Peptides: HHS Announces Limited Enforcement Discretion for Compounding of Six Peptides

The highly anticipated policy announcement from the Department of Health & Human Services (HHS) regarding the legality of compounding certain peptide drugs has finally arrived.

At issue is the applicable regulatory status of compounding by 503A pharmacies using six peptide bulk drug substances: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.  Written comments can be submitted until two weeks after the date of publication in the Federal Register (i.e., Nov. 13, 2026). 

Key Takeaways:

• For the six specified bulk peptides, HHS will exercise limited enforcement discretion under certain circumstances as outlined below.

• HHS does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using any of the six peptide bulk drug substances when all specified circumstances are met. The policy does not add these substances to the 503A bulks list or constitute FDA approval of the compounded products.

Background: For a bulk drug substance to satisfy section 503A’s bulk drug substance eligibility requirements, it must meet one of several conditions. It must,

• (1) comply with any applicable United States Pharmacopeia–National Formulary (USP/NF) monograph, or
• (2) be a component of an FDA approved drug, or
• (3) appear on FDA’s “bulks list.”

The six peptides in question do not meet any of these conditions.

In April 2026, FDA announced that a July 2026 meeting of the Pharmacy Compounding Advisory Committee (PCAC) would evaluate seven peptide products for inclusion on the bulks list (Emideltide was nominated in addition to the six listed above). A PCAC consultation is required before FDA may propose to add a bulk drug substance to the bulks list via notice-and-comment rulemaking – a rulemaking process that can take many months to years to complete.

At the July 2026 PCAC meeting, despite opposition from FDA career scientists, the PCAC narrowly voted in favor of recommending that FDA place the six peptides (out of seven considered) on the bulks list. On October 28, 2026, HHS issued the document, HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances(“limited enforcement discretion policy”). FDA’s future rulemaking may propose adding some or all of these substances to the bulks list.

Key Circumstances to be Met for Limited Enforcement Discretion:

This “limited enforcement discretion policy” states that the Secretary of HHS has determined that, if all specified circumstances are met, HHS does not intend to take enforcement action against covered compounders using these six peptide bulk drug substances. The circumstances include:

• The peptide appears in an appendix to the policy (i.e., the six peptides covered by the policy).
• The peptide has the identity and limited route of administration set forth in an appendix to the policy.
• The bulk drug substance is from an FDA-registered facility and includes a valid certificate of analysis (COA).
• The original bulk drug substance manufacturer is registered with FDA and in compliance with current good manufacturing practice (CGMP).
• Compounders report serious adverse events to FDA’s MedWatch program.
• Product labeling includes the statement: “This is a compounded drug product. Not for resale.”
• The compounded product only contains one single active ingredient.
• Compounders of oral peptide products maintain documentation that the specific formulation is adequately bioavailable in humans.
• The only drug delivery device co-packaged with or containing the compounded drug is an FDA 510(k)-cleared syringe.
• The product is compounded in accordance with all other applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

When all these circumstances are met, HHS does not intend to take action (i.e., it will exercise enforcement discretion) against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using one of the specified peptide bulk drug substances. The policy noted that the Secretary determined that the 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” and that it “advances patient choice and freedom while appropriately protecting patient safety.” Notably however, the policy also says that HHS “may revisit” the policy if it identifies a safety signal or product quality issues arise with a product in scope of the policy.

Foley will continue to monitor how this policy develops in practice, and what this eventually means for other peptide bulk drug substances that were not included.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, our Health Care & Life Sciences Sector, or our Health Care Practice Group with any questions.