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Hard on the heels of the tragic meningitis outbreak stemming
from unsanitary procedures at the New England Compounding Center in
Massachusetts, and despite his statements to those involved that he would hold
off and work with others, Congressman. Ed Markey (D-MA) is now considering introducing
legislation to give FDA greater enforcement powers over compounders. Compounding
pharmacies are already regulated through state pharmacy boards, so this move
would usurp state authority.
Congressman Markey’s bill would empower FDA to create a list of
drugs that cannot be compounded—and FDA would have sole discretion on which
drugs get on the list. The bill limits compounding to a per-patient
prescription basis, eliminating important “office use” compounding by
physicians. More to the point, none of this is necessary. FDA can already move
against compounding pharmacies that engage in illegal or harmful activities,
and giving FDA greater authority won’t address the agency’s lack of resources
and its inability to carry out its current mandate.
Your Bill to Address Compounding Pharmacies, HR 6584
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