The Food and Drug Administration proposed on April 30, 2026 to keep semaglutide, tirzepatide and liraglutide off its 503B bulks list. When we checked FDA.gov and the Federal Register on October 8, 2026, we found no final determination. The public comment period closed on July 30, 2026.

For a practice that sells a weight-loss line, that leaves the federal compounded GLP-1 rules where they stood in the spring. A proposal is on the table. Comments are in. No decision has been published, and one could appear at any time.

What the proposal covers

Outsourcing facilities are compounders that operate under section 503B of the Federal Food, Drug, and Cosmetic Act. They may or may not obtain patient-specific prescriptions, FDA's notice says, so they can ship compounded drugs to practitioners as "office stock" held ahead of patient need.

An outsourcing facility may compound from a bulk drug substance in only two cases, according to FDA. Either the substance is on the 503B bulks list, which names substances for which the agency has found a clinical need, or the drug is on FDA's shortage list at the time it is compounded, distributed and dispensed.

FDA's notice, published in the Federal Register on May 1, 2026, tentatively finds "no basis to conclude that there is a clinical need" for outsourcing facilities to compound from any of the three substances and proposes not to include them. The agency wrote that it does not treat supply problems such as backorders as clinical need. Nor does it weigh the cost of a compounded product against an approved one.

"When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need," said FDA Commissioner Marty Makary in the agency's April 30 announcement.

One limit on all of this. The notice is about section 503B. Section 503A, the provision that covers compounding by state-licensed pharmacies, appears only in a footnote comparing manufacturing requirements.

Where the process stands

Comments were first due June 30, 2026. On June 26, FDA published an extension to July 30, saying it was responding to a request for more time.

The May 1 notice sets out the rest. After reviewing comments, the agency will consider whether to consult its Pharmacy Compounding Advisory Committee. It may then finalize the proposal unchanged or modify it, and it intends to publish the final determination in the Federal Register. We found no deadline in the notice.

On October 8, the agency's 503B list page named none of the three substances, on either its list of substances with a clinical need or its list of those found to have none. The most recent Federal Register document we found in the docket (FDA-2018-N-3240) was the June 26 extension.

The enforcement running alongside

FDA has not waited for the list question to act on marketing. Holland & Knight, in an August 5, 2026 client alert, counted three rounds of warning letters over compounded GLP-1 advertising: more than 55 to online sellers in September 2025, 30 to telehealth companies in March 2026, and 25 issued on June 8, 2026 and posted on June 16. The law firm said the June letters cited claims implying "sameness" with approved drugs and advertising that obscured who actually made the product. None was aimed at med spas specifically, the firm wrote, though it said the concerns apply to any entity marketing compounded GLP-1 products. We covered advertising claims in our guide to social posts and reviews.

The agency's own page on unapproved GLP-1 drugs, marked current as of October 1, 2026, says FDA had received 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide as of May 31, 2026. It cautions that it is not always possible to tell whether the drug caused the event. Compounded drugs are not FDA-approved, the same page says.

What comes next is a final determination published in the Federal Register under docket FDA-2018-N-3240. Until then, the April 30 proposal is still a proposal.

Sources