Pharmacy Compounders Defend Semaglutide Compounding Amid Continued Shortages

As both the FDA and the Alliance for Pharmacy Compounding (APC) are cautioning patients about buying compounded semaglutide from online pharmacies that are using smeaglutide salts, the APC said that its compounders are allowed to produce legitimate compounded semaglutide¹—contrary to some state boards of pharmacies, Novo Nordisk, and media reports.

High demand for popular diabetes and weight loss drugs such as pushed several of these medications onto the FDA’s Drug Shortages list last year.² As a result, the FDA allowed compounded forms of semaglutide.³

As of May 2023, Ozempic and Wegovy are still listed on the Drug Shortages list. “A drug can be compounded if it is currently in shortage,” APC President Scott Brunner told Drug Topics®.

“Contrary to recent communications issued by some boards of pharmacy, FDA-approved semaglutide drugs remain ‘currently in shortage’ on the FDA drug shortage list,” APC said. “Currently in shortage” does not necessarily mean that a drug is completely unavailable, only that there may not be sufficient supply to meet demand, the organization added.

However, Novo Nordisk asserts that its patent on its finished product containing semaglutide prohibits the compounding of medications containing the same active pharmaceutical ingredient and has sent cease-and-desist letters to some compounding pharmacies, according to both the APC and Novo Nordisk.

“We are aware that several compounding pharmacies, weight loss clinics, and medical spas are claiming to sell or offer compounded products purporting to contain ‘semaglutide,’” a Novo Nordisk spokesperson told Drug Topics. “Novo Nordisk is actively monitoring and taking action (including but not limited to issuing cease-and-desist letters) against these entities that are engaging in the unlawful sale of compounded semaglutide, disseminating false advertising, and infringing its trademarks.”

Novo Nordisk is the only company in the United States with FDA-approved products containing semaglutide under the trade names Wegovy, Ozempic, and Rybelsus, the company said. “No FDA-approved generic versions of semaglutide currently exist.”

Additionally, compounded products “do not have the same safety, quality, and effectiveness assurances as our FDA-approved drugs, and may expose patients to health risks,” the Novo Nordisk spokesperson said. As such, the pharmaceutical manufacturer “cannot validate the safety or effectiveness of products claiming to contain semaglutide that are not one of our own branded products. We do not sell semaglutide for the purposes of compounding.”

However, the FDA’s guidance on compounding when medications are on its Drug Shortages list makes no distinction for a patented drug, according to APC. “Rather, the guidance indicates that if an FDA-approved drug is listed as on the FDA shortage list—again, as FDA-approved semaglutide drugs currently are—[the] FDA will not view compounded versions of it as ‘essentially a copy’ of the FDA-approved drug,” APC said.

Assertions in news stories that the only legitimate semaglutide active pharmaceutical ingredient must be obtained directly from Novo Nordisk are “flatly incorrect,” the APC said. “Remember that Novo Nordisk’s patent is on the finished drug product. The company is not, to our knowledge, manufacturing the semaglutide [active pharmaceutical ingredient] itself. Rather, it’s purchasing it from FDA-registered manufacturers (just as pharmacy compounding API wholesalers and compounding pharmacies do) and adding excipients to create its finished product.”

So although Novo Nordisk may exercise control over the supply of the API via its contracts with manufacturers, it has not (yet) completely locked down the supply chain on the active pharmaceutical ingredient, APC said, “based on reports we’ve heard from some compounding pharmacies that say they are able to access semaglutide base from FDA-registered facilities.”

Nevertheless, the organization is advising pharmacy compounders to seek the advice of legal counsel related to the patent issue and compounding semaglutide medications.

Meanwhile, the FDA is warning patients to be aware that some products sold as “semaglutide” may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations.⁴

“Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective. Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA,” the agency said.

Health care professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide, the agency said. The FDA is “not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.”

The APC echoed FDA's concerns. “It is APC’s current position that compounding with semaglutide sodium technically is not eligible to be used in a compounded medication,” the organization said.

References

1. Statement on rules governing compounding, what FDA guidance says about permissibility of compounding “essentially a copy” of an FDA-approved drug – and what those have to do with semaglutide. Statement. Alliance for Pharmacy Compounding. Revised May 22, 2023. Accessed June 6, 2023. https://a4pc.org/files/APC-Compounding-Semaglutide-Media-Brief-REVISED-22May2023-1.pdf

2. Drug shortages. FDA. Reviewed June 7, 2023. Accessed June 15, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

3. Section 503A of the Federal Food, Drug, and Cosmetics Act. FDA. Reviewed June 21, 2018. Accessed June 15, 2023. https://www.fda.gov/drugs/human-drug-compounding/section-503a-federal-food-drug-and-cosmetic-act

4. Medications containing semaglutide marketed for type 2 diabetes or weight loss, Statement. FDA. Updated May 31, 2023. Accessed June 6, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss.