BI Insight: Impact of Drug Quality and Security Act on Compounding Facilities
In 2013, President Obama signed the Drug Quality and Security Act following the FDA‘s request to manage compounding facilities. As a result, the FDA created a new list of registered pharmacy manufacturers called 503B Outsourcing Facilities. The Interim Guidance document provides the provisions and covenants required by outsourcing facilities. The quality and regulatory requirements are detailed following the quality standards of 21 CFR Part 210 and 21 CFR Part 211.
Outsourcing facilities are allowed to manufacture compound sterile and non-sterile non-commercial formulations, repackaging, drug shortages production and dilute, mix and repackage Biologic Agents. All products produced are expected to go through product validations, stability testing and finished product release testing. Biomed Innova seeks to assist outsourcing facilities with the quality and regulatory requirements as demanded by the FDA for patients’ safety and the trust of healthcare practitioners.