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FDA Outlines Supply Chain Security Waiver Process

May 9, 2018

The FDA outlined its latest thinking on granting exemptions from drug supply chain security requirements in a new draft guidance. 

In reviewing requests for waivers and exemptions, subject matter experts inside the agency will assess whether a waiver of requirements in Section 582 of the Food, Drug & Cosmetic Act is warranted, either because complying with the requirements would result in undue economic hardship or if the waiver is appropriate for emergency medical reasons.

The agency will notify the requester in writing of its decision and explain its rationale for the determination and it may post information explaining the decision on its website if that is deemed necessary for public health.

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