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 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,鈥 said FDA Commissioner Scott Gottlieb, M.D. 鈥淲hen we find outsourcing facilities that continue to violate the law by not adhering to these manufacturing requirements, and put patients at risk, we鈥檙e going to hold them accountable under the law. At the same time, we鈥檙e also pursuing new policy steps to help make it more feasible for compounders to meet the requirements of becoming an outsourcing facility.鈥

Related News Articles

Headline
The Senate Appropriations Committee July 31 advanced the fiscal year 2026 appropriations bill for the Departments of Labor, Health and Human Services,鈥
Chairperson's File
Public
The recently enacted One Big Beautiful Bill Act will bring big changes to health care. AHA President and CEO Rick Pollack joined me for a Leadership Dialogue鈥
Chairperson's File
Public
This month Congress enacted the One Big Beautiful Bill Act 鈥 a sweeping package that contained many of President Trump鈥檚 legislative priorities on taxes,鈥
Headline
The AHA July 2 expressed support for the Resident Physician Shortage Reduction Act (H.R. 3890), bipartisan legislation that would add 14,000 Medicare-funded鈥
Headline
The House July 3 voted 218-214 to pass the final version of the One Big Beautiful Bill Act (H.R. 1), which enacts many of President Trump鈥檚 legislative鈥
Headline
The Senate narrowly passed the One Big Beautiful Bill Act (H.R. 1) on July 1 by a 50-50 tally, with Vice President J.D. Vance casting the tie-breaking vote.鈥