2022-25622: Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's regulatory and enforcement priorities regarding preparation of beta-lactam oral antibiotic suspension products that appear on FDA's drug shortage list by a licensed pharmacist in a State- licensed pharmacy or Federal facility.
The agency’s own summary, as published.
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