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FDA: No more enforcement discretion with compounding pharmacies

from American Society of Health-System Pharmacists

The FDA recently signaled that the agency will stop exercising "enforcement discretion" toward companies that compound large volumes of sterile drug preparations and distribute them to healthcare facilities without receiving patient-specific prescriptions. In a letter to PharMEDium Services LLC, the director of FDA's Center for Drug Evaluation and Research stated that the agency would no longer accept the company's approach to linking a patient to a compounded drug. more


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