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Blood Establishments That Can Distribute Derivatives

02/01/2006

Federal Register Proposed rule: FDA proposes to amend its regulations to allow certain registered blood establishments that qualify as health care entities to distribute drug products that are blood derivatives. This proposed rule, which is specific to registered blood establishments and the distribution of blood derivatives, if finalized, would amend certain limited provisions of the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the Modernization Act of 1997. These regulations currently restrict the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs purchased by hospitals and other health care entities. To view this proposed rule, click here.

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