HHS Peptide Compounding Policy: What Changes?

Peptide compounding is entering a new phase in the United States.

The Department of Health and Human Services (HHS) announced an interim enforcement-discretion policy covering six peptide substances used by 503A compounders.

The policy means HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians using the listed ingredients, provided they meet specified conditions.

The move comes as telehealth company Hims & Hers prepares to expand its peptide offerings and manufacture BPC-157 and TB-500 domestically, renewing attention to oversight, product quality and patient safety.

What does the HHS peptide compounding policy cover?

It covers six substances:

• BPC-157
• Epitalon
• KPV
• MOTS-c
• Semax
• TB-500

It covers specified forms and routes of administration, rather than unrestricted use, and applies to compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act while HHS and the FDA develop the 503A bulk list.

HHS says the approach is intended to expand and improve patient access to peptides.

Also Read: How Pharma Contract Manufacturing Can Win Big in Weight-Loss Drugs

Does the policy mean these peptides are FDA-approved?

No. Compounded drugs are not FDA-approved, and the agency does not review their safety, effectiveness or quality before marketing.

For peptide compounding, enforcement discretion is not drug approval or proof that a substance is safe and effective. FDA scientific staff have raised concerns about the evidence and potential risks associated with some of these substances.

How could the change affect pharmaceutical manufacturing?

Hims & Hers said it plans to offer NAD+, sermorelin and glutathione treatments, and later manufacture BPC-157 and TB-500 in the United States.

The announcement puts domestic production and quality control in focus as demand for peptide products grows.

Potential opportunities include:

• Pharmaceutical-grade active ingredient production.
• Peptide synthesis, purification and analytical testing.
• Traceable sourcing, batch documentation and quality assurance.

However, the policy applies to qualifying 503A compounding; it does not create a blanket pathway for commercial-scale manufacturing. Companies must still meet applicable federal and state requirements.

The change creates a regulatory opening while making evidence, ingredient quality and patient-safety monitoring critical as peptide compounding expands.