In late October 2026, the Department of Health and Human Services and the FDA published a policy that changes how six compounded peptides can be prepared in the United States. Under it, the FDA will not enforce certain compounding rules against state-licensed 503A pharmacies that prepare BPC-157, TB-500, KPV, MOTS-c, Epitalon or Semax, as long as the pharmacy meets a list of conditions. The six are the compounds the FDA's Pharmacy Compounding Advisory Committee reviewed on July 23 and 24, 2026. DSIP was not included. This article explains what the policy says, what it does not say, and what it means for a patient who has read about these compounds.
The short version
The FDA is choosing not to enforce some compounding rules for six compounds while it writes a final rule. The compounds are still not FDA-approved. A prescription from a licensed clinician is still required. Most vials sold online as "research use only" do not meet the policy's sourcing rule. Pallas does not offer any of the six today.
What happened
The notice is Federal Register document 2026-22192, filed under docket HHS-OASH-2026-0496. It opens a public comment period of two weeks after publication. The policy is in effect from publication and lasts until the FDA issues a final rule on these compounds.
The policy is a statement of enforcement discretion. That is a specific legal term. It means the agency has decided, for now, not to take action against pharmacies that compound these six compounds within the policy's conditions. It does not place the compounds on the section 503A bulks list, and it does not approve them.
The government says this plainly in the policy itself. Compounded drugs are not FDA-approved. The FDA does not review their safety, effectiveness or quality before they are marketed. A reader who sees a headline saying the FDA "approved" these compounds is reading a headline that is wrong.
What a pharmacy has to do to qualify
The policy applies only to 503A pharmacies, which prepare a medication for one named patient against a valid prescription. To stay inside it, a pharmacy must meet every one of these conditions.
- Sourcing. The bulk substance has to come from a manufacturer registered with the FDA, meet the specifications the FDA published for that compound, and arrive with a certificate of analysis that matches those specifications.
- Reporting. The pharmacy has to report adverse events and quality problems to the FDA through MedWatch.
- Labeling. Every product has to carry the words "This is a compounded drug product. Not for resale."
- One active ingredient. A product may contain only one of the six. Combination products, often marketed online as "stacks," are outside the policy.
- Injectables. An injectable product has to be dispensed in a standard syringe the FDA has cleared through its 510(k) process.
- Oral forms. A pharmacy that prepares an oral form has to hold documentation that the compound is absorbed in humans by that route.
- State law. The policy changes nothing about state pharmacy law. A pharmacy still needs its state license and still has to follow its state board's rules.
The routes and uses the committee reviewed
The policy's appendix lists a route of administration for each compound. It also records the use the advisory committee reviewed in July. Reviewed is the right word. The committee looked at the evidence for each use. It did not approve any of them, and the FDA has not approved any of them.
| Compound | Route in the appendix | Use the committee reviewed |
|---|---|---|
| BPC-157 | Subcutaneous, intramuscular, oral or topical | Ulcerative colitis |
| TB-500 | Injection | Wound healing |
| KPV | Topical or oral | Wound healing and inflammation |
| MOTS-c | Injection | Obesity and osteoporosis |
| Semax | Intranasal | Cerebral ischemia and migraine |
| Epitalon | Injection, given in courses | Insomnia |
A product outside its listed route is outside the policy. An intranasal product of a compound listed for injection, for example, would not be covered.
What this means for a patient
Four points matter most.
First, almost nothing sold online today meets the sourcing rule. Vials labeled "research use only" or "not for human consumption" are, by their own labels, not drug products from an FDA-registered manufacturer with a conforming certificate of analysis. A pharmacy cannot use them under this policy. A patient should not assume a vial bought that way is the thing the policy describes.
Second, compliant supply will take time. Manufacturers have to register, produce material to the published specifications and document it. Pharmacies then have to source that material, validate their process and build the reporting steps the policy requires. Compliant supply is expected to take months, not weeks.
Third, a prescription from a licensed clinician is still required. The 503A pathway exists for one patient at a time, and only after a clinician has decided the compound is appropriate for that patient. A website that sells any of the six without a clinician's prescription is not operating under this policy.
Fourth, the policy can change. A comment period is open, and the policy ends when a final rule replaces it. The final rule may be narrower or broader than today's policy.
Questions to ask a provider
A patient offered one of the six compounds can ask a short set of questions. The answers should be specific.
- Is the pharmacy a state-licensed 503A compounding pharmacy, and in which state?
- Where does the bulk substance come from, and is that manufacturer registered with the FDA?
- Does the product come with a certificate of analysis that matches the FDA's published specifications?
- Does the pharmacy report adverse events and quality problems through MedWatch, and how would a patient report a problem?
- Is the product a single active ingredient, or a combination?
- Will a licensed clinician review the patient's history and write the prescription?
A provider that cannot answer these questions is not operating inside the policy.
Where Pallas stands
Pallas does not offer any of the six today. If one becomes available through its pharmacy partners under the conditions above, Pallas will say so on its site. Readers who want to hear when a new treatment is added can leave an email address at What's next.
Sources
- Federal Register. Document 2026-22192. Docket HHS-OASH-2026-0496.
- U.S. Department of Health and Human Services. Section 503A Peptide Enforcement Discretion Policy, Appendix B.
- U.S. Food and Drug Administration. July 23 and 24, 2026: Meeting of the Pharmacy Compounding Advisory Committee.
- U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act.
