FDA chief seeks new powers to police pharmacies

Associated Press Modified: November 14, 2012 at 9:47 am •  Published: November 14, 2012

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They are typically overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise. Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs on hand.

NECC shipped more than 17,000 single-dose vials of the steroid linked to the outbreak, which were given to an estimated 14,000 patients in 23 states.

Hamburg says Congress should put in place a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, but larger pharmacies would be subject to FDA oversight.

Pharmacies that ship bulk product or produce complex drugs would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. These non-traditional compounding pharmacies would also have to meet the more stringent manufacturing standards required of pharmaceutical companies.

"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding," Hamburg states in her testimony.