Twelve peptides came off the FDA's do-not-compound list. None of them are legal to compound.

On April 15, 2026 the FDA republished its interim 503A bulk drug substances list and took twelve peptides off Category 2, the do-not-compound category.

Your vendor has probably already told you what that means. Your vendor is wrong.

Coming off Category 2 does not make a single one of these compoundable. Frier Levitt put it in one sentence: "Removal from Category 2 does not render these bulk drug substances eligible for compounding under section 503A." They also sit outside FDA's interim enforcement discretion, because that policy covers Category 1 only. So twelve compounds moved from a list that said no into a gap that says nothing.

This page tracks where each one actually is. It gets updated when the paperwork moves, not when somebody's email list needs a reason to open.

For any of these to be compounded legally, FDA has to add it to the 503A bulks list. That takes a proposed rule, a public comment window, a review of the record, and a final rule.

There is no statutory deadline on any of it.

The last time FDA finished a bulks rulemaking, the proposed rule came in December 2016 and the final rule came in February 2019. More than two years, and it added six of the ten substances under review and rejected four.

That is the fastest honest version of this timeline. Over two years from proposed rule to final rule, and nothing on this list has a proposed rule yet.

Every row above needs the same thing next. A proposed rule, a comment period, and a final rule. None of them has one.

Went to the Pharmacy Compounding Advisory Committee meeting on July 23 and 24, 2026. The panel voted in favor. FDA's own staff had recommended against it. Not on the 503A bulks list.

Same July meeting, same favorable panel vote, same staff recommendation against. Not on the bulks list.

Not reviewed yet. Slated for advisory committee consultation before the end of February 2027. The topical versions were never in this fight.

July 2026 meeting, favorable panel vote, staff recommendation against. Not on the bulks list.

Not reviewed yet. Advisory committee consultation expected before the end of February 2027.

July 2026 meeting, favorable panel vote, staff recommendation against. Not on the bulks list.

Not reviewed yet. Consultation expected before the end of February 2027.

Seven substances went to the July meeting. Six are named in the vote reporting and DSIP is the one left unaccounted for, so it most likely went too. I have not found it named in any source, so this row is unconfirmed and marked that way until it is.

July 2026 meeting, favorable panel vote, staff recommendation against. Not on the bulks list.

July 2026 meeting, favorable panel vote, staff recommendation against. Not on the bulks list.

Not reviewed yet. Consultation expected before the end of February 2027.

Not reviewed yet. Consultation expected before the end of February 2027.

FDA staff recommended against all seven. The July panel voted in favor of six peptides. Agency staff had already recommended against every substance under review. The vote is advisory. FDA can accept it, decline it, attach conditions, ask for more information, or sit on it.

The committee was short on members. The advisory committee lacked a quorum going into the July meeting because of unfilled vacancies.

Pharmaceutical-grade API may not exist yet. For some of these peptides there is no commercially available pharmaceutical-grade active ingredient. So even a compound that clears rulemaking can sit there uncompoundable because nobody is making the input to the required grade.

If you sell: nothing changed. A favorable advisory vote is not a legal status, and saying otherwise in your marketing copy is the exact pattern FDA built five warning letters on in August.

If you buy: the research-use-only market is where these compounds exist at all right now, and that is still true on the two-year timeline above. Anyone telling you BPC-157 is about to be available by prescription is describing a proposed rule that has not been written.

If you run a clinic or a telehealth operation: watch for Category 1. The only move that would let any of these be compounded before rulemaking finishes is FDA shifting one into Category 1, where the interim enforcement policy actually applies. That has not happened to any of the twelve.

Last updated October 12, 2026. This page is maintained. When a proposed rule publishes, a row changes here.