New Study Finds Compounded GLP-1s Remain Robust Despite End of Shortages

A new cross-sectional study published in JAMA Health Forum found that compounded glucagon-like peptide-1 receptor agonist (GLP-1 RA) products remain widely available at brick-and-mortar weight loss clinics and medical spas, even after the FDA declared the semaglutide and tirzepatide shortages resolved. Researchers from the University of Colorado Anschutz Medical Campus conducted secret shopper calls to 75 businesses in West Virginia and Oklahoma between August and October 2025, finding that most were still offering compounded products, frequently combined with additives whose clinical benefit remains unproven.¹

Study Finds Widespread Compounding Often With Additives

Of the 75 businesses confirmed to offer compounded GLP-1 RAs, 69 (92.0%) reported offering compounded semaglutide and 65 (86.7%) reported offering compounded tirzepatide. Seven businesses (9.3%) offered oral or sublingual formulations. Additives were common, with 44 of 75 businesses (58.7%) confirming their products were compounded with an additive, most often B vitamins (42 businesses, 56.0%), followed by levocarnitine (5 businesses, 6.7%) and glycine (4 businesses, 5.3%).¹

Most consultations were conducted by nurse practitioners or physician assistants (42 of 75 businesses, 56.0%), rather than physicians (30 businesses, 40.0%). Most businesses (52 of 75, 69.3%) required in-person consultations, and 46 of 75 (61.3%) required follow-up appointments at least once monthly, though 17 businesses (22.7%) required less-frequent follow-up or none at all.¹

Researchers also identified 24 compounding pharmacy suppliers behind these products, located across at least 6 states. Among 21 facilities for which sterile compounding license status could be confirmed, 4 (19.0%) were not licensed to perform sterile compounding. One facility had received 2 FDA warning letters since 2023, both citing sterile compounding violations, and 3 of 22 facilities (13.6%) had faced state board of pharmacy disciplinary action. The study authors concluded that the FDA's decision to resume enforcement against copycat compounding appears to have pushed the market toward additive-based products rather than eliminating it.¹

FDA Moves to Close the Bulk Compounding Pathway

The study's findings land alongside a broader FDA effort to tighten the regulatory window for GLP-1 compounding. The agency has proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulk list, the list of active pharmaceutical ingredients that FDA-registered outsourcing facilities may use to compound in bulk. The proposal would not directly affect 503A pharmacies, which compound to individual patient prescriptions under state board oversight rather than the bulk list, though 503B facilities may still compound these drugs during a declared shortage.²

The regulatory tightening follows a wave of FDA warning letters to 30 telehealth companies over marketing claims that compounded GLP-1s are "identical" to approved products and litigation from Novo Nordisk alleging that some compounded semaglutide contained impurities as high as 86%.^2,3

Separately, a National Pharmacy Association survey covering 6000 British pharmacies found that roughly 1 in 10 online pharmacies had their websites or social media accounts cloned by criminals seeking to sell counterfeit weight-loss medications. Two in 5 pharmacies reported encountering patients who had unwittingly purchased treatments from unregulated sources. In some cases, counterfeiters stole legitimate pharmacist videos or copied regulator logos to appear credible. One pharmacy reported a patient who discovered they had been defrauded only after a counterfeit tirzepatide pen produced no health benefit.³

"The lesson is simple and has been consistent, which is 503A pharmacies must remain patient-specific in both form and reality," Dae Lee, PharmD, Esq, CPBS, shareholder at Buchanan Ingersoll & Rooney, said.³ "High-volume, standardized formulation, and national distribution are no longer being treated as aggressive compounding. They're being treated as manufacturing. If your GLP-1 business model depends on the scale rather than individualized prescriptions, you might be exposed."

What This Means for Pharmacists

For pharmacists navigating this landscape, the compliance stakes are rising alongside enforcement. Annie Lambert, PharmD, BCSCP, clinical program manager for compliance solutions at Wolters Kluwer, said community pharmacists compounding GLP-1s need to be able to justify their anticipatory batch sizes.⁴

"For community pharmacists that are performing GLP-1 compounding, they really need to be prepared to justify their rationale for their anticipatory batch quantities to avoid the impression of mass production," Lambert said.⁴ "I think that's where the FDA is really targeting in on some of their quantities."

Lambert noted that pharmacies not directly involved in compounding still play a role, since patients often bring questions about sourcing and legitimacy directly to the counter. She recommended that pharmacies emphasize accreditation, such as Pharmacy Compounding Accreditation Board certification or National Association of Boards of Pharmacy Verified Pharmacy Program status, and be transparent that 503A compounding requires a prescription rather than a menu of selectable products.⁴

Taken together, the new study and the surrounding regulatory activity suggest that even as the FDA narrows the legal pathways for large-scale GLP-1 compounding, patient demand—and the risks that come with meeting it outside FDA-approved channels—show little sign of receding.

REFERENCES

1. DiStefano MJ, Tilley A, Paratane D, et al. Postshortage compounded GLP-1 RA market in 2 states with potentially high demand. JAMA Health Forum. 2026;7(7):e262207. doi:10.1001/jamahealthforum.2026.2207

2. FDA proposes to exclude GLP-1s from 503B bulk list. Drug Topics. Accessed July 20, 2026. https://www.drugtopics.com/view/fda-proposes-to-exclude-glp-1s-from-503b-bulk-list

3. Gallagher A. One in 10 online pharmacies found website cloned for counterfeit GLP-1s. Drug Topics. April 22, 2026. Accessed July 20, 2026. https://www.drugtopics.com/view/one-in-10-online-pharmacies-found-website-cloned-for-counterfeit-glp-1s

4. Nowosielski B, Lambert A. Q&A: pharmacists must navigate GLP-1 compounding regulations carefully, compliantly. Drug Topics. March 18, 2026. Accessed July 20, 2026. https://www.drugtopics.com/view/pharmacists-must-navigate-glp-1-compounding-regulations-carefully-compliantly