Prescription Drug Marketing Act Pedigree Requirements; Effective Date and Compliance Policy Guide; Request for Comment

概要

The Food and Drug Administration (FDA) does not intend to further delay the effective date of certain provisions of the final regulation published in the Federal Register of December 3, 1999 (64 FR 67720). The provisions will therefore go into effect on December 1, 2006. In addition, FDA is announcing the availability of a new compliance policy guide (CPG) 160.900 entitled "Prescription Drug Marketing Act Pedigree Requirements Under 21 CFR Part 203" for public comment. This CPG describes how the agency intends to prioritize its enforcement efforts during the next year with respect to pedigree requirements set forth in the Federal Food, Drug, and Cosmetic Act (the act) and certain FDA regulations.