AAM, HDA Weigh Draft Guidance on DSCSA Waivers

Regulatory NewsRegulatory News | 09 July 2018 |  By 

The Association for Accessible Medicines (AAM) and the Healthcare Distribution Alliance (HDA) sought several specific changes with a recent draft guidance on the waiver, exception and exemption processes under the Drug Supply Chain Security Act (DSCSA).

The draft from May, known as “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act,” is supported by both organizations, though both take issue with particular aspects.

For instance, AAM members (generic drug companies) are looking for the US Food and Drug Administration (FDA) to provide an estimate of the typical length of time it will take to review and determine the status of a request for a waiver, exception or exemption.

“This would indicate to manufacturers how much ‘lead time’ they should plan for in terms of making a request against compliance deadlines,” AAM said.

The group also questions the process for notifying trading partners once a waiver, exemption or exception request is granted by FDA.

“For example, if a manufacturer is granted an exception for a certain product from the serialization (and therefore the enhanced verification) requirement due to a package size that is not appropriate to accommodate the barcode, a notification procedure with proof of the exception would need to be provided to anyone downstream who would own the package,” AAM said. “This would likely include authorized trade partners who do not trade directly with said manufacturer, but who may own the package at any time. If notification is not accomplished, the trade of that package may be stopped for lack of compliance with the serialization requirement. A downstream trade partner could consider such unserialized product as suspect, when it would be perfectly good product.”


HDA, meanwhile, took issue with FDA’s plan to require investigational products to abide by DSCSA rules, saying it does “not believe a product should be subject to DSCSA requirements until it is approved.” The group noted that the supply chain “has long assumed that unapproved drugs (including biologics) being distributed under INDs [investigational new drugs] as part of clinical development would not be covered by the DSCSA at all.”

The group also said that applying a product identifier to an investigational product “could allow for the identification of the product, thereby potentially undermining a clinical trial’s blinding.”



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