Peptides and FDA 503A Compounding: Status Tracker
Where things stand
As of 2026-10-24, no peptide reviewed at FDA's July 23-24, 2026 Pharmacy Compounding Advisory Committee has been added to the 503A Bulks List, and FDA has posted no minutes, vote results or decision. Trade and legal press reported that the committee voted to recommend several of the seven peptides it reviewed; FDA staff briefing documents concluded the criteria weigh against all seven. An HHS/FDA 'Interim Access Policy for Compounding Using Certain Peptides' (RIN 0910-ZD94) has been under White House (OIRA) review since 2026-10-14; its contents are not public.
Status by item
| name | category status | latest action | date | Source |
|---|---|---|---|---|
| BPC-157 (free base / acetate) | Reported (trade press): committee recommended Jul 2026; not on 503A Bulks List | PCAC to recommend inclusion for ulcerative colitis; FDA staff briefing concluded the criteria weigh against inclusion. Nomination had been withdrawn; FDA elected to present it anyway. | 2026-07-23 | Source |
| KPV (free base / acetate) | Reported (trade press): committee recommended Jul 2026; not on 503A Bulks List | PCAC to recommend inclusion for wound healing and inflammatory conditions (RAPS reports the BPC-157/KPV votes together); FDA staff briefing weighed against inclusion. | 2026-07-23 | Source |
| TB-500 (thymosin beta-4 fragment, free base / acetate) | Reported (trade press): committee recommended Jul 2026; not on 503A Bulks List | Reported (trade press): committee recommended inclusion for wound healing. FDA staff briefing weighed against inclusion. | 2026-07-23 | Source |
| MOTS-c (free base / acetate) | Reported (trade press): committee recommended Jul 2026; not on 503A Bulks List | Reported (trade press): committee recommended inclusion for obesity and osteoporosis. FDA staff briefing weighed against inclusion. | 2026-07-23 | Source |
| Epitalon (free base / acetate) | Reported (trade press): committee recommended Jul 2026; not on 503A Bulks List | Reported (trade press): committee recommended inclusion for insomnia. FDA staff briefing weighed against inclusion. | 2026-07-24 | Source |
| Semax (free base / acetate) | Reported (trade press): committee recommended Jul 2026; not on 503A Bulks List | Reported (trade press): committee recommended inclusion for cerebral ischemia, migraine and trigeminal neuralgia. FDA staff briefing weighed against inclusion. | 2026-07-24 | Source |
| Emideltide (DSIP, free base / acetate) | PCAC did not recommend (Jul 2026); not on 503A Bulks List | PCAC against inclusion for opioid withdrawal, chronic insomnia and narcolepsy. FDA staff briefing weighed against inclusion. | 2026-07-24 | Source |
| GHK-Cu | Category 1 for non-injectable routes; injectable nomination withdrawn | FDA removed GHK-Cu from Category 1 on 2026-04-22 after nominations were withdrawn, then re-added non-injectable routes to Category 1 after a nominator clarified on 2026-05-05. FDA intends to consult the PCAC before the end of February 2027. | 2026-05-14 | Source |
| Cathelicidin LL-37 | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. Inclusion on a second PCAC agenda is reported by law-firm summaries but not confirmed on FDA.gov. | 2026-04-22 | Source |
| Dihexa acetate | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. Inclusion on a second PCAC agenda is reported by law-firm summaries but not confirmed on FDA.gov. | 2026-04-22 | Source |
| Melanotan II | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. Inclusion on a second PCAC agenda is reported by law-firm summaries but not confirmed on FDA.gov. | 2026-04-22 | Source |
| Mechano growth factor, pegylated (PEG-MGF) | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. Inclusion on a second PCAC agenda is reported by law-firm summaries but not confirmed on FDA.gov. | 2026-04-22 | Source |
| Mechano growth factor (MGF, non-pegylated) | Category 3 (nominated without adequate support) | Listed in 503A Category 3 in FDA's categories list updated 2026-05-14. | 2026-05-14 | Source |
| AOD-9604 | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. | 2026-04-22 | Source |
| CJC-1295 | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. | 2026-04-22 | Source |
| Ipamorelin acetate | 503A: nomination withdrawn; 503B: Category 2 | FDA lists ipamorelin in the withdrawn-nomination table (503A) and in Category 2 for 503B outsourcing facilities (added 2023-09-29). | 2026-04-22 | Source |
| Selank acetate (TP-7) | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. | 2026-04-22 | Source |
| Thymosin alpha-1 (Ta1) | Previously Category 2; nomination withdrawn (not on 503A Bulks List) | Listed by FDA in its table of substances previously in Category 2 whose nominations were withdrawn; FDA does not give a withdrawal date. Not on the 503A Bulks List. | 2026-04-22 | Source |
| Kisspeptin-10 | Category 2 (significant safety risks) | Remains in 503A Category 2 (added 2023-09-29) in FDA's categories list updated 2026-05-14. | 2026-05-14 | Source |
| GHRP-2 | 503A Category 3; 503B Category 2 | Listed in 503A Category 3 (list updated 2026-05-14); FDA safety page lists it in 503B Category 2 (added 2023-09-29). | 2026-05-14 | Source |
| GHRP-6 | 503A Category 3; 503B Category 2 | Listed in 503A Category 3 (list updated 2026-05-14); FDA safety page lists it in 503B Category 2 (added 2023-09-29). | 2026-05-14 | Source |
| Ibutamoren mesylate (MK-677; non-peptide GH secretagogue) | Category 2 (significant safety risks) | Listed in 503A Category 2 in FDA's categories list updated 2026-05-14. | 2026-05-14 | Source |
| Vasoactive intestinal peptide | Category 1 (under evaluation) | Listed in 503A Category 1 in FDA's categories list updated 2026-05-14. | 2026-05-14 | Source |
| Thymulin acetate | Category 3 (nominated without adequate support) | Listed in 503A Category 3 in FDA's categories list updated 2026-05-14. | 2026-05-14 | Source |
| Cibinetide (ARA-290) | Category 3 (nominated without adequate support) | Listed in 503A Category 3 in FDA's categories list updated 2026-05-14. | 2026-05-14 | Source |
Timeline
- · Regulatory
Interim peptide access policy sent to White House review
OIRA lists 'Interim Access Policy for Compounding Using Certain Peptides' (RIN 0910-ZD94, notice stage) as received 2026-10-14 and pending review. Its contents have not been published; press reports describe it as enforcement discretion for some peptides, including BPC-157.
Reginfo.gov: RIN 0910-ZD94 - · Regulatory
FDA warning letters to 'research use only' peptide sellers
FDA issued warning letters to five online peptide vendors, finding that 'for research use only' labels did not change products' status as unapproved new drugs intended for human use.
FDA Warning Letter: Royal Peptides LLC (MARCS-CMS 734884) - · Regulatory
PCAC day 2: epitalon and semax recommended, emideltide not
The committee recommended epitalon (insomnia) and semax (cerebral ischemia, migraine, trigeminal neuralgia) and voted against emideltide (DSIP). Votes are advisory.
FDA: July 23-24, 2026 PCAC meeting - · Regulatory
PCAC day 1: BPC-157, KPV, TB-500, MOTS-c recommended
The committee to recommend BPC-157 and KPV, and also recommended TB-500 and MOTS-c, against FDA staff conclusions.
RAPS: FDA advisory committee backs two controversial peptides - · Regulatory
FDA updates 503A categories list
GHK-Cu (non-injectable routes) was returned to Category 1 after a nominator clarified its withdrawal; Kisspeptin-10 and ibutamoren remain in Category 2.
FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A - · Regulatory
Withdrawn peptide nominations moved out of Category 2
FDA's safety-risk page now lists BPC-157, TB-500, MOTS-c, semax, epitalon, emideltide, LL-37, melanotan II, CJC-1295, AOD-9604 and others as previously in Category 2 with nominations withdrawn. Leaving Category 2 does not make a substance eligible for compounding.
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks - · Regulatory
Federal Register notice schedules PCAC review of seven peptides
FDA announced the July 23-24, 2026 meeting (Docket FDA-2025-N-6895) to discuss BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon for the 503A Bulks List.
Federal Register 2026-07361 - · Regulatory
FDA places several peptides in Category 2
FDA added peptides including kisspeptin-10 (503A) and ipamorelin, GHRP-2 and GHRP-6 (503B) to Category 2, citing immunogenicity and impurity risks and limited safety data.
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
Questions
Did the July 2026 advisory committee vote make BPC-157 legal to compound?
No. The committee's votes are advice to FDA. A substance can be used under 503A only after FDA adds it to the 503A Bulks List through rulemaking, or under a separate FDA enforcement policy. As of 2026-10-24, neither has happened.
What is the 'interim access policy'?
It is an HHS/FDA document titled 'Interim Access Policy for Compounding Using Certain Peptides' that OIRA received on 2026-10-14. Its text has not been published. Press reports describe it as enforcement discretion for some peptides, but that is not confirmed.
What does removal from Category 2 mean?
Category 2 is FDA's list of nominated substances with significant safety concerns. Removal after a nomination is withdrawn means the substance is no longer under evaluation. It does not add the substance to the 503A Bulks List.
What did FDA's own staff conclude?
For all seven peptides discussed in July 2026, FDA's briefing documents concluded that 'a balancing of the criteria weighs against' inclusion on the 503A Bulks List.
Regulatory status changes; check the linked primary source before relying on any entry. This tracker is information, not legal advice. Report an error.