The Drug Quality and Security Act (DQSA) of 2013 has undergone several amendments in the past decade, and the most recent change provides new guidance from the Federal Food and Drug Administration (FDA). Specifically, it outlines the method for requesting a waiver, exception, or exemption from a drug manufacturer. Understanding these new updates is crucial for producers to avoid potential product liability issues down the road.
What Is the DQSA?
The Drug Quality and Security Act (DQSA) was created in November of 2013. It directed the FDA to enact national standards for the licensure of wholesale distributors and transportation providers. Specifically, Title II of DQSA – also referred to as the Drug Supply Chain Security Act (DSCSA) – is meant to establish a method of tracing products at the package level from manufacturer to sale. This aids the FDA in locating and removing tainted products, as well as in warning the public about risks and recalls.
Product tracing is also invaluable when identifying whether drugs are counterfeit or stolen. The purpose of the latest update to the DQSA is to describe the process an authorized distributor or other party may follow to be released from certain aspects of Title II.
What Does the New Guidance Address?
At the start of August 2023, the FDA released the “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” This document outlines how an authorized trading partner or certain other stakeholders could request an exemption from specific requirements. Initially drafted in 2018, the guidelines under Section 582 address product identifiers and product tracing.
Much like the fast-track program for drug approvals, this update is an attempt to relieve some of the burden on those involved in the distribution process in certain situations. Specifically, eligible parties may request a waiver, exception, or exemption when:
- Complying with Section 582 would cause an undue economic hardship.
- A public health emergency has been declared.
- The product packaging is too small or unsuitable for the required labeling.
By requesting a waiver from the standard requirements for tracing and identification, companies may be able to get necessary medications to the public faster and with less cost. However, these requests can be a double-edged sword if used in a way that could lead to questions about safety or contamination.
How to Make Requests Under the New Guidance
Parties eligible to file for waivers, exemptions, and exceptions under the document include authorized trading partners, such as drug manufacturers, wholesale distributors, dispensers, and repackagers. Those who make a request should include the following information:
- Contact information for the requesting party and their primary contact
- Full description of the activities and products affected by the request
- Specific statute of Section 582 that forms the basis of the request
- Detailed explanation of the controls and methods the party will use to ensure supply chain security for their drug under the requested action
- Time period for the request
- Discussion of special circumstances (such as undue hardship)
- Statement detailing the reasons for the request
- Any supporting documentation
In addition, the contact or representative for the requesting party must include a statement affirming that the information is correct and complete.
Requests should be made electronically, if possible, to speed processing and review. Timing for a request depends on the authorized partner’s estimation of how it will affect public health. To begin the process of asking for a waiver, exception, or exemption, the party should access the FDA’s CDER NextGen Portal, which allows them to track the progress of their request and provide additional required information.
Timing for New Requests
After a request has been granted, it’s important that the recipients notify the FDA promptly if there is a material change in the details of the request or the circumstances around the initial filing. For example, if the public health emergency in a state is lifted, manufacturers are expected to amend their request accordingly.
Requests will be reviewed individually, and recipients may need to provide additional documentation or details. Because the guidance document went into effect in late November 2023, parties should expect a number of requests in addition to theirs, meaning it could take some time for the request to be fully reviewed.
Finally, it is unclear how this new guidance will affect existing requests for waivers, exemptions, or exceptions. Overall, the FDA must weigh the effect of the request against others within the same industry that may involve the same or multiple trading partners. In instances where granting a request could affect downstream parties, the FDA intends to address these effects and provide relief as needed.
Additional Considerations Under This New Guidance
There are other areas stakeholders should include in their decisions about requesting a waiver, exception, or exemption under the document, such as:
Potential FDA-Initiated Exceptions and Exemptions
An important consideration under this new guidance is the possibility that the FDA may initiate exceptions and exemptions on its own if an issue will impact a large portion of an industry. If several trading partners must act to address a public health emergency, for example, the FDA may institute an exception to speed manufacture and logistics for a necessary drug.
These FDA-initiated actions will remain under the guidance established by Congress in the DSCSA. Notification to affected authorized trading partners will be through targeted letters or through public notification when an exemption or exception has wide-ranging effects.
Approval Renewal and Termination
If your request is approved, the FDA plans to review lengthier requests every two years. They will examine whether the approval should be renewed based on current circumstances and whether there has been a material change. The FDA may request additional and updated documentation to issue a renewal. Approved trading partners and stakeholders can also request a limited review when requesting an extension of their approved request.
When the FDA finds that a waiver, exception, or exemption is no longer valid, it will notify the appropriate entities of this decision. It will then establish a date of termination for the request, although parties may provide further documentation in an attempt to receive an extension. If the exception or exemption was FDA-initiated, the agency will again issue a targeted letter or use public methods to notify members of the affected industry at large. To avoid product liability issues down the road, contact our Texas commercial litigation attorneys for legal advice.