The Compounding Quality Act of 2012 was a direct outcome of increased regulation over compounding. This landmark legislation is also called the Drug, Quality and Security Act (DQSA) of 2013. The first section, Title I, is concerned with compounding. Title II deals with Track and Trace rules.
The DQSA established for FDA clear authority over certain aspects of compounding. The Act also created a new entity, called Outsourcing Facilities. Section 503B of the FD&C Act was added by this bill to govern outsourcing facilities.
Requiring board certification of pharmacists and/or accreditation of compounding pharmacies to provide complex compounding services could also be a result of the fungal meningitis outbreak. The Board of Pharmaceutical Specialties is developing a specialty designation for sterile compounding.
