21 CFR 211.208 - Drug Product Salvaging

What it says

Drug products subjected to improper storage conditions, including extreme temperatures, humidity, smoke, fire, flood or equipment failure, must not be salvaged and returned to the marketplace unless there is evidence, through appropriate testing, that the product meets all applicable standards and has not been affected by the incident.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision addresses product exposed to an environmental or storage incident specifically, distinct from the broader returned product provision, and carries a higher evidentiary bar given the nature of the exposure.
• Testing to demonstrate the product was unaffected must be specifically relevant to the type of incident - temperature excursion testing addresses a different risk than smoke or flood exposure would.
• Salvaging decisions require documented, product-specific evidence, not a general assumption that packaging protected the product from the incident.

What FDA inspectors look for

• Whether salvaging decisions following a storage or environmental incident are supported by testing specifically relevant to the type of exposure that occurred.
• Whether the full population of product potentially affected by an incident, not just a sample assumed representative, was assessed before any salvaging decision.
• Whether documentation clearly distinguishes salvaged product handled under this provision from routine returned product handled more generally.

Related regulations