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 House Energy and Commerce Committee today advanced by a 30-24 vote along party lines its portion of the fiscal year 2025 reconciliation bill following a…
Headline
Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 14 testified on President Trump’s discretionary budget proposal for fiscal year…
Headline
The House Ways and Means Committee today advanced its portion of the fiscal year 2025 reconciliation bill by a 26-19 vote along party lines, following an hours…
Headline
The House Energy and Commerce Committee late on May 11 released legislative text in advance of the May 13 markup on its portion of the reconciliation bill.…
Headline
The House committees with jurisdiction over Medicaid and other health care programs have announced they will begin marking up their portions of the budget…
Headline
The AHA May 8 voiced support for the Save Healthcare Workers Act to House and Senate sponsors of the legislation. The bipartisan bill would make it a federal…