What’s up with all the 483s?

A Quick Overview of FDA Form 483 As part of its federal authority, the FDA has oversight for the approval, manufacturing, and ongoing regulation of drug product in the US healthcare market. The FDA Form 483 relates to the manufacturing portion of FDA oversight. When...

503B Outsourcing Pharmacy

In April of 2014, Premier Pharmacy Labs registered with the FDA as a 503B Outsourcing Facility under the new Drug Quality and Security Act (DQSA). This voluntary registration is made available to large-scale facilities engaged in non-prescription anticipatory...