A draft enforcement policy published by the U.S. Department of Health and Human Services in the Federal Register on October 30, 2026 sets out an interim approach to six peptide bulk drug substances used in 503A compounding. The Precision Peptide Company (CSE: BPC), which takes its ticker from BPC-157, issued a statement on November 3 saying the policy is potentially relevant to its U.S. prescription platform.

Section 503A of the Federal Food, Drug, and Cosmetic Act is the pathway that lets state-licensed pharmacies compound a drug for an individual patient against a specific prescription. HHS says the policy is an interim measure while the FDA develops its list of bulk substances eligible for that pathway, and that the intent is to expand patient access while protecting patient safety.

The conditions attached

Under the policy, HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding from the six peptides, provided defined conditions are met. Those include a single active ingredient per product, bulk substance from an FDA-registered manufacturer operating under current good manufacturing practice, a valid lot-level certificate of analysis, a patient-specific prescription, and reporting of serious adverse events to the FDA.

That list is the most interesting part of the document, and it is the part the press release treats as a selling point rather than a hurdle. Verified sourcing and lot-level testing are exactly what the gray peptide market has never had.

Routes, not just substances

The policy also specifies recognized routes of administration for each peptide. BPC-157 is recognized for subcutaneous, intramuscular, oral and topical forms, KPV for oral and topical, Semax for intranasal, and Epitalon, MOTS-c and TB-500 for injectable forms.

Three of the six therefore carry non-injectable recognition, which is the hook the company builds its statement around. BPC says needle-free delivery has been its focus from the start, and that it now offers patches, oral and topical formulations and clinician-prescribed therapies under one brand.

Draft means draft

HHS states plainly that the policy is not binding and may be revised or withdrawn, including if a safety signal or product quality issue arises. It applies only to compounded products prepared under 503A and does not constitute FDA approval of any peptide.

Whether any of the six substances actually joins the 503A bulks list will be decided through future FDA rulemaking. The July 2026 Pharmacy Compounding Advisory Committee vote recommending the same six is a signal, not a decision.

Where this sits

The company says it is evaluating with its 503A compounding partner how the policy may apply to its 16-therapy prescription formulary, announced October 29. Compounded medications are not FDA-approved and have not been evaluated by the agency for safety, effectiveness or quality, a caveat the release carries and that any coverage of this story should carry too.