Court Refuses to Alter Compounding Decision
ePT--the Electronic Newsletter of Pharmaceutical Technology
Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.
Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice’s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.
The court ruled in Medical Center Pharmacy, et al. v. Gonzalez that compounded pharmaceuticals do not fit FDA’s definition of new drugs and that such products are therefore exempt from the new drug application process. The court further held that the agency could not block pharmacists from creating individually tailored drugs with bulk ingredients.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
