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Key Takeaways On April 1, 2026, FDA issued astatementreminding 503A pharmacies and 503B outsourcing facilities that compounded drugs qualify for the statutory exemptions under the Federal Food, Drug, and Cosmetic Act (FD&C Act), only when applicable conditions are satisfied, with specific focus on the essentially a copy standard.

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doi: 10.1177/15593258231200527

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