Peptide■America

Reference table

The 2026 record

What happened to United States peptide compounding law in 2026, in order?

The answer

Twelve peptides left a prohibition category in April and an advisory committee recommended six of them for listing in July; no peptide reviewed in 2026 became lawful to compound, because the FDA has issued no final rule.

The ground moved twice in 2026, in opposite-seeming directions, and the two events are routinely collapsed into one another. In April the FDA removed twelve peptides from Category 2 of its interim 503A bulks list without adding them to Category 1. In July an advisory committee recommended six of the seven it reviewed for the section 503A list. Neither action authorized a pharmacy to compound anything.

The chronology below is every dated entry this index holds, newest first, across every molecule it tracks. It is not a summary of the year; it is the ledger itself, and it extends back to the approvals and listings that set the positions 2026 moved.

Denominator

Every dated entry in this index's regulatory ledger is listed, for all molecules it tracks. The list is not a record of every FDA action on every peptide; it is the record this index has verified, molecule by molecule, on the dates its monographs carry.

Rows are read from MOLECULES[].record[].date, MOLECULES[].record[].text, MOLECULES[].name — the same dated ledger the molecule index renders. No cell on this page is typed by hand.

DateMoleculeWhat the record states
August 2026GlutathioneListed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
August 2026NAD+Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
August 2026SermorelinCompounded by 503A pharmacies with a valid prescription; the discontinued approval was withdrawn for commercial, not safety, reasons.
July 2026BPC-157The Pharmacy Compounding Advisory Committee votes 8–6 to recommend adding BPC-157 to the section 503A bulks list. The vote is advisory; FDA rulemaking is required before any pharmacy may compound it.
July 2026DSIPPCAC votes 6–7 (one abstention) against recommending 503A listing — the panel's only rejection.
July 2026EpitalonPCAC votes 7–5 (one abstention) to recommend 503A listing; advisory only.
July 2026KPVPCAC votes 8–6 (one abstention) to recommend 503A listing; advisory only.
July 2026MOTS-cPCAC votes 7–5 (two abstentions) to recommend 503A listing; advisory only.
July 2026SemaxPCAC votes 8–5 (one abstention) to recommend 503A listing; advisory only.
July 2026TB-500PCAC votes 8–6 (one abstention) to recommend 503A listing; advisory only.
April 2026BPC-157FDA removes BPC-157 and eleven other peptides from Category 2 without adding them to Category 1; the removal ends the explicit prohibition but confers no authorization.
April 2026DSIPRemoved from Category 2 without Category 1 listing.
April 2026EpitalonRemoved from Category 2 without Category 1 listing.
April 2026GHK-CuInjectable GHK-Cu removed from Category 2 without Category 1 listing; not among the seven peptides reviewed at the July 2026 PCAC meeting.
April 2026KPVRemoved from Category 2 without Category 1 listing.
April 2026MOTS-cRemoved from Category 2 without Category 1 listing.
April 2026SemaglutideFDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet.
April 2026SemaxRemoved from Category 2 without Category 1 listing.
April 2026TB-500Removed from Category 2 without Category 1 listing.
April 2026TirzepatideFDA proposes excluding tirzepatide from the 503B bulks list; the lawful remainder is patient-specific 503A compounding with documented clinical need.
March 2025TesamorelinFDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV.
September 2024CJC-1295Removed from Category 2 after nominator withdrawal; not added to Category 1.
September 2024IpamorelinRemoved from Category 2 after nominator withdrawal; not added to Category 1.
September 2023BPC-157FDA places BPC-157 in Category 2 of the interim 503A bulks list, citing immunogenicity risk and impurity concerns; Category 2 placement bars pharmacy compounding.
November 2010TesamorelinFDA approves tesamorelin (EGRIFTA) for the reduction of excess abdominal fat in adults with HIV and lipodystrophy.

The final slot is deliberately empty. Each monograph for a molecule awaiting rulemaking renders an FDA final-action line that reads as unfilled until an action lands; nothing in this ledger fills it. The pending page carries the six recommendations, and the vote ledger carries the arithmetic that produced them.

Elsewhere in this index

Other tables

Evidence reviews

Monographs in this table