FDA Reexamines Its Exercise of Enforcement Discretion Regarding Valid, Patient-Specific Prescriptions and Compounding Pharmacies

Topics: Compounding

In a letter (PDF) to PharMEDium Services LLC, Food and Drug Administration (FDA) Center for Drug Evaluation and Research indicates that it will no longer exercise enforcement discretion that allowed the company to produce non-patient specific drug products for distribution to hospitals across the country. Such enforcement discretion had been exercised as of January 27, 2005, with the condition that PharMEDium implemented a barcode system for linking its compounded drugs to specific patients after the drugs were received at the hospital. FDA states in the letter that “it does not appear that PharMEDium has consistently implemented and maintained the conditions under which” the agency was “willing to exercise enforcement discretion.” Among other examples, FDA notes that inspections of one PharMEDium facility revealed that there was no linkage of the company’s products to specific patients. The agency explains that in light of the recent fungal meningitis outbreak due to contaminated compounded injectable drugs, FDA has “reexamined its exercise of enforcement discretion with regard to the need for valid, patient-specific prescriptions.” The letter specifies that both Section 503A of the Federal Food, Drug, and Cosmetic Act and the FDA Compliance Policy Guide 460.200 on Pharmacy Compounding recognize that “traditional [compounding] pharmacy practice involves receipt of valid prescriptions for individually identified patients prior to distribution of a drug.” The letter also states that new legislation would be needed to facilitate the effective oversight of firms that engage in large volume compounding of non-patient specific sterile drug products, and that in absence of such legislation, FDA will apply its existing legal authorities.