PDMA Definition Of Authorized Distributor Is Too Restrictive, APhA Says
Executive Summary
FDA should revise its definition of authorized distributor in the proposed final rule to the Prescription Drug Marketing Act to allow wholesalers without formal manufacturer agreements to qualify, the American Pharmaceutical Association suggests.
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PDMA six-month extension
FDA is further delaying enactment of certain requirements of the Prescription Drug Marketing Act final rule relating to unauthorized distribution of prescription drugs from Oct. 1 to April 1, 2002. "The delay will give distributors additional time to exhaust inventories of drugs that do not have acceptable pedigrees to avoid economic harm," the final rule published in the March 1 Federal Register states. FDA will submit recommendations on the final rule to the House Appropriations Committee by March 15; the report was originally due to Congress by Jan. 15 (1"The Pink Sheet" Nov. 6, 2000, p. 14)
PDMA six-month extension
FDA is further delaying enactment of certain requirements of the Prescription Drug Marketing Act final rule relating to unauthorized distribution of prescription drugs from Oct. 1 to April 1, 2002. "The delay will give distributors additional time to exhaust inventories of drugs that do not have acceptable pedigrees to avoid economic harm," the final rule published in the March 1 Federal Register states. FDA will submit recommendations on the final rule to the House Appropriations Committee by March 15; the report was originally due to Congress by Jan. 15 (1"The Pink Sheet" Nov. 6, 2000, p. 14)
PDMA Gives Manufacturers New Pricing Power Over Wholesalers - NACDS
FDA's Prescription Drug Marketing Act regulations would give manufacturers new pricing power over wholesalers, according to the National Association of Chain Drug Stores.