On May 9, 2018, FDA issued draft guidance on Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FDCA. Section 582 requires trading partners (defined in Section 581(23) of the FDCA) in the pharmaceutical distribution supply chain, with the exception of third-party logistic providers, to comply with certain traceability requirements. The draft guidance provides recommendations for how trading partners and stakeholders should request an exemption from FDA under Section 582. The draft guidance also describes the process for both FDA-initiated Exceptions and Exemptions, as well as FDA review and renewal of waivers, exceptions, and exemptions.

A party seeking a waiver, exception, or exemption from the requirements of 582 should submit a written request to the FDA according to the guidelines established in the draft guidance. All trading partners required to follow Section 582 may request a waiver under section 582(a)(3)(A)(i), but only a manufacture or repackager may request an exemption under 583(A)(3)(A)(ii) and any interested stakeholder may request an exemption under 582(A)(3)(A)(iii). The FDA itself may also initiate exceptions and exemptions under 582(a)(3)(A)(ii) and 582(a)(3)(A)(iii).

Upon the FDA’s determination that the request lacks sufficient information to permit a substantive review, the Agency may deny the request or contact a requesting trade partner or stakeholder to clarify an aspect of the request. If a review is permitted, the FDA intends to determine whether:

  1. A waiver is warranted because complying with the requirements would result in an undue economic burden or is appropriate due to emergency medical reasons. Section 582(a)(3)(A)(i)
  2. An exception is warranted because the product identified in the request is packaged in a container that unable to fit a label with sufficient space to bear the information required. Section 582(a)(3)(A)(ii)
  3. Exempting the product and or transaction identified in the request is appropriate to maintain public health or is otherwise appropriate. Section 582(a)(3)(A)(iii)

Requesting parties will be notified in writing by the FDA of its determination and explanation to grant, deny, or take other appropriate action on the request. If the FDA grants a request that the Agency itself initiated, FDA will communicate the information in writing using an appropriate method for the parties affected. If a request is granted, the recipient is responsible for notifying the FDA within a reasonable amount of time if there is a material change in the circumstances that were the basis for granting the initial request for relief.

The Agency intends to review the granted requests every 2 years and renew such requests as applicable. Recipients of granted requests may submit a renewal request to the FDA Center that originally issued the waiver. The FDA does not intend to accept a renewal request for an FDA-initiated exception or exemption.

Readers are encouraged to read the draft guidance, also available on the FDA’s website.