Breaking: October 30, 2026
HHS peptide compounding 2026: BPC-157 and 5 more peptides pharmacies can now make
On October 28, 2026 HHS said it will not go after 503A pharmacies, federal facilities or physicians that compound BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 for a named patient, as long as they stick to the routes and quality rules below. It is not FDA approval. It is a hold on enforcement while FDA writes the formal rule, and comments close November 13. New to this? Start with the plain-English guide.
Data as of . Part of the Peptide Evidence Index. License CC BY 4.0.
6
4 of 6
3 of 6
16.3%
How: A protocol listed with an unspecified route counts as covered.
Nov 13
The six peptides, route by route
Routes come from the policy's Appendix B. Evidence levels and dose protocols are ours, from each peptide's page: the last column counts published protocols that use a route the policy leaves out.
| Peptide | Pharmacies may compound it as | Not covered | Human evidence | Animal only | Protocols outside covered routes |
|---|---|---|---|---|---|
| BPC-157 | Subcutaneous injection, Intramuscular injection, Oral, Topical | Intravenous (IV), Nasal | Limited human data | No | 0 of 23 |
| Epitalon | Subcutaneous injection, Intramuscular injectionIn intermittent courses | Intravenous (IV), Oral, Nasal, Topical | Limited human data | No | 2 of 23 |
| KPV | Topical, Oral | Subcutaneous injection, Intramuscular injection, Intravenous (IV), Nasal | Animal data only | Yes | 11 of 18 |
| MOTS-c | Subcutaneous injection, Intramuscular injection | Intravenous (IV), Oral, Nasal, Topical | Animal data only | Yes | 0 of 16 |
| Semax | Nasal | Subcutaneous injection, Intramuscular injection, Intravenous (IV), Oral, Topical | Limited human data | No | 8 of 30 |
| TB-500 | Subcutaneous injection, Intramuscular injection | Intravenous (IV), Oral, Nasal, Topical | Animal data only | Yes | 0 of 19 |
Every product holds one peptide only, so blends such as BPC-157 with TB-500 are out. The policy names the salt form too: acetate for five of them, Semax as the free base.
The conditions
Miss one and the pharmacy is back outside the policy.
Who: 503A pharmacies, federal facilities and physicians
HHS says it will not take enforcement action against a state-licensed pharmacy, a federal facility or a licensed physician compounding with a peptide on the list.
Sources: HHS policy, Federal Register public inspection
A prescription for a named patient
The usual 503A rule stays: each product is compounded on a valid, patient-specific prescription.
Sources: HHS policy, Frier Levitt
Bulk powder from an FDA-registered, CGMP manufacturer
The original maker of the peptide powder, not a repacker or distributor, must be registered with FDA (section 510), follow current good manufacturing practice, and print its facility address on the certificate of analysis. A registered reseller must have validated that maker and its certificate.
Sources: HHS policy, FDA Law Blog
A lot certificate of analysis with real testing
Each lot needs a certificate of analysis that matches the peptide's exact identity in Appendix B (sequence, formula, molecular weight) and reports the testing standard there: identity, assay, peptide impurities, residual solvents, elemental impurities, counter-ion, water, bioburden and bacterial endotoxins.
Sources: HHS policy, Frier Levitt
One peptide per product
Each product may contain only one active ingredient from the list. Blends and stacks, such as BPC-157 with TB-500, are outside the policy.
Sources: HHS policy, FDA Law Blog
Only the routes listed for each peptide
Each peptide is covered only in the dosage forms the policy names (the table above). For an oral form the pharmacy must keep documentation that the exact formulation is absorbed well enough in humans.
Sources: HHS policy, BakerHostetler
Syringes, labels and safety reports
The only device that may come with a product is a 510(k)-cleared syringe. Labels read "This is a compounded drug product. Not for resale." Pharmacies report what they compound, plus serious adverse events and quality problems, to FDA MedWatch and the states involved.
Sources: HHS policy, FDA Law Blog
What it does not cover
Every other peptide
Only the six on the list. CJC-1295, ipamorelin, AOD-9604, GHK-Cu, Selank and the rest are not covered, including the five FDA advisers have not voted on yet.
Sources: Frier Levitt, FDA Law Blog
Routes not on a peptide's list
No peptide is covered for IV use. Injectable KPV and injectable Semax are out; KPV is topical and oral only, Semax is nasal only. Other forms of the molecule are out too, such as N-acetyl Semax amidate.
Sources: HHS policy, BakerHostetler
503B outsourcing facilities
The larger outsourcing facilities that make medicines in higher volumes are not covered.
Sources: BakerHostetler, Frier Levitt, NPR
Research chemicals and supplements
Products sold as research chemicals or dietary supplements get nothing from this policy.
Source: BakerHostetler
FDA approval
It is a draft, non-binding enforcement policy, not approval and not a listing. It holds until FDA settles each peptide in a final 503A bulks rule, and HHS may revisit it if a safety signal or quality problem shows up.
Sources: HHS policy, Federal Register public inspection
How we got here
Every date links to the source we read. The full review history, with the advisory votes and the five peptides still waiting, is on the peptides in FDA's compounding review.
FDA lists BPC-157 and others as compounding safety risks
FDA's 503A list update puts BPC-157, the TB-500 fragment and other peptides in Category 2, so pharmacies stop compounding them.
Source: FDA
FDA takes 12 peptides off Category 2
Their nominations were withdrawn, so FDA removed them and sent them to its advisers. Leaving the list did not make them legal to compound.
Sources: FDA, Holland & Knight
FDA advisers back six of seven
The Pharmacy Compounding Advisory Committee recommends BPC-157, KPV, TB-500, MOTS-c, epitalon and Semax for the 503A bulks list, against FDA staff advice, and turns down DSIP. Advisory only.
Interim peptide policy goes to the White House budget office
HHS and FDA send an "Interim Access Policy for Compounding Using Certain Peptides" to the Office of Management and Budget for review.
Sources: Holland & Knight, AP
HHS announces enforcement discretion for the six
HHS releases the policy and files it with the Federal Register at 11:15 am. It is signed by HHS Secretary Robert F. Kennedy Jr.
Sources: Federal Register public inspection, HHS policy, NPR
Published in the Federal Register; comments open
FR Doc. 2026-22192 (91 FR 68526), docket HHS-OASH-2026-0496. Anyone can comment on regulations.gov.
Sources: Federal Register, Regulations.gov
Comment period closes
Comments are accepted until 11:59 pm Eastern on November 13, 2026, two weeks after publication. Late comments are not accepted.
Sources: Regulations.gov, Federal Register public inspection
How it is counted
Which peptides and routes: the records whose FDA status is HHS enforcement discretion, with the routes stored on that status. “Not covered” lists the common routes (injection under the skin or into muscle, IV, oral, nasal, topical) missing from a peptide's list. A dose protocol counts as outside when its route is one the policy does not list for that peptide.
Sources: the HHS policy with its appendices (read from the Internet Archive copy, because hhs.gov refuses automated fetches), the Federal Register notice and the regulations.gov docket, cross-checked against law-firm readings and NPR's report.
Human evidence is the strongest level any source shows for the peptide. “Animal only” means animal or cell studies alone.
Every number on this page is computed in code from the same records that build our peptide pages; no model writes one. Full rules on the methodology page, and the whole dataset is free to download.
Licensed CC BY 4.0. Reuse any number, including in commercial work. Credit “TruePeptideSource” and link to this page.
Cite this dataset
TruePeptideSource. (2026). HHS peptide compounding 2026: BPC-157 and 5 more peptides pharmacies can now make (Peptide Evidence Index, version 2026-10-30) [Data set]. https://truepeptidesource.com/data/hhs-peptide-compounding-2026