February 24, 2022
The U.S. Food and Drug Administration has decided to undertake administrative rulemaking regarding a memorandum that had created new regulations to fully implement a decades-old rule governing pharmacy compounding.
September 21, 2021
A D.C. federal judge on Tuesday ordered the U.S. Food and Drug Administration to either perform an analysis of its memorandum that created new regulations to fully implement a decades-old rule governing pharmacy compounding, or certify that the memo won't greatly impact small businesses, like the pharmacies challenging the memo.
March 17, 2021
A group of pharmacies challenging the U.S. Food and Drug Administration's new regulations concerning compounded medication distribution told a D.C. federal court Wednesday that its lawsuit is ripe for judicial review, slamming the agency's claim that the case is premature.
March 04, 2021
The federal government is gunning to end a group of pharmacies' suit accusing the U.S. Food and Drug Administration of unlawfully issuing new regulations last October concerning compounded drug distribution, telling a D.C. federal court their case is not ripe for judicial review.
October 28, 2020
A group of pharmacies has accused the U.S. Food and Drug Administration of exceeding its authority by developing new agreements with states that upend long-standing regulations on compounding pharmacies, a move the group says will limit interstate commerce and add burdensome reporting requirements.