Category Archives for News

New Issue of NCCIH Update: Message from the Director on Pain Research

National Center for Complementary and Integrative Health sent this bulletin at 05/22/2019 07:48 AM EDT

Click here to view in browser.AnnouncementsNCCIH Director’s Message: Perspectives on Pain ResearchNCCIH colleagues and I recently participated in the American Pain Society Scientific Meeting in Milwaukee, Wisconsin. The meeting centered on the theme “Combating the Opioid Epidemic Through Innovations in the Treatment of Pain” and offered a valuable forum for sharing scientific findings and insights into the complexities of treating pain. Many NCCIH staff shared their expertise and were available to answer questions about our Center’s role in pain research.

FDA: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

May 22, 2019

U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration, Pharm D Solutions, LLC, as well as the company’s owners, Luis R. De Leon and Juan C. De Leon, continued to violate the law, putting patients at risk.“We understand that compounded drugs can be important for patients whose medical needs cannot be met by FDA-approved drug products, and we’re continuing efforts to advance policies to help further…
Read More
U.S. Food and Drug Administration10903 New Hampshire Avenue, Silver Spring, MD 209931-888-INFO-FDA (1-888-463-6332)Privacy Policy | www.fda.gov

Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities

May 22, 2019
U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development. The company has four registered outsourcing facilities located in Memphis, Tenn.; Cleveland, Miss.; Sugar Land, Texas and Dayton, N.J.  According to the complaint, despite previous warnings from the U.S. Food and Drug Administration and repeated promises from PharMedium to correct deficiencies, PharMedium continued to violate the law. 
“PharMedium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable,” said Acting FDA Commissioner Ned Sharpless, M.D. “We will continue to take appropriate enforcement actions when compounding pharmacies and outsourcing facilities produce drugs under …
Read More
U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Privacy Policy | www.fda.gov

>