Hearings Held on Compounding Pharmacy

Published Online: Thursday, December 13, 2012
Follow Pharmacy_Times:
In 2 days of hearings held in November 2012, congressional representatives and senators began to grapple with how to respond to the ongoing fungal meningitis outbreak linked to tainted steroids produced by a Massachusetts compounding pharmacy. In general, senators from both parties and Democratic representatives seemed inclined to give the FDA greater authority over compounding pharmacies, whereas some Republican representatives were hesitant. Lawmakers from both parties criticized the FDA for not doing more to prevent the outbreak.

At the hearings, FDA Commissioner Margaret Hamburg, MD, called her agency’s authority over compounding pharmacies, which are generally overseen by state pharmacy boards, “limited, unclear, and contested.” She proposed creating a distinction between “traditional” compounding pharmacies, which produce medications in response to individual prescriptions, and “nontraditional” compounding pharmacies, which would be required to follow rules that apply to drug manufacturers.

Several Republicans on the House Energy and Commerce Oversight and Investigations Subcomittee, however, suggested that the FDA already had the authority necessary to have prevented the outbreak and failed to properly exercise it. Hamburg countered that none of the actions the agency could have taken under existing law would have prevented the outbreak.

Related Articles
The first and only FDA-approved vaccine for active immunization to prevent invasive serogroup B meningococcal disease in patients aged 10 to 25 years is now available for order by retail pharmacies.
At the 2014 National Association of Chain Drug Stores (NACDS) Total Store Expo, Lauren Forni, PharmD, RPH, of CVS/pharmacy, discusses how the new standing order for providing immunizations has expanded the role of pharmacists.
Lauren Forni, PharmD, RPH, of CVS/pharmacy, explains why pharmacists are providing vaccines to 2014 National Association of Chain Drug Stores (NACDS) Total Store Expo attendees.
The FDA has approved the use of Sanofi’s Menactra vaccine as a booster immunization against meningococcal disease in patients at continued risk.
Latest Issues
$auto_registration$