Issue link: https://www.e-digitaleditions.com/i/1462155
42 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Supply Chain (2D) barcode (e.g., GS1 DataMatrix) barcode, and homogeneous cases must include either a 2D or linear (e.g., GS1-128) barcode. The application of standardized data facilitates product traceability throughout the healthcare supply chain and will be used to associate the physical product mark- ings with serialized electronic data exchange that will be required in 2023. It took a few years and a lot of work, but pharma manufacturers are now barcoding nearly all their products accordingly. Annual assessments con- ducted between 2017–2020 by AmerisourceBer- gen, McKesson Pharmaceutical, and Cardinal Hea lt h, in collaboration w it h GS1 US, docu- mented steady progress in barcode implementa- tion. Each year, the big three wholesalers scanned product barcodes in three different facilities and evaluated them for correct application of the required data standards. The 2020 assessment found over 90% of scanned packages and cases met all the labeling requirements, and the success rate has likely improved since then (1). Ready, set… Now that the products are serialized and barcoded with standardized product information, systems in- teroperability is the remaining lynchpin for meeting the DSCSA's intent. All trading partners must be able to record, capture, read, and exchange the product data contained in the barcode, in addition to other tracking information such as locations and events such as shipping, receiving, and more. Combined, all that information provides a history of a product's journey through the supply chain. The chain of cus- tody, product information, and related supply chain events can then be traced back when needed—as in the case of a recall or adverse event. Suppliers and wholesaler/distributors need to establish systems compatibility and conduct rig- orous testing to ensure viable data exchange on the front end of the supply chain. Then, they will be able to progress testing throughout the supply chain to ensure traceability and interoperability all the way to the final point of sale. This includes many thousands of clinical and retail facilities, large and small, with a wide range of IT capabili- ties, infrastructure, and preparedness for receiv- ing and leveraging the data. Establishing downstream capabilities DSCSA's interoperability requirement places new responsibilities on the downstream partners who receive and dispense the medications. Many of the industry's smaller clinical organizations and pharmacies do not currently have compatible systems they will need for data capture and ex- change. Intensive collaboration between manu- facturers, wholesaler/distributors, providers, and dispensers is needed to bring them on board. The FDA draft guidance, Enhanced Drug Distribu- tion Security at the Package Level under DSCSA, states that dispensers should be able to respond to FDA data requests within one day and that clerical errors such as missing data should be resolved in three business days (2). While data errors or discrepancies are being resolved, the DSCSA's interoperability requirement places new responsibilities on the downstream partners who receive and dispense the medications.