Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors and third-party logistics providers (3PLs), which are set to replace the current patchwork system of state licensing standards. The standards implement aspects of the Drug Supply Chain Security Act (DSCSA) and are meant to plug holes in the country’s pharmaceutical supply chain.
The generic drug industry lobby said it supported the fact that licensing rules would not apply to manufacturers that distribute their own products and requested that the final rule eliminate the practice for “manufacturer licenses” in some states for manufacturers that distribute their own products.
There were also calls from the Healthcare Distribution Alliance (HDA) to better align licensing rules between wholesale distributors and 3PLs. All wholesalers and 3PLs will be held to these licensing standards once a final rule take effect.
The comments were made in response to FDA’s proposed rule issued in February 2022. (RELATED: FDA issues long-awaited licensing rules for drug distributors and 3PLs, Regulatory Focus 3 February 2022)
DCSCA views 3PLs and distributors as partners in the supply chain that provide warehousing or logistical services to manufacturers or dispensers but who do not take ownership of products. Manufacturers distributing their own drug products will not be subject to these licensing rules…
