Important Comment from Reader Regarding DQSA working....

Anonymous said...

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.

December 31, 2014 at 3:58 PM