The Prescription Drug Marketing Act of 1987 — modified by the Prescription Drug Amendments of 1992 — establishes legal safeguards for human prescription drug marketing and distribution to ensure safe and effective pharmaceuticals. It is designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent and expired prescription drugs. Among other things, the PDMA prohibited, with certain exceptions, the sale, purchase or trade of any prescription drug that was purchased by a hospital or other health care entity. Wholesale distributors of drugs or retail pharmacies licensed under state law are not included in the term "entity." Regulations related to this section of the PDMA were issued in 1999, but FDA delayed the effective date on several occasions due to numerous concerns raised by various stakeholders.
AABB follows developments relating to the PDMA and works with the FDA to help ensure that certain blood establishments can continue to play a critical role in providing drugs indicated for bleeding or clotting disorders and anemia; specific blood collection containers; or drugs that are blood derivatives, including recombinant or synthetic forms of blood derivatives.