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Tuesday, December 30, 2014
Third Question of the Day December 30, 2014 Are compounding pharmacies more out of control now than before the DQSA? Why or why not? With less enforcement now from most state boards of pharmacy should Congress amend the DQSA to give the FDA even more authority to get the problem under control before more deaths and illnesses occur?
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The DQSA is not perfect, but it is working, especially indirectly, to reshape the compounded drug market, making those products easier for FDA to oversee. Many pharmacies, particularly the smaller ones, have ceased sterile compounding, rather than (a) make the investments required to comply with cGMPs, and (b) subject themselves to FDA regulation. This will tend to centralize production in the larger, less numerous outsourcing facilities that are directly overseen by FDA.
A regulatory framework is only as effective as the agency enforcing it. Practically all of the nation's 50,000+ community pharmacies, together with the thousands more hospital and clinic pharmacies, engage in some level of compounding, at least occasionally. FDA simply lacks the personnel, infrastructure, and institutional expertise to operate at this level.
Further, FDA oversight is not a panacea. FDA's track record, even with commercially manufactured drugs, is ... mixed: Thalidimide, Vioxx, Heparin, Crestor, Duract, Pisocor, Rezulin, Baycol, Accutane, to name a few.
And state enforcement is not "less" these days. Many states have tightened regulations and more importantly, practically every state has gotten more serious about enforcement and (especially) inspections. Why? Mostly because state pharmacy boards understand FDA's limited front-line capabilities.
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