At the tail end of August, the FDA released the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (Compliance Policies) Guidance Document, where they announced they did not plan to take action to enforce various aspects of the Enhanced Drug Distribution Security (EDDS) requirements (582(g)) of the DSCSA until 11/27/2024 (See Table 2 below for a list of these EDDS Requirements). This Guidance did not affect the existing requirements currently in place today under the DSCSA Requirements (See Table 1 below for a list of the current requirements).

Is this a delay?

Sort of. Over the past year or so, the FDA has received comments from various trade and professional organizations (including NCPA and APHA) and even Congress about concerns that the industry is not quite ready to fully comply with the EDDS requirements. In the end, these comments all pointed to the supply chain coming to a halt and patients being unable to receive their medication if the data provided electronically as part of EDDS is not 100% accurate.

While the enforcement is delayed, the “FDA generally expects trading partners to have the systems and processes in place to meet these [EDDS] requirements as of November 27, 2023, we [FDA] recognize that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time. (Page 4 of the Guidance)

FDA further states the Guidance “is 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 under section 582(g)(1) [EDDS] of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements. (Page 5 of the Guidance)”

A few days after the release, we saw the FDA refer to this delay of enforcement as a 1-year stabilization period to accommodate additional time that trading partners in the pharmaceutical supply chain may need to adhere to DSCSA requirements for electronic drug tracing at the package level (DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems (8/30/2023)).” They then go on to reiterate in the same piece, “this period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA.”

So, to answer the question, is there a delay? Sort of. There is a delay in enforcing the EDDS section of DSCSA only, but not in the FDA’s expectation of compliance with the EDDS. The FDA knows this EDDS Compliance will have some operational and technical issues, and they see that as an inevitable part of this evolution in the supply chain. It is unknown what other entities (State Boards, PBMs, and others) will do with this expectation of compliance during the credentialing and inspections.

What is in effect and being enforced today?

Pharmacies must be in compliance and prepared for enforcement with the existing DSCSA Requirements, including authorized trading partner, product identifier, product tracing, and verification sections currently in enforcement, and compliance with these elements is still required. These requirements will continue to be included in audits from the FDA, State Boards of Pharmacy, PBMs, and the DEA and are fully covered with the ADVASUR/PRS DSCSA 360™ Program.

Table 1: Requirements remaining in full enforcement currently:

Authorized trading partners – Pharmacies must validate the authorized trading partners
Product identifier – All products the Pharmacy receives must have the product identifier in a  human-readable form and machine-readable 2D barcode. The product identifier is the standardized numerical identifier (NDC and serial number), lot number, and product expiration date.
Product Tracing – The Pharmacy must receive the transaction statement, transaction information, and transaction history from their authorized trading partners before or during delivery for all covered products.
Product Tracing – The Pharmacy must retain the transaction statement, information, and history for six years.
Product Tracing – The Pharmacy may return saleable products to the authorized trading partner they purchased the product.
Product Tracing – The Pharmacy may return nonsaleable returns to the manufacturer or re-packager, to the wholesale distributor from whom such product was purchased, to a returns processor, or to a party acting on behalf of such an organization
Product Tracing – The Pharmacy must be able to provide the transaction data (in an electronic or paper format) to an appropriate representative of an inspecting authority
Verification – The Pharmacy will review all received products to identify suspect products.
Verification – The Pharmacy will quarantine all suspect products.
Verification – The Pharmacy will investigate all potentially suspect products.
Verification – The Pharmacy will notify the FDA within 24 hours of determining a suspected product is illegitimate. The Pharmacy will follow the FDA’s instructions on how to dispossess any illegitimate product. The Pharmacy will also notify any training partners that the Pharmacy received the products from.
Verification – The Pharmacy will respond to the FDA or a trading partner upon notification that a product is illegitimate.

What is in effect on 11/27/2023 and being enforced on 11/27/2024?

As stated above, the FDA expects all trading partners to comply with the EDDS requirements as of 11/27/2023, and they plan to enforce compliance on 11/27/2024. This gap ensures that the Pharmacies’ trading partners have time to fix technical and operational issues and provide continued patient access to their medication.

Table 2: Requirements subject to full enforcement effective 11/27/2024:

The Pharmacy must receive and maintain the transaction information and the transaction statement in a secure, interoperable, electronic manner from their authorized trading partners for all covered products.
The Pharmacy must receive transaction information that includes the product identifier.
The Pharmacy must have a process for verifying products at the package level, including the standardized numerical identifier.
The Pharmacy must be able to provide the transaction data (in an electronic or paper format) to the appropriate Federal or State official within one business day upon request.
The Pharmacy will return saleable returns to the authorized trading partner they purchased the medication from only after the authorized trading partner has identified the original transaction information.

Conclusion

The EDDS requirements are going into effect on 11/27/2023, and the FDA expects Pharmacies to be compliant. This requires Pharmacies to prepare now to ensure they can receive interoperable electronic Transaction Data. The Pharmacy should also amend its existing SOPs (policies and procedures) to match the EDDS requirements. While the FDA and other entities are already enforcing most of DSCSA, the FDA will begin enforcing the EDDS requirements on 11/27/2024.

The PRS DRUGSUPPLYTrack™ and Advasur 360™ have been combined to create DSCSA 360™ to ensure 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 service and solution leaders Advasur and PRS stand ready to serve dispenser pharmacies for full compliance with current and future DSCSA requirements with minimal disruption to business workflow operations and patient care.