APhA supports FDA’s concept of risk-based framework for pharmacy compounding

Comment letter follows agency’s intergovernmental meeting


Addressing FDA’s proposed regulatory framework for pharmacy compounding and the role for state and federal oversight, APhA has submitted a comment letter to FDA following the agency’s December 19, 2012, intergovernmental meeting.

FDA is considering a risk-based framework that would create two categories of compounding: “traditional” and “nontraditional.” As proposed, traditional compounding—as discussed by FDA in testimony at the November 2012 congressional hearings and the December 2012 stakeholder meetings—would remain under state jurisdiction. Nontraditional compounding would be subject to federal standards based on higher-risk factors such as the amount of product being made or whether the drug is being dispensed to someone other than the ultimate user.

APhA believes that this tiered regulatory approach “has its merits, generally supports the concept, and is very interested in continuing dialogue with FDA, Congress, States and other stakeholders to explore potential solutions,” according to its January 18, 2013, comment letter to FDA.

The Association recommended considering the following areas for further clarifications and additions:

  • Compounding standards: APhA supports efforts to ensure proper resources and funding for state boards of pharmacy for compounding regulatory activity.
  • Sterile compounding licensure: APhA supports consideration of enhanced standards and state licensure for sterile compounding to ensure consistent standards across all states and providers in all practice settings.
  • Manufacturer versus compounder: APhA agrees with ongoing dialogue that the definition of compounding versus manufacturing needs to be clearly defined.
  • Amount/quantity
  • Compliance policy guide
  • Education and training resources
  • Communication
  • Accreditation

The Association’s January 18 letter to FDA built on the December 2012 intergovernmental meeting; APhA’s discussions with FDA at the December 2012 pharmacy stakeholders listening session; APhA’s comments to the Senate Health, Education, Labor, and Pension Committee in November 2012; meetings with House Energy & Commerce Committee staff; and APhA’s ongoing dialogue with congressional and agency staff, the pharmacy community, and other stakeholders.