By Healthcare Brew Staff
less than 3 min read
Definition:
Compounding is when a doctor, pharmacist, or someone supervised by a pharmacist creates a custom drug that’s modeled after an FDA-approved drug.
What are the rules?
Compounding is legal in only a few circumstances, like if a patient is allergic to an ingredient in a branded drug or if a drug is in shortage. Compounded drugs are not allowed to be exact copies of a drug unless that drug is on the FDA’s drug shortages list.
There are strict rules around the advertising of compounded drugs, too. For one, compounders cannot claim their drugs have the same active ingredients as an FDA-approved drug or imply their drug is approved. Health experts called out telehealth company Hims & Hers in February 2025 over a Superbowl ad, claiming the company didn’t make it clear enough that its drug was a compounded one.
Compounded GLP-1s
Compounded drugs are primarily overseen by state boards of pharmacy, though the FDA still regulates and inspects mass-compounding facilities.
The FDA also enforces drug advertising rules and has sent warning letters to companies, with a particular focus on GLP-1 compounders.
GLP-1 compounds were allowed on a broad scale during a nationwide shortage that ended Feb. 21, 2025. But after the shortage ended, prescriptions actually increased, research firm Iqvia found in an October 2025 report.
Novo Nordisk, creator of the popular GLP-1 medication Wegovy, has filed over 100 lawsuits against companies that sell compounded drugs, as of September 2026.
