FDA SNI Guidance on Section 505D
Title: FDA SNI Guidance on Section 505D
Date Posted: 01/15/09
Tags: REGULATORY UPDATE, NORTH AMERICA, FDA
On January 15, 2009, the FDA released a guidance paper with an intention to address provisions that were set by Section 505D of the Federal Food, Drug, and Cosmetic Act regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA identified package-level SNIs as an initial step to facilitate other measures for securing the drug supply chain. Signed on September 27, 2007 this release is an amendment to FDA’s Amendments Act of 2007 (FDAAA) (Public Law 110-85), section 913 of which is the legislation that created section 505D of the Federal Food, Drug, and Cosmetic Act (the act).
The act required the Secretary of Health and Human Services (the Secretary) to consult with specific entities to prioritize and develop standards for identification, validation, authentication, and tracking and tracing of prescription drugs. That act states:
No later than 30 months after the date of enactment of FDAAA, the statute also directs the Secretary to develop an SNI to be applied to a prescription drug at the point of manufacturing and repackaging at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug. An SNI applied at the point of repackaging is to be linked to the SNI applied at the point of manufacturing, and to the extent practicable, the SNI should be harmonized with international consensus standards for such an identifier. (See Section 505D(b)(2).) The provisions in section 505D(b) of the act complement and build on FDA’s longstanding efforts to further secure the U.S. drug supply.
This means that by March 2010, FDA shall develop a standard identifier, and by October 2012, all manufacturers and repackagers of Pharmaceutical Drugs in the US have to have applied package level SNI’s to their lines according to the standards put forth by the FDA. For the purposes of this guidance, the FDA considers the package to be the smallest saleable unit placed into interstate commerce by the manufacturer or the repackager for sale to the pharmacy or other dispenser of the drug product. Hence, this guidance addresses only package-level SNI and is intended to be the first of many guidance’s and regulations that FDA plans on issuing in the future to assist with the development of standards and systems for identification, authentication, and tracking and tracing of prescription drugs. "The guidance documents reflect the FDA’s continued vigorous efforts to minimize the chances of unsafe products reaching American consumers," said Jeffrey Shuren, M.D., J.D., Associate commissioner for policy and planning.
The guidance recommends that SNI for most prescription drug packages should be a serialized National Drug Code (sNDC) that reflects each corresponding manufacturer or repackager, combined with a unique 8-digit numerical serial number generated by the manufacturer or repackager for each individual package. Expiration date and/or lot or batch numbers are not part of the SNI as they are readily accessible because of the FDA regulation to have this on the label of each drug product.
FDA believes that sNDC serves the needs of the drug supply chain as a means of identifying individual prescription drug packages. That identification can in turn facilitate authentication and tracking and tracing of the prescription drugs throughout the supply chain. The 8 digit numeric code also minimizes the duplications and should support billions of units of marketed products. Also, the use of sNDC is compatible with, and may be presented within, a serialized Global Trade Item Number (serialized GTIN or sGTIN) which is s a global standard for item and object identification, established by GS1, a consensus-based, not-for-profit, international standards organization that works with manufacturers, distributors, retailers, and others in the drug supply chain.