Food and Drug Administration Commissioner Margaret Hamburg lauded a new Institute of Medicine report on “Countering the Problem of Falsified and Substandard Drugs” for its “thorough discussion and recommendations.” IOM’s report identifies causes and public health consequences of substandard and falsified drugs and recommends strategies to address the problem.
On Feb. 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 sent a warning letter to P.A. Benjamin Manufacturing, a drug company based in Jamaica, detailing violations of current good manufacturing practice regulations, as well as unapproved new drug and misbranding violations. Specific problems included labeling violations and use of active ingredients that do not comply with requirements for cold and cough medicines for over-the-counter use. FDA said it may continue to refuse admission of drugs manufactured at P.A. Benjamin’s Kingston facility as a result.
On Feb. 11 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 Feb. 4-10, 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:
The Food and Drug Administration posted an online training module for foreign aquaculture producers to help them comply with FDA seafood import regulations. The module is hosted by the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland, which also provides certificates upon completion. The training course is designed to clarify how FDA regulates drugs for aquaculture, and provides information to help identify what drugs may be used and how they should be used to prevent unacceptable residues. The course also includes a section on the judicious use of antimicrobials. The module is available here.
On Feb. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
DZH Import & Export Inc. of New York is recalling its “Curiosity Of Dashan” dried mushrooms imported from China because of undeclared sulfites that could provoke allergic reactions. The recalled mushrooms come in a 3.5oz containers, packed on a plastic tray with the following code: BEST BEFORE: MAY 3rd, 2013. The UPC code is 6939457003484. The product was sold in New York City.
On Feb. 7 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’s Cincinnati District, in conjunction with Xavier University, will hold the “PharmaLink 2013” conference on the global pharmaceutical supply chain March 12-14 in Cincinnati. Topics on the agenda include the impact of new legislation on the global supply chain, FDA policy and guidance, and the impact of contract manufacturing on drug shortages. Advance registration ends Feb. 18, but registration will be available after that date and onsite at increased rates. Registration and the conference agenda are available here.