Browse the corpus

National Drug Code Law and Expiration Dating are two laws created by the Food and Drug Administration to help regulate the use, production, and management of medications in the United States. All commercially distributed medications within the United States must have a National Drug Code and expiration date. This activity reviews National Drug Code Law and Expiration Dating and explains the role of the interprofessional team in improving care for patients who take medications regulated under these laws. Objectives: Summarize the National Drug Code Law and the requirements for a drug to be submitted for a National Drug Code. Outline the stability testing performed when determining an expiration date for medications. Review the different federal programs and acts that allow for the extension of expiration dates. Explain the importance of patient education on the proper disposal of expired medications. Access free multiple choice questions on this topic.

In 1972, the United States Congress passed the Drug Listing Act to allow for the Food and Drug Administration (FDA) to have an up-to-date list of all drugs that are commercially distributed. The law stated that all commercially available drugs were to have a unique National Drug Code (NDC). Every drug establishment, foreign or local, involved in the manufacturing, production, or compounding of commercially available drugs for use within the United States must be listed with the FDA.[1] Starting in 1979, the United States Food and Drug Administration stated that all prescription and over-the-counter (OTC) medications would need an expiration date. After September 27, 1979, any drug product packaged is required by law to contain an expiration date. This expiration date would guarantee a medication's stability and efficacy up to that date in the original container. All expiration dates must be clearly printed on the label of medications. Drug manufactures are required by law to perform stability testing on all medications to ensure proper expiration dating. [Title 21, Chapter I, Subchapter C, Part 211, Subpart C, Section 211.137]

Patient education by all healthcare team members about the proper disposal of expired medications can reduce costs to the healthcare system and save lives. Members of the healthcare team should be aware of projects such as National Drug Take-Back Day, which is coordinated by the DEA. This program allows patients to turn in expired and unused medications for safe disposal. If there are currently no programs available, healthcare members can educate patients on proper disposal techniques located on the FDA’s website. Infographics are provided by the FDA and can be displayed in clinics and pharmacies to increase patient awareness. It is easy to educate patients on the importance of taking the medications they are being prescribed, but members of the healthcare team sometimes neglect the importance of educating patients on how to dispose of left-over medications.[13]