On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution security (“EDDS”) requirements until November 27, 2026.^[1] 

The FDA had previously announced a stabilization period effectively delaying enforcement of these EDDS requirements for all trading partners until November 27, 2024.^[2] Generally, the EDDS requirements are the DSCSA compliance requirements that become effective once trading partners are required to exchange drug product data through an interoperable secure electronic system, as further summarized here. Recently, the FDA widened the exemption from the EDDS requirements to apply to other DSCSA stakeholders, though the length of time for the exemption varies by stakeholder type.

Missing and Incomplete Data Issues

On July 29, 2024, the National Association of Chain Drug Stores (“NACDS”) published a letter to the FDA raising the concern that only 25% to 50% of drug products received by pharmacies had accurate, consistent, and complete EPCIS data.^[3] NACDS asked for staggered start dates for the EDDS requirements based on trading partner type.^[4]  The Healthcare Distribution Alliance (“HDA”) raised similar concerns and endorsed a similar approach in an August 19, 2024 letter to the FDA.^[5]  If incomplete or inaccurate DSCSA data is not received by a trading partner from an upstream trading partner, then the receiving trading partner should not accept or further distribute that drug product. With such a large volume of inaccurate data, the risk to patient access to drugs and shortages would be high.

Following these two letters, both NACDS and HDA engaged in separate listening sessions with the FDA in late September. During those sessions, they reiterated the concerns that they had outlined in their summer letters. The stakeholders noted that while the percentage of inaccurate or missing data had dropped to 25%, that still meant that on any given day a quarter of serialized drug packages had inaccurate data. The stakeholders also raised concerns that the large volume of independent waiver, exception, and exemption (“WEE”) requests that had been submitted to the FDA if granted, would make the November 27, 2024 transition complex and difficult, and emphasized that further stabilization would be necessary to avoid risks to patient drug access and public health.^[6] 

FDA Exemptions with Phased-In Start Dates

Very quickly after these listening sessions, on October 9, 2024, the FDA published exemptions from the EDDS requirements for manufacturers, repackagers, wholesalers, and larger dispensers, using a gradual phased-in approach. More specifically, with regard to the EDDS requirements, manufacturers and repackagers will need to comply starting May 27, 2025, wholesalers will need to comply starting August 27, 2025, and larger dispensers that do not meet the small dispenser exemption requirements will need to comply starting November 27, 2025.^[7]

Though these exemptions should widely apply to all relevant trading partners in each category, reliance upon these exemptions is dependent upon a trading partner having successfully completed data connections with their immediate trading partners or documenting efforts that they have taken to establish data connections, even if such connections are not fully complete.^[8]  These conditions appear to be targeted toward trading partner laggards, who have taken little or no action toward compliance since the original effective EDDS date of November 27, 2023. The FDA also expects that trading partners that rely upon these exemptions will communicate their reliance to their immediate trading partners, along with a mechanism by which trading partners can confirm the applicability of the exemption.^[9] It is unclear exactly what such a mechanism would look like or how it would operate, but the FDA has provided no further clarity.

Dispenser Impacts Prior to November 27, 2025

Even though dispensers, large and small, have more time than other trading partners to comply with the EDDS requirements, they will likely see certain impacts from EDDS as soon as the wholesaler start date arrives on August 27, 2025. For example, presently, saleable returns can be sent by a dispenser to any wholesaler and not necessarily the wholesaler that sold the dispenser the drug. However, as of August 27, 2025, wholesalers will only accept a saleable return if they can associate the product with the transaction information and transaction statement that the wholesaler originally sent with the product. Oddly, large dispensers need not comply with this requirement until November 27, 2025, and small dispensers need not comply until November 27, 2026. As a practical matter, if wholesalers will no longer be authorized to accept products that they did not sell in the first place, then the August 27, 2025, start date would appear to be the de facto start date for large and small dispensers for this requirement, as well. This requirement also has implications in the context of the 340B drug program, where the transaction data is being sent to a 340B covered entity, but the drug product is sent to a 340B contract pharmacy. The contract pharmacy and covered entity will need to coordinate on saleable returns of 340B drugs closely.
 

ENDNOTES

[1] DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Business Dispensers, July 12, 2024, FDA.

[2] https://www.fda.gov/drugs/drug-safety-and-availability/dscsa-compliance-policies-establish-1-year-stabilization-period-implementing-electronic-systems

[3] July 29, 2024 Letter from Steven C. Anderson to Douglas C. Throckmorton, M.D., Leigh Verbois, Ph.D. and Abha Kundi, located at https://downloads.regulations.gov/FDA-2023-N-4806-0021/attachment_1.pdf.

[4] See id.

[5] August 19, 2024 Letter from Chester Davis, Jr. to Douglas C. Throckmorton, M.D., Leigh Verbois, Ph.D. and Abha Kundi, located at https://www.hda.org/getmedia/801aea6d-1b12-4e6e-bfda-a9d8a19b011e/HDA-Comments-FDA-Industry-Readiness-8-19-24.pdf.

[6] Listening Session Report, Partnership for DSCSA Governance.

[7] DSCSA Exemptions from Section 582(g)(1) and Other Requirements of the FD&C Act for Certain Trading Partners, October 9, 2024.

[8] See id.

[9] See id.