title: Pharmacy compounding primer for physicians: prescriber beware.
abstract: Since the development of federal standards for drug approval, the practice of medicine has historically involved the compounding of medications based on a physician's determination that a US FDA-approved product either did not exist, or could not be used for medical reasons. Today, prescriptions for non-FDA-approved compounded drugs may be driven by fanciful and largely unregulated pharmacy advertisements to physicians and patients and/or payer reimbursement policies, thus placing prescribers in the backseat for clinical decision making. This article outlines essential differences between FDA-approved drugs and compounded drugs and reasserts the primary medical role of physicians for determining what medical circumstances may necessitate treatment with non-FDA-approved products. In addition, liability concerns when prescribing non-FDA-approved drugs are discussed. While representing a US perspective, underlying principles apply globally in the setting of magistral and extemporaneous formulations produced outside national regulatory frameworks.
authors.affiliation: q-Vigilance LLC, North Barrington, IL 60010, USA. sarahsellers@mac.com
authors.forename: Sarah
authors.initials: S
authors.lastname: Sellers
authors.forename: Wulf H
authors.initials: WH
authors.lastname: Utian
mesh_terms: D004339:Drug Compounding / Q000592:standards*; D006801:Humans; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000592:standards*; D010818:Practice Patterns, Physicians' / Q000592:standards*; D055553:Prescription Drugs / Q000009:adverse effects / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D004366:Nonprescription Drugs; D055553:Prescription Drugs