Guidance for Industry on Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance document provides an overview of FDA's policy on enforcement of the pharmacy compounding provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (the act) during the transition to full implementation of that section, which was added by the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).