21 CFR 211.122 - Labeling Issuance and Control

What it says

Labels and labeling must be carefully examined before issuance for use in a labeling operation, strict control must be exercised over labels and labeling to prevent mix-ups, and gang printing of labels for different products or different strengths is only permitted with specific distinguishing features and additional controls.

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

What it means in practice

• Label control is a preventive system, catching potential mix-ups before they occur through examination and controlled issuance, rather than a detective system relying on catching errors after the fact.
• Gang printing, printing multiple product labels on a single sheet, is specifically restricted because it is a recognised historical source of mix-up risk, and carries its own additional control expectations.
• This provision covers the labeling operation as a controlled process with defined issuance, use and reconciliation steps, not simply a requirement that the final label be correct.

What FDA inspectors look for

• Whether label issuance is documented and controlled with a clear chain of custody, from storage through to use on a specific batch.
• Whether obsolete or superseded label versions are effectively removed from circulation, not simply marked as outdated while remaining accessible.
• For gang-printed labels specifically, whether the additional distinguishing and control measures the provision expects are actually in place.

Related regulations