On Dec. 13 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 amended its regulations to allow the collection of user fees to cover the costs of amending the Food Safety Modernization Act third-party certification program. The final rule (here) sets fees on third-party accreditation bodies that will accredit third-party certifiers. It also sets fees for when FDA directly accredits third-party certifiers, though FDA has said it will only do so if no third-party accreditation bodies have been accepted. FDA also issued a separate notice setting program user fees for fiscal year 2017 (here). FDA has said it anticipates importers will use third-party certifiers to verify their suppliers’ compliance for Foreign Supplier Verification Program purposes (see 1511190058), and will require use of third-party certifiers for importers participating in the Voluntary Qualified Importer Program (see 1611100028). This final rule on user fees, along with a recently issued guidance document (see 1612060025), were seen as final steps before the third-party certifier program could begin.
The Food and Drug Administration on Dec. 13 issued guidance on the use of fruit and vegetable juices as color additives in food, it said (here). The guidance document (here) includes a list of juices and FDA’s position on whether they are allowed as color additives in food under FDA’s regulations.
On Dec. 12 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 is correcting a final rule it issued in August to clarify drug establishment registration requirements for manufacturers of investigational drugs, it said (here). The original final rule setting electronic registration requirements for human and animal drug and biologics establishments included an incorrect statement that establishments that make investigational drugs must register. FDA now says “manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale are exempt from the establishment registration requirement” if they’re not required to register due to other activities.
On Dec. 9-10 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 issued a new guidance document to assist members of the drug supply chain in complying with the Drug Supply Chain Security Act, it said (here). The guidance (here) “is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain,” FDA said. It also describes how trading partners under the law should notify FDA of illegitimate products and how to terminate such notifications, it said. Comments are due Feb. 7.
On Dec. 8 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 Dec. 7 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
On Dec. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: