Sarah Karlin-Smith

$HIMS 🚨 HHS INTERIM ENFORCEMENT PEPTIDE POLICY "The Secretary of HHS [RFK Jr.] has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative." "Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety." "Until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list, HHS does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product, the subject of an applicable USP or NF monograph, or on the 503A bulks list codified at 21 CFR 216.23(a), when all of the following circumstances are present:" 1. 503A Interim Access List: BPC-157, TB-500, MOTS-c, KPV, Semax, or Epitalon 2. Peptide Identity: The peptide must meet the identity specifications and administration-route limitations in Appendix B 3. Characterization & Testing: The substance must come from an FDA-registered facility and have a valid Certificate of Analysis (COA) confirming identity, purity, potency, and contaminant testing 4. Manufacturer Requirements: The original manufacturer must be FDA-registered, comply with CGMP requirements, and be identified on the COA. Intermediaries must validate suppliers 5. Reporting Requirements: Compounders must report products compounded, serious adverse events, and product quality issues to FDA and relevant states. Reporting instructions must appear on product labeling 6. Product Labeling: Labels must state: “This is a compounded drug product. Not for resale.” 7. Single Active Ingredient: Each compounded product may contain only one peptide API from Appendix A. No peptide combinations. 8. Oral Bioavailability: Oral formulations require documentation demonstrating adequate human bioavailability. 9. Drug Delivery Devices: Only FDA 510(k)-cleared syringes may be packaged with or contain the compounded drug. 10. Compliance With Existing Law: Products must satisfy other applicable FD&C Act requirements, including sanitary compounding conditions and valid patient-specific prescriptions.

New: Top officials at HHS and FDA have been working to balance Health Secretary Robert F. Kennedy Jr.’s push to expand access to buzzy peptides with safety concerns raised by agency scientists. A peek behind the curtain with new details on the path ahead w/ the dream team @rileyraygriffin @g0ingmad @nyahphengsitthy 🎁: bloomberg.com/news/articles/…