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FEDERAL COURT AFFIRMS YOUR RIGHT TO PRESCRIBE CUSTOM COMPOUNDED MEDICATIONS

August 30, 2006 (Midland Texas) -- In a much-anticipated landmark ruling, U.S. District Court Judge Robert Junell ruled that compounding custom prescriptions from bulk ingredients based on a prescription is legal and not under the jurisdiction of the Food and Drug Administration (FDA). The FDA had argued that compounded medications are "new unapproved drugs" and that the agency should therefore have jurisdiction over compounding pharmacies.

In his opinion, Junell wrote that "compounded drugs are implicitly exempt from the new drug definitions contained in" FDA regulations and that the FDA had overstepped its authority by attempting to inspect the records of pharmacists who operate legally according to their state regulations. Of the FDA argument that it should regulate compounding pharmacists, Junell wrote “If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval.”

The Court also ruled that compounding from bulk pharmaceutical ingredients for non-food animals is legal. This is an important issue for animal owners and their veterinarians who prescribe compounded medications to treat a variety of conditions, many of which require medications that are only available by compounding bulk pharmaceutical ingredients. Without them, animals may needlessly suffer or even die. Until now, FDA asserted that prescribing and preparing these treatments was illegal.

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