The crackdown on pharmacy compounding in the wake of the fungal meningitis crisis continues to intensify as states such as Iowa, Massachusetts, California and Virginia pursue a combination of stronger regulations and licensing requirements, more frequent inspections, aggressive enforcement, and a better understanding of the operations of compounders selling in their states.
The shock waves from the tragedy caused by the lack of quality control in injectable steroid production at the New England Compounding Center continue to reverberate across the pharmaceutical regulatory, legislative and health policy landscape, and the states are joining in the effort to fill the oversight gaps that the tragedy has brought into high relief. [See IPQ’s Special Report on “The Current Crisis in Pharmacy Compounding and its Implications” and follow-up coverage on November 26, November 27, and December 26, 2012.]
Iowa is among states placing heightened attention, in particular, on sterile compounders located elsewhere that ship across their state lines and is working with the National Association of Boards of Pharmacy (NABP) to develop a more cooperative interstate regulatory approach.
Iowa’s pharmacy board in conjunction with NABP has established a three-step plan aimed at gaining a clearer picture of pharmacy compounding operations and when those operations go beyond the scope of traditional compounding.
The three-step process is comprised of: ● identifying compounding entities registered or licensed as pharmacies but engaged in manufacturing activities and provide that information to the various states involved ● establishing an inspection program that distinguishes between traditional compounding and manufacturing and examines compliance with applicable state and federal laws, and ● providing training to state boards of pharmacy and their inspectors on the relevant state and federal laws, standards and regulations that limit compounding activities.
At a Food and Drug Law Institute (FDLI) “dialogue” on pharmacy compounding held at the law firm Hyman, Phelps and McNamara in early February in Washington D.C., Iowa Board of Pharmacy head Lloyd Jessen detailed the steps being taken in a joint effort between his state agency and the national association. Jessen serves on the NABP executive committee. [Editor’s Note: For more from Jessen on the three-pronged joint initiative, see box below.]
The Iowa board provided NABP with a list of over 600 “nonresident” pharmacies, and with the association’s help developed a state-specific spreadsheet for each of the state pharmacy boards to complete regarding the pharmacies under its jurisdiction selling products in Iowa. The results of the questionnaires helped with prioritization of the inspections.
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