On October 30, 2026, the Department of Health & Human Services (HHS) published a notice in the Federal Register announcing an “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” The Food and Drug Administration (FDA) is still building the Section 503A bulks list through rulemaking. Until it finishes, HHS does not intend to take enforcement action against State-licensed pharmacies, Federal facilities or licensed physicians that compound with six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
In support of this policy, HHS pointed to the recommendations made by the Pharmacy Compounding Advisory Committee (PCAC) and to data on peptide use, which it says shows significant interest in the use of these substances in compounding. HHS states that the policy will discourage widespread use of research-use-only peptides from foreign manufacturers that pose a safety risk to U.S. patients. Each peptide had been in Category 2 from September 2023 until April 22, 2026, and the Center for Drug Evaluation and Research (CDER) had recommended against listing all of them. HHS justified the inclusion for each peptide by pointing to newer evidence on the characterization records, documented historical use, and the safeguards built into the policy.
The policy is interim and non-binding, and HHS may revisit the policy if a safety signal or product quality issue arises. FDA may later propose adding some or all of the six peptides to the 503A bulks list.
The conditions for application of this interim enforcement policy are available here. It is noteworthy that the policy is described as the enforcement policy of HHS, not FDA. Most enforcement discretion policies relating to compounding have been issued by FDA.
Commentators have raised concerns about this permissive posture towards bulk compounding peptides, which stands in stark contrast to FDA’s recent adoption of a more stringent approach towards bulk compounding, such as in the context of GLP-1s. In particular, the American Society of Health-System Pharmacists (ASHP) raised concerns about the lack of clinical and safety data for these peptides, and the lack of sufficient guardrails relating to their use in compounding.
Compounding under this enforcement discretion policy has limitations beyond those identified in the policy itself. Because pharmacies compounding pursuant to Section 503A are subject to state oversight and licensure, they will be subject to limitations under state law. State boards of pharmacy may impose additional restrictions or choose not to recognize this enforcement discretion policy.
