The US Food & Drug Administration (FDA) is announcing the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers as required by the Drug Supply Chain Security Act (DSCSA). The proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.
Requirements for wholesale drug distributors currently vary significantly across state lines creating a patchwork system. In passing DSCSA, Congress believed a uniform national standard would address this issue. This proposed rule would provide clarity and consistency for wholesale distributors and third-party logistics providers seeking licensure. When final and effective, every US wholesale distributor and third-party logistics facility would be held to these standards. Only those licensed according to the national standards would be able to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain. Where a state does not have a licensing program in accordance with the regulation, FDA would be the licensing authority.
National standards will help diminish opportunities for dangerous and criminal conduct affecting the supply of prescription drugs in the United States. Theft and diversion of prescription drugs are public health issues that can lead to patient harm. Unlicensed wholesale distributors have been involved in incidents of distribution of illegitimate products like counterfeit, stolen and otherwise harmful drugs.