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A year after a fungal meningitis outbreak originating in Massachusetts killed 64 and infected over 750 people in 2012, regulators and lawmakers are now beginning to take strides in regulating the pharmacy compounding industry.

Earlier this month, House Representatives Gene Green, Morgan Griffith and Diana DeGette introduced the Compounding Clarity Act (CCA), a bipartisan bill aimed at preventing future tragedies such as the one caused by the New England Compounding Center.

The CCA sets out to define the roles that the FDA and individual states should take to ensure the quality and safety of all compounded drugs in the country.

The core of the CCA aims to distinguish between small-scale and larger-scale compounders by clarifying the roles that individual states and the FDA have in regulating such facilities. Additionally, the CCA seeks to preserve the current physician-patient-pharmacist relationship and maintain access to compounded medications.

How will the Compounding Clarity Act prevent another public health crisis? (1)

  • Traditional pharmacies will remain under the jurisdiction of state boards of pharmacy and remain exempt from the FDA’s manufacturing authority.
  • Access to customized, compounded medications that patients need will be protected.
  • All compounding must be done pursuant to a patient-specific prescription, while allowing for anticipatory compounding based on a pre-existing relationship with a patient or doctor.
  • An enforceable safety standard for all compounded drugs will be implemented.
  • The practice of office use where drugs are dispensed in healthcare settings will be continued, provided a prescription or patient name is reconciled back to the pharmacy within seven days.
  • A notification system will be implemented that will facilitate coordination and communication between FDA and state boards of pharmacy relating to concerns over inspections, products or practices.
  • The FDA will have authority over “compounding manufacturers” that provide over 5% of their compounded medications for use in a facility such as a hospital, as well as “outsourcing facilities” that ship medications across state lines.
  • The FDA will enforce annual registration for all “compounding manufacturers” and “outsourcing facilities,” as well as reporting and listing of compounded drugs.

Expecting frequent or routine examinations from state pharmacy boards and the FDA, compounding operations are evaluating their equipment, engineering controls, facility design, and the standard operating procedures for compounding. This article highlights the results from one such audit that was performed recently: Design and Certification of Compounding Pharmacies.

Sterile compounding facilities are now required to be certified on a semi-annual basis to reasonable ensure compliance with regulatory expectations. To help, one non-profit organization – The Eagleson Institute is offering a one-day class on the design elements required for a compounding facility to pass certification and operate properly. Included is instruction on primary engineering controls that may often be utilized within a compounding facility (biological safety cabinets).