On Oct. 25 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 posted more information on its proposed food safety rules for animal feed and pet food, in conjunction with its release of the proposed rule Oct. 25 (see 13102519). The webpage includes an overview of the rules, a fact sheet, and a questions and answers document. It also has a table on exemptions and modified requirements for both preventative controls and CGMP requirements for animal food. FDA said it will publish within six months of its final animal food rule a guidance document that explains the new regulations in plain language to help businesses comply with the rule.
On Oct. 24 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 Oct. 23 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Oct. 23 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 the Interstate Certified Shellfish Shippers List (ICSSL) for October. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Oct. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Northern California U.S. District Court rejected on Oct. 21 the Food and Drug Administration’s attempt to delay the court’s Nov. 30 deadline for the agency’s intentional adulteration proposed rule. FDA had asked for a stay of the deadline for the Food Safety Modernization Act-required rulemaking while the U.S. Court of Appeals for the 9th Circuit hears the case. FDA has also filed a request for an “emergency stay” of the Nov. 30 intentional adulteration deadline with the appellate court.
The Food and Drug Administration ended its Centralized Entry Review Pilot on Sept. 30 as a result of the partial government shutdown, said CBP in a CSMS message. The pilot, which is hoped to help improve efficiency of document reviews by centralizing the agency's entry review resources, was originally scheduled to continue through Nov. 2 (see 13061915).
The Food and Drug Administration is asking for comments by Dec. 23 on a new draft guidance on elemental impurities in pharmaceutical products. The draft guidelines (here), agreed to by the joint U.S.-European Union-Japan International Conference on Harmonization, would set safety limits for specific elements, and emphasizes control of supply chains and risk assessments, FDA said. The joint standard would set consistent expectations for test requirements and regulatory filings among the three ICH countries, said FDA.