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.