Commentary: Prescriber beware: it is ill advised to administer compounded sincalide.

Because of the current inavailability of Kinevac, the form of sincalide for injection approved by the U.S. Food and Drug Administration (FDA), nuclear medicine clinics may consider alternatives, including purchasing a compounded product, and some pharmacists may be considering compounding this drug (1). However, several concerns relative to compounded sincalide make such practices ill advised. The FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs on receipt of a valid prescription for an individually identified patient from a licensed practitioner (2). For more than 40 years, nuclear pharmacies have demonstrated an outstanding record of providing safe and reliable compounded drugs. However, evidence suggests that an increasing number of establishments with retail pharmacy licenses are engaged in manufacturing and distributing unapproved new drugs for human use in a manner that is clearly outside the bounds of traditional pharmacy practice. In several instances, pharmacies have cloaked large-scale manufacturing activities under the guise of compounding. The U.S. Centers for Disease Controls (CDC) continue to investigate a multistate outbreak of fungal meningitis in patients receiving compounded preservative-free methylprednisolone acetate prepared by the New England Compounding Center (NECC). This single product is believed to have caused 750 cases of fungal meningitis in 20 states, resulting in 64 deaths. The FDA and CDC have also found bacterial and fungal contamination in numerous drugs prepared by NECC that have been linked to reports of other persistent illnesses. Such large-scale compounding establishments and their activities are now the focus of increased regulatory and legislative efforts that seek to ensure the safety of patients receiving compounded drugs. State boards of pharmacy provide oversight of pharmacy practices, including drug compounding. When the FDA learns of compounding practices that raise public health concerns, the agency may refer the matter to state boards of pharmacy for investigation. Using a risk-based approach, the FDA may also take enforcement action against pharmacies for circumstances described in FDA guidance that are not consistent with traditional compounding, including but not limited to (2): (1) Compounding drugs prior to receipt of a valid prescription; (2) compounding drugs removed from the market for safety reasons; and (3) compounding drugs that are essentially copies of commercially available products. The FDA recognizes that in cases of supplier outages of commercially available pharmaceuticals or radiopharmaceuticals, short-term compounding of such preparations is appropriate. When compounding any drug, adherence to " good pharmacy practice " is necessary …