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FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in White Oak, Maryland. This webpage provides further information for potential attendees.  The upcoming event will be the first public meeting convened by FDA to address DSCSA-related issues.  The DSCSA requires the Agency to conduct at least 5 such meetings during the lengthy implementation period in order to keep it engaged and communicating with relevant stakeholders.

As we have described previously (see here and here), the goal of the DSCSA is to implement enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.  It created phased-in obligations for various “trading partners,” such as manufacturers, distributors, and dispensers, over a 10-year period, beginning with the law’s passage at the end of 2013.

Among many others, one of the impending obligations facing industry is the requirement that manufacturers and repackagers affix or imprint a product identifier, at the package level, to prescription drug products that they introduce into commerce.  This product identification step is also referred to as "serialization," and eventually trading partners will only be allowed to sell and buy serialized drug products.  Manufacturers and repackagers must comply with their initial product serialization mandates by November 2017 and November 2018, respectively.

FDA’s upcoming public meeting will examine the supply chain’s progress toward implementing the product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and product identification. In its notice, the Agency listed two other topics that might be considered at the meeting, including:

  • An assessment of the steps taken by supply chain members to build capacity for a unit-level system for electronic product tracing, including the impact on:
    • the ability of the health care system to maintain patient access to medicines;
    • the scalability of such requirements, including as it relates to product lines; and
    • the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier.
  • Information related to the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain.

In addition, pursuant to other provisions of the DSCSA, the Agency is planning by the end of this year to issue draft regulations that would establish minimum standards for State licensing of wholesale distributors and third-party logistics providers, as well as a Federal licensing system that would kick in when a State does not have its own license requirement.  (While it remains to be seen whether FDA will meet this December 2016 goal, it's worth noting that these draft rules are a long time coming, given that the law mandated that these final licensing standards and rules should have been done by the end of 2015.)

We recommend all affected stakeholders use this opportunity to share information with FDA and to listen in on the October 14th meeting to hear about how other supply chain trading partners are progressing with their implementation efforts.  The deadline for submitting written comments in relation to this public meeting and the various topics discussed is November 14th (Docket FDA-2016-N-2673).

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.