FDA DSCSA delay Archives - rfxcel.com

FDA Postpones Enforcement of Key DSCSA Requirements to November 27, 2024

In a guidance document published on Friday, August 25, the U.S. Food and Drug Administration (FDA) announced that it was delaying by one year enforcement of key requirements under the Drug Supply Chain Security Act (DSCSA). This “extended stabilization period” moves the enforcement date to November 27, 2024.

The guidance is primarily for manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products. We provide the specifics below.

The key takeaway: Don’t stop preparing for the DSCSA requirements. If you have questions about the DSCSA delay 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 are committed to meeting DSCSA compliance for all our customers in a timely manner.

And if you’re going to the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C., stop by Table-Top 21 to meet our team and talk about the developments in person. Click here to learn more.

Overall FDA rationale for the DSCSA delay

The FDA said extending enforcement will give supply chain stakeholders — particularly manufacturers, wholesale distributors, dispensers, and repackagers — the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

Furthermore, the Agency said, “additional time beyond November 27, 2023, may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

What DSCSA requirements are affected?

Product identifiers

The requirement. Trading partners must include the product identifier at the package level for each package in a transaction into the transaction information. Furthermore, a product’s manufacturer or repackager must incorporate the PI at the package level for each package “introduced in a transaction into commerce.” These requirements are included in section 582(g)(1)(B) of the Food, Drug, and Cosmetics Act (FD&C Act).

Reasoning for DSCSA delay. The FDA said the delay will “accommodate the additional time (beyond November 27, 2023) that may be needed by trading partners to achieve compliance and to help ensure continued access to prescription drugs as trading partners continue to refine processes” to include the PI at the package level. Furthermore, the FDA said “this policy will facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.”

What is a PI? The PI is a standardized graphic that contains, in both human-readable form and on a machine-readable data carrier, four data elements:

      1. National Drug Code (NDC)
      2. Serial number
      3. Lot number
      4. Expiration date

Saleable returns

The requirement. Each person accepting a saleable return must have systems and processes in place to allow acceptance of the product. Furthermore, they may accept saleable returns only if they can associate the product with its transaction information — including the PI — and transaction statement. These requirements are included in section 582(g)(1)(F) of the FD&C Act.

Reasoning for DSCSA delay. FDA said delaying enforcement of this requirement until November 27, 2024, will “facilitate the continued use of methods currently being used by wholesale distributors for associating a saleable return product with its applicable transaction information and transaction statement while accommodating the additional time that may be needed for all trading partners to mature the new systems and processes required for acceptance of saleable returns.”

Interoperable, electronic product tracing at the package level

The requirement. Transaction information and transaction statements must be exchanged in a secure, interoperable, electronic manner. This requirement is included in section 582(g)(1)(C) of the FD&C Act; the standards for exchange are established under section 582(h) of the DSCSA.

Furthermore, systems and processes for verifying products at the package level, including the standardized numerical identifier, must meet the standards established in DSCSA section 582(a)(2) and the guidance in DSCSA section 582(h).

Reasoning for DSCSA delay. The FDA these policies will allow trading partners to continue to provide, capture, and maintain data for the data exchange for product tracing and verification while providing additional time that may be needed to “continue to develop and refine systems and processes for electronic data exchange.”

Investigating suspect and illegitimate products

The requirement. In the even of a recall or to help investigate a suspect or illegitimate product, stakeholders must be able to promptly provide product transaction information and transaction statement when requested by the FDA secretary or other appropriate federal or state official. This requirement is included in section 582(g)(1)(D) of the FD&C Act.

Furthermore, Section 582(g)(1)(E) of the FD&C Act requires stakeholders to “produce the transaction information for each transaction going back to the manufacturer” in certain situations, including a recall or investigating a suspect product or an illegitimate product.

Reasoning for DSCSA delay. FDA believes these compliance policies will facilitate the continued use of methods currently being used by trading partners to respond to the type of requests for information described above while accommodating the additional time that may be needed for trading partners to mature the new systems and processes required for such activities under section 582(g)(1)(D) and (E) of the FD&C Act.

Comprehensive DSCSA Timeline: Prepping for DSCSA Compliance

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:

      • 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

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:

      • 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.


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.