Tuesday, April 2, 2013

States Address Compounding Pharmacies--National Conference of State Legislatures has an excellent summary of state action relating to compounding pharmacies in 2013 and compendium of existing laws and resources as previously noted on this blog and also hyperlinked under Resources--As of March 10, 2013, there have been 16 bills proposed in 11 states


Sharon Anglin Treat, Executive Director, at www.reducedrugprices.org has posted the following regarding the summaries:

The National Conference of State Legislatures has put together a handy summary of state action on compounding pharmacies in 2013, as well as a compendium of existing laws and other resources on the issue. According to NCSL, as of March 10, 2013 there have been 16 bills related to the regulation of compounding pharmaceuticals proposed in 11 states.

Virginia's legislation and Utah's legislation has passed through committee and been sent to their respective Governors. House Bill 3161 and senate bill 183 are similar and pending in South Carolina; you can research S. Carolina bill status here. Bills are also pending in California, and the Massachusetts House andSenate. Three bills are pending in Minnesota, and House and Senate bills are in committee in New Jersey. The New Hampshire bill has been reported positively out of committee in amended form, and the Oklahoma bill has passed the House and been sent to the Senate. Maine's legislation will be printed next week. Mississippi's legislation died in committee and Hawaii's legislation may also not be enacted according to this database.

Compounding pharmacies, unfortunately, continue to be in the news; last week the FDA warned of another recall, this time of Avastin compounded by a Georgia pharmacy, reported here.
As NCSL points out, some of the issues addressed in the state bills include clarifying which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category; updating definitions for compounding, wholesale, specialty and hospital-based pharmacies, and clear language about "sterile" and "non-sterile" compounding; inspection of facilities; enforcement responsibilities; funding; and transparency of records.

Quoted from here

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