Peptide Straight Talk · Flash · October 28, 2026
The Department of Health and Human Services has released the text of its new peptide compounding policy. It names six peptides: BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV. HHS says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound these peptides under section 503A of the Federal Food, Drug, and Cosmetic Act, as long as a list of conditions is met [1][2].
The notice went on public inspection at the Federal Register today, October 28, at 11:15 a.m. ET (10:15 a.m. CT). It is scheduled to publish in the Federal Register on Friday, October 30 [1].
The six peptides, their forms and routes
Each peptide is covered in one specific form and only for the routes listed in the policy's Appendix B [2].
Peptide | Form | Allowed route(s) |
|---|---|---|
BPC-157 | Acetate | Subcutaneous, intramuscular, oral, topical |
TB-500 | Acetate | Subcutaneous or intramuscular injection |
MOTS-c | Acetate | Subcutaneous or intramuscular injection |
Epitalon | Acetate | Subcutaneous or intramuscular injection, dispensed in intermittent courses |
Semax | Free base | Intranasal |
KPV | Acetate | Topical and oral |
In every case, the compounded product has to be made from an active ingredient that comes with a certificate of analysis (COA) meeting the policy's conditions [2].
What the policy is
Who issued it: the HHS Office of the Secretary. The notice is signed by HHS Secretary Robert F. Kennedy, Jr. [1]
What it does: it is an enforcement-discretion policy. HHS is saying it does not intend to act against compounding with these peptides, even though they are not yet on the 503A “bulks list” of substances pharmacies may compound with [1][2].
How long it lasts: it covers the period while FDA develops the 503A bulks list through rulemaking. For each peptide, it applies until a final rule decides whether that peptide is on the list [2].
Its status: the Federal Register notice calls it a “draft” policy, and the policy calls itself “interim.” It “does not establish any rights for any person and is not binding on HHS or the public” [1][2].
It is not FDA approval: HHS states that compounded drugs are not FDA-approved, meaning FDA does not review their safety, effectiveness or quality before they are marketed [1][2].
It can change: HHS may revisit the policy, in whole or in part, if a safety signal or product quality issue arises with a compounded product it covers [1][2].
What comes next: FDA's future rulemakings “may propose adding some or all of these peptides to the 503A bulks list based on the available evidence” [1].
Who it applies to
The policy covers state-licensed pharmacies, federal facilities and licensed physicians compounding under section 503A [1][2]. It applies to peptides that are not part of an FDA-approved drug, have no USP or NF monograph, and are not on the 503A bulks list at 21 CFR 216.23(a) [2].
The 10 conditions
All of the following must be met [2]:
On the list. The peptide is one of the six in Appendix A.
Correct identity and route. The peptide matches the identity in Appendix B (amino acid sequence, chemical structure, molecular weight and molecular formula, among other things) and is used only by the routes Appendix B allows.
Tested and documented. The bulk substance comes from an FDA-registered facility and has a valid COA with test results that meet FDA's criteria in Appendix B. HHS says this covers identity, purity, potency, and the absence of contaminants such as endotoxins, heavy metals, microbes and impurities.
Registered original manufacturer. The original manufacturer, not a later packer, repacker, labeler or distributor, is registered with FDA, follows current good manufacturing practice (CGMP) and other FD&C Act requirements, and has its facility's physical location listed on the COA. If the peptide comes through an FDA-registered repacker, relabeler or reseller, that company must have performed and documented validation of the manufacturer and its COA.
Reporting. Compounders report the products they make, serious adverse events and product quality problems to FDA and to the states where products are compounded and sent. Serious adverse events—regardless of whether they are considered drug-related—and product quality problems are reported to FDA through MedWatch. Product reports include the active ingredient and strength, the original manufacturer with its facility identifier, and the dosage form and route. Patient labeling should explain how to report problems.
Labeling. Product labeling includes the statement: “This is a compounded drug product. Not for resale.”
One peptide per product. Each product contains only a single active ingredient from Appendix A. HHS says this makes it easier to link side effects or outcomes to a specific substance.
Oral forms need supporting documentation. Because peptides are hard to absorb by mouth, a compounder making an oral form is expected to keep documentation that the specific formulation reaches an adequate level of oral bioavailability in humans.
Limits on packaged delivery devices. The only drug delivery device packaged with or containing the product is an FDA 510(k)-cleared syringe. HHS says more complex devices add patient risk.
Other applicable requirements. The product must meet all other applicable FD&C Act requirements, including the prohibition on insanitary compounding conditions and section 503A’s patient-specific prescription requirement.
Why HHS says it acted
HHS says the policy is meant to “discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers” that it says pose a safety risk, and to give patients “a more controlled alternative.” The Secretary determined that the policy “advances patient choice and freedom while appropriately protecting patient safety” [2].
HHS also cites significant interest in these peptides, based on the Pharmacy Compounding Advisory Committee (PCAC) and peptide-use data. It adds that public comments may provide more evidence for FDA's rulemaking [1][2].
The background in the text
According to Appendix B, all six peptides were in FDA's “Category 2” from September 2023 until April 22, 2026, and neither the placement nor the removal changed their status under section 503A. For each peptide, FDA's drug center (CDER) recommended against listing it, and the PCAC voted in favor [2].
HHS gives a separate justification for each peptide, citing updated manufacturing and testing information, documented historical use, and its assessment of the available safety evidence. The supporting evidence differs by peptide; these are HHS’s reasons for enforcement discretion, not findings of FDA approval [2].
Appendix B also sets a detailed testing standard for peptide ingredients. The required COA information includes the grade “Intended for human drug compounding” [2].
How to comment
Written comments can be submitted until two weeks after the notice publishes in the Federal Register (publication is scheduled for Friday, October 30) at Regulations.gov on Docket No. HHS-OASH-2026-0496 [1]. The HHS contact listed is Victoria Marshall, Office of the Assistant Secretary for Health, [email protected] [1]. HHS says its website has the most current version of the policy [1].
Sources
Federal Register, public inspection notice, “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” FR Doc. 2026-22192 (filed Oct. 28, 2026; publication Oct. 30, 2026). View the Federal Register notice
HHS, “HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” with Appendices A and B. View the HHS policy and appendices
Educational only. Not medical advice.
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