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International Academy of Compounding Pharmacists (IACP) Responds to FDA's Appeal of the U.S. District Court Ruling on Pharmacy Compounding
Date:11/11/2011

HOUSTON, Nov. 11, 2011 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration (FDA) appealed the September 2011 U.S. District Court for the Middle District of Florida ruling in US vs. Franck's Lab, Inc., which had decided in favor of pharmacy compounding for veterinary patients.  This lawsuit, brought by the Food & Drug Administration against Paul Franck, R.Ph., FIACP of Franck's Lab in Ocala, Fla., alleged that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food producing animals was illegal.  

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In this landmark pharmacy compounding court decision, Judge Timothy Corrigan had ruled that:

  • The FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy's activities are not manufacturing.  That rests with individual state Boards of Pharmacy.
  • Congress did not give FDA jurisdictional authority when it enacted the FDCA in 1938 to take enforcement action against a pharmacy that is engaged in the traditional practice of compounding.
  • The FDA cannot use its CPG for veterinary compounding issued in 2003 as the basis for enforcement action.
  • The regulations enacted by the FDA based upon AMDUCA are in error – AMDUCA did not give FDA authority to prohibit the use of bulk APIs in veterinary compounding.
  • Size and scope of compounding does not mean a pharmacy is a manufacturer.  
  • The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.

IACP Response on FDA's Appeal Today

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SOURCE International Academy of Compounding Pharmacists (IACP)
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