought a formal regulation that would add the peptides to the list of bulk drug substances permitted for compounding, AP reported. But FDA officials warned that agency scientists had significant safety concerns and would not support such a rule, prompting HHS to pursue an interim enforcement-discretion policy instead. FDA staff subsequently helped develop safeguards addressing ingredient sourcing, quality testing and adverse event reporting.

The decision also follows controversy surrounding FDA's Pharmacy Compounding Advisory Committee. It had previously been reported that several committee members had ties to peptide-selling businesses or clinics, although HHS said they had cleared standard ethics reviews.