09May2018 FDA issued the draft guidance Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. Section 582 of the FD&C Act describes the requirements for pharmaceutical distribution supply chain partners to enable the traceability and security of certain prescription drugs as they are distributed in the United States. This guidance describes recommendations for how authorized manufacturers, repackagers, wholesale distributors, and dispensers may request a waiver, how manufacturers and repackagers may request exceptions and how any interested stakeholder may request an exemption from the requirements of section 582.
During the review FDA intends to assess whether a waiver is warranted because compliance with section 582 would result in undue economic hardship or is appropriate for emergency medical reasons, an exception to the requirements for product identifiers may be necessary because the product package is too small or otherwise unable to accommodate a label with sufficient space necessary for compliance, and whether granting the request is appropriate to maintain public health or is otherwise appropriate. Waivers, exceptions or exemptions that will cover a broad segment of industry and/or multiple trading partners may be denied or deferred if the Agency determines that an FDA-initiated action would be more appropriate.
FDA intends to review waivers, exceptions and exemptions that are valid for longer than 2 years on a biennial cycle to assess whether there has been a material change in circumstances.