The issue of pharmaceutical compounding may have dominated much of 2012 and the first half of 2013, but regulators have released few Warning Letters to compounding pharmacies in almost a year, and none since a new trio of compounding guidances came out in December 2013. Now the agency has released its first Warning Letter to a compounding pharmacy in six months, reflecting new authorities and old problems. The 14 January 2014 letter to Triangle Compounding Pharmacy com...

2013 was a momentous year for the US Food and Drug Administration (FDA) for many reasons, but perhaps no issue loomed as large as pharmaceutical compounding , the vestige of a 2012 outbreak of fungal meningitis that was traced back to a Massachusetts-based compounder. While the issue may have appeared to have been settled near the end of 2013, one legislator now says that he plans to maintain his scrutiny of FDA in 2014 in the hopes of ensuring "proper implementation" o...

Just days after President Barack Obama signed the Drug Quality and Security Act ( DQSA ) into law, the US Food and Drug Administration (FDA) has released three draft guidance documents intended to interpret its provisions and provide definitional clarity for compounding pharmacies. Background The DQSA contains two sets of measures: One intended to better secure the pharmaceutical supply chain, and the other to more rigorously regulate the compounding pharmacy se...

The Senate, after a series of long delays , has finally passed the Drug Quality and Security Act (DQSA) , all but assuring the law's provisions to institute a national track and trace system and new compounding regulations will be signed into law later this month. Background The  DQSA  was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While Californi...