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FDA Delays Requirements for Rx/Blood Distributors

02/23/2004

Federal Register Final rule: FDA is further delaying, until 12/1/06, the effective date of certain requirements of a 12/3/99 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. FDA has delayed this final rule six times. This final delay was based, in part, on comments received on FDA's Counterfeit Drug Task Force's Interim Report. If track and trace technologies are widely adopted through FDA’s counterfeit drug initiative they are expected to help resolve many of the concerns that are raised with respect to the final rule. To view this final rule, click here.

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