On Sept. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Sept. 7-13, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Sept. 14 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 on Sept. 15 issued a final rule that makes it easier for the agency to destroy small shipments of illegal prescription drugs imported via international mail or express courier (here). The new regulations would allow FDA to destroy drug shipments valued at $2,500 or less that have been refused admission to the U.S., without giving the consignee the option of exporting the drugs. FDA is still required to give notice to the owner or consignee and the opportunity to request a hearing. The final rule takes effect Oct. 15.
On Sept. 11 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 final rule setting new current good manufacturing practice and preventive controls requirements for animal food (here). Set to be published in the Sept. 17 Federal Register alongside FDA’s final rule on preventive controls for human food (see 1509100021), the final rule sets CGMP requirements and mandates a written preventive controls plan similar to that for human food for animal food facilities require to register with FDA. The new regulations include exemptions, including for small businesses. Importers of animal foods would have to verify their foreign suppliers’ compliance with these CGMP and preventive controls regulations as part of the Foreign Supplier Verification Program.
On Sept. 9 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 issuing its Food Safety Modernization Act final rule on animal foods (here). The final rule, set for publication on Sept. 17, establishes current good manufacturing practice (CGMP) requirements for food for animals, and adds requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls. FDA concurrently issued its final rule on preventive controls for human food (see 1509100021). International Trade Today will have more details on the animal food rule in a later issue.
On Sept. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: