House Compounding Legislation Introduced

Bipartisan legislation that would preserve state board of pharmacy oversight of the vast majority of independent community pharmacies that compound medications was introduced in the House last week. H.R. 3089 is sponsored by Reps. Morgan Griffith (R-Va.), Diana DeGette (D-Colo.), and Gene Green (D-Tex.).

If a pharmacy prepares sterile medications for office use such as by a physician or hospital, ships those medications across state lines, and such medications account for more than 5% of all drugs it dispenses, then the compounding provider would fall under the legislation’s newly established category of “outsourcing facilities” subject to Food and Drug Administration regulation.

Moreover, the bill would help ensure more effective coordination and communication between FDA and state boards of pharmacy, thereby directly addressing one of the key breakdowns that helped facilitate and prolong the meningitis outbreak.