FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582)
Posted: 10 May 2018 08:08 PM PDT
Drug Supply Chain Security Act (“DSCSA”), FDA has finally published a draft guidance document on waivers, exceptions, and exemptions (“WEE”) from certain requirements of FDCA Section 582.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.Notwithstanding a statutory deadline of two years after the enactment of the 2013
The short draft guidance document describes generally that WEE requests should be in writing (either paper or electronic), and submitted by a trading partner or stakeholder to the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other WEE requests, including CDER-regulated products, such requests should be submitted to CDER as set forth in the draft guidance.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The draft guidance details what a requester should include in each WEE request:
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.
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