Pharmacies Sue FDA Over Compounded Drug Agreements
Law360 (October 28, 2020, 3:03 PM EDT) -- 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.
The FDA's recent memorandum of understanding, or MOU, that created new regulations to fully implement a decades-old rule governing pharmacy compounding under the Federal Food, Drug, and Cosmetic Act is deeply flawed and improperly developed, Wellness Pharmacy Inc. and other pharmacies said in their suit filed in D.C. federal court Tuesday.
"The final standard MOU is defective both...
Stay ahead of the curve
In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
Create custom alerts for specific article and case topics and so much more!