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Judge rules for compounding pharmacists

05/28/2006

In a landmark ruling, U.S. District Judge Rob Junell, in Midland, Texas, ruled that customized compounds created by compounding pharmacies are not new, unapproved drugs that must be sanctioned by the U.S. Food and Drug Administration. AAPS assisted by filing two amicus briefs in support of the compounding pharmacies.

Millions of Americans take customized preparations prescribed by physicians and mixed by compounding pharmacies instead of mass-produced, FDA-regulated drugs. These include hormones, topical creams for nausea, dermatologic and ophthalmologic preparations, and pain medication.

Austin lawyer Terry Scarborough, who filed the lawsuit against the FDA on behalf of 10 pharmacists, praised the decision: “We are pleased the court ruled from the bench on the most important issue — that compounds don’t create ‘new’ drugs as the FDA suggested.”

Scarborough said that Judge Junell indicated he would issue an injunction barring FDA inspections that exceed its authority.

Kristie Zamrazil, a spokeswoman for the Texas Pharmacy Association, said the decision preserves the roots of pharmacy. “Compounding has been part of pharmacy practice since its origins. Judge Junell’s ruling is a win for patients and recognizes the important health care service that pharmacists have provided through the ages” (Lavlan Copelin, Austin American-Statesman 5/27/06).

A new drug is subject to the FDA’s onerous new drug application process, noted AAPS General Counsel Andrew Schlafly, who filed an amicus brief for the pharmacists.

According to this ruling, “[C]ompounded drugs are fully legal and not subject to the requirements and prohibitions imposed on new drugs by the 1938 Food, Drug and Cosmetic Act,” Schlafly states.

A written order to make this ruling binding will be issued in late July.

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