Just 10 weeks before theDrug Supply Chain Security Act(DSCSA) requires drug manufacturers to begin applying a serialized product identifier in barcode and human-readable form to drug packages and homogeneous cases, the FDA has recommended a human-readable format that differs from what the majority of manufacturers have already chosen. What’s going on here? What options do manufacturers have?
我一直在谈论这个问题几年。这是迹纵横道RxTrace专注于它的散文（最近的散文是今天最相关的）：
• May 4, 2015, “The DSCSA Product Identifier On Drug Packages”
• July 27, 2015, “I’ve Changed My Mind, Follow GS1’s HRI Specification”
•2016年4月25日，“Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1”
•2016年5月2日，“Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2”
• February 19, 2018, “Human Readable Text Controversy”
A reoccurring theme in most of these essays is that the FDA had not yet provided guidance for the human-readable part of the DSCSA product identifier. As of September 20, 2018, we now have that guidance, indraft format least (see “FDA发布两个最终DSCSA指南和产品标识符问答文件Q＆A文件。”)
The new draft guidance is controversial in the industry because it differs from the practices that drug manufacturers adopted in the absence of guidance as they prepared for their November 27, 2017, and then 2018 serialization and verification deadline. The three most notable differences are:
- FDA says NDC, majority using GTIN
For regular readers of RxTrace, this is no surprise. Those who are only occasional readers or are new to RxTrace are probably surprised. Notice this is not just a “recommendation,” FDA uses “…must…”. Unfortunately, the industry pays closer attention to not violating GS1 standards than they do to not violating the DSCSA when it comes to the human-readable portion of the product identifier. The DSCSA is pretty clear about the need to print the NDC (as one element of the Standardized Numerical Identifier, SNI) and there are solid patient safety reasons to do that. Those reasons trump the supply chain benefits of following the historical GS1 Human Readable Interpretation (HRI) standard to a tee. The FDA, in this draft Q&A, is simply telling us what the DSCSA has always said. But I believe there are ways to meet both (see “Human Readable Text Controversy。”)
- FDA建议使用GS1应用标识符（AI）的文本字段名称，多数
Again, no surprise here. More and more, companies have been moving to AIs加有足够的空间的产品文本。这肯定会符合FDA推荐方法的精神，但它需要很多空间。同样，原因是患者安全，再次，我认为有一个坚实的中间地面。
- FDA recommends new format for expiration date, majority doing something else
This draft Q&A offers a new date format that I’ve never seen before in FDA documents. In fact, it differs pretty significantly from the date format discussed in the 2013 draft guidance “安全Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” that most companies were probably trying to follow, and which is even used as a reference in this new draft guidance. OK, they are both “draft,” but the one that just came out reflects the FDA’s “current thinking,” so companies should probably gravitate toward it. That older draft guidance is probably worthy of being updated for other reasons, too, now that the DSCSA is a reality.
谈到“草案”指导的概念，意识到FDA目前正在要求对这一新的利益相关方评论。你才到2018年11月19日到提交您的意见。You know,less than a week before the serialization and verification deadline!直到指导最终确定（如果它是 - 没有时间表），它标志着“草案 - 不适合实施”，但它仍然反映了FDA的“当前思想”。即使/当指导草案最终确定，它仍将被标记为“包含非挤出建议”，除非他们使用“必须”或“须”等单词，这通常只在直接从原始要求时完成法律或规则，而不是“可能”甚至“应该”。
是什么让这个新的指导令人沮丧的是，当公司仍在设计他们的解决方案时，它并没有三个甚至两年前。在每次药品制造商完成11月截止日期之前，每次药品制造商都完成了配置，测试，部署和验证其序列化解决方案后发布。这意味着，如果他们想符合这一指导，他们将需要进行更改，这可能会触发某些数量的重新验证。
Two of the three things I list above are just FDArecommendations。没什么大不了。在下次对您的解决方案中执行其他时间来使这些更改变为触发器重新验证 - 即使需要几年。但GTIN / NDC问题（上面的＃1）不仅仅是一项建议。它基于DSCSA本身中发现的文本。即便如此，我认为任何人都不应该放弃一切，并在11月底之前尝试在他们的系统中克切。紧紧抓住。
我希望这部分指导草案产生了许多书面答复。我预测，响应将压倒性地支持gtin，可能有一个机会（a非常苗条chance) that FDA may make some kind of exception to allow it (if they even can—the DSCSA is an国会行为after all). Those responses should be really interesting to read. Once they are all posted later this year I will write a review of the ideas expressed in them and analyze the implications.
BTW, while researching this essay I discovered that the FDA has significantly changedCFR 21第207部分，Subpart C，国家药物代码（以前称为CFR 21第207.35部分）在过去两年的某些时候。我在我之前的一篇文章中添加了一个注释，从本节中提取过时文本。
Editor’s note: This article was originally published Oct. 1, 2018 onrxtrace.com.。It is used here with permission by author Dirk Rodgers, Regulatory Strategist forSystech International.rxtrace的创始人。
