Pulse & DSCSA
Pulse is NABP’s inclusive, accessible, and secure means of simplifying DSCSA compliance.
NABP has a 120-year history of solving complex regulatory challenges to meet its mission of protecting public health. After the Drug Supply Chain Security Act (DSCSA) was signed into law in 2013, we explored its impact on trading partners.
Requirements under DSCSA include:
- Members of the supply chain may only transact with authorized trading partners.
- Trading partners must develop a process for dealing with products that are suspected of being falsified, adulterated, or counterfeit. Suspect products must be quarantined, investigated, and reported.
- Upstream supply chain members must distribute electronic transaction information, transaction history, and transaction statements (commonly referred to as T3 information) to downstream partners.
- Each product must have a 2D product identifier that includes the National Drug Code (NDC), lot number, expiration date of the drug, and a unique serial number.
- November 27, 2023 marked the final DSCSA milestone, which requires trading partners to participate in a fully interoperable electronic system that enables products to be tracked through the drug supply chain.
- FDA has issued a 1-year stabilization period for all stakeholders to complete and normalize system and process implementations prior to expected full enforcement starting November 27, 2024.
We sought input from an industry-wide network of regulators and stakeholders and conducted our first pilot program in early 2022. In the process, we uncovered interoperability gaps between industry participants and state regulators. To further explore DSCSA interoperability, a second pilot program was held in late 2023 with a significant representation of the drug supply chain industry. The pilot aimed to understand business requirements and uncover outstanding gaps in the tools and processes needed to meet DSCSA requirements. Pulse supports the industry by offering a comprehensive directory of trading partners, streamlining communication, and reducing administrative work – all within a secure, interoperable system.
How Pulse Supports DSCSA Compliance
- Provides a uniform state regulator request form.
- Allows trading partners to designate a point of contact within their organization for regulator requests.
- Provides an easy way for trading partners to get in touch with regulators or with the right point of contact at another organization.
- Helps regulators recreate transaction histories for investigations.
- Allows a user to demonstrate their relationship with an Authorized Trading Partner.
- Links multiple unique identifiers (such as license number and GLN) for each trading partner in a single directory listing.
- Allows users to easily check state licenses and Authorized Trading Partner status.
Learn About DSCSA
DSCSA Resources
Reference Guide: FDA’s list of DSCSA law and policy documents
Blog Series: Industry topics and action steps ahead of the November DSCSA compliance deadline
Online Resources: DSCSA resource website for dispensers that we put together with our partner organizations
DSCSA Webinars
Sign up for the following on-demand webinars to learn more about getting ready for the DSCSA requirements.
Preparing for DSCSA: What the Deadline Means for Trading Partners
Learn what the DSCSA deadline means for trading partners across the supply chain and how to prepare for the upcoming requirements. Panelists will discuss many frequently asked questions.
Getting to Know 3PLs
Learn the role third-party logistics providers (3PLs) play and how DSCSA will affect 3PLs. Hear from various 3PLs who describe their operations.
DSCSA Update – Are We Ready for November 27?
Explore the threat that counterfeits pose to our nation’s drug supply, what dispensers can do to protect the supply chain, and how NABP is facilitating interoperability.
DSCSA Update – What Do Regulators and Pharmacies Really Need to Know?
Hear about the NABP DSCSA pilot project and the impact of what needs to be accomplished in the time remaining the November 2023 deadline. A panel will discuss what regulators and pharmacies really need to know about the DSCSA and how to prepare for the future.
Understanding New DSCSA Requirements and Common Diversion Schemes
Gain an understanding of the DSCSA requirements and how regulations will be impacted. Plus, learn how NABP’s accreditation programs play a pivotal role in preventing counterfeit drugs and devices from entering the US drug supply.