Unused labels and labeling materials must be: Response:

Question

Options

• ARecycled within the facility
• BControlled and documented
• CUsed for training purposes
• DDiscarded with general waste

• A
  5% (1)
• B
  82% (18)
• C
  5% (1)
• D
  9% (2)

Explanation

Controlled and documented is correct because in regulated industries (pharmaceuticals, medical devices, food manufacturing), labels are considered controlled materials. Regulatory frameworks such as FDA 21 CFR Part 211 and GMP guidelines require that all unused labels be tracked, reconciled, and their disposition recorded - this prevents label mix-ups, counterfeiting, and unauthorized use, which can pose serious safety risks.

A (Recycled) is wrong because recycling is not a recognized regulatory disposition - recycled labels could re-enter the supply chain and be misused, which defeats the purpose of control.

C (Training) is wrong because repurposing controlled labels for training creates uncontrolled copies that could be used fraudulently; training should use clearly marked specimens, not real controlled labels.

D (Discarded with general waste) is wrong because uncontrolled disposal allows labels to be retrieved and fraudulently applied to unapproved or substandard products - proper destruction must be documented.

Memory tip: Think of unused labels like unused checks in a checkbook - you wouldn't throw them in the trash or recycle them. You'd account for every one and destroy them with a record. Labels = accountability trail.

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