# HHS opens compounding to 6 peptides: what changed on October 28, 2026

*Astra Health · Last updated October 28, 2026 · Web version: https://try-astra.com/news/hhs-peptide-compounding-policy/*

## The short answer

On **October 28, 2026**, the U.S. Department of Health and Human Services (HHS) issued an interim **enforcement-discretion policy** for six peptides: **BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV**. HHS says it will not take enforcement action against a **state-licensed 503A compounding pharmacy, a federal facility or a licensed physician** that compounds one of them for a patient with a valid prescription, **as long as ten conditions are met**.

This is **not FDA approval**. None of the six is an FDA-approved drug, and the policy says so. It is a temporary pathway that lasts until FDA finishes rulemaking on each peptide, and HHS can withdraw it if a safety or quality problem appears.

## What changed: the timeline

| Date | What happened |
|---|---|
| Sept 29, 2023 | FDA places all six on its Category 2 list of bulk substances that raise "significant safety risks". Pharmacies stop compounding them |
| Apr 22, 2026 | FDA removes them from Category 2. That alone did not make them compoundable under section 503A |
| Jul 23–24, 2026 | FDA's Pharmacy Compounding Advisory Committee (PCAC) votes in favor of all six and against a seventh, DSIP (emideltide). FDA's drug center (CDER) had recommended against listing every one of them |
| Oct 15, 2026 | Reuters reports that a draft peptide compounding policy has been submitted for review |
| **Oct 28, 2026** | **HHS files the enforcement-discretion policy** (Docket HHS-OASH-2026-0496, FR Doc 2026-22192) |
| Oct 30, 2026 | Official publication in the Federal Register |
| About Nov 13, 2026 | Public comment window closes (two weeks after publication) at regulations.gov |
| Not yet scheduled | FDA rulemaking decides whether each peptide joins the permanent 503A bulks list. The interim policy ends for a peptide once that final rule exists |

The policy is issued by the HHS Secretary's office and does not state FDA's own position. Lawyers at Hyman, Phelps & McNamara note that only six substances have completed 503A bulks-list rulemaking in roughly 15 years, so "interim" may last a long time. It could also end quickly if a safety signal appears.

## The six peptides, and the only forms covered

The policy covers one specific chemical form of each peptide, by specific routes. Anything else falls outside it.

| Peptide | Form covered | Routes covered | Not covered |
|---|---|---|---|
| BPC-157 | acetate | injection (subcutaneous or intramuscular), oral, topical | nasal sprays; other salt forms such as arginate |
| TB-500 | acetate | injection (subcutaneous or intramuscular) | oral, nasal, topical |
| MOTS-c | acetate | injection (subcutaneous or intramuscular) | oral, nasal |
| Epitalon | acetate | injection (subcutaneous or intramuscular), in intermittent courses | continuous use; nasal |
| Semax | free base | intranasal | injection |
| KPV | acetate | oral, topical | injection |

Source: HHS policy, Appendix B, which also lists each peptide's amino-acid sequence, molecular formula and HHS's reasoning.

## Why HHS overrode its own scientists

For all six peptides, CDER recommended against adding them to the 503A list, while the advisory committee voted in favor. HHS gives the same three-part reason in each case:

1. **New quality data.** Lot-specific certificates of analysis from FDA-registered manufacturers now report the identity, purity, endotoxin, microbial and residual-solvent results CDER had found missing.
2. **Documented use.** Real-world compounding use is now "documented and quantified" where CDER had been unable to measure it.
3. **Safeguards.** HHS describes CDER's safety concerns as "mechanistic" or "inferential" rather than observed harm, and points to the policy's own conditions (single ingredient, lot testing, adverse-event reporting) as the control.

HHS also states a policy goal: to "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers" by giving patients "a more controlled alternative".

## The 10 conditions

HHS's forbearance applies only when all ten are met. Read them as a checklist.

| # | Condition | What it means in practice |
|---|---|---|
| 1 | The peptide is listed in Appendix A | One of the six named above |
| 2 | Identity and route match Appendix B | The covered form, by a covered route |
| 3 | The raw ingredient comes from an FDA-registered (section 510) facility with a full certificate of analysis | Tested for identity, purity, potency, endotoxins, heavy metals, microbes and residual solvents |
| 4 | The original manufacturer is FDA-registered, follows CGMP and is named on the certificate | Resellers must document that they validated the manufacturer and its certificate |
| 5 | Serious adverse events and quality problems are reported to FDA MedWatch and to the states | The reporting procedure must be on the patient's label |
| 6 | The label reads "This is a compounded drug product. Not for resale." | Required wording |
| 7 | Only one active ingredient | No blends or "stacks" |
| 8 | Oral forms need documented human bioavailability | Capsules need evidence that the peptide is absorbed |
| 9 | The only device is an FDA 510(k)-cleared syringe | No pens or auto-injectors |
| 10 | A patient-specific prescription and all other FD&C Act requirements | A licensed clinician must evaluate the patient |

### What the conditions exclude

- **Blends.** Combination products such as BPC-157 with TB-500 fail condition 7. HHS says single-ingredient products make it possible to attribute side effects to a specific substance.
- **Pens and auto-injectors.** Condition 9 allows a 510(k)-cleared syringe only.
- **"Research use only" products.** These have no prescription, no licensed pharmacy and no adverse-event reporting. HHS designed the policy to draw patients away from them.

## Compounded, research-use and FDA-approved: the differences

| | FDA-approved drug | Compounded under the HHS policy | "Research use only" peptide |
|---|---|---|---|
| FDA reviewed safety and effectiveness | Yes | No | No |
| Prescription | Required | Required, patient-specific | None, sold as "not for human use" |
| Made by | FDA-inspected manufacturer | State-licensed 503A pharmacy | Unlicensed vendor, often overseas |
| Raw-material testing | Full FDA review | Certificate of analysis from a registered manufacturer, per lot | The seller's own claim |
| Adverse-event reporting | Mandatory | Required by the policy (MedWatch) | None |
| Clinician oversight | Yes | Yes | None |

## What it costs: published BPC-157 prices

These prices were published by providers **before** the policy took effect, checked October 14 to 15, 2026 and compiled by PeptideCareIndex. Some may change as providers adapt to the conditions above.

| Provider | Purchase | Published first-order cost | Repeat order |
|---|---|---|---|
| Rx Peps Direct | 15 mg vial | $134 ($80 product, $39 review, $15 shipping) | $134 |
| Love My Peptides | 15 mg vial | $234 ($120 product, $99 visit, $15 shipping) | $135 |
| Pepti | four-week fill, 5 to 30 mg | $209 to $299 per fill | Same, every 28 days |
| Moonshot Medical | monthly plan, in person | $250 a month, or $635 for three months | Not stated |
| Desert Mobile Medical | monthly program | $399 a month plus a processing fee | Not stated |
| Florida Surgery & Weight Loss Center | one-month program | From $449, including a $99 consultation | Not stated |
| Research-chemical sellers | 5 mg vial labeled "not for human use" | About $40 to $60 | Not a prescription product |

A prescription costs more than a research vial because it includes a clinician, a licensed pharmacy and a tested ingredient from a registered manufacturer.

## What the policy does not settle

- **Safety and effectiveness.** FDA's own scientists recommended against all six, citing limited human data. Much of the research on BPC-157 and TB-500 is in animals.
- **State law.** State boards of pharmacy can still restrict these peptides. Whether states follow HHS is an open question.
- **How long it lasts.** HHS can revisit the policy "in whole or in part" if a safety signal or quality issue appears.
- **Sport.** BPC-157 and TB-500 remain on the World Anti-Doping Agency's prohibited list.

## Frequently asked questions

**Is BPC-157 legal in the US now?**
As of October 28, 2026, HHS says it will not take enforcement action against a licensed 503A pharmacy or physician compounding BPC-157 acetate for a patient with a prescription, if ten conditions are met. BPC-157 is still not FDA-approved, and research-chemical BPC-157 is still not sold for human use.

**Which peptides does the HHS policy cover?**
Six: BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV. DSIP (emideltide) was voted down by the FDA advisory committee and is not covered.

**Are compounded peptides FDA-approved?**
No. Compounded drugs are not FDA-approved, and the policy states that it does not establish their safety or effectiveness.

**Does the policy cover BPC-157 and TB-500 blends?**
No. It covers products with a single active ingredient only.

**Can KPV or Semax be injected under the policy?**
No. KPV is covered for oral and topical use only, and Semax for intranasal use only.

**Is TB-500 legal to buy in 2026?**
Only as a prescription compounded by a state-licensed pharmacy, as an injection, under the policy's conditions. TB-500 sold as a research chemical is not for human use.

**How long will the policy last?**
Until FDA issues a final rule for each peptide, or until HHS withdraws it. There is no fixed end date.

**How can I comment on the policy?**
At regulations.gov, docket HHS-OASH-2026-0496, until about November 13, 2026.

## Sources

- HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B: https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
- Federal Register notice, FR Doc 2026-22192, Docket HHS-OASH-2026-0496: https://public-inspection.federalregister.gov/2026-22192.pdf
- FDA, Bulk drug substances used in compounding under section 503A: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- Hyman, Phelps & McNamara, FDA Law Blog, "The PEPTIDE-L Wave Reaches HHS" (October 28, 2026): https://www.thefdalawblog.com/2026/10/the-peptide-l-wave-reaches-hhs-enforcement-discretion-not-the-finish-line/
- Reuters, "US health department to allow temporary sale of some unapproved peptides" (October 28, 2026): https://www.reuters.com/legal/litigation/us-health-department-allow-temporary-sale-some-unapproved-peptides-2026-10-28/
- PeptideCareIndex, BPC-157 cost survey (checked October 14 to 15, 2026): https://peptidecareindex.com/bpc-157-cost/

*This article is educational and is not medical advice. Compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness or quality.*