Authorized Distributor of Record (ADR)
The United States Food & Drug Administration (USFDA) recently announced that the federal regulations (21 CFR 203) implementing the requirements of The Prescription Drug Marketing Act (PDMA) of 1987 were to become effective for compliance and enforcement purposes. As of Friday, December 1, 2006, every manufacturer is required to maintain, update and make available upon request a listing of its Authorized Distributors of Record (ADR). This listing must document those entities which have an ongoing relationship (within the meaning of federal law and regulation) with a prescription drug manufacturer. This is commonly referred to as an "Authorized Distributor of Record List", or "ADR List".
If you have any questions related to Baxter's distribution licensing, please send an email to the attention of the Global Regulatory Affairs Pharmaceutical Compliance group (GRAPC) at GRAPC@Baxter.com