Notwithstanding a statutory deadline of two years after the enactment of the 2013 Drug Supply Chain Security Act (“DSCSA”), FDA has finally published a draft guidance document on waivers, exceptions, and exemptions (“WEE”) from certain requirements of FDCA Section 582. Since late November 2013, the pharmaceutical drug supply chain and FDA have been inching towards implementation of the DSCSA’s multi-layered requirements aimed at enhancing drug supply chain security. Pursuant to Section 582, trading partners in the pharmaceutical distribution supply chain must implement over a period of time certain tracking, tracing, and product identification requirements. Section 582(a)(3) contains a “waiver, exception, and exemption” provision permitting under certain circumstances trading partners to apply to FDA for a WEE from what can be onerous compliance provisions (and FDA can initiate waivers and exemptions on its own). Although lacking in much detail on what types of products or under what conditions trading partners may receive the requested WEEs, at least there is a process in place to attempt to obtain one before the effective date of FDA’s product identification (i.e., serialization) requirements go into effect later this year.
The short draft guidance document describes generally that WEE requests should be in writing (either paper or electronic), and submitted by a trading partner or stakeholder to the product correspondence file associated with the particular application for CBER-regulated products. For all other WEE requests, including CDER-regulated products, such requests should be submitted to CDER as set forth in the draft guidance. (An appendix to the guidance contains FDA contact information for submissions.)
The draft guidance details what a requester should include in each WEE request:
- The name, telephone number, and email address of an individual who FDA can contact about matters relating to the proposed waiver, exception, or exemption
- The identity of the trading partner(s) that would be covered by the proposed waiver, exception, or exemption
- A description of the activities and/or products (including the national drug code number) for which the proposed waiver, exception, or exemption is being sought
- The requested effective period of the waiver, exception, or exemption
- The requirements of FDC Act Section 582 to which the proposed waiver, exception, or exemption would apply
- A detailed statement of the reasons why FDA should grant the proposed waiver, exception, or exemption, including pertinent supporting documentation
FDA will also require the applicant to complete an attestation concerning the veracity of the information pursuant to 18 U. S.C. § 1001. FDA states that it will review the requests, and determine whether the request is sufficient. Along with considering risks to the security of the supply chain, the Agency will review a request with its subject matter experts, and determine as follows:
- Whether a waiver request concerning the Section 582 requirements identified in the request is warranted because compliance with it would result in undue economic hardship or is appropriate with emergency medical reasons.
- Whether a request for an exception to Section 582’s requirements relating to product identifier is warranted because the product package is too small or otherwise unable to accommodate a label with sufficient space to hold all the required information
- Exempting products and/or transactions identified in the request from Section 582 requirements is appropriate to maintain public health “or is otherwise appropriate.”
Furthermore, FDA states that the Agency may initiate its own WEE, or may grant a request of limited duration. To minimize risks to the supply chain, FDA expects to limit the duration of WEEs that it grants. FDA will notify requesters in writing of its determinations and may post such information on its website as well, consistent with laws concerning disclosure of such information.
FDA expects to review or reevaluate requests biennially. It will renew such WEEs “as applicable” and determine whether there has been a material change in circumstances affecting the necessity of the WEE. FDA specifically notes as an example of requesting additional information: a situation where a recipient received an “undue economic hardship” waiver may be asked to submit financial information so FDA may determine whether financial circumstances changed.
With respect to “material changes” after a request is granted (i.e., an increase in package size such that the package would be able to accommodate a product identifier), FDA expects the requestor to notify FDA of the material change, and not await FDA’s biennial review of the request. FDA also describes its proposed process for FDA-initiated exceptions and exemptions, stating it only intends to use these as necessary when an issue affects broad segments of a product market (i.e., a drug container is too small or unable to accommodate a label to bear information required under the DSCSA). These situations will seemingly be rare, as FDA states it will only initiate such exceptions and exceptions when necessary to protect the public health.