What does essentially a copy mean?
Essentially a copy is the FDA's term for a compounded drug that matches an FDA-approved drug on the market. A 503A pharmacy may not make one regularly or in large amounts unless the prescriber documents a patient need for a change.
Why it matters for GLP-1s
While semaglutide and tirzepatide were in shortage, the rule did not block copies. With both off the shortage list, compounders sell versions with a documented difference, such as a dose the brand does not sell or an added ingredient like vitamin B12.
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What it means for the price
This rule is why compounded GLP-1s are still sold at cash prices well below the brands, and why their product names now include words like personalized or with B12.
Questions
Is compounded tirzepatide essentially a copy of Zepbound?
A plain copy would be. Sellers now offer formulations that differ for a documented reason, which is how they stay within the rule.
Sources
- FDA guidance, Compounded drug products that are essentially copies of a commercially available drug product under section 503A
- 21 U.S.C. 353a (section 503A)
Prices on GLP Chart are read from each program's own pricing page. How: how we check prices. Every program's price this month: the GLP-1 price index.