On Friday, August 4^th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” This document outlines the process for an authorized trading partner or other stakeholder under the Drug Supply Chain Security Act (“DSCSA,” or “Act”) to request a waiver, exception, or exemption from certain requirements related to product tracing, product identifiers, authorized trading partners, and verification requirements under the DSCSA. It also describes the factors FDA intends to consider when evaluating these requests, making this document particularly useful for businesses looking to maximize their likelihood of success in getting approved for these waivers and exemptions. This document finalizes the draft guidance of the same name issued in May of 2018. (It seems the FDA is cutting it close with this guidance, as it is being issued only four months prior to the effective date of many DSCSA provisions, despite having had 10 years to prepare!)

Who Can Make Requests

The document makes clear that waivers of DSCSA requirements may only be requested by authorized manufacturers, repackagers, wholesale distributors, or dispensers, when compliance would result in an undue economic hardship or when necessary for emergency medical reasons (e.g., a public health emergency declaration). Conversely, only manufacturers or repackagers may request exceptions to the product identifier requirements if a product is packaged in a container that is too small or otherwise unsuitable to accommodate a label bearing all the information required under the Act.

Any interested stakeholder is permitted to request an exemption of the DSCSA requirements.

What to Include in Requests

The FDA clarified a number of items that should be included in every request, regardless of whether it is for a waiver, exception, or exemption. These include:

1. Contact information for the entity contact, as well as of the entity making the request;
2. Description of the activities and/or products (including the NDC number) related to the request;
3. Identification of the specific statutory provision of Section 582 being used as the basis of the request;
4. Description of the measures or controls that will be implemented to ensure security of the drug supply chain while operating under the waiver, exception, or exemption;
5. The requested effective period;
6. Any undue or special circumstances that may be relevant to the request; and
7. A detailed statement describing the reasons justifying the request, along with any pertinent supporting documentation.

Additionally, FDA is requiring requesting entities to affirm the following statement in the request:

I affirm that the information in this statement is correct, and I understand that under 18 U.S.C. 1001 it is illegal to make a materially false, fictitious, or fraudulent statement or representation in this matter within FDA’s jurisdiction.

How to Submit Requests

The FDA strongly suggests submitting all requests electronically, and the guidance document includes a table summarizing where requests and communication associated with the requests should be made. Requests for CBER-reviewed products should be submitted as product correspondence to the appropriate license application (e.g., the BLA, NDA, or ANDA) in the electronic common technical document (eCTD) format. CDER-related product requests should be submitted through the CDER NextGen Portal.

The guidance document also makes clear that recipients of a waiver, exception, or exemption should notify the FDA Center that originally issued it whenever there is a material change in the circumstances forming the basis of the initial request.

Process for Reviewing Requests

The FDA clarified that it will evaluate each request on a case-by-case basis, and will request additional information from the requester as needed. If the request lacks sufficient information to permit a substantive review, FDA may deny the request and may consult with relevant subject matter experts to determine whether the statutory reasons for granting a waiver, exception, or exemption have been satisfied.

In addition, FDA will consider the potential risks posed to the supply chain in granting the request and may deny requests affecting broad segments of the industry or multiple trading partners. These requests may be deferred if FDA determines an FDA-initiated exception, exemption, or other regulatory action would be more appropriate. And in cases where granting a request may affect DSCSA requirements of downstream trading partners, FDA intends to provide corresponding relief to those partners.

The document does not set a specific turnaround time for requests to be approved or denied, though it does indicate FDA intends to process these “in a timely manner.” It does state that FDA intends to include an explanation of the basis for its determination, along with effective dates (if approved). The FDA may post information regarding its determination to its website if it concludes it to be in the best interest of public health. Denials may be reconsidered by FDA if new information is presented justifying a more favorable decision, but FDA recommends making such requests no later than 12 business days after the date of the denial.

If recipients want FDA to reconsider the scope of granted relief, they will be required to include new information necessary to explain the nature of their request and justify a change in FDA’s prior conclusions.

We note that the guidance document does not indicate how FDA plans to handle pending requests for waivers, exceptions, or exemptions, and does not indicate whether it will require compliance with the DSCSA provisions at issue while the requests are pending. As a reminder, many of these DSCSA requirements will become enforceable as of November 23, 2023. Thus, it remains to be seen whether FDA will permit entities requesting a waiver, exception, or exemption to comply with the status quo while it reviews requests that have been pending prior to the November effective date. We do note that FDA wants applicants to include their requested effective period, including the start date of the period, which may permit applicants to provide for retroactive relief. Of course, such relief is only useful if FDA ultimately approves the request, so we are curious to see how FDA decides to handle this issue.

FDA-Initiated Exceptions and Exemptions

In addition to requests initiated by authorized trading partners and other stakeholders, FDA may initiate its own exception or exemption when necessary to address an issue affecting a broad segment of the industry or multiple trading partners, impacts many drug distribution activities, or involves numerous drugs. However, the guidance clarifies that FDA will only use this authority in the context already established by Congress—i.e., an exception may be granted for containers too small for the required labels, and exemptions may be given for public health or other appropriate reasons. These will be communicated in a manner appropriate in the situation, e.g., via targeted letters to affected businesses or via public posting for exceptions/exemptions with broader applicability.

Renewals and Terminations of Approvals

Generally, FDA plans to review approved requests lasting longer than two years biennially to determine if a material change in the circumstances warranting the approval has occurred. More limited approvals may be reviewed upon request by the entity receiving the approval, and such request should include a detailed statement justifying the continuance of the approval along with the desired length of the extension, as well as the affirmation described above.

Finally, if FDA determines a granted request is no longer appropriate, it will terminate the approval after notifying the entity of its decision. For FDA-initiated exceptions and exemptions, it will announce the termination using an appropriate written method.