FDA Announces Availability of the Standard Memorandum of Understanding for Signature by States – the 365 Day Countdown to 5% Begins
By EsqSocial Corporation 29/10/20
The U.S. Food and Drug Administration (FDA) announced October 26 the availability for the signing of the final standard Memorandum of Understanding Addressing Certain Distribution of Compounded Human Drug Products (MOU) between state boards of pharmacy or other state agencies and the FDA. The MOU was part of the rulemaking delegated to FDA under section 503A of the federal Food, Drug and Cosmetic Act (FDCA). Section 503A of the FDCA prohibits compounding pharmacies from distributing “inordinate...
By: Bass, Berry & Sims PLC