Are you storing your pharmaceutical labels properly?

There are many FDA regulations surrounding pharmaceutical labels; from the issuance of the labels to the way in which they are stored.

Subpart G of CFR 211 is dedicate to Labeling and Packaging. Specifically section 211.125 states “Returned labeling shall be maintained and stored in a manner to prevent mixups and provide proper identification.” Because pharmaceutical labels are used for each different drug product, strength, dosage form, or quantity of contents, it is important to keep such labels organized and limited to authorized personnel. Properly storing your labels helps to prevent mislabelling your drug products.

A company recently received this 483 observation:

….. Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.

Specifically, your label room is not setup in a manner to prevent mix-ups.  Similar labels may be stored next to each other.  Outdated labeling is stored immediately adjacent to current labels.  Labels appear to be stored wherever space is available and storage locations are not identified for each different drug product.

For more observations pertaining to packaging and labeling see Issue 1037 .  It also has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.

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