Guidelines for Standardized Numerical Identifiers Released by FDA

April 5, 2010 4:56 pm

As part of Food and Drug Administration (FDA) measures to secure the drug supply chain, and to help implement section 505D of the Federal Food, Drug, and Cosmetic Act, the agency has published a guidance document including detailed recommendations for the development of standardized numerical identifiers (SNIs). Section 505D requires the Secretary of Health and Human Services to develop standards and identify effective technologies to secure the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs. The new FDA guidance is intended to help develop standards and systems for identification, validation, authentication, and tracking and tracing of prescription drugs. FDA plans to issue additional guidance documents and regulations to help implement section 505D.