该文件，“将GS1标准应用于美国药品供应链业务流程，以支持《药物供应链安全法》，“是与GS1 HealthcareUS®合作开发的，GS1 Healthcareus®是美国行业领导的标准计划。该指南为制药行业利益相关者提供了满足直接地段管理截止日期的最佳实践，并为项目级别的物品级别的可食用性奠定了基础。
“随着《药物安全与质量法案》和《 DSCSA》的通过，我们现在制定了一项声音，国家政策，以确保药物保护和一致，标准化的方法来打击美国药品供应链中的伪造，盗窃和转移。”Siobhan O’Bara, Senior Vice President of Industry Engagement, GS1 US. “The new guideline, developed by industry for industry, is timely and needed to address key decisions that must be made now. It establishes a solid standards framework as the industry continues its transition to a safer, automated, and serialized supply chain.”
The guideline focuses on how GS1 Standards, particularly the GS1 Electronic Product Code Information Services (EPCIS), support the Act’s January 1, 2015 lot-level management deadline for manufacturers, wholesalers, and repackagers, and the July 1, 2015 deadline for hospital and retail pharmacies. As a GS1 data sharing standard, EPCIS provides the data attributes and message structure needed to comply with the information handling and retrieval provisions of the DSCSA law, including Transaction Statement (a statement of compliance to specific DSCSA requirements), Transaction Information (the transfer of goods from one party to another), and Transaction History (all prior Transaction Information records). In addition, the EPCIS-based approach enables users to address requirements for serialization, starting in 2017, and item-level traceability, starting in 2023. The guideline also addresses the application of other GS1 Standards to support the law’s requirements for product serialization and item traceability, including the Global Location Number (GLN), the Global Trade Item Number® (GTIN®), the Serial Shipping Container Code (SSCC), and GS1 Data Carriers and Application Identifiers.
O’Bara补充说：“利益相关者能够在批次级别共享信息并在项目级别识别和追踪处方药的能力对于在药品供应链中提供关键的透明度和问责制至关重要。”“新指南为如何满足要求提供了最佳思维和实际应用，同时还为制药行业建立了稳固的业务流程，因为我们过渡到完全自动化和序列化的供应链。”
GS1 Healthcare US成立于2008年，旨在将领先的制造商，批发商，医疗保健提供者，政府机构和行业协会汇总，以应对医疗保健中的监管和业务流程挑战。在2013年11月通过的《联邦法案》通过后，美国制药供应链的GS1 US和50多名倡议成员迅速动员起来，以更新加利福尼亚州法律的现有序列化和可追溯性准则，以符合新的联邦DSCSA要求。该指南，可在www.gs1us.org/dscsa-guideline，是GS1 US DSCSA资源网站的最新补充。
GS1 US将继续与行业合作，以扩展指南，以支持历史数据，合同制造，重新包装，异常处理以及地段和项目级别数据管理的管理管理期间的10年过渡期。有关GS1医疗保健的更多信息，请访问www.gs1us.org/healthcare，以及有关GS1美国的更多信息，请访问www.gs1us.org。
