IACP’s plan to bring together pharmacy and medicine for collaborative and focused effort to correct the many problems within the Drug Quality & Security Act (DQSA) is progressing rapidly.
“There are a series of steps to offer technical corrections to this unworkable and cumbersome law already underway,” said IACP President Pat Stephens. “Our Academy already has a meeting of key stakeholders scheduled for Monday, October 27 in Washington, DC where pharmacy and medicine will develop their strategy for changing DQSA.”
“Over the past three months we have worked with our key allies on both the Senate and House side to show why we need technical corrections to the DQSA” explained Cynthia Blankenship, Vice President of Government Affairs for IACP. “Once the FDA put in writing that they consider that office-use compounding is not permitted, despite previous agreements with and clear instructions from Congress, legislators realized that their intent was not going to be followed. Changing the law became a ‘must do’ rather than a ‘wait and see what happens.”
IACP’s Board of Directors and Legislative Committee have gone through 503A to identify all of the constraints and problems with the bill, prioritized those, and are offering up recommended language to the upcoming stakeholders meeting. Included in that list are the following:
• Definitive language permitting office-use compounding in those states which allow that by practitioners.
• A revised process for the use of APIs that is based upon definitions within the national standards of USP <795> and <797> rather than a cumbersome and lengthy review process by an FDA controlled committee.
• Clear distinction that any proposed Memorandum of Understanding between the FDA and the states must focus on communication about issues related to compounded preparations and not the fulfillment of prescription dispensing nor arbitrary limits on quantities.
• That the inspection of compounders by the FDA must be based upon the standards required by the states. Too many compounders are being inspected using CGMPs (Current Good Manufacturing Practices) which are neither required nor appropriate for a pharmacy practice regulated by a state Board of Pharmacy.
Have you pledged to support the FIX DQSA initiative? IACP needs your commitment to be at the ready to call your federal and state legislators for support when the technical corrections legislation is offered. IACP needs your commitment to alert your patients and your colleagues in medicine when their voice will also be needed. If you haven’t made your pledge to stand up and be heard, you can do that right now. Please click here!