What the February announcement actually changed

In February, U.S. Health Secretary Robert F. Kennedy Jr. floated in several interviews that the administration intended to revisit the FDA’s restrictions on a category of peptides used by compounding pharmacies. The remarks moved markets, lit up clinic newsletters, and produced a wave of “peptides are back” headlines.

We have now had three months to watch what comes next. Here is what has actually changed, and what has not.

The 2023 context, in one paragraph

In 2023, the FDA placed several peptides — including BPC-157, TB-500, AOD-9604, GHK-Cu, ipamorelin, and others — onto the Category 2 list of bulk drug substances under Section 503A of the Food, Drug, and Cosmetic Act. Category 2 substances are not banned outright, but the agency stated that pharmacies should not compound them under its current interim policy due to “significant safety risks” identified during a review. The practical effect: legitimate 503A pharmacies stopped offering them.

Separately, semaglutide and tirzepatide compounding had its own arc. Those compounds were prepared widely under the FDA’s drug shortage exception. When the agency declared each shortage resolved (semaglutide in early 2025, tirzepatide in late 2024), the legal path for compounded versions narrowed sharply.

What the February remarks were

The Secretary did not announce a rule. He did not direct the FDA to publish a proposed rule. The statements were a signal: that the administration would review the 2023 designations and consider whether the evidence supports keeping the listed substances restricted.

That is not a small thing. Public signals from HHS routinely precede formal rulemaking. But “precede” is not “equal to.” The Federal Register — the legally binding record of agency action — has not, as of this writing, published any proposed or final rule modifying the Category 2 list since February 2026. The list as published in 2023 remains operative.

What that means in practice today

For a 503A compounding pharmacy, the calculus is unchanged. The FDA’s interim policy continues to instruct them not to compound Category 2 substances. A pharmacy that resumed compounding on the strength of a press conference, without a corresponding Federal Register filing, would be operating ahead of the agency’s posted guidance.

For a patient or curious reader, the regulatory status of each listed peptide is the same today as it was in January. A site that tells you otherwise is reading a press cycle, not a rule.

For a clinician fielding patient questions, this is the honest answer: an HHS-level review has been signaled, no rule has issued, and the 2023 restrictions remain the FDA’s published position.

Four paths this can take

Watching the Federal Register and FDA’s compounding guidance pages for the next phase will be more informative than watching cable news. Here are the four shapes a real action could take:

1. A proposed rule with a comment period. The administrative-law standard path. A draft rule appears in the Federal Register, public comments open for typically 60 to 90 days, the FDA responds to comments, then issues a final rule. From signal to final rule, twelve to twenty-four months is normal.

2. Updated agency guidance. Faster, lower friction. The FDA could publish a guidance document changing how it intends to enforce the 2023 designations without rewriting the underlying list. Guidance is not legally binding the way a rule is — but in practice it is what pharmacies plan around.

3. A re-review with no change. The agency reviews the 2023 record, restates its findings, and the list stands. This is a real outcome, and it would also produce a Federal Register entry.

4. Substance-by-substance reclassification. Some peptides move out of Category 2 (perhaps into Category 1, the “may be compounded” list) and others stay restricted. This is the most likely path if the agency takes the question seriously, because the evidence base differs substantially across compounds. BPC-157’s published human data, for example, is in a different position than semaglutide’s.

What we are watching for

A few concrete signposts that would mean something has actually shifted:

• A Federal Register entry under “FDA — proposed rule” referencing 21 CFR 216 or the 503A bulks list.
• A revised compounding guidance posted to the FDA’s compounding webpage with a date later than the 2023 final guidance.
• A commissioner-level FDA statement referencing specific substances — not the HHS Secretary, who does not run the FDA day-to-day.
• State pharmacy boards updating their inspection guidance to reflect a federal change. State boards typically follow but sometimes lead.

Until those appear, the right intellectual posture is: the 2023 designations are the law. A press cycle is not.

What we will not do at The Peptide Column

We will not adjust our profile pages to soften the Category 2 framing on any of the listed peptides until a formal rule appears. The educational material on this site is sourced to the FDA’s current published position — that position has not changed, and we will not pretend otherwise to chase the news.

We will also not predict the outcome. The administrative process is opaque from the outside, and confident predictions about FDA rulemakings are usually wrong. What we will do is publish the rule, in plain English, the same week it issues.

In the meantime, the most useful thing a reader can do is bookmark the Federal Register search for peptide compounding and set a calendar reminder to check it monthly. That feed is the ground truth. Everything else is commentary.

— The Editors