The large dispenser exemption to the Enhanced Drug Distribution Security (EDDS) Requirements of the DSCSA will be eliminated on November 26, 2025, meaning that all large dispensers must be compliant with all DSCSA requirements, including EDDS, as of November 27, 2025. Hopefully, if you are a large dispenser, you have dedicated time over the past year to plan and implement your compliance with the upcoming mandated EDDS Requirements, developing SOPs, employee training, and a means to receive and maintain properly formatted transaction data.
For the remainder of this blog, I would like to summarize who qualified for the large dispenser exemption before we delve into the requirements that will take effect on November 27, 2025. Then, we will discuss what was covered by the exemption, followed by a brief review of the DSCSA Requirements that you should have already been following before the EDDS Exemption.
And one last thing, do not expect another delay. Manufacturers became compliant on May 27, 2025, and Wholesalers became compliant on August 27, 2025.
Who Qualified for the Exemption from the November 27, 2025, Requirements?
The exemptions did not apply blanketly to all large dispensers. To qualify, a pharmacy must have met specific criteria:
- Active attempt at compliance: The FDA’s notice limits the exemption to pharmacies that have already initiated system and process implementations (e.g., data interconnections with immediate trading partners) or have at least documented their efforts to establish those connections, even if full completion with all partners hasn’t yet been achieved.
- Size threshold: A “large dispenser” for this purpose is defined as a pharmacy whose owning organization, as of November 27, 2025, employs 26 or more full-time equivalents (FTEs) who are licensed as pharmacists or qualified pharmacy technicians (this count may span multiple locations or operations).
- The IRS defines a full-time employee as one averaging at least 30 hours per week (or 130 hours per month) over a calendar month.
If a dispenser met all of these criteria, it may have elected to operate under the temporary exemption.
Note: Small dispensers (those with 25 or fewer full-time licensed pharmacists or qualified pharmacy technicians) remain exempt until November 27, 2026.
What Was Covered by the Exemption?
The exemption covered the following requirements of DSCSA that were to go into effect on 11/27/2024 and, for the qualified large dispensers discussed above, was delayed until 11/27/2025:
- Product Verification: Dispensers were to use the entire product identifier (NDC, serial number, lot number, and expiration date) when investigating suspect products to determine their legitimacy. During the exemption, we found that most investigations would use the entire product identifier, as it was a first-level check to assess the potential legitimacy of a product.
- Electronic Transaction Data: Dispensers were to receive the transaction information (TI) and transaction statements (TS) from their authorized trading partners (ATPs) in an electronic, secure, and interoperable format. During the exemption, large dispensers could continue to use the wholesaler portals to collect the required transaction data in any format.
- Package-Level Product Identifier: Dispensers were to receive the complete product identifier (NDC, serial number, lot number, expiration date) within the transaction information (TI) portion of the transaction data. During the exemption, dispensers were to receive the NDC (at a minimum).
- Verification Systems for Packages: Systems that verify products at the package level, including checking standardized numerical identifiers (NDC and Serial Number), can continue to use current verification methods until November 27, 2025.
- Responding to Requests for Product Data: Dispensers were to provide TI/TS promptly if requested by the FDA or state authorities (for recalls or investigations) within 24 hours. Exemption-eligible dispensers could use their existing methods for responding during this period.
- Gathering Historical Transaction Data: Dispensers were to have the ability to collect transaction data dating back to the manufacturer upon request (for recalls, investigations, or by authorized trading partners). Essentially, you should collaborate with your ATPs when conducting investigations and responding to requests. During the exemption period, the transaction data would include a portion called the transaction history (TH), which would encompass data dating back to the manufacturer.
- Accepting Saleable Returns: Authorized Trading Partners (ATPs) were only permitted to accept saleable returns if they could be linked to the TI/TS. During the exemption, we started to see the ATPs already enforcing this requirement.
What Should I Have Already Been Doing (and Should Continue to Do After the Exemption Period)?
The EDDS Section of the DSCSA is the final phase of the DSCSA Requirements, and there were several areas that all Pharmacies needed to be compliant with to help ensure the safety of the United States Drug Supply Chain.
Utilizing Authorized Trading Partners
All products ordered by the Pharmacies must be ordered and received from authorized trading partners (wholesalers and manufacturers).
To be authorized:
- A Wholesaler must be licensed in the state where the receiving Pharmacy resides
- A Manufacturer must be registered with the FDA
- ATPs selling controlled substances must maintain DEA Permit
Pharmacies should ensure they receive (from the ATP or the actual license/permitting entity website), maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies upon request.
Post Exemption: No Changes to this requirement.
Receiving Products that are Labeled with Product Identifiers
All products received must contain a product identifier on the manufacturer’s packaging. The product identifier is made up of:
- NDC (or GTIN)
- Serial Number
- Lot Number
- Expiration Date
Post Exemption: No Changes to this requirement.
Receiving and Reviewing Product Tracing Information
All products covered by DSCSA must be accompanied by the 3Ts (transaction information, transaction statement, and transaction history). The 3Ts must be received before or during product delivery and match the information on the physical product. The 3Ts can be in any format (paper, PDF, email), provided the required contents are all present. The requirement that every Pharmacy must maintain and have access to the 3Ts of all DSCSA-covered products for six years remains in place.
Post-Exemption: The 3Ts become 2Ts. The transaction history requirement will sunset, leaving the transaction information and transaction statement to be received in a secure, electronic, and interoperable format.
Conducting Verification
The Pharmacy must review all products and transaction data coming into the Pharmacy to ensure they are not suspect or illegitimate, including counterfeit, diverted, stolen, resulting from a fraudulent transaction, or unfit for distribution. If you believe a product is suspect, you must work with your ATPs (and the manufacturer) to investigate and determine if it is legitimate.
All suspect products should be investigated, and the Pharmacy must notify the FDA and ATPs within 24 hours if they are illegitimate.
Post-Exemption: The product verification and investigation process must include the use of the complete product identifier (NDC, serial number, lot number, and expiration date).
Conclusion
On November 27, 2025, the large dispenser exemption to the EDDS requirements of the DSCSA will no longer apply. Large dispensers must now be fully compliant with all DSCSA obligations, including the use of complete product identifiers, secure electronic transaction data, and proper verification of incoming products. The exemption period provided pharmacies with time to implement these processes, but moving forward, compliance is mandatory. Continuing to work closely with authorized trading partners, maintaining proper documentation, and ensuring all products and transaction data meet DSCSA standards will be critical to meeting regulatory requirements and protecting the supply chain.
The PRS DRUGSUPPLYTrack™ and Advasur 360™ have been combined to create DSCSA 360™, ensuring your Pharmacy has the tools to be compliant today and into the future. If you have any questions about DSCSA, please do not hesitate to call us at 1-800-338-3688. DSCSA 360 was created to collect all transaction data from your Authorized Trading Partners (ATPs) and consolidate it on one online platform, ensuring easy access to all your transaction data. The Program also includes SOPs and employee training to ensure compliance with all DSCSA requirements.
DSCSA service and solution leaders, Advasur and PRS, are ready to support dispensing pharmacies in achieving full compliance with current and future DSCSA requirements with minimal disruption to business workflow operations and patient care.
