Diario

Compounded semaglutide and tirzepatide after the shortage

While tirzepatide or semaglutide was on the FDA shortage list, compounders had an opening to make versions. The FDA is not your mother. It did publish the day that opening closed.

On December 19, 2024, the FDA said the tirzepatide injection shortage was resolved. That is Lilly's Mounjaro and Zepbound. The agency then allowed a wind-down. State-licensed pharmacies and physicians under section 503A had until February 18, 2025. Outsourcing facilities under section 503B had until March 19, 2025. Those dates are in the December 19, 2024 note on the FDA's GLP-1 compounding page.

Semaglutide was next. On February 21, 2025, the FDA said that shortage was resolved too. The approved products named in the order are Novo's Ozempic and Wegovy. Section 503A compounders had until April 22, 2025. Section 503B outsourcing facilities had until May 22, 2025. The FDA said supply met present and projected demand. A resolved shortage is a supply call. It is not a ban on wanting the drug.

After those dates, a straight copy was no longer sitting on the shortage exception. The same FDA page, current as of April 1, 2026, still says tirzepatide and semaglutide are not on the shortage list and are not on the 503B bulk list. Compounded drugs are not FDA-approved drugs.

What the phone survey found

The market did not treat the calendar as the last day of sales. University of Colorado researchers called weight-loss clinics and med spas in West Virginia and Oklahoma from August through October 2025. That is months after both wind-downs. They confirmed 75 businesses. Drug Topics reported the paper on July 20, 2026. The paper is in JAMA Health Forum, 2026, volume 7, article e262207.

Sixty-nine of 75, which is 92.0 percent, offered compounded semaglutide. Sixty-five of 75, 86.7 percent, offered compounded tirzepatide. Seven of 75, 9.3 percent, offered an oral or sublingual form.

Forty-four of 75, 58.7 percent, said the mix included an additive. B vitamins were the usual additive, at 42 businesses, 56.0 percent. A few named levocarnitine or glycine. Drug Topics said those additives do not have an established benefit here. The authors' read was that enforcement pushed sellers toward additive products instead of ending the trade.

This note will not tell anyone how to keep compounding. An added vitamin is not Wegovy, and it is not Zepbound. The FDA has written that a semaglutide mix with a B vitamin can still count as a copy of the commercial drug, depending on the strength and how it is given. "We added something" is a sales line until you know what is in the bottle and who made it.

The risk in the same calls

The callers traced 24 suppliers in at least six states. They could check a sterile-compounding license for 21 facilities. Four of those 21, 19.0 percent, did not have one. One facility had two FDA warning letters since 2023 for sterile-compounding problems. Three of 22 facilities, 13.6 percent, had state board discipline. A menu is not a license.

Drug Topics also noted Novo Nordisk litigation alleging impurities as high as 86 percent in some compounded semaglutide. That is an allegation in a lawsuit, not a test of every bottle. A shared nickname is not a shared substance.

On February 6, 2026, the FDA said it intended to act against mass-marketed unapproved GLP-1 compounds, including seizure and court orders, and that sellers cannot call those compounds the same as the approved drug. On April 30, 2026, the FDA proposed keeping semaglutide, tirzepatide, and liraglutide off the 503B bulk list. A proposal is not a finished rule. The July 2026 write-up still treated it as a proposal. The phone survey had already shown the menus were up.

An approved pen, a compounded clinic product, and a research vial are three different things. You can want a lower price and still refuse to blur them.

FDA GLP-1 compounding timeline. Tirzepatide order, December 19, 2024. Semaglutide order, February 21, 2025. Drug Topics, July 20, 2026. FDA statement, February 6, 2026. Bulk-list proposal, April 30, 2026.

Vials on singlevialpeptides are research material, for adults 21 and older, not for people or animals.

Viales de investigación. 21 años o más. No es para personas ni animales. No es consejo médico.