FDA New Draft Guidance Review by Lachman
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FDA New Draft Guidance Review by Lachman

On Tuesday, the US Food and Drug Administration (FDA) published new draft guidance to help trading partners in the pharmaceutical supply chain request waivers or exemptions from requirements in the Drug Supply Chain and Security Act (DSCSA).

The DSCSA, which was signed into law in 2013, aims to build a system by 2023 to identify and trace pharmaceuticals as they are distributed through the US supply chain, including the requirement of placing unique identifiers on medicine packaging that can be scanned and verified.

The eight-page draft guidance provides guidance detailing circumstance in which a trading partner in the supply chain can request an exception, exemption or waiver from those requirements.  The law says the HHS security may grant such waivers or exemptions from certain DSCSA requirements if they “would result in an undue economic hardship or for emergency medical reasons, including a publish health emergency declaration pursuant to section 319 of the Public Health Service Act.”

Aside from economic hardship and emergency medical reasons for a waiver, the FDA guidance also notes that an exemption might be granted for a product packaged in a container that is too small to accommodate a label with a product identifier.Regardless, all requests made to the FDA will be weighed against the security of the drug supply chain.

For an informative overview of the new draft guidance, read this review by our friends at LachMan Consultants.  

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