Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, May 3, 2013
FDA has wish list on regulating compounders Congress might be listening as quality control issues at compounders cause health-related death and illness -
By Eric F. Greenberg, Contributing Editor/Legal Columnist
Those big news stories last fall about the contaminated injectable steroids from New England Compounding Center in Massachusetts might have been the first news you heard about compounding pharmacies, but it’s not hardly the start of the story. The U.S. Food and Drug Administration and industry have been struggling for years over the proper regulatory treatment for these facilities, and Congress and the courts have both helped change the shape of things as well. FDA is now asking for even more changes to give it a better ability to regulate compounding pharmacies.
The Massachusetts compounder marketed products that killed more than 50 people and made hundreds more sick. The company pretty clearly had poor quality procedures, but many people blamed FDA for not cracking down on them. FDA, in turn, lamented that its legal powers are more limited over compounders than over conventional drug manufacturers, even when, as in this case, the compounders were behaving much the same way as a manufacturer.
- See more at: http://www.packworld.com/trends-and-issues/regulatory/fda-has-wish-list-regulating-compounders. Continue reading here