The Food and Drug Administration issued a draft guidance with additional questions and answers it intends to add to its existing guidance document on food facility registration. The new sections further detail who is required to register in certain circumstances, including where a manufacturer leases its facility’s building and where a manufacturer stores its food in a self-storage warehouse. FDA also issued a new version of its final guidance on food facility registration, finalizing new sections proposed at the end of 2017 regarding registration exemptions and definitions (see 1612230026) and a recent FDA final rule amending registration requirements (see 1611070022).
On Aug. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Aug. 15 that lists 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 Aug. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration will hold a public hearing Nov. 5 to discuss planned changes to the format of national drug codes, it said in a notice. The agency will sometime in the future begin issuing 11-digit NDCs once it runs out of the five-digit drug labeler codes that make up a portion of NDCs. FDA anticipates that will happen in about 15 years. The hearing will include discussion of how a change to 11-digit codes will impact the pharmaceutical supply chain, as well as issues related to the current lack of uniformity among NDCs. Written comments are due by Jan. 5, 2019.
On Aug. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: