No one can forget the news about the contaminated injections made by the New England Compounding Center in Framingham, Massachusetts that led to a meningitis outbreak—sickening almost 750 people and killing more than 60 across our nation. It is a fact that compounding pharmacies operate without much supervision to make drug combinations, and many believe that stricter laws should be enacted to help keep consumers safe.
Because this issue has been a hot topic in the Commonwealth of Massachusetts and across the nation, Massachusetts recently passed new compounding regulations to overhaul pharmaceutical compounding in the state, specifically addressing safety concerns raised by the outbreak. Coming two years after the meningitis outbreak, Governor Deval Patrick of Massachusetts signed HB 4235 into law on July 10, 2014.
This new bill to tighten regulations on the compounding practice won’t just apply to those pharmacists who compound within the state, but it will also apply to those who ship compounded preparations into the state. In fact, those who ship into the state will have to adhere to the new law this December, but the entire law doesn’t take effect until June 30, 2015.
Compounding Law Brings About Major Changes
Some of the changes this new law will bring about include:
- New licensing requirements. Pharmacists have to complete 20 hours of continuing education in order to renew their licenses, and five of those 20 hours have to be dedicated to sterile compounding for those pharmacists involved in compounding practices. Additionally, any pharmacy that compounds in the state or ships compounding medications into the state has to obtain the proper license.
- New licensing fees. The new licensing fees will help implement the new law by giving the money to the state board of pharmacy to hire and train inspectors.
- Random inspections by trained agents. Trained inspectors will perform unannounced inspections of compounding pharmacies and their sterile products before a pharmacy can renew its license. Inspectors can fine pharmacies found in violation of the new law and suspend their licenses.
By making these improvements, the state believes consumers will be better protected against pharmacy errors. “This is model legislation that other states should be taking a look at,” said Christian Hartman, Senior Director at Wolters Kluwer Health in Boston.
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