Thursday, October 31, 2013

Mass. Senate OKs compounding pharmacy regulation bill

The Senate today unanimously approved legislation regulating compounding pharmacies, nearly a year after a deadly national meningitis outbreak that originated at a Framingham pharmacy.

The House approved its version of the bill earlier this month.

Sen. John Keenan (D-Quincy), who co-chairs the Committee on Public Health, said the legislation brings compounding pharmacies "out of the shadows" and regulates them to ensure there are no more tragedies.

Thousands of people were sickened by a tainted steroid originating from the New England Compounding Center in Framingham, and 64 people died.

Differences in the two bills now have to be reconciled. The Senate bill (H 1899) exempts hospital pharmacies from aspects of the regulations, a difference Sen. Mark Montigny (D-New Bedford) criticized. Montigny said he wondered why hospitals would be exempt when they do a significant amount of compounding, and pointed out that hospitals make medical errors too that result in injury and death.

The bill establishes sterile compounding and complex non-sterile compounding specialty licenses to be issued by the Board of Registration of Pharmacy and requires inspectors to conduct both planned and unplanned inspections of licensed pharmacies. It also reconstitutes the Board of Registration of Pharmacy, and requires continuing education hours for pharmacists in sterile and complex non-sterile compounding.

Stores and pharmacies would also be required to report any improper dispensing of prescription drugs that result in serious injury or death to the Department of Public Health, as well as report any adverse drug events.

No comments:

Post a Comment