Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now

On Friday, August 25^th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and repackagers (“Trading Partners”) to begin complying with the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”).

Specifically, FDA indicated it does not intend to take enforcement action against Trading Partners for their noncompliance with the enhanced drug distribution security requirements until November 27, 2024, thus giving these businesses an extra year to update and implement these new systems and processes.

The “enhanced drug distribution security requirements” refer to DSCSA’s requirement for Trading Partners to:

• Implement secure, interoperable, electronic approaches to exchange transaction information, including the use and verification of package-level product identifiers.
• Create systems and processes to verify products at the package level.
• Have systems and processes in place to promptly respond to government officials with the transaction information in the event of a recall or investigation of suspect or illegitimate products.
• Be able to quickly gather transaction information for products going back to the product’s manufacturing.
• Accept the saleable returns under appropriate conditions by being able to associate the returned product with its transaction information.

These requirements were set to go into effect this year on November 27^th, but FDA has determined that additional time will be necessary to ensure Trading Partners are prepared for these requirements.

The November 2023 deadline was originally included in DSCSA when it was passed into law in 2013. Many Trading Partners are likely already prepared or nearly prepared for the enhanced drug distribution security requirements, and the guidance makes clear Trading Partners should not view this extension as a justification for delaying efforts to enter into compliance with these enhanced measures. As such, the FDA is suggesting that Trading Partners should view this extension as a grace period, rather than a new deadline for compliance. We remind our readers that these guidance documents do not have the same force as law, and therefore FDA could consider any unreasonable delay in preparation for these requirements a valid reason to take enforcement action against such businesses.

To the extent Trading Partners do not believe they are able to comply with these enhanced requirements, they may consider FDA’s recently-released guidance pertaining to Waivers, Exceptions, and Exemptions from these DSCSA requirements issued earlier this month. See Quarles’ coverage of that guidance document here.

If you have any questions pertaining to this final guidance, please contact your local Quarles attorney, or:

• Susan Brichler Trujillo: (602) 229-5318 / susan.trujillo@quarles.com
• Ted Sullivan: (202) 372-9533 / ted.sullivan@quarles.com
• Ben Lockwood: (414) 277-5661 / ben.lockwood@quarles.com