You Previously Qualified for a Small Dispenser DSCSA Exemption. Now What?
As welcome as this compliance extension may be for those who qualify, it is critical they understand both their current and future regulatory obligations.
While it seems that every entity throughout the pharmaceutical ecosystem is now filing for a waiver, exception, and exemption (WEE) from the FDA, small dispensers were already granted an exemption in June 2024 from certain requirements of section 582 of the Food, Drug, and Cosmetic Act (FDCA) until November 27, 2026. As welcome as this compliance extension may be for those who qualify, it is critical they understand both their current and future regulatory obligations.1
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Small dispensers—defined as those with 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians—must remain mindful that the exemption applies only to specific elements of the Act related to electronic interoperability. It is expected that small dispensers already be compliant with all other requirements of section 582(d)(4) of the FDCA that were enforceable prior to November 27, 2023.2
What DSCSA-mandated functionality must small dispensers already have in place?
Even as this temporary exemption makes evident the FDA’s sensitivity to the challenges faced by small dispensers in trying to establish electronic interoperability, the Agency still expects these businesses to facilitate a “tighter, closed prescription drug supply chain” and do everything necessary to protect patients from receiving harmful, counterfeit, or illegitimate drugs. Therefore, small dispensers must:
1. Confirm the entities that they do business with are licensed and registered. This mandated confirmation is a central tenant of DSCSA. Requiring that pharmacies engage exclusively with licensed, registered, and reputable trading partners—including manufacturers, re-packagers, wholesale distributors, and third-party logistics providers—is a keystone element to ensuring only legitimate drugs enter the US pharmaceutical supply chain.
Therefore, small dispensers must continuously check to see that any manufacturer or re-packager they do business with has a valid FDA Establishment Registration. This same ongoing diligence must be exercised by dispensers in confirming the licensure of any wholesale drug distributor or third-party logistics provider with whom they do business.
Pharmacy operators should check the appropriate state licensure website to determine if these trading partners have a valid license in the state where they are conducting business. Additionally, they should check the FDA’s annual reporting database to determine if these parties have submitted the annual report required by the Agency.
2. Receive, store and provide comprehensive product tracing documentation. Small dispensers—after the November 2024 enforcement deadline—should only accept prescription drugs from trading partners when the purchased medications are accompanied by a transaction report, referred to as a T3. This designation reflects the 3 informational elements that comprise the report: transaction information, transaction history, and a transaction statement.
This tracing information, documenting in detail the chain of ownership for all medications coming into the pharmacy, must be safely and accessibly stored for 6 years. Conversely, if the pharmacy sells a prescription drug to a trading partner, then the pharmacy must generate the product tracing documentation and provide the information to the purchaser.
It’s also important to note that, currently, it’s allowable for product tracing to use the National Drug Code (NDC) and shipment quantity but, ultimately, all pharmaceutical transiting the supply chain must be traceable by their smallest salable unit.
3. Investigate and properly manage suspect and illegitimate drugs. Strict adherence to the requirements of DSCSA by all members of the pharmaceutical industry promises greater safety for patients, but universal supply chain integrity is not guaranteed. Therefore, dispensers must have a process in place for investigating and physically managing suspect and illegitimate prescription drugs.
Small dispensers must be able to quarantine suspect prescription drugs and investigate if they are counterfeit, diverted, stolen, intentionally adulterated, or otherwise unfit for distribution. If it is determined that the quarantined drugs are, in fact, illegitimate, the pharmacy should work with the supplying trading to ensure the drugs are not distributed nor dispensed.
Lastly, pharmacies must notify the FDA and all involved trading partners within 24 hours after determining a product is illegitimate. Illegitimate product notifications should be made by the dispenser to the FDA through the 3911 platform in CDER NextGen—the Agency’s preferred method—or using a Form FDA 3911 and submitting it via email.
Dispensers must pursue electronic interoperability now.
This summer’s action by the FDA was intended to provide small dispensers additional time to establish needed security and reporting procedures and move effectively toward full implementation of all DSCSA requirements—and those qualifying for the extension would be well served to take full advantage. Waiting to establish electronic inoperability cannot, and should not, wait. The FDA has made it clear that future enforcement of DSCSA will be rigorous.
For some small dispensers, waiting any time at all is not an option. As more and more of their trading partner manufacturers stop supporting sending advanced shipping notices and begin employing serialized data singularly, affected pharmacies will have no choice but move ahead with establishing interoperability.
Greater, exclusive use of the new data standard by manufacturers means some dispensers will find themselves needing to verify receipt of saleable-level product using the serialized data received from the manufacturers well ahead of the November 27, 2026, exemption expiration date.
Yes, there’s some relief for some pharmacies. But it’s temporary. So now is the time for small dispensers to act.
