Specialty pharmacies seek FDA oversight

Feb. 22, 2013 at 3:20 PM   |   Comments

WASHINGTON, Feb. 22 (UPI) -- The U.S. government should regulate pharmacies that operate like drug manufacturers, the head of a group representing "compounder" pharmacies says.

The statement by the International Academy of Compounding Pharmacists is a reversal of its previous stance that its members should be regulated only by state pharmacy boards, The Washington Post reported Thursday.

David G. Miller, executive vice president of the 2,700-member academy, said Thursday compounding manufacturers should have to register with the Food and Drug Administration and that the agency should have the power to enforce safety standards on the industry.

Miller's change of heart came after a Post report said 15 major compounding pharmacies that make custom-order medications don't have to register with the FDA or follow the safety rules for drug manufacturers even though they operate as manufacturers.

A meningitis outbreak in October that killed 47 people and sickened 660 was linked to contaminated steroids made by a Massachusetts compounding pharmacy.

Officials who represent state regulators say the compounding industry has determined additional oversight is needed for non-traditional pharmacies and want to have a role in shaping regulations that appear certain to occur.

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