FDA Issues Draft Packaging Guidance and Pilot Program to Help Secure Supply Chain

Rockville, MD (Jan. 22)-Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.

The guidance is part of the agency’s efforts to implement Section 913 of the 2007 Food and Drug Administration Amendments Act (FDAAA) and recommends standards industry should use to identify individual packages of prescription drugs. Section 913 requires the Secretary of Health and Human Services to develop standards and identify and validate effective technologies for securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs. The guidance is meant to “facilitate the adoption of a uniform electronic track-and-trace system for prescription drugs to further improve their safety and security,” according to a Jan. 15 FDA release.

The draft guidance specifically focuses on standardized numerical identifiers (SNIs) for prescription drug packages, which for most prescription drug packages is a serialized National Drug Code (sNDC). “FDA chose the sNDC because we believe that it 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,” says the guidance.

The guidance does not specify a particular means of incorporating an SNI onto the package nor does it specify a location on the package where an SNI should be placed.

FDA’s new voluntary, two-year pilot program is also meant to help secure the supply chain by promoting the safety of drugs and active pharmaceutical ingredients produced outside the United States. The agency plans to select 100 applicants to participate in its Secure Supply Chain pilot program. Qualified applicants must “maintain control over the drug products from the time of manufacture through entry into the country,” according to an agency release (see the full announcement for additional qualifications).

“The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program,” says the release. “Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant.”

In related news, the agency opened several offices abroad over the past few months, including in Beijing, Shanghai, Guangzhou, Brussels, Mumbai, and New Delhi.

Comments on the draft guidance should be submitted within 90 days of publication in the Federal Register to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.