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USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act

Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research released final guidance on "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act".

Section 582 of the FDC Act is introduced to establish a system for tracking and tracing prescription drugs throughout the supply chain to prevent the entry of counterfeit or adulterated drugs into the market.

The goal is to enhance drug safety and protect consumers from potentially harmful or ineffective medicines.

  • A waiver is a formal decision by the U.S. Food and Drug Administration (FDA) to temporarily suspend specific requirements of Section 582 for a particular drug product or entity.

  • Exceptions are narrow circumstances under which certain transactions are not subject to all the requirements of Section 582.

  • Exemptions, on the other hand, are a complete relief from specific requirements of Section 582 for a particular product, entity, or transaction.

The guidance explains how authorized trading partners and other stakeholders should request waivers, exceptions, or exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In addition to the factors FDA intends to consider when evaluating such requests from an authorized trading partner or other stakeholder, and when deciding whether to grant FDA-initiated exceptions and exemptions, FDA intends to consider these factors.

This guidance also outlines the procedure the FDA intends to follow once every two years when reviewing and determining whether to renew a previously approved waiver, exception, or exemption.

For products that are reviewed by CBER, waivers, exceptions, and exemptions are submitted as product correspondences to biologics license applications (BLAs), new drug applications (NDAs), or abbreviated new drug applications (ANDAs), which are submitted in electronic common technical document formats (eCTD).

A request for a waiver, exception, or exemption for products that CDER reviews should be submitted through FDA’s CDER NextGen Portal.

Click this LINK to know more about How to Submit a Request. Also, check out this draft guidance "Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief" which provides recommendations for applications for single-entity antiretroviral (ARV) and ARV fixed-combination (FC) drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1) infection that are intended for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR).


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