FDA Begins Implementation of the Drug Supply Chain Security Act: Calls for Comments and a Workshop

By William T. Koustas –

FDA has begun its efforts to implement the Drug Supply Chain Security Act (“DSCSA”), also known as Title II of the Drug Quality and Security Act.  As we have reported in prior posts (here and here), the DSCSA requires FDA to issue a series of guidance documents and hold public meetings with respect to the exchange of transaction information, transaction history, and transaction statements (“TI/TH/TS”), the serialization of prescription drug products, and the handling of suspect or illegitimate prescription drugs.  FDA took a first step in that direction in February, when it issued a call to pharmaceutical supply chain stakeholders for their comments with respect to these issues.  In a Federal Register notice, 79 Fed. Reg. 9745 (Feb. 20, 2014), FDA asked stakeholders and interested parties to provide comments on: (1) their current practices and ideas for the interoperable exchange of TI/TH/TS in paper and electronic format; (2) the feasibility of establishing standardized documents to facilitate the exchange of TI/TH/TS; and (3) current practices and ideas on the exchange of information between supply chain members and FDA with respect to verification requests and notifications for suspect or illegitimate drug products.  The federal register notice includes several questions in these areas to which stakeholders can respond or they can submit general comments with respect to these topics.  Comments are due by April 21, 2014.

On April 2, 2014, FDA issued a notice for a public workshop titled, “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs, in Paper or Electronic Format,” 79 Fed. Reg. 18562 (April 2, 2014).  The purpose of this workshop, which will be held May 8th and 9th at FDA’s White Oak Campus, is to provide an opportunity for interested parties to share information on current practices, research, and ideas regarding the feasibility of creating standardized TI/TH/TS documents.  FDA notes that it is particularly interested in using the workshop to learn about current practices, processes, and systems stakeholders use to exchange information as well as how trading partners could respond to verification requests and notifications as required by the DSCSA.  People interested in attending this workshop must register by April 24, 2014.  FDA is also accepting comments regarding the workshop until June 9, 2014.     

FDA has also created a website that summarizes the implementation timeframes created by the DSCSA.  These timeframes are currently based on statutory deadlines, but FDA indicated that it will “update” this website as appropriate.