PHARMACY BOARDS ARE URGED TO REGULATE Rx COMPOUNDING

Pharmacy Times, Volume 0, 0

Representatives of thenation's pharmacy regulatorscalled for "increasedscrutiny" of pharmacistcompounding activity bystate boards of pharmacy.In a series of recommendationsto the National Association ofBoards of Pharmacy (NABP), the group'sspecial task force on compoundingdeclared the practice "a complex area ofgrowing concern." It called on state officialsto become more "vigilant and proactiveconcerning the regulation of nonsterilecompounding" by pharmacists.

In addition, the task force stressed theneed for pharmacy boards to recognizethat topical creams, gels, ointments, andother nonsterile compounded medications"may pose significant risks as well."

The NABP task force also noted thatstate regulators continue to find pharmacistswho "manufacture" bulk preparationsunder the guise of compounding. Indeciding whether to take action againstthese practitioners, the group urgedpharmacy boards to take into considerationsuch factors as the presence ofcommercial-scale manufacturing andtesting equipment in the pharmacy, andwhether or not the compounded productis "essentially a copy" of a commerciallyavailable FDA-approved drug.