On May 24, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 23 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 20, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

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 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.

On May 18, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA has issued its Enforcement Report for May 18, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

On May 17, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 16, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 13, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: