Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances

概要

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled ``Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act''. The draft guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act. When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance. The Agency is also announcing the withdrawal of a guidance entitled, ``Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act,'' which was issued in November 1998, and the withdrawal of CPG Section 460.200 of the Compliance Program Guidance (CPG) Manual entitled, ``Pharmacy Compounding,'' which was issued in May 2002. These guidances are being withdrawn because they are no longer consistent with the Agency's current thinking on the issues they address.