The US Food and Drug Administration (FDA) has issued draft guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, to specify the criteria for trading partners and stakeholders to request a waiver, exception, or exemption from requirements of the Drug Supply Chain Security Act (DSCSA). The DSCSA was signed into law in November 2013 and outlined steps to build an electronic, interoperable system by 2023 that will identify and trace prescription drugs that are distributed within the US.

The draft guidance says a trading partner or stakeholder (an authorized manufacturer, repackager,

wholesale distributor, or dispenser) seeking a waiver, exception, or exemption from requirements of the DSCSA should submit a written request to the FDA. The draft guidance details what information each request should contain, including the requested effective period of the exemption and a detailed statement of the reasons why the FDA should grant the proposed exemption.

In addition to assisting with the request of waivers, the draft guidance also describes how the FDA intends to review and decide such requests and determine FDA-initiated exceptions and exemptions. “FDA intends to evaluate a request to ensure that it contains sufficient information to permit a substantive review by the Agency,” the draft guidance states. “If FDA determines that a request lacks sufficient information to permit a substantive review, the Agency may deny the request. FDA may also contact a requesting trading partner or stakeholder to clarify an aspect of the request (e.g., the products covered by the request) or to ask for additional information related to the subject of the request.”

During the FDA’s review, the FDA says it intends to consult with subject matter experts within the agency as appropriate and assess, as applicable, whether:

• A waiver identified in the request is (1) warranted because complying with the requirement(s) would result in undue economic hardship or (2) appropriate for emergency medical reasons;
• An exception relating to product identifiers is warranted because the product identified in the request is packaged in a container that is too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with these requirements;
• Exempting the product(s) and/or transaction(s) identified in the request is appropriate to maintain public health or is otherwise appropriate.

Additionally, the draft guidance describes how the FDA intends to biennially review and renew waivers, exceptions, and exemptions. During this review, the agency says it intends to assess whether there has been a material change in circumstances such that the waiver, exception, or exemption is no longer appropriate. The draft guidance says a recipient of a waiver, exception, or exemption should notify the FDA Center that originally issued the waiver, exception or exemption whenever there is a material change in the circumstances that were the basis for granting the initial request for exemption.

Source: FDA