Created as Title II of the Drug Quality and Security Act (DQSA), the Drug Supply Chain Security Act (DSCSA) is designed to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. The DSCSA timeline has established requirements and deadlines to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.
In August 2023, the FDA announced a “stabilization period” that postponed enforcement of key requirements until November 27, 2024, giving pharma companies an extra year to prepare, get their systems running, and be ready for full compliance.
With this in mind, here’s a recap of the DSCSA timeline.
Understanding the DSCSA Timeline
The “end game” for the Drug Supply Chain Security Act is full interoperable electronic unit-level traceability (serialization) of every regulated drug in the United States. Key dates of the DSCSA timeline include the following:
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- November 27, 2013: DSCSA enacted
- November 27, 2014: Third-party logistics providers (3PLs) must report licensure information to FDA annually
- November 27, 2015: Manufacturers must print lot numbers on packaging
- November 27, 2017: Manufacturers must serialize and verify products
- November 27, 2018: Repackagers must serialize products
- September 23, 2019: FDA delays enforcement of saleable returns requirement for wholesalers
- November 27, 2019: Wholesalers/distributors can only receive and distribute serialized products
- August 25, 2023: FDA announces extended stabilization period, postponing enforcement for one year
- November 27, 2024: Full interoperable electronic unit-level traceability for all stakeholders
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So, by November 27, 2024, manufacturers, wholesale distributors, dispensers (i.e., pharmacies, healthcare systems), repackagers, and 3PLs must have interoperable systems in place to share and verify package-level product identifier data electronically.
DSCSA Compliance Requirements
DSCSA compliance requirements vary by stakeholder, but it’s important to know how the regulations will affect both you and your trading partners.
The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. Each is important, but four are particularly vital because they require these stakeholders to have specific systems in place to be fully compliant. These are what we’ve been calling the “four cornerstones” of DSCSA compliance:
Product identification (serialization)
Manufacturers and repackagers must put a unique product identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically.
Product tracing
Manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about drug and who handled it each time it’s sold:
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- Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred.
- The transaction statement (TS) is a paper or electronic attestation by the business transfer-ring ownership of the product that it has com-plied with the DSCSA.
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Verification
Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drugs packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS).
Authorized trading partners (ATPs)
All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs.
In broad terms, to be an ATP you must meet certain registration, licensing, and licensure reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and comply with state licensing requirements. The definitions of ATP also include language about accepting or transferring direct ownership or possession of products.
Strategies for Compliance
Preparing for DSCSA compliance requires a lot of work, but it’s manageable with the right strategies and technologies. Start by understanding your role in the pharma supply chain and the specific requirements you’re expected to meet. Create a checklist for each requirement and make sure you have the resources needed to meet those standards.
The FDA made it clear that the stabilization period is not an excuse for pharma stakeholders to take a break from preparing. It’s quite the opposite, in fact: The Agency said the stabilization period was “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.”
You can read the FDA’s official document about the stabilization period here.
Technology and DSCSA Compliance
Technology is your greatest ally when it comes to achieving and maintaining DSCSA compliance. During the stabilization period, companies need to assess their readiness and implement and test serialization and data-exchange solutions. Your solution must be capable of verifying product identifiers (serialized data), aggregation, and electronic data exchange.
Resources for Ongoing Compliance
There are numerous FDA and third-party resources that can assist with your compliance efforts.
This FDA webinar, entitled “Implementing DSCSA: Stabilization Period and Expectations,” is a good place to begin. The FDA’s main DSCSA page also includes numerous resources, as well as a link to sign up for email updates.
We also highly recommend our own DSCSA Compliance Library. It has links to our articles, webinars, white papers, and other resources that will help you better understand the DSCSA requirements.
Navigate the DSCSA Timeline with rfxcel
As the DSCSA timeline leads the industry to November 27, 2024, you’ll need to ensure that your organization is ready. That’s where we can help.
If you have questions about the DSCSA timeline and your obligations or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We can provide you with the latest information and the solutions to protect consumers, identify suspect products, and maintain compliance.
