A U.S. federal court judge has ruled that an effort by the Food and Drug Administration to boost oversight of compound pharmacies violated the law and ordered the agency to rethink its approach to ensure that small compounders will not be jeopardized.
At issue is an attempt to clarify state and federal responsibilities for monitoring inordinate amounts of medicines that are shipped by two different types of compounders — those making large quantities and smaller pharmacies dispensing medicines for individual patients. The distinction was created in 2013 as part of a federal law passed in response to a fatal outbreak of meningitis traced to a large compounder.
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