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
COVID-19 Resources | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

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
Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

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
Blogs & Articles | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)