If androids dream of electric sheep, do pharma stakeholders dream of GS1’s Electronic Product Code Information Services (EPCIS) standard? Considering recent FDA DSCSA guidance and the industry reaction, the answer could very well be “yes.”
On July 5, the FDA published two draft guidance documents about the Drug Supply Chain Security Act (DSCSA). One deals with using electronic standards for tracing pharmaceutical products in the U.S. supply chain and one addresses authorized trading partners (ATPs):
Let’s take a closer look at the FDA DSCSA guidance and where the pharma industry stands as we count down to November 27, 2023. That’s when manufacturers, wholesalers, distributors, and dispensers will be required to exchange serialized product information and verify their ATP status.
Quick history of FDA DSCSA guidance
The FDA has released DSCSA guidance and policy documents since 2014, most of which are all available on the Agency’s “Drug Supply Chain Security Act Law and Policies” page. This year, in addition to the July draft guidance, the Agency published the following:
- National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers (draft guidance, February 2)
- Certain Requirements Regarding Prescription Drug Marketing (proposed rule, February 2)
- Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Withdrawal (proposed rule, February 2)
- Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers (final guidance, February 2)
- Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (proposed rule, March 10)
What did the July FDA DSCSA guidance say?
Electronic traceability standards/EPCIS
The new FDA DSCSA guidance for electronic traceability standards confirms that paper-based product tracing “will no longer be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies.” Furthermore, it recommends that stakeholders use EPCIS to exchange information.
It’s worth quoting the guidance at length, as the Agency clearly states its position on EPCIS, including that it will “help secure” DSCSA compliance:
FDA recommends that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. Use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with the DSCSA requirements and is compatible with a range of different technological approaches. FDA believes that EPCIS is an appropriate globally recognized standard, and FDA understands there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution security requirements.
The comment period for this guidance ends September 6.
Identifying trading partners
The FDA said it issued this guidance “to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the” DSCSA. It also does the following:
- Explains how to determine when certain statutory requirements will apply to entities that are considered trading partners.
- Discusses the activities of private-label distributors, salvagers, and returns processors and reverse logistics providers.
- Discusses the distribution of drugs for emergency medical reasons, office use, non-human research purposes, and research purposes in humans under an investigational new drug application.
The comment period for this guidance also ends September 6. As for licensure for trading partners, the FDA put a reminder on its DSCSA page that wholesalers and third-party logistics providers (3PLs) are required “to report licensure and other information to FDA annually under sections 503(e)(2) and 584 Federal Food, Drug, and Cosmetic Act.” The intro on this page references the July 5 draft guidance.
Industry reaction to the FDA DSCSA guidance
The Regulatory Affairs Professionals Society (RAPS) earlier this month published an excellent article about industry reaction. Here are some of the key takeaways:
- Trading partners need to begin testing and piloting data exchanges now to identify and remedy any glitches.
- Manufacturers in particular need to focus on data accuracy to ensure legitimate products aren’t rejected.
- The FDA must clarify if web portals will be allowed for data exchanges. Web portals are a good solution for smaller companies (e.g., dispensers) that might not have the means to build compliant tracing systems from scratch.
- The FDA should finalize its proposed rule on licensing standards for 3PLs.
The July FDA DSCSA guidance was another important marker along the 10-year rollout of the law. We’ll be writing more about this next week, when we sit down with Herb Wong, rfxcel’s senior vice president of product and strategy.
If you don’t know Herb, he’s a DSCSA guru who’s been deeply involved in outreach, education, and initiatives to help the industry prepare for November 2023. For example, he was integral to the formation of the EPCIS Center of Excellence and led our FDA-approved pilot to extend testing of the Verification Router Service (VRS). He was also recently name-checked by the Open Credentialing Initiative (OCI), which focuses on meeting ATP requirements, for his “collaborative spirit and dedication to improving the U.S. pharmaceutical supply chain.”
So check back next week for our conversation with Herb. In the meantime, if you have questions or feel you’re not on track to comply by November 2023, contact us today to build a solution tailored to your exact needs. Also visit our DSCSA Compliance Library to access our extensive collection of articles, webinars, white papers, and news.