DSCSA 2023 GUIDE

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AS a US Dispenser, are you ready to comply with US Drug Supply Chain Security Act regulations that will be effective starting 27 November 2023?

Most players in the industry expect a flurry of activity in 2023. Per a recent survey conducted by the HDA: Distributors feel that dispensers’ understanding of the regulations varies considerably (44%), with 37% of dispensers not having an understanding of the regulations. This is true of independent pharmacies, chain stores, hospitals, and health systems.

The main challenges are collaboration with trading partners, connectivity/communications, technical challenges, and establishing standards. Roughly 30%-35% of manufacturers expect their non-direct purchasers (e.g. dispensers) not to have a technology solution (or come through a distributor) for verification requests. Manufacturers expect to handle these types of requests manually; they are also unsure of how to support verification requests from such purchasers.

THIS PAGE WILL HAVE MOST OF WHAT YOU WILL NEED TO PREPARE FOR COMPLIANCE AS A US DISPENSER.

01. WHAT IS SERIALIZATION AND TRACK & TRACE?

Serialization is a process of assigning a unique identifier, such as a serial number to a given product or a packaging level. During Serialization each item of the product is be labeled with a unique item identifier. Typically the item identifier is a Datamatrix-Code containing at least the product-related GTIN paired with a serial number (e.g. EPC).

In the Supply Chain industry, Track & Trace refers to the ability to identify the past and present locations of Serialized goods and the history of product custody.

Tracking means recording what exactly happened to the Serialized product across the Supply Chain, including goods movements and aggregation changes among others. Tracing means retrospectively identifying and verifying the recorded historical information about Serialized products.

Another important term/operation is Aggregation. It is the process of building packaging hierarchies and storing this relationship in a database. If, for example, single products get packed in a case and these cases are packed on a pallet.

Serialization and aggregation together with capturing the movements of these aggregated products achieve Track & Trace.

As can be expected, there will be a flurry of activity in 2023 in a scramble to meet the regulations’ deadline of November 2023. It is critical that you, as a US Dispenser, get started as soon as possible. The time for waiting has long passed. If you are starting now, we have you covered.

Check the Compliance Checklist in the last chapter.

02. DSCSA REQUIREMENTS

Deadline: Nov 2023
Impacted: Manufacturers, Distributors, Wholesalers, 3PLs and Dispensers (e.g., Pharmacies)
Key requirement: Interoperability to enable:
- Product Identification
- Product Tracing
- Product Verification

Product Identification: NDC, Batch Number, Expiry Date, Serial Number
Product Tracing: ”3Ts”:
- Transactional Information
- Transactional History
  (eASN to replace this requirement)
- Transactional Statement
Product Verification: on item level, to consider aggregation if available

3Ts to be transmitted electronically to subsequent authorized trading partners before shipment/ change of ownership
EPCIS needed for transmitting the information within Supply Chain
Any suspicious products must be reported to FDA (or other controlling entity) within 24 hours
Record retention: 6 years
No central repository
Saleable returns to be also reported (no need for Dispenser to send data)

DRUG SUPPLY CHAIN SECURITY ACT TIMELINE

03. USEFUL LINKS

Regulations can be found here:
https://pdsaonline.org/dscsa-information/phase-ii-implementation/

HDA’s blog on Dispenser roles & responsibilities:
https://www.hda.org/news/hda-blog/2022/09/28/10/46/dscsa-2023-dispensers-role-and-responsibilities?rtb=1

*HDA's recent research paper:
https://www.hda.org/resources/2022-serialization-readiness-survey

Overview of DSCSA milestones:
https://dscsa.pharmacy/

GS1 Education site:
https://site.gs1us.org/DSCSA-Dispenser-Online-Certificate-Course.html

04. SOLUTION REQUIREMENT

The vendor selection process is full of hidden obstacles and challenges, especially as the DSCSA approach is unique in the world of Track and Trace. Be sure your vendor and your solution is capable of the following:

5. COMPLIANCE GUIDE

To assist you with compliance requirements, especially if you feel you are a little behind, we have put together a comprehensive guide to help you comply with US DSCSA regulations. Click on the below to download. The guide will be regularly updated

Here are the six steps of full compliance that a Dispensary needs to pass till the November of 2023. We’ll unpack these stages in further editions of the guide.

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