FDA Category 2 Peptides: What Changed, What It Means

Dated regulatory context

This article was first published March 26, 2026. The following regulatory text was corrected against the cited FDA substance tables checked October 10, 2026.

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 FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks.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

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 Injectable: nomination withdrawn.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=

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 Exact FDA substance context: Ipamorelin acetate: 503A withdrawn / 503B Category 2.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 Previously in Category 2; FDA still identifies potential significant safety risks for the named withdrawn substance.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=

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=

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=

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

FDA also names withdrawn nominations for Epitalon, MOTS-c, AOD-9604, CJC-1295, LL-37, Emideltide (DSIP), Dihexa acetate, KPV, Selank acetate, Semax, thymosin alpha-1, PEG-MGF and Melanotan II. Named salts and fragments must not be extrapolated to other identities.

Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Full source-linked compound context: Compound Index