A Texas federal drug has ruled that state-compliant pharmacists may compound drugs if they have a legitimate prescription and do not create "new drugs" or "animal drugs" requiring the FDA stamp of approval. Pharmacists won the battle after the issue was taken to court by 10 compounding pharmacies seeking declaratory relief regarding the FDA's right to regulate compounded drugs.
In his ruling, US District Judge Robert Junell said, "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." He added, "It is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner."
The FDA estimates at least 30,000 pharmacies in the United States currently provide compounding services. The pharmacies range from independents to chain drugstores, and make at least 30 million prescriptions every year.
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