A waiver from sanitary transportation requirements for retail food applies only to establishments that sell human food, the Food and Drug Administration said in a guidance document issued Aug. 14. The waiver, issued in April (see 1704050026), had been the subject of some confusion, because the term “retail food establishment” can also apply to animal food, FDA said. Establishments that sell both human and animal food may qualify for the waiver, FDA said. But the “retail food establishment waiver does not extend to establishments that sell food for animals and do not sell food for humans,” FDA said. The sanitary transportation rule, required by the Food Safety Modernization Act, began taking effect in April (see 1604050023).
On Aug. 11 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 exercise enforcement discretion regarding the use and labeling of fluid ultrafiltered milk (UF milk) and fluid ultrafiltered nonfat milk (UF nonfat milk) to make certain cheeses and related cheese products," the agency said in a notice. The FDA issued a guidance for industry detailing the agency's enforcement stance and "current thinking." The guidance follows "recent changes in some export markets that have caused the U.S. dairy industry to experience an oversupply and pricing challenges with domestically produced UF milk," the FDA said.
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:
The Food and Drug Administration issued updated guidance on its recent extension of compliance dates for its rule deeming e-cigarettes, cigars and pipe tobacco as tobacco products subject to the agency’s regulation, it said. The new enforcement policy delays premarket review compliance deadlines, previously set for 2017 and 2018, depending on the product and type of submission, until 2021 and 2022. Other deadlines in the final rule remain unchanged (see 1605050011). The updated guidance includes a table outlining compliance dates for the various provisions included in the final rule, including the extended premarket requirements.
On Aug. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 4 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 announced the availability of new guidance documents on drug products. The draft guidances provide "product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)," FDA said. The new guidance documents cover Acarbose; Acetaminophen, Aspirin, Caffeine; Acetaminophen, Butalbital, Caffeine, Codeine phosphate; Acitretin; Amoxicillin (multiple reference listed drugs); Amoxicillin, Clavulanate Potassium; Aspirin, Butalbital, Caffeine (multiple reference listed drugs); Aspirin, Butalbital, Caffeine, Codeine Phosphate; Atenolol; Atenolol and Chlorthalidone; Cetirizine HCl; Chlorthalidone; Citalopram HBr; Citalopram hydrobromide; Clarithromycin; Clindamycin HCl; Clomiphene Citrate; Clonazepam; Clozapine; Cyclobenzaprine HCL; Cycloserine; Dapsone; Desipramine HCl; Desmopressin Acetate; Diflunisal; Diphenhydramine HCl; Dipyridamole; Disulfiram; Donepezil HCl; Doxazosin mesylate; Doxepin HCl; Doxercalciferol; Eprosartan Mesylate; Ethambutol HCl; Hydrochlorothiazide, Losartan Potassium; Hydrochlorothiazide, Triamterene; Hydrochlorothiazide, Valsartan; Hydrocodone bitartrate, Ibuprofen; Hydrocortisone; Hydromorphone HCl; Selegiline hydrochloride; Sotalol HCl; Tenofovir Disoproxil Fumarate; Tiagabine HCl; Valproic acid; and Verapamil HCl.
The Food and Drug Administration on Aug. 2 posted a new draft guidance document on child-resistant packaging statements in drug labeling, it said in a notice. The document is “intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling,” FDA said. Topics covered include what information that should be included to support statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements to these applications, FDA said. Comments are due Oct. 2.