FDA clarifies track-and-trace requirements for pharmacists

APhA makes agency aware of profession’s concerns

Activity around the Drug Supply Chain and Security Act (DSCSA), better known as track and trace, is picking up, with FDA releasing several draft guidances to help implement the law, which have a direct impact on pharmacists. The agency is also holding two additional public meetings in December 2017 and February 2018 to gather feedback regarding FDA’s implementation of other aspects of the law.

DSCSA, enacted as part of the Drug Quality and Security Act of 2013, outlines the steps manufacturers, repackagers, wholesale distributors, dispensers (i.e., pharmacies), and third-party logistics providers need to take to develop an electronic, interoperable system that tracks a drug at the unit-level throughout the drug supply chain. DSCSA includes provisions on product identification and verification, data sharing, detection and response to suspect any illegitimate products, recordkeeping, and unified licensure standards for wholesale distributors, and third-party logistics providers.

Although several of the law’s deadlines have already been delayed, the schedule may be broken down into three phases:

Phase 1: Lot-level traceability and verification of product and transactions (2015)

Phase 2: Drug product serialization and enhanced verification of serialized product (2017–2020)

Phase 3: Unit-level traceability (2023)

Dispensers’ requirements for Phase 1 are already in effect. In January 2015, FDA expected dispensers to have established a system for verification and handling of suspect or illegitimate products, and to confirm that trading partners (i.e., manufacturers, wholesale distributors) are appropriately registered or licensed with FDA or state authority. As of March 2016, FDA began enforcing the requirement that dispensers only accept ownership of a product if they receive product tracing information (transaction history, information, and statement), prior to or at the time of the transaction. In addition, dispensers must maintain such information for no less than 6 years after the date of the transaction.

As FDA shifts its focus to Phases 2 and 3, the agency is hosting mandated public meetings and releasing guidance documents to clarify several aspect of the law, including those related to Phase 1 requirements. In addition, FDA has taken steps to advance pilot projects related to implementation.

On August 24, FDA released a draft guidance, “Identifying Trading Partners Under the Drug Supply Chain Security Act,” which clarifies the circumstances when certain activities would likely result in a member of the supply chain being classified as a different type of trading partner. For example, a pharmacy could be both a dispenser and wholesale distributor if selling medication to another pharmacy without a specific patient need. It is important for dispensers to be aware of FDA’s interpretation of this issue because it may have an impact on current business practices, recordkeeping, and potentially, licensure. APhA will be submitting comments in response to the draft guidance, with the goal of limiting the burden DSCSA imposes on dispensers. However, it is important that dispensers are aware of the agency’s current approach.

Another recent draft guidance for industry, “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy,” was released on June 30. This guidance “informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions,” according to FDA. This information is relevant to pharmacists because, starting in 2020, dispensers must only accept a product that is affixed or imprinted with a product identifier. FDA’s decision to delay the deadline for manufacturers did not have a cascading effect on the deadlines for other members of the supply chain. Consequently, dispensers may have less experience handling prescription drug packages and cases with a product identifier than envisioned when the law was enacted. APhA submitted comments to FDA regarding this important issue, among others related to the draft guidance.

On July 20, FDA released a notice regarding the agency’s Pilot Project Program required under DSCSA. The program is intended to assist the development of the interoperable electronic system to be established by 2023. The notice indicates that FDA will be seeking pilot project participants from the pharmaceutical distribution supply chain, including dispensers. It is expected that FDA will begin the program in 2018, however, those interested in participating or learning more are encouraged to review the notice and provide feedback to FDA or APhA. APhA will be submitting comments on September 18.

In addition to the new draft guidances and notice, FDA scheduled three public meetings, titled “Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA).” The first meeting was held on August 23 and the next two are in December and February 2018. APhA provided public comments and served as a panelist in the August 23 meeting, calling for more clarity on requirements for dispensers, and for the Agency to carefully consider the impacts that such requirements have on patient care and other regulations imposed on pharmacists.

APhA is convening a work group to meet on a monthly basis to discuss DSCSA to further inform APhA’s communications with FDA and other members of the supply chain as implementation advances. Those interested in participating, such as pharmacy owners or those responsible for ordering medications or receiving shipments, should contact Jenna Ventresca, APhA director of health policy, at jventresca@aphanet.org by September 22.