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FDA Allows More Comments on Proposed Drug Supply Chain Security Act 3PL Licensing Standards
May 23, 2022 by Brian Feito|FDA

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.

FDA Proposes to Amend Regulations on Medical Gases
May 20, 2022 |FDA

FDA is proposing to amend its current good manufacturing practice and post-marketing safety reporting regulations for medical gases, it said. The proposed rule would also establish regulations “regarding certification of designated medical gases and amend the labeling regulations that apply to certain medical gases,” FDA said. “This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area.” Comments are due Aug. 22.