The Food and Drug Administration (FDA) continues to recommend additions to the 503(B) Bulks List (https://www.fda.gov/media/94164/download). A component of the Drug Quality and Security Act of 2013, the list includes drug products that 503(B)... Read More
Outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act may use a bulk drug substance to compound a drug if: the Food and Drug Administration (FDA) has determined there is clinical need to compound with the... Read More
In keeping in line with its 2018 Compounding Policy Priorities Plan, the Federal Food and Drug Administration (FDA) released four compounding updates on Monday, July 23rd, including: Compounding risk alert regarding the bulk drug substance,... Read More
On Sept. 7, 2017, Allergan filed two lawsuits in the US District Court for the Central District of California against Imprimis Pharmaceuticals and Sincerus Florida, two US FDA-registered 503B outsourcing facilities, and Prescriber's Choice, a... Read More
The FDA recently issued an Interim Policy on compounding using bulk drug substances under Section 503A and 503B of the Food Drug and Cosmetic Act (FD&C Act) offering important guidance for compounding pharmacies. 503A Section 503A sets forth... Read More
