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For 503A pharmacies, FDA reiterated a limited enforcement policy from its 2018 guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: the agency does not intend to take action where a compounder fills four or fewer prescriptions per calendar month of a drug that is “essentially a copy” of a commercially available drug
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