North Carolina News: Item 2160 - Compounding OTC Products

April 1, 2008 2:36 pm Topics: Compounding, Over the counter, and Prescription label

Reprinted from the April 2008 North Carolina Board of Pharmacy Newsletter.

North Carolina Board of Pharmacy staff periodically receives questions about the compounding of over-the-counter (OTC) products. Compounding of OTC products can involve at least two scenarios.
First, a pharmacist may receive a patient-specific prescription order from a physician or other authorized prescriber to compound a medication using OTC active ingredients. Such orders may of course be compounded, subject to the laws, rules, and standards governing compounding.

Second, some pharmacies in North Carolina are apparently compounding OTC medications not pursuant to a patient-specific prescription, but rather for general resale in the pharmacy. This type of “compounding” does not comply with law. A product composed of OTC active ingredients is nonetheless a “drug” under the Federal Food, Drug, and Cosmetic Act. Marketing of an OTC drug does not necessarily require submission of a new drug application with proof of safety and efficacy. But any entity that wishes to market an OTC product must, among other things, register with Food and Drug Administration (FDA) as a drug establishment, comply with current Good Manufacturing Practices, and market OTC products that comply in all respects with FDA labeling requirements.