Policy tracker
Peptide policy tracker
Last checked: October 21, 2026. Educational only, not medical advice. PeptideX is not affiliated with any drug manufacturer.
Educational only, not legal or medical advice. The interim-policy section was checked October 21, 2026. The compounding timeline below it was last source-checked October 10, 2026 and is historical context, not a new verification.
Status today
| Item | Status | Source |
|---|---|---|
| Policy name | Interim Access Policy for Compounding Using Certain Peptides | reginfo.gov |
| Agency | HHS / FDA (RIN 0910-ZD94) | reginfo.gov |
| Sent to White House (OMB/OIRA) review | October 14, 2026 | reginfo.gov |
| Stage | Notice; "Economically significant: No"; no legal deadline | reginfo.gov |
| OMB stakeholder meetings | Scheduled Oct 21 and Oct 23, 2026 | reginfo.gov meetings |
| Policy text / list of peptides | Not public | none yet |
| In effect? | No | none |
What it is, and what it isn't
- Is: an FDA policy, under White House review, about compounding certain peptides. The title alone tells you that much.
- Reported, not confirmed: news coverage says it would let qualifying compounding pharmacies make some popular peptides (BPC-157 is frequently named) under FDA enforcement discretion (AP, Politico). HHS Secretary Kennedy has publicly said the administration wants a regulated, quality-controlled market for peptides (AP, Oct 20 2026).
- Isn't: FDA approval of any peptide. It does not establish that any peptide is safe or effective, and it does not make "research use only" products legal for human use.
Why it matters
Today, many popular peptides are sold online labeled "research use only." The FDA does not treat those as approved drugs. A compounding policy could create a supervised, prescription-based route for some of them. Which peptides it covers, under what conditions, and when it starts are all unknown until the text is published.
What to watch next
- OMB concludes its review (watch the reginfo.gov entry).
- FDA publishes the text, likely as a notice or guidance on FDA.gov or in the Federal Register.
- The list of covered peptides and the conditions for pharmacies.
- Any public comment period.
Related
- FDA human drug compounding
- FDA concerns with unapproved GLP-1 drugs
- PeptideX compound profiles (evidence tiers)
- Retatrutide approval tracker
Compounding record
These rows are the shared compound dataset's identity-specific labels. A salt, fragment, or route that FDA did not name does not inherit another record's label. Regulatory sources for these rows were checked October 10, 2026. That date is not a check of the October 2026 interim policy.
HHS proposed 503A enforcement discretion (not final). FDA substance context: BPC-157. Named in the proposed HHS 503A enforcement-discretion notice (Federal Register 2026-22192, October 2026). The policy is proposed, not final, and is not FDA approval. FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks. Regulatory source checked October 29, 2026. Sources: https://www.federalregister.gov/public-inspection/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
HHS proposed 503A enforcement discretion (not final). FDA substance context: Thymosin beta-4 fragment (LKKTETQ), also known as TB-500; not full-length thymosin beta-4. Named in the proposed HHS 503A enforcement-discretion notice (Federal Register 2026-22192, October 2026). The policy is proposed, not final, and is not FDA approval. FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks. Regulatory source checked October 29, 2026. Sources: https://www.federalregister.gov/public-inspection/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Route-dependent status. FDA substance context: GHK-Cu. Injectable: nomination withdrawn. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Non-injectable: 503A Category 1, under evaluation. Neither route is an approval claim. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks https://www.fda.gov/media/94155/download?attachment=
HHS proposed 503A enforcement discretion (not final). FDA substance context: Epitalon (Epithalon). Named in the proposed HHS 503A enforcement-discretion notice (Federal Register 2026-22192, October 2026). The policy is proposed, not final, and is not FDA approval. FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks. Regulatory source checked October 29, 2026. Sources: https://www.federalregister.gov/public-inspection/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
HHS proposed 503A enforcement discretion (not final). FDA substance context: MOTS-c. Named in the proposed HHS 503A enforcement-discretion notice (Federal Register 2026-22192, October 2026). The policy is proposed, not final, and is not FDA approval. FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks. Regulatory source checked October 29, 2026. Sources: https://www.federalregister.gov/public-inspection/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Regulatory source not verified; no checked date is assigned.
Status not verified. Status not verified. Exact FDA substance context: Ipamorelin acetate: 503A withdrawn / 503B Category 2. This record does not specify acetate; other forms are not verified. Previously in Category 2; FDA still identifies potential significant safety risks for the named withdrawn substance. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks https://www.fda.gov/media/94155/download?attachment=
Nomination withdrawn. FDA substance context: CJC-1295 (not all no-DAC analogs). Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Regulatory source not verified; no checked date is assigned.
Nomination withdrawn. FDA substance context: Thymosin alpha-1. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Regulatory source not verified; no checked date is assigned.
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Regulatory source not verified; no checked date is assigned.
503B Category 2 / 503A Category 3. FDA substance context: GHRP-2 for injectable and nasal routes. 503B Category 2 identifies potential significant safety risks; 503A Category 3 means the nomination lacks adequate supporting information. Neither classification establishes approval or compounding eligibility. Other routes are not verified. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks https://www.fda.gov/media/94155/download?attachment=
503B Category 2 / 503A Category 3. FDA substance context: GHRP-6. 503B Category 2 identifies potential significant safety risks; 503A Category 3 means the nomination lacks adequate supporting information. Neither classification establishes approval or compounding eligibility. Other routes are not verified. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks https://www.fda.gov/media/94155/download?attachment=
Status not verified. Status not verified. Exact FDA substance context: Ibutamoren mesylate (MK-677): 503A & 503B Category 2. This record does not specify mesylate; other forms are not verified. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks https://www.fda.gov/media/94155/download?attachment=
503A Category 2. FDA substance context: Kisspeptin-10. 503A Category 2 identifies potential significant safety risks. This is not a drug-product approval or eligibility determination. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
503A Category 3. FDA substance context: Mechano Growth Factor (MGF), non-pegylated: 503A Category 3 (inadequate supporting information). Distinct from PEG-MGF (PEGylated mechano growth factor), whose nomination was withdrawn; FDA still identifies potential significant safety risks for PEG-MGF. Neither establishes approval or compounding eligibility. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/media/94155/download?attachment= https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Earlier regulatory timeline
Carried forward from the former regulatory-landscape page. These entries describe what was reported at the time. They were not all re-verified on October 21, 2026. Check the cited source. Manufacturer expansion items are omitted.
September 2023 · High
FDA moves 17 peptides to Category 2
The FDA updated its 503A bulk drug substances list to classify 17 widely-used peptides as Category 2 — identifying them as presenting potential significant safety risks. Category 2 identifies potential significant safety risks; 503A and 503B entries must be distinguished. This historical entry does not describe current nomination status. Affected: BPC-157, GHK-Cu (injectable), GHRP-2, GHRP-6, Ipamorelin, CJC-1295, MOTS-c, Epitalon, Melanotan II, KPV, LL-37, and others.
September 2024 · Medium
Legal settlement — five peptides removed from Category 2
Following a legal challenge from compounding pharmacy groups, the FDA agreed to submit key peptides for PCAC review. Five substances — CJC-1295, Ipamorelin acetate, Thymosin Alpha-1, AOD-9604, and Selank acetate — were removed from Category 2 after nominators withdrew and resubmitted, resetting the review process.
October–December 2024 · High
PCAC votes against Ipamorelin and CJC-1295
The Pharmacy Compounding Advisory Committee reviewed Ipamorelin (October 2024) and CJC-1295 and AOD-9604 (December 2024) for inclusion on the 503A bulks permitted list. The committee voted against including all three, an advisory vote is not a product approval or a current eligibility determination. Consult the source-linked substance contexts above.
Early 2025 · High
GLP-1 shortage designation lifted — compounding window closes
The FDA declared the semaglutide and tirzepatide shortages resolved, effectively closing the compounding exemption that had allowed 503B outsourcing facilities and 503A pharmacies to produce these GLP-1 drugs. FDA enforcement intensified, with dozens of warning letters issued to compounders and telehealth providers continuing to compound standard GLP-1 formulations.
December 2025 · Medium
FDA reinstates NMN dietary supplement status
The FDA reversed its 2022 decision excluding NMN (beta-nicotinamide mononucleotide) from dietary supplement classification, confirming it may be lawfully marketed as a supplement. NMN is a key NAD+ precursor, and the decision resolves a 3-year period of regulatory uncertainty for an ingredient widely used in longevity products.
February 27, 2026 · Watch
RFK Jr. signals intent to reclassify 14 Category 2 peptides
HHS Secretary Robert F. Kennedy Jr. stated on a public podcast interview his intention to move approximately 14 of 19 Category 2 peptides back to Category 1. A public statement does not establish compounding eligibility. No formal FDA rulemaking has been enacted as of March 2026. Practitioners should not act on public statements in lieu of official FDA action.
Changelog
- 2026-10-21: Page created from the interim-policy tracker and the former regulatory landscape. OMB receipt Oct 14; meetings Oct 21/23. Sourcing and prescription-access pages now land here.
Get an email when a peptide's status changes
We email you when the FDA or HHS makes a move on a peptide you care about. Every email links the official source. No spam, no sales.
We don't collect health information. Unsubscribe anytime. Privacy policy
Canonical: https://peptidex.ai/policy