The Food and Drug Administration (FDA) recently granted an exemption from the medication distribution security requirements of the Drug Supply Chain Security Act (DSCSA)’s Section 582 of the Federal Food, Drug, and Cosmetic (FD&C) Act for specifically eligible trading partners.
The DSCSA is a law that was signed in November, 2013 that was intended to prevent harmful medications from entering the U.S. medication supply chain, identify dangerous medications if they enter the supply chain, and allow for the swift removal of harmful medications from the supply chain, all in an effort to protect patients.
The DSCSA added Section 582 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which serves to protect the integrity of the U.S. medication supply chain by electronically tracking and tracing prescription medications from the manufacturer all the way to the patient to ensure suspect medications do not enter the medication supply chain. To achieve this objective, every physical product will have an identical digital version that will be encoded in the barcode, and it will have its identifier data in a readable format on the label. Every time a medication moves throughout the medication supply chain, each entity must provide, receive, and maintain documentation about the chain of ownership of the medication; prior to the addition of Section 582, that information could be provided electronically or in paper format. Section 582 of the FD&C Act seeks to create a more seamless flow of data between “trading partners.” Specifically:
- Section 581(23) states that a trading partner “means a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or…a third-party logistics provider.”
- Section 581(3) states that a dispenser “means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”
The requirements for electronic or paper documentation were scheduled to go into effect November 2023, but were delayed until November 2024 to allow trading partners an opportunity to become compliant with this change. However, that delay was recently extended further to minimize supply chain disruptions, which can affect patient access to medications. The length of the exemption is based upon the eligible trading partners, specifically:
- Manufacturers and Repackagers: May 27, 2025
- Wholesale Distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
- Dispensers with 25 or fewer full-time employees: November 27, 2026
Per the FDA’s guidance, trading partners requesting an exemption should include the following information in their request:
- A detailed statement describing the reason justifying the exemption request
- Applicable and pertinent documentation
- Any unique circumstances related to the request, medication, or transaction
Helpful, though not required, information to include in the exemption request includes:
- Steps taken to implement Section 582 of the FD&C Act up to this point, and steps that will be taken to be fully compliant
- Number of full-time employees employed by the trading partner
Steps to submit the exemption request to the FDA are as follows:
- Center for Drug Evaluation and Research (CDER)-regulated products: All requests should be submitted through “CDER NextGen” at https://cdernextgenportal.fda.gov/Login_CDER?ec=302&startURL=%2Fs%2F
- Center for Biologics Evaluation and Research (CBER)-regulated products:
- All requests associated with a biologics license application, new drug application, or abbreviated new drug application should be submitted through FDA’s Electronic Submissions Gateway
- All requests not associated with a biologics license application, new drug application, or abbreviated new drug application should be sent to DSCSA-CBER-WEER@fda.hhs.gov.
At Advis, we are keeping abreast of all updates with the DSCSA, including any potential changes to the law and/or effective dates for implementation. Download our free DSCSA Medication Safety and Compliance Considerations Whitepaper. For any questions regarding the DSCSA standards, or to perform a review of your current operations at your institution, please contact Advis through our website or give us a call at 708-478-7030.
