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Peptide Regulatory Status Tracker

No. BPC-157 is not an FDA-approved drug for any use. In July 2026 an FDA advisory committee voted 8-6 to recommend adding it to the list of substances pharmacies may compound with, but that vote is not binding and FDA has not yet proposed a rule. Until it does, pharmacies cannot legally compound BPC-157 from bulk powder.

Last updated Oct 11, 2026.

Recent changes

What the statuses mean

FDA-approved drug
Approved by FDA as a specific branded medicine for specific uses, after clinical trials. Approval covers that product, not powders sold online under the same name.
Advisory panel backed, FDA decision pending
FDA's Pharmacy Compounding Advisory Committee voted to recommend adding it to the 503A bulks list. The vote is advisory: FDA can disagree, and nothing changes until FDA finishes rulemaking. It is still not an approved drug.
Advisory panel voted against
The advisory committee voted not to recommend it for the 503A bulks list. FDA has not yet made a final decision.
Off Category 2, review pending
FDA took it off the Category 2 safety-risk list in April 2026 and plans an advisory committee review. Leaving Category 2 does not by itself make it legal to compound.
FDA Category 2: significant safety risk
FDA has identified significant safety risks with compounding it. Pharmacies that compound it from bulk powder can face enforcement action.
Nomination withdrawn
It was once nominated for compounding and placed in Category 2, then the nominator withdrew it. Nothing is under review, it is not on the 503A bulks list, and it is not an approved drug.
Investigational, not approved
Still in clinical trials. No version is FDA-approved, so anything sold today is not a legal medicine.

Key terms

FDA-approved drug
A finished medicine FDA has reviewed for safety and effectiveness for a specific use, such as Wegovy (semaglutide). Approval belongs to that product, made by that manufacturer.
Research chemical / "research use only"
A label some sellers put on unapproved peptides. FDA decides by how a product is marketed: in August 2026 it sent warning letters to peptide sellers despite their "not for human use" labels.
Compounding (503A)
A licensed pharmacist or doctor mixing a drug for an individual patient. They may only start from a bulk powder that has a USP monograph, is part of an approved drug, or is on the 503A bulks list.
503A bulks list
FDA's list of extra bulk substances pharmacies may compound with. Adding a substance takes formal rulemaking: a proposed rule, public comments, then a final rule.
Category 1 and Category 2
While FDA works through nominations, it sorts them. Category 1: enough information to evaluate, and FDA does not intend to act against compounders while it does. Category 2: FDA has identified significant safety risks.
PCAC
The Pharmacy Compounding Advisory Committee: outside experts who advise FDA on what belongs on the bulks list. FDA isn't bound by its votes.

Status by compound

CompoundStatusLast changeDetails
SemaglutideFDA-approved drugAug 24, 2026Approved as Ozempic (type 2 diabetes), Rybelsus (oral, type 2 diabetes), Wegovy injection and, since December 2025, the Wegovy pill (weight management). The national shortage ended in February 2025, which closed the shortage route for compounded copies.
TirzepatideFDA-approved drugAug 24, 2026Approved as Mounjaro (type 2 diabetes) and Zepbound (weight management). FDA declared the shortage resolved in December 2024, ending the shortage route for compounded copies.
TesamorelinFDA-approved drugAug 24, 2026Approved as Egrifta to reduce excess abdominal fat in people with HIV-associated lipodystrophy. Later versions (Egrifta SV, Egrifta WR) replaced the original. "Research" tesamorelin sold online is not the approved product.
Bremelanotide (PT-141)FDA-approved drugAug 24, 2026Approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women. Vials sold as "PT-141" are not the approved product.
SetmelanotideFDA-approved drugNov 25, 2020Approved as Imcivree for weight management in specific rare genetic forms of obesity (such as POMC, PCSK1 or LEPR deficiency and Bardet-Biedl syndrome). Not approved for general obesity.
RetatrutideInvestigational, not approvedAug 24, 2026An investigational triple agonist in phase 3 trials. It is not FDA-approved, so any retatrutide sold today is an unapproved drug.
BPC-157Advisory panel backed, FDA decision pendingJul 23, 2026Off Category 2 since April 2026. In July 2026 FDA's advisory committee voted 8-6 (1 abstention) to recommend adding it to the 503A bulks list, against FDA staff's recommendation. FDA has not proposed a rule, so pharmacies still cannot compound it from bulk. It is not an FDA-approved drug.
TB-500 (thymosin beta-4 fragment)Advisory panel backed, FDA decision pendingJul 23, 2026Off Category 2 since April 2026. The advisory committee voted in July 2026 to recommend it (evaluated for wound healing) for the 503A bulks list; FDA rulemaking is still pending. It is not an FDA-approved drug.
KPVAdvisory panel backed, FDA decision pendingJul 23, 2026Off Category 2 since April 2026. The advisory committee voted in July 2026 to recommend it (evaluated for wound healing and inflammatory conditions); FDA rulemaking is still pending. It is not an FDA-approved drug.
MOTS-cAdvisory panel backed, FDA decision pendingJul 23, 2026Off Category 2 since April 2026. The advisory committee voted 7-5 (2 abstentions) in July 2026 to recommend it (evaluated for obesity and osteoporosis); FDA rulemaking is still pending. It is not an FDA-approved drug.
EpitalonAdvisory panel backed, FDA decision pendingJul 24, 2026Off Category 2 since April 2026. The advisory committee narrowly voted in July 2026 to recommend it (evaluated for insomnia); FDA rulemaking is still pending. It is not an FDA-approved drug.
SemaxAdvisory panel backed, FDA decision pendingJul 24, 2026Off Category 2 since April 2026. The advisory committee narrowly voted in July 2026 to recommend it (evaluated for cerebral ischemia, migraine and trigeminal neuralgia); FDA rulemaking is still pending. It is not an FDA-approved drug.
DSIP (emideltide)Advisory panel voted againstJul 24, 2026Off Category 2 since April 2026, but in July 2026 the advisory committee voted 7-6 (1 abstention) against recommending it for the 503A bulks list. It is not an FDA-approved drug.
LL-37Off Category 2, review pendingApr 22, 2026Off Category 2 since April 2026. FDA plans an advisory committee review before the end of February 2027. Until FDA adds it to the 503A bulks list, pharmacies cannot compound it from bulk. It is not an FDA-approved drug.
DihexaOff Category 2, review pendingApr 22, 2026Off Category 2 since April 2026. FDA plans an advisory committee review before the end of February 2027. Until FDA adds it to the 503A bulks list, pharmacies cannot compound it from bulk. It is not an FDA-approved drug.
GHK-Cu (injectable)Off Category 2, review pendingApr 22, 2026Off Category 2 since April 2026 (the Category 2 entry covered injectable routes only). FDA plans an advisory committee review before the end of February 2027. Until FDA adds it to the 503A bulks list, pharmacies cannot compound it from bulk. It is not an FDA-approved drug.
PEG-MGFOff Category 2, review pendingApr 22, 2026Off Category 2 since April 2026. FDA plans an advisory committee review before the end of February 2027. Until FDA adds it to the 503A bulks list, pharmacies cannot compound it from bulk. It is not an FDA-approved drug.
Melanotan IIOff Category 2, review pendingApr 22, 2026Off Category 2 since April 2026. FDA plans an advisory committee review before the end of February 2027. Until FDA adds it to the 503A bulks list, pharmacies cannot compound it from bulk. It is not an FDA-approved drug.
IpamorelinFDA Category 2: significant safety riskApr 22, 2026In Category 2 for outsourcing facilities (503B). FDA cites possible immune reactions from impurities and aggregation, and a published study reporting serious adverse events, including death, with intravenous use. Its 503A nomination was withdrawn. Not an FDA-approved drug.
GHRP-2FDA Category 2: significant safety riskSep 29, 2023In Category 2 (503B) for injectable and nasal routes. FDA cites immunogenicity risk and reports of serious adverse events, while noting causality was not established. Not an FDA-approved drug.
GHRP-6FDA Category 2: significant safety riskSep 29, 2023In Category 2 (503B). FDA cites immunogenicity risk, limited safety data and possible effects on cortisol and blood sugar. Not an FDA-approved drug.
Ibutamoren (MK-677)FDA Category 2: significant safety riskSep 29, 2023In Category 2 for both pharmacies (503A) and outsourcing facilities (503B). FDA cites a risk of congestive heart failure in some patients: a hip-fracture trial was stopped early over that safety signal. Not an FDA-approved drug.
Kisspeptin-10FDA Category 2: significant safety riskSep 29, 2023In Category 2 (503A). FDA cites possible immune reactions and says it has little or no safety information for the proposed routes. Not an FDA-approved drug.
CJC-1295Nomination withdrawnApr 22, 2026Once in Category 2; the nomination was later withdrawn, so FDA is not reviewing it. It is not on the 503A bulks list and is not an FDA-approved drug.
AOD-9604Nomination withdrawnApr 22, 2026Once in Category 2; the nomination was later withdrawn, so FDA is not reviewing it. It is not on the 503A bulks list and is not an FDA-approved drug.
SelankNomination withdrawnApr 22, 2026Once in Category 2; the nomination was later withdrawn, so FDA is not reviewing it. It is not on the 503A bulks list and is not an FDA-approved drug.
Thymosin alpha-1Nomination withdrawnApr 22, 2026Once in Category 2; the nomination was later withdrawn, so FDA is not reviewing it. It is not on the 503A bulks list and is not an FDA-approved drug.

Common questions

Is BPC-157 FDA approved?

No. BPC-157 is not an FDA-approved drug for any use. In July 2026 an FDA advisory committee voted 8-6 to recommend adding it to the list of substances pharmacies may compound with, but that vote is not binding and FDA has not yet proposed a rule. Until it does, pharmacies cannot legally compound BPC-157 from bulk powder.

Is it legal to buy peptides labelled "for research use only"?

A "research use only" label does not make an unapproved drug legal to sell for human use. In August 2026 FDA sent warning letters to five peptide sellers, saying their websites showed the products were intended as drugs for people despite the disclaimers. State laws vary; this page covers federal FDA status only and is not legal advice.

Which peptides are FDA approved?

Among compounds covered here: semaglutide (Ozempic, Wegovy, Rybelsus, Wegovy pill), tirzepatide (Mounjaro, Zepbound), tesamorelin (Egrifta), bremelanotide/PT-141 (Vyleesi) and setmelanotide (Imcivree). Approval covers those branded products for their labelled uses, not research-grade powders with the same name.

What does removal from FDA Category 2 mean?

Category 2 is where FDA puts nominated compounding substances with significant safety risks. In April 2026 FDA took 12 peptides off it, including BPC-157, TB-500 and GHK-Cu (injectable). Removal does not by itself let pharmacies compound them; each still needs to be added to the 503A bulks list through rulemaking.

Can a pharmacy compound semaglutide or tirzepatide?

FDA ended the shortages of tirzepatide (December 2024) and semaglutide (February 2025), and the temporary allowances for compounding copies have since ended. In April 2026 FDA also proposed excluding both from the 503B bulks list used by outsourcing facilities.

Crestigen is an educational research reference. Nothing here is medical advice; many of these compounds are not approved for human use. Talk to a licensed clinician before using any substance.