Key Takeaways
- The interim policy provides enforcement discretion for BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 while FDA continues rulemaking on the 503A bulks list.
- Compounders must meet detailed requirements involving peptide identity and permitted routes of administration, FDA-registered and CGMP-compliant manufacturers, certificates of analysis and testing, patient-specific prescriptions, adverse-event and product-quality reporting, labeling, and single-API formulations.
- HHS describes the policy as interim and may revisit it if safety signals or product-quality concerns arise.
In a development for patient access and pharmacy compounding, the U.S. Department of Health and Human Services (HHS) announced the availability of the ‘Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.’ The policy, issued under the authority of the HHS secretary, describes the circumstances in which HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound drug products containing specified peptide bulk substances while rulemaking on the 503A bulk substances list continues.
The peptides addressed in the policy and route of administration parameters are as follows:
- BPC-157 acetate: subcutaneous, intramuscular, oral and topical dosage forms
- TB-500 acetate: subcutaneous or intramuscular injectable dosage forms
- Epitalon acetate: subcutaneous or intramuscular injectable dosage forms, dispensed in intermittent courses
- Semax free base: intranasal use
- KPV acetate: topical and oral dosage forms
- MOTS-c acetate: subcutaneous or intramuscular injectable dosage forms
Under the policy, enforcement discretion applies when the following are in place:
- A licensed pharmacist or licensed physician must compound the drug product using the standards outlined in the announcement.
- The peptide bulk substance is one of the six listed and matches the identity and route of administration parameters described in the policy.
- The bulk substance is manufactured by an establishment registered with the U.S. Food and Drug Administration (FDA) under Section 510 of the Federal Food, Drug, and Cosmetic Act and is accompanied by a valid certificate of analysis that includes testing consistent with the criteria referenced in the policy.
- The original manufacturer is in compliance with Current Good Manufacturing Practice requirements.
- The drug product is compounded pursuant to a valid patient-specific prescription and contains only a single active ingredient from the list.
- Serious adverse events and product quality issues are reported to FDA’s MedWatch program and the relevant state authorities.
- Labeling includes the statement “This is a compounded drug product. Not for resale.”
- For any oral dosage form, the compounder maintains documentation confirming adequate bioavailability.
- The only co-packaged or containing delivery device is an FDA-cleared syringe.
- All other applicable requirements of Section 503A and the Federal Food, Drug, and Cosmetic Act are satisfied, including compounding under sanitary conditions.
The policy does not constitute FDA approval and does not apply to outsourcing facilities operating under Section 503B or to products sold as research chemicals or dietary supplements. HHS has stated that it may revise or withdraw the policy in whole or in part if safety signals or product quality issues arise.
The notice is scheduled for formal publication in the Federal Register Oct. 30. Comments may be submitted until two weeks after publication in the Federal Register. The unpublished PDF version is available here.
For additional information about this policy, please contact Lee Rosebush, who is a registered pharmacist and an attorney at BakerHostetler with deep experience in FDA regulation, pharmacy law and the Drug Quality and Security Act. He has long advocated for clear, science-based rules that keep patients in the regulated healthcare system rather than in the gray and black markets and that provide patients and providers with safe access to the medications they need.
During the July Pharmacy Compounding Advisory Committee meetings, Rosebush and supporting organizations spoke during the public comment period. He and the American Academy of Peptide Medicine also highlighted efforts to raise standards, including the creation of the Peptide Council to support pharmacy accreditation and manufacturing quality controls for compounded peptides.
Lee Rosebush can be reached at lrosebush@bakerlaw.com.
