PHARMACY BOARDS ARE URGED TO REGULATE Rx COMPOUNDING

MAY 01, 2006

Representatives of the nation's pharmacy regulators called for "increased scrutiny" of pharmacist compounding activity by state boards of pharmacy. In a series of recommendations to the National Association of Boards of Pharmacy (NABP), the group's special task force on compounding declared the practice "a complex area of growing concern." It called on state officials to become more "vigilant and proactive concerning the regulation of nonsterile compounding" by pharmacists.

In addition, the task force stressed the need for pharmacy boards to recognize that topical creams, gels, ointments, and other nonsterile compounded medications "may pose significant risks as well."

The NABP task force also noted that state regulators continue to find pharmacists who "manufacture" bulk preparations under the guise of compounding. In deciding whether to take action against these practitioners, the group urged pharmacy boards to take into consideration such factors as the presence of commercial-scale manufacturing and testing equipment in the pharmacy, and whether or not the compounded product is "essentially a copy" of a commercially available FDA-approved drug.



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