Draft Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages." This draft guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standardized numerical identifiers for prescription drugs. We are also requesting responses from interested stakeholders to questions posed in this Federal Register notice related to the draft guidance.