Compounding Pharmacies Legislative Action


The US Congress is taking action to put compounding pharmacies under greater control of the USFDA.  The US Senate introduced S. 959 Pharmaceutical Quality, Security, and Accountability Act May 15, 2013, and the House has introduced H.R. 3089 To amend section 503A of the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding September 12, 2013,

According to Ethridge (2013), both bills create a new pharmacy category, for pharmacies that compound sterile produces and ship across state lines, these facilities would be regulated by FDA.

While both of these bills are in the early stages and subject to change during the legislative process, according to Ethridge (2013) the current versions would require the compounding facilities register with FDA, submit a compounding list, adverse event reporting, product labeling, and would be subject to FDA inspection.

Process and production errors associated with sterile compounding first became known from the Meningitis outbreak linked to the New England Compounding Center.  As of March 13, 2013 there have been 50 fatalities, with another 722 people still sick with infections (Sweet, 2013).

Ethridge, E. (2013).  House Bill would Expand FDA Role in Pharmacy Oversight. CQ News. Retrieved from http://tinyurl.com/mfoq3vv

Sweet, L. (2013) Deaths continue in Meningitis outbreak tied to Framingham pharmacy. Boston Herald.  Retrieved from http://tinyurl.com/lw9xhva