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Draft Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages

PharmaManufacturing.com
01/22/2009

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step to facilitating other measures for securing the drug supply chain.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

For more information, visit http://www.fda.gov/oc/guidance/drugsupplychain.html.