While the Drug Quality and Security Act (DQSA), which created significant implications for compounders by effectively reinstating Section 503A the Federal Food Drug and Cosmetic Act (FD&C Act), was signed in November 2013, its full effect has... Read More
Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

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