Which peptides can legally be compounded right now?

This is the single most misreported development in compounding this year. Within days of the April announcement, peptide retailers and telehealth marketing pages were describing the change as though the FDA had approved these substances. It did not. Understanding precisely what changed — and what did not — is the difference between a defensible compounding decision and one that a board inspector will take apart.

What Category 2 actually is

Under section 503A of the Federal Food, Drug, and Cosmetic Act, a compounding pharmacy may only use a bulk drug substance if it meets one of three conditions: it is the subject of a USP or NF monograph, it is a component of an FDA-approved drug, or it appears on the FDA’s 503A bulk drug substances list. That list is the affirmative permission slip.

While evaluating nominated substances for that list, the FDA sorts them into interim categories. Category 1 substances may be used at the agency’s discretion during evaluation. Category 2 substances raise significant safety risks, and the FDA has stated it intends to take action against their use in compounding. Category 3 covers substances nominated without adequate supporting information.

The practical consequence people miss: Category 2 is a warning label applied during evaluation. Taking a substance off that list removes the warning. It does not complete the evaluation, and it does not create the affirmative permission that section 503A requires.

The twelve peptides removed in April 2026

Retatrutide is included in the table because it is consistently and incorrectly grouped with the twelve. It was never on Category 2 and its situation is entirely different: it is an investigational drug that has not completed FDA review, and the agency has told state boards directly that it cannot be used in compounding under federal law. We cover that separately in Can retatrutide be compounded?

What happened at the July 2026 PCAC meeting

The Pharmacy Compounding Advisory Committee convened on July 23–24, 2026 to consider bulk drug substances for inclusion on the 503A list, including BPC-157 in its free base and acetate forms. The committee reviews the available safety and effectiveness evidence and votes on a recommendation.

Two things to hold onto about PCAC. First, the committee advises — it does not decide. The FDA is not bound by its recommendation and issues the final determination separately, on its own timeline. Second, a favorable vote is not a green light on the day of the vote. Pharmacies that begin compounding on the strength of a committee recommendation are acting ahead of the rule.

We are updating this page as the outcome and any subsequent FDA action publish.

What this means if you are a compounding pharmacy

The honest operational read: the April change lowered the immediate enforcement temperature around these twelve substances without giving anyone affirmative permission to use them. That is an uncomfortable place to make decisions from, and it is worth being clear-eyed about the exposure.

• The 503A three-condition test still governs. If a substance has no USP or NF monograph, is not a component of an approved drug, and is not on the bulks list, it does not satisfy section 503A — regardless of which interim category it sits in.
• State boards are not bound to the federal timeline. Several states apply their own standards to compounded preparations, and a state action does not wait for a PCAC vote.
• Accreditation bodies apply their own criteria. PCAB/ACHC standards for sourcing and documentation apply independently of the FDA’s listing process.
• Documentation is what survives an inspection. Whatever a pharmacy decides, the decision and its basis need to be written down before the inspector asks, not after.

Where Meridian fits

We make cold chain packaging. We do not manufacture, sell, or distribute peptides, and nothing here is legal advice — a compounding attorney or your accreditation body is the right party for a determination on any specific substance.

We maintain this tracker because the shipping question and the sourcing question keep arriving together. A pharmacy calling about a packout for a preparation whose regulatory footing is unsettled usually has the bigger problem upstream, and it is more useful to say so than to sell a box.