HTC Considerations for 2023 DSCSA Requirements
by Michael V. Fusaro, PharmD., Compliance Officer – The Alliance Pharmacy

A brief history
The Drug Supply Chain Security Act (DSCSA) became public law in November of 2013. DSCSA created a series of phased requirements to improve visibility across the supply chain. The 10-year timeline was defined by 3 main phases. Lot-level management was the focus of phase 1, and Item serialization was implemented with Phase 2. Many readers will be familiar with phase 2 changes and the unique serial numbers and 2D barcodes (data-matrix) now printed on medication containers. The third phase will bring with it “Serialized Traceability” and enhance the way individual items are tracked across the supply chain.

How are Hemophilia Treatment Centers impacted?
In 2015, the FDA provided draft guidance included definitions of each “Trading Partner” who would be included in the DSCSA’s new requirements³. There are several categories of “Trading Partners”, and while the relationship between Covered Entities and Contract Pharmacies is complex, the general understanding is that a 340B Covered Entity falls under the “Dispenser” entity type. While many of the requirements set forth in the DSCSA fell under the responsibility of manufacturers, repackagers, and wholesale drug distributors, dispensers still have a significant part to play.

What’s up next?
The final phase of the DSCSA is the unit-level traceability requirement by November of 2023. Many vendors already provide lot-level transaction data to customers via an online portal (commonly referred to as “T3”). Phase three will require the addition of unit level serialization data. This will be a significant increase in the amount of information provided.

The FDA is working with GS1, a non-profit organization that designs and maintains global standards for business communications, to establish a universal language for this data. The format that the FDA and GS1 have developed is called “Electronic Product Code Information Services” (EPCIS).

EPCIS is the GS1 standard that is used to generate, capture, and maintain information at specific instances throughout the supply chain. EPCIS is used to track “events” along a product’s lifespan. This includes events such as, receiving, unpacking, dispensing, destroying, and decommissioning. This standard allows all involved parties in the supply chain to capture and store that data, and then to share it with partners in the supply chain. This data will enhance the supply chain’s visibility of where products are at any given time, and the system’s overall ability to recognize counterfeit/illegitimate products. This will be tremendously useful to identify and promptly notify all necessary parties in the case of a drug recall.

How can a dispenser prepare for 2023?

• Start planning how you will maintain EPCIS data.
While upstream partners will be required to both generate and receive EPCIS data, most dispensers will only need to have a means of storing it. Now is a good time to start asking your suppliers what options they have. Many distributors, including The Alliance Pharmacy (TAP), already host your transaction data through their online portals and will be hosting EPCIS data through similar means. By hosting customer data, the customer can satisfy the DSCSA requirements to maintain access to transaction information data in a readily retrievable manner². As we get closer to November of 2023, dispensers should know who is maintaining this data (for every product).
• Confirm your site’s Global Location Number (GLN) or alternative accepted Identifier
As mentioned, EPCIS data defines the fundamental structure of an “event” with data dimensions of what, when, where, and why. The “Where” component will require specific identifiers for each trading partner. These will be in the form of a Global Location Number (GLN)¹. The GLN number is an additional standard developed by GS1. All trading partners will need to have a GLN (or other unique identifier^*) for the EPCIS data to generate correctly. Now is a great time to determine if you already have a GLN and if not, who would be the appropriate person to contact regarding this.
Read GS1’s Quick Start Guide for Pharmaceutical Dispensers and Healthcare Providers (Pharmaceutical Dispenser Global Location Number Quick Start Guide)

As the 2023 deadline approaches, expect to see and hear more conversations around DSCSA. Now is the time to familiarize yourself with applicable requirements and identify any potential opportunities. Discuss company readiness with your compliance and regulatory colleagues. For more information, see the following great resources.

Resources

• GS1 Homepage, with several resources (www.gs1us.org)
• Drug Supply Chain Security Act (DSCSA) | FDA (www.fda.gov)
• Drug Supply Chain Security Act (DSCSA) Resources for Dispensers (dscsa.pharmacy)


<sub>Disclaimer: The information contained in this article is provided for informational purposes. It is not to be considered as medical, legal, or other professional advice. The information contained in this article is provided solely on an “as is” basis, without any representations or warranties, express or implied. No recipients or readers of this article should act or refrain from acting on the basis of any content included in this article. The content of this article contains general information only, and may not reflect the most current standards, legal developments, regulations, or laws.
* Some vendors will accept alternate unique identifiers for customers, such as HIN or DEA. Check with your vendor to confirm.
1 Implementation Guide: Applying GS1 Standards for DSCSA and Traceability, Release 1.2. Retrieved September 18, 2019 from https://www.gs1us.org/industries/healthcare/standards-in-use/pharmaceutical/dscsa-implementation-guideline
2 Title II of the Drug Quality and Security Act Sec.582(d)(1)(B) https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act
3 https://www.fda.gov/files/drugs/published/Identifying-Trading-Partners-Under-the-Drug-Supply-Chain-Security-Act-Guidance-for-Industry.pdf (493)</sub>