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Massachusetts tightens rules for compounding pharmacies

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BOSTON | Thu Nov 1, 2012 4:33pm EDT

BOSTON (Reuters) - Massachusetts adopted new regulations on Thursday that it said will allow it to keep a closer eye on compounding pharmacies, a class of drug supplier linked to the U.S. meningitis outbreak that has so far killed 29 people.

The state, home to the New England Compounding Center that produced the injectable steroids at the heart of the outbreak, said the new rules give it the authority to track the volume and distribution of drugs that compounding pharmacies sell to determine if they are operating like manufacturers.

Compounding pharmacies - which are meant to assemble the raw ingredients of any medication one prescription at a time, not in industrial scale runs - had prior to this year's outbreak largely escaped the U.S. Food and Drug Administration's attention.

"Together with our federal partners, we will ensure that Massachusetts fulfills its responsibility in overseeing this transforming industry," said Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health.

The outbreak of fungal meningitis was triggered by steroids used as a treatment for back pain. Health authorities have said the New England Compounding Center failed to make medications in sterile conditions in its facility in Framingham, Massachusetts, outside Boston.

Massachusetts has closed three compounding pharmacies since the start of the outbreak.

(Reporting By Scott Malone. Editing by Andre Grenon)

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Comments (2)
santefe wrote:
There is a petition to request greater regulation of drug compounding facilities on the ”We the People” WhiteHouse.gov website. Compounding facilities need greater regulation to meet the medical standards that warrant Americans’ trust in healthcare.

Nov 01, 2012 9:14pm EDT  --  Report as abuse
tyg wrote:
Dr. Lauren Smith, you don’t need Harvard Lawyers to remind you that the transformation from pharmacy compounders to manufacturers occurred in 1906 and 1938 with the establishment of the Food Drug and Cosmetic Act. Lawyers, the courts, congress, and the FDA funded by pharma interests have taken us back to the pre-regulation era where anyone can establish a drug manufacturing firm like NECC in Massachusetts. This is the interim commissioner in Massachusetts? Now they are going to start cracking down when the people are in the grave? Who knows how many people have suffered because of public health agencies where their board members are also regulatory officers in pharmaceutical corporations?

Nov 02, 2012 11:14pm EDT  --  Report as abuse
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