Abstract

Following the devastating results of the New England Compounding Center debacle resulting from contaminated compounded steroid injections, which occurred in 2012, state and national attention focusing on the safety of compounded sterile products has continued to escalate. The Drug Quality and Security Act (DQSA) was passed, which created voluntary outsourcing facilities under section 503B as a new class of compounders regulated by the FDA. Section 503B compounding follows Current Good Manufacturing Process (cGMP) standards. FDA guidance documents addressing sterile compounding are also continuing to increase in volume and specificity. Traditional compounding efforts under DQSA section 503A remain the purview of state oversight but FDA does reserve the right to intervene at any time for quality concerns. The primary standards for 503A compounding are found in the United States Pharmacopeia (USP) Chapter <797>. These standards are currently under revision and the enhanced standards are scheduled for implementation December 2019. Typically, State Boards of Pharmacy have provided oversight and inspections on compounding but these efforts have been focused mainly on pharmacy operations. Ophthalmic compounding outside of hospital or retail pharmacy settings has gone largely unregulated. However, the revised USP <797> is intended to address all sites providing sterile compounding and eye centers performing these functions will be expected to be in full compliance with the new standards by the implementation date.