[January 1, 2014, AJHP News]
BETHESDA, MD 16 December 2013—A year after Congress began investigating deadly fungal infections linked to tainted medications prepared by a Massachusetts compounding pharmacy, a new law to improve the safety and quality of compounded sterile products is now on the books.
President Obama signed into law the Drug Quality and Security Act on November 27. The law was supported by ASHP, the American Pharmacists Association, the National Community Pharmacists Association, and the National Association of Chain Drug Stores.
Joseph Hill, ASHP's assistant director of government affairs and director of federal legislative affairs, said the law does two major things relating to pharmacy compounding: It eliminates language in the Federal Food, Drug, and Cosmetic Act that has resulted in conflicting court opinions on the federal regulation of pharmacy compounding, and it creates a new, voluntary process for entities to register with FDA as outsourcing facilities that prepare compounded sterile products.
continue to read here
No comments:
Post a Comment