The Department of Health and Human Services said Wednesday it will not take enforcement action against licensed compounding pharmacies and physicians that make six peptides the Food and Drug Administration has never approved, including BPC-157 and TB-500, opening a temporary legal path for products that have been sold mostly online as “research chemicals.”
The policy, signed by Health Secretary Robert F. Kennedy Jr., covers BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. HHS filed a notice with the Federal Register on Oct. 28 announcing the availability of the policy, which the notice calls a draft and which is scheduled for formal publication on Oct. 30. The policy document says it will stay in place while the FDA decides, through rulemaking, whether to add the peptides to the official list of ingredients compounders may use.
“By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative,” Kennedy wrote in the document.
What exactly did HHS announce?
Under federal law, a pharmacy that compounds a drug, meaning it mixes ingredients into a medicine tailored to one patient, can generally only use ingredients that are part of an FDA-approved drug, are covered by a U.S. Pharmacopeia monograph, or appear on a list set by regulation. None of the six peptides meets those tests today, according to the policy.
Instead of changing that list, which requires a formal rule, HHS used what is known as enforcement discretion. The department says it “does not intend to take enforcement action” against a state-licensed pharmacy, federal facility or licensed physician that compounds one of the six peptides, as long as a list of conditions is met. NBC News reported that, in practice, the move means pharmacies can begin offering the peptides now.
The department says it may revisit the policy, in whole or in part, if a safety signal or product quality problem emerges. The Federal Register notice says written comments can be submitted through regulations.gov, under docket HHS-OASH-2026-0496, for two weeks after the notice is published.
Which peptides are covered, and how can they be used?
The policy limits each peptide to specific forms:
- BPC-157: injections under the skin or into muscle, oral and topical forms.
- TB-500: injections under the skin or into muscle.
- Epitalon: injections under the skin or into muscle, given in intermittent courses.
- MOTS-c: injections under the skin or into muscle.
- Semax: nasal use only.
- KPV: topical and oral forms.
Peptides are short chains of amino acids. Some, such as insulin and the GLP-1 drugs used for diabetes and weight loss, are FDA-approved medicines. The six in this policy have been promoted online for uses ranging from faster healing to anti-aging, but none has been approved by the FDA for any condition.
What safeguards do pharmacies have to follow?
To fall under the policy, compounders must meet 10 conditions. Among them:
- The raw ingredient must come from an FDA-registered manufacturer and carry a certificate of analysis showing tests for identity, purity, potency and contaminants such as endotoxins, heavy metals and microbes.
- Pharmacies must report serious adverse events, whether or not they appear drug-related, and product quality problems to the FDA’s MedWatch program and to the states involved.
- Each product may contain only one of the six peptides, a rule HHS says makes it easier to link side effects to a specific substance.
- Labels must say, “This is a compounded drug product. Not for resale.”
- The only delivery device allowed is an FDA-cleared syringe, and oral products need documentation showing the body actually absorbs them.
- Products still require a valid prescription for an individual patient.
Why is HHS doing this now?
Kennedy has argued that Americans are already buying these peptides through a “gray market” of websites that label them “for research use only.” The policy says the Secretary determined that allowing limited compounding “will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients.”
The document also says the FDA’s Pharmacy Compounding Advisory Committee voted in favor of including each of the six peptides, and that HHS now has manufacturing test data and records of how widely the products are used that were not available to agency reviewers earlier.
“Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides,” HHS spokesperson Emily Hilliard said in a statement to NBC News.
What do critics and FDA reviewers say?
The FDA’s own drug center, the Center for Drug Evaluation and Research, had recommended against allowing each of the six peptides to be compounded, according to the HHS policy itself. NBC News reported that FDA scientists concluded there is insufficient data to show the peptides are safe and effective.
Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest, told NBC News the FDA was essentially “turning a blind eye” to widen access to drugs that have not been proven to work.
What should patients know before trying a compounded peptide?
Compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness or quality before they are sold, as the FDA notes and the HHS policy itself states. The new policy does not change that. It also does not cover peptides sold as research chemicals, products that mix more than one of the six peptides, or other peptides that are not on the list.
Anyone considering one of these products should talk with a doctor, use only a licensed pharmacy that fills an individual prescription, and report side effects to MedWatch. The FDA has separately warned about unapproved versions of other popular drugs sold online, a problem HNC covered in its report on the experimental weight-loss drug retatrutide.
Key Takeaways
- HHS said Oct. 28 it will not take enforcement action against licensed pharmacies and doctors that compound six unapproved peptides: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500.
- The interim policy lasts while the FDA decides through rulemaking whether to add the peptides to its approved compounding ingredient list.
- Pharmacies must use tested ingredients from FDA-registered makers, make single-peptide products, require a prescription and report serious side effects to the FDA.
- The FDA’s drug center had recommended against allowing the peptides, and none is FDA-approved for any use.
Frequently Asked Questions
Which peptides does the new HHS policy cover?
The policy covers six peptides: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. Each is limited to certain forms, such as injections, nasal spray or topical use.
Are BPC-157 and TB-500 now FDA-approved?
No. The policy does not approve any of the six peptides. It says HHS will not take enforcement action against licensed pharmacies and physicians that compound them under certain conditions while the FDA considers a formal rule.
Do I need a prescription for compounded peptides?
Yes. The policy requires that products be compounded under a valid prescription for an individual patient, by a state-licensed pharmacy, federal facility or licensed physician.
Can the public comment on the policy?
Yes. The Federal Register notice says written comments can be submitted at regulations.gov under docket HHS-OASH-2026-0496 for two weeks after the notice is published on Oct. 30, 2026.
Is the policy permanent?
No. HHS calls it an interim policy that applies until the FDA decides each peptide’s status through rulemaking, and says it may revisit the policy if safety or quality problems arise.
Featured image: A U.S. Air Force pharmacy technician prepares an IV medication in a hospital pharmacy, 2016. Illustrative photo; it does not show peptide compounding. (U.S. Air Force photo by Senior Airman Justyn M. Freeman, public domain, via Wikimedia Commons)
