FDA Allows More Comments on Proposed Drug Supply Chain Security Act 3PL Licensing Standards

FDA will extend until Sept. 6 the period for comments on its proposed rule on standards for licensing of third-party logistics providers and wholesale distributors under the Drug Supply Chain Security Act (DSCSA), it said in a notice released May 23. Under the Feb. 3 proposal (see 2202030023), wholesale distributors and 3PLs must obtain a license for each of their facilities from the state in which they are located, or obtain a license from FDA if no state licensing scheme is in place. The proposal sets standards for state licensing requirements, preempting any that are more stringent or burdensome than outlined in the standards, and harmonizes requirements between states. Carriers engaged only in transportation would be exempt from licensing requirements.