In response to “concern[s] that electronic systems used to exchange, capture, and maintain product tracing information will not be operational” by the July 1, 2015, deadline, the Food and Drug Administration (“FDA”) issued a new guidance yesterday (“Guidance”) indicating they will not begin to enforce dispenser1 (primarily pharmacy) requirements under section 582(d)(1) of the Food, Drug, and Cosmetic Act until November 1, 2015.2The Drug Supply Chain Security Act (“DSCSA”) was signed into law on November 27, 2013, with the goal of creating an electronic interoperable system to trace and identify prescription drugs by November 27, 2023. Section 582 requires trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) to exchange transaction information, transaction history, and a transaction statement (i.e., product tracing information) when engaging in transactions involving certain prescription drugs. The goal is to establish standardized documentation along the pharmaceutical distribution chain and to facilitate the exchange of lot level, and eventually package-level, data in order to remove compromised or counterfeit drugs from the market. The DSCSA is being implemented by the FDA in numerous steps over a 10-year period. Under section 582(d)(1)(A), dispensers are required to obtain a transaction history with each shipment listing every company that previously owned certain prescription drugs, as well as product tracing information. These documents allow a dispenser to verify that the prescription drugs come from authorized trading partners. Dispensers are also required to maintain records of this information for not less than 6 years after the date of the transaction and report to the FDA any product that is determined to be counterfeit, stolen, or otherwise adulterated. Section 582 requires that the implementation of the exchange of this transaction information occur in two phases. The first phase included manufacturers, repackagers, and wholesaler distributors, and this second phase includes dispensers. The deadline for manufacturers, repackagers, and wholesale distributors was originally set for implementation on January 1, 2015, but the FDA extended the deadline to May 1, 2015.3 The deadline for dispensers was July 1, 2015; however, in a June 22, 2015 letter,4 a group of pharmacy organizations urged the FDA to exercise the same discretion and extend the deadline for dispensers, and provide pharmacies with much needed additional time to adequately prepare to comply with the product tracing requirements. Moreover, the pharmacists argued that by extending the deadline for manufacturers, distributers and packagers, FDA compressed their implementation timetable.5 In the Guidance document, the FDA recognized some dispensers may require additional time to work with trading partners to ensure that the product tracing information is captured and maintained. 6 While the FDA stated that it does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of a product without receiving tracing information, it recommended that if a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, such dispenser should “work with the previous owner to receive that information.”7 This would allow dispensers to meet their obligations under section 582(d)(4) to identify and quarantine a suspect product, and to investigate whether the product is illegitimate.8 Finally, the FDA reminded dispensers the compliance policy did not extend to the requirements under section 582(b)(1), (c)(1), and (e)(1) that other trading partners provide product tracing information to dispensers.9 In addition, it does not extend to transactions where dispensers are required to provide tracing information to a subsequent owner under section 582(d)(1)(A)(ii). 1 Section 581(1) identifies a dispenser as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs. . . .” 2 DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy, Guidance for Industry, July 2015, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM453225.pdf. 3 DSCSA Implementation: Product Tracing Requirements – Compliance Policy, Guidance for Industry, Dec. 2014, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM427867.pdf. 4 Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement, available at http://www.ncpanet.org/newsroom/news-releases/2015/06/24/pharmacy-groups-ask-fda-to-delay-enforcement-of-'track-trace'-requirement. 5 Id. 6 Guidance, at 3. 7 Id. 8 Id. Dispenses are still required to comply with the requirements under the DSCSA for the verification of suspect and illegitimate product and may only engage in transactions with authorized trading partners. 9 Id. Download PDF
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