The U.S. District Court for the Northern District of Mississippi has entered a consent decree prohibiting Delta Pharma from manufacturing or distributing compounded drugs until they comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations, the Food and Drug Administration announced Friday. The company is registered as an outsourcing facility under Section 503B of the Act. "That legislation envisioned an important role for outsourcing facilities to help supply providers with compounded medicines, but it also required that these firms meet good manufacturing practice requirements,” said FDA Commissioner Scott Gottlieb, M.D. “When we find outsourcing facilities that continue to violate the law by not adhering to these manufacturing requirements, and put patients at risk, we’re going to hold them accountable under the law. At the same time, we’re also pursuing new policy steps to help make it more feasible for compounders to meet the requirements of becoming an outsourcing facility.”

Related News Articles

Headline
The Senate yesterday passed and sent to the president for his signature AHA-supported legislation that would provide funding for states to develop maternal…
Headline
Congress yesterday passed a farm bill conference report that authorizes assistance for rural hospitals to refinance a debt obligation as an eligible loan or…
Headline
The House of Representatives yesterday voted 400-11 to pass a health care bill (H.R. 7127) that includes the ACE Kids Act.
Headline
The House of Representatives today passed AHA-supported legislation (H.R. 1318) that would provide funding for states to develop maternal mortality review…
Headline
The Food and Drug Administration yesterday released revised draft guidance for facilities that compound human drugs as outsourcing facilities.
Headline
Nine health insurance, employer and consumer organizations today proposed guiding principles for federal legislative action to protect patients from surprise…