Pharmacy Times
Volume 0

A Texas federal drug has ruled that state-compliant pharmacists may compounddrugs if they have a legitimate prescription and do not create "newdrugs" or "animal drugs" requiring the FDA stamp of approval. Pharmacistswon the battle after the issue was taken to court by 10 compounding pharmaciesseeking declaratory relief regarding the FDA's right to regulate compoundeddrugs.

In his ruling, US District Judge Robert Junell said, "If compounded drugswere required to undergo the new drug approval process, the result would bethat patients needing individually tailored prescriptions would not be able toreceive the necessary medication due to the cost and time associated withobtaining approval." He added, "It is in the best interest of public health to recognizean exemption for compounded drugs that are created based on a prescriptionwritten for an individual patient by a licensed practitioner."

The FDA estimates at least 30,000 pharmacies in the United States currentlyprovide compounding services. The pharmacies range from independentsto chain drugstores, and make at least 30 million prescriptions every year.

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