Congress drafts compounding legislation -- defines compounded drugs as new drugs under the FFDCA and creates bright line between traditional compounders and compounding manufacturers *

USA - April 29 2013
In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight…

Co-authors: Elinor L. Hart.

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Compounding animal drugs from bulk ingredients *

USA - April 17 2013
Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded…

Co-authors: Elinor L. Hart.

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FDA emphasizes patient-specific prescriptions *

USA - March 21 2013
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health…

Co-authors: Elinor L. Hart.

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FDA tightens requirement for patient-specific prescriptions in the wake of the meningitis outbreak *

USA - February 25 2013
In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate…

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U.S. government's use of the Park Doctrine to police pharmacies *

USA - January 7 2013
The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act…

Co-authors: Frederick R. Ball.

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