Peptide Legal Status Tracker

Category 1 in FDA's 503A materials for non-injectable routes. Injectable GHK-Cu is not on that footing and is not authorized for compounding. Law-firm reporting from the July 2026 PCAC meeting says FDA signalled a further PCAC consultation on GHK-Cu and four other peptides; FDA has published no meeting notice, docket, or date for it, so we treat the timing as unconfirmed.

A second peptide PCAC meeting including GHK-Cu is reported but unscheduled. Watching the FDA advisory committee calendar and the Federal Register.

Category 1 in the current FDA 503A list. It is a coenzyme, not a peptide, and Category 1 is not FDA drug approval.

Category 1 in the current FDA 503A list if all compounding conditions are met.

Category 2 in the current FDA 503A list. Treat as not currently compoundable.

Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance.

Category 2 for injectable and nasal routes in FDA's safety-risk materials. Treat as not currently compoundable.

Category 2 in FDA's safety-risk materials. Treat as not currently compoundable.

Category 2 in the current FDA 503A list. Included because it is frequently grouped with growth hormone peptides in consumer searches.

Category 1 in FDA's 503A materials for non-injectable routes. Injectable GHK-Cu is not on that footing and is not authorized for compounding. Law-firm reporting from the July 2026 PCAC meeting says FDA signalled a further PCAC consultation on GHK-Cu and four other peptides; FDA has published no meeting notice, docket, or date for it, so we treat the timing as unconfirmed.

A second peptide PCAC meeting including GHK-Cu is reported but unscheduled. Watching the FDA advisory committee calendar and the Federal Register.

Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend BPC-157, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported. FDA's own review team had recommended against all seven substances on the agenda, and its slides state that BPC-157 acetate 'is not well-characterized.' A recommendation is advisory. FDA has taken no action, so BPC-157 is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend KPV, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated use was wound healing and inflammatory conditions. A recommendation is advisory. FDA has taken no action, so KPV is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend TB-500, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated use was wound healing. FDA opened the meeting with a talk on 'conflated bulks': one trade name can map to different sequences from different suppliers, which is exactly the TB-500 problem — the name is used for both full-length thymosin beta-4 and a short fragment. A recommendation is advisory. FDA has taken no action, so TB-500 is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend MOTS-c, free base and acetate salt, for the list — 7 yes, 5 no, 2 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated uses were obesity and osteoporosis. A recommendation is advisory. FDA has taken no action, so MOTS-c is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 24, 2026 the FDA advisory committee voted to recommend Semax, free base and acetate salt, for the list — 8 yes, 5 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated uses were cerebral ischemia, migraine, and trigeminal neuralgia. A recommendation is advisory. FDA has taken no action, so Semax is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. Emideltide was the only one of the seven substances the advisory committee voted against on July 24, 2026 — 6 yes, 7 no, 1 abstain as reported. FDA's evaluated uses were opioid withdrawal, chronic insomnia, and narcolepsy. Both the FDA review team and the committee landed against inclusion, so there is no pathway in progress.

No FDA action expected from this vote. Treat as not compoundable.

Not on the 503A Bulks List and not Category 1. On July 24, 2026 the FDA advisory committee voted to recommend Epitalon, free base and acetate salt, for the list — 7 yes, 4 no, 1 abstain as reported (some outlets reported 7-5-1; only 12 members were eligible to vote on this substance). FDA's evaluated use was insomnia. A recommendation is advisory. FDA has taken no action, so Epitalon is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not currently Category 1. FDA PCAC reviewed AOD-9604-related bulk substances in December 2024; no current Category 1 listing identified.

Not currently Category 1. FDA PCAC reviewed CJC-1295-related bulk substances in December 2024; no current Category 1 listing identified.

Not currently Category 1. FDA PCAC reviewed thymosin alpha-1-related bulk substances in December 2024; no current Category 1 listing identified.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend BPC-157, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported. FDA's own review team had recommended against all seven substances on the agenda, and its slides state that BPC-157 acetate 'is not well-characterized.' A recommendation is advisory. FDA has taken no action, so BPC-157 is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend KPV, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated use was wound healing and inflammatory conditions. A recommendation is advisory. FDA has taken no action, so KPV is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend TB-500, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated use was wound healing. FDA opened the meeting with a talk on 'conflated bulks': one trade name can map to different sequences from different suppliers, which is exactly the TB-500 problem — the name is used for both full-length thymosin beta-4 and a short fragment. A recommendation is advisory. FDA has taken no action, so TB-500 is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend MOTS-c, free base and acetate salt, for the list — 7 yes, 5 no, 2 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated uses were obesity and osteoporosis. A recommendation is advisory. FDA has taken no action, so MOTS-c is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 24, 2026 the FDA advisory committee voted to recommend Semax, free base and acetate salt, for the list — 8 yes, 5 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated uses were cerebral ischemia, migraine, and trigeminal neuralgia. A recommendation is advisory. FDA has taken no action, so Semax is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 24, 2026 the FDA advisory committee voted to recommend Epitalon, free base and acetate salt, for the list — 7 yes, 4 no, 1 abstain as reported (some outlets reported 7-5-1; only 12 members were eligible to vote on this substance). FDA's evaluated use was insomnia. A recommendation is advisory. FDA has taken no action, so Epitalon is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

FDA-approved products exist. Broad copy compounding is not a Category 1 peptide-bulk pathway, and FDA flags unapproved GLP-1 products and salt forms as safety risks. FDA's May 1, 2026 proposal to exclude semaglutide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding closed for comment on or about July 30, 2026. As of August 15, 2026 FDA had issued no final determination and no follow-on Federal Register document, and no court challenge to the proposal had been filed. Separately, on July 28, 2026 FDA published revised draft product-specific guidances for generic semaglutide — a bioequivalence-recommendation update, not an approval, and not a change to compounding law.

Comment period on the proposed 503B bulks-list exclusion closed July 30, 2026 (docket FDA-2018-N-3240). Watching for a final FDA determination; none had issued as of August 15, 2026.

FDA-approved products exist. Copy compounding is constrained by approved-drug and shortage rules, not Category 1 peptide-bulk status. FDA's May 1, 2026 proposal to exclude tirzepatide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding closed for comment on or about July 30, 2026. As of August 15, 2026 FDA had issued no final determination and no follow-on Federal Register document. Separately, on July 28, 2026 FDA published revised draft product-specific guidances for generic tirzepatide — a bioequivalence-recommendation update, not an approval, and not a change to compounding law.

Comment period on the proposed 503B bulks-list exclusion closed July 30, 2026 (docket FDA-2018-N-3240). Watching for a final FDA determination; none had issued as of August 15, 2026.

FDA-approved products exist. This is an approved-drug pathway, not a Category 1 peptide-bulk listing. FDA's May 1, 2026 proposal to exclude liraglutide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding closed for comment on or about July 30, 2026, and FDA had issued no final determination as of August 15, 2026. Liraglutide is also covered by FDA's July 28, 2026 revised draft product-specific guidances for generic peptide products.

Comment period on the proposed 503B bulks-list exclusion closed July 30, 2026 (docket FDA-2018-N-3240). Watching for a final FDA determination; none had issued as of August 15, 2026.

FDA-approved product exists. Any compounding analysis starts from approved-drug rules rather than Category 1 bulk status.

FDA-approved product exists for a specific indication. That approval does not validate non-approved indications.

FDA-approved drug products exist. This is not a consumer peptide-bulk compounding status.

FDA-approved product exists under an approved-drug pathway. It is not a Category 1 compounded bulk peptide.

Category 2 in the current FDA 503A list. Treat as not currently compoundable.

Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law. Enforcement pressure sharpened in mid-2026: FDA's Import Alert 66-80, republished August 13, 2026, includes import entries keyed to the word 'Retatrutide'; the UK MHRA said on July 24, 2026 that anyone selling retatrutide in the UK is doing so illegally; and on August 12, 2026 Eli Lilly filed six lawsuits against research-use-only sellers, a compounding pharmacy, and a med spa, arguing the 'research use only' label is pretext for selling an unapproved new drug. Those complaints are allegations — no defendant has been found liable.

No ruling, injunction, or settlement in the Lilly cases as of August 15, 2026.

Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.

Category 2 in the current FDA 503A list. Treat as not currently compoundable.

Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance.

Category 2 for injectable and nasal routes in FDA's safety-risk materials. Treat as not currently compoundable.

Category 2 in FDA's safety-risk materials. Treat as not currently compoundable.

Category 2 in the current FDA 503A list. Included because it is frequently grouped with growth hormone peptides in consumer searches.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend BPC-157, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported. FDA's own review team had recommended against all seven substances on the agenda, and its slides state that BPC-157 acetate 'is not well-characterized.' A recommendation is advisory. FDA has taken no action, so BPC-157 is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend KPV, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated use was wound healing and inflammatory conditions. A recommendation is advisory. FDA has taken no action, so KPV is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend TB-500, free base and acetate salt, for the list — 8 yes, 6 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated use was wound healing. FDA opened the meeting with a talk on 'conflated bulks': one trade name can map to different sequences from different suppliers, which is exactly the TB-500 problem — the name is used for both full-length thymosin beta-4 and a short fragment. A recommendation is advisory. FDA has taken no action, so TB-500 is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 23, 2026 the FDA advisory committee voted to recommend MOTS-c, free base and acetate salt, for the list — 7 yes, 5 no, 2 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated uses were obesity and osteoporosis. A recommendation is advisory. FDA has taken no action, so MOTS-c is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. On July 24, 2026 the FDA advisory committee voted to recommend Semax, free base and acetate salt, for the list — 8 yes, 5 no, 1 abstain as reported, against FDA's own review team's recommendation to exclude it. FDA's evaluated uses were cerebral ischemia, migraine, and trigeminal neuralgia. A recommendation is advisory. FDA has taken no action, so Semax is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not on the 503A Bulks List and not Category 1. Emideltide was the only one of the seven substances the advisory committee voted against on July 24, 2026 — 6 yes, 7 no, 1 abstain as reported. FDA's evaluated uses were opioid withdrawal, chronic insomnia, and narcolepsy. Both the FDA review team and the committee landed against inclusion, so there is no pathway in progress.

No FDA action expected from this vote. Treat as not compoundable.

Not on the 503A Bulks List and not Category 1. On July 24, 2026 the FDA advisory committee voted to recommend Epitalon, free base and acetate salt, for the list — 7 yes, 4 no, 1 abstain as reported (some outlets reported 7-5-1; only 12 members were eligible to vote on this substance). FDA's evaluated use was insomnia. A recommendation is advisory. FDA has taken no action, so Epitalon is not legal to compound today.

FDA must publish a proposed rule and run notice-and-comment before anything changes. None had issued as of August 15, 2026.

Not currently Category 1. FDA PCAC reviewed AOD-9604-related bulk substances in December 2024; no current Category 1 listing identified.

Not currently Category 1. FDA PCAC reviewed CJC-1295-related bulk substances in December 2024; no current Category 1 listing identified.

Not currently Category 1. FDA PCAC reviewed thymosin alpha-1-related bulk substances in December 2024; no current Category 1 listing identified.

Not currently Category 1. FDA's safety-risk page continues to flag the substance even though nomination-status changes affected Category 2 placement.

Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law. Enforcement pressure sharpened in mid-2026: FDA's Import Alert 66-80, republished August 13, 2026, includes import entries keyed to the word 'Retatrutide'; the UK MHRA said on July 24, 2026 that anyone selling retatrutide in the UK is doing so illegally; and on August 12, 2026 Eli Lilly filed six lawsuits against research-use-only sellers, a compounding pharmacy, and a med spa, arguing the 'research use only' label is pretext for selling an unapproved new drug. Those complaints are allegations — no defendant has been found liable.

No ruling, injunction, or settlement in the Lilly cases as of August 15, 2026.

Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.