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

Samenvatting

The Food and Drug Administration (FDA) is issuing a proposed rule to set forth agency policies and requirements and to provide administrative procedures, information, and guidance for those sections of the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), that were not implemented by the final rule that set forth Federal guidelines for State licensing of wholesale drug distributors (55 FR 38012, September 14, 1990). FDA is also proposing to amend the definitions section of the State licensing guidelines to make the definition of ``wholesale distribution'' consistent with that in this proposed regulation.