Compliance Policy Guide - Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR Part 203

• By: Staff Editor
• Date: August 15, 2009
• Source: www.fda.gov

This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR §§ 203.3(u) and 203.50.