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 AHA yesterday voiced support for the Competitive Health Insurance Reform Act (H.R. 1418/S. 350), legislation that would repeal the antitrust exemption…
Headline
The AHA today voiced support for the Improving Seniors’ Timely Access to Care Act (H.R. 3107), bipartisan legislation that would establish requirements for the…
Headline
The House of Representatives today passed and sent to the President a Medicaid-related bill (H.R. 3253) that includes a provision extending the Certified…
Headline
Medicaid disproportionate share hospital payments to eligible hospitals covered 51% of their uncompensated care costs in 2014, the most recently available…
Headline
The House of Representatives today passed 284-149 a two-year budget agreement (H.R. 3877) that increases discretionary funding limits and suspends the debt…
Headline
Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., today released a description of the chairman’s mark, the…