Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Delay of Effective Date

The Food and Drug Administration (FDA) is further delaying, until April 1, 2002, the effective date regarding certain requirements of the final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA is further delaying the effective date for certain requirements in the PDMA final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. In the Federal Register of May 3, 2000 (65 FR 25639), the agency previously delayed until October 1, 2001, the effective date of these requirements. The other provisions of the final rule became effective on December 4, 2000. The agency is taking this action to address concerns about the requirements raised by affected parties. FDA believes that this further delay of the effective date of certain requirements in the PDMA final rule satisfies the memorandum of January 20, 2001, from the Assistant to the President and Chief of Staff, entitled "Regulatory Review Plan," published in the Federal Register on January 24, 2001 (66 FR 7702). That memorandum requested Federal agencies to delay by 60 days the effective date of any regulation that was not effective as of January 20, 2001. The action taken in this document to further delay the effective date of certain requirements of PDMA exceeds 60 days. To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, the agency's implementation of this action without opportunity for public comment, effective immediately upon publication today in the Fe