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July 15, 2015
Pharmacists Get a Brief Break on Some “Track and
Trace” Requirements Washington, D.C.—In response to the requests of three leading pharmacy associations, the FDA granted a reprieve on some aspects of the Drug Supply Chain Security Act (DSCSA), which had been scheduled for full implementation July 1. In a guidance document, the FDA announced shortly before that date that it “does not intend to take action against dispensers” until November 1 on some of the DSCSA requirements. As of the first of this month, pharmacists were going to be required to capture and maintain transaction information, transaction history, and a transaction statement (i.e., product tracing information) for each drug product received for 6 years from the date of the transaction. The new FDA guidance provides 4 months of breathing room. “We are very pleased with today’s announcement,” said Stacie Maass, BSPharm, JD, senior vice president of Pharmacy Practice and Government Affairs at the American Pharmacists Association. “We are very appreciative to the FDA for working with and listening to pharmacists and other stakeholders regarding the implementation of the DSCSA to best benefit our patients.” The pharmacy organizations had argued in a letter to the FDA that a compressed implementation timetable could cause disruption in the pharmaceutical supply chain. “With the December, 2014, FDA enforcement discretion delaying enforcement of the product tracing requirements until May 1, 2015, this implementation timetable has been compressed,” leadership of the American Pharmacists Association, National Alliance of State Pharmacy Associations and National Community Pharmacists Association, wrote to the FDA. “Our organizations remain concerned that despite the extensive efforts by pharmacy and wholesale distributor associations to educate dispensers, some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain.” The groups added in a letter to Ilisa Bernstein, PharmD, JD, deputy director of the FDA’s Office of Compliance, “Our members fully intend to continue intense, concerted efforts toward full compliance, but by exercising its enforcement authority, FDA would allow progress to continue while minimizing the risk of product shortages or disrupting patient access to prescription drugs.” The organizations cited a recent NCPA survey finding that, while about half of the respondents reported being in contact with wholesale distributors to discuss how the transaction information would be provided, about another half said they were unaware of services being offered to maintain and store that information. In addition, fewer than 15% said they had entered into contractual arrangements with wholesalers. The letter also noted concerns about reporting by secondary wholesalers when used during a drug shortage or to access a drug not available from primary wholesalers. The enforcement delay doesn’t apply to every aspect of the DSCSA, however. The requirement that pharmacists must provide product tracing information to a subsequent owner, which includes pharmacy-to-pharmacy transfers, except for a specific patient need, did not have its deadline extended. The FDA points out that if a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, the FDA recommends that the dispenser work with the previous owner to receive this information. A “subsequent owner” does not include a patient.
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