Significance and Use
4.1 Medication errors occur when users are confused by the similar size, shape, color, typeface, and layout of labels that are used for a range of a manufacturer’s drugs with widely dissimilar actions or potencies. The human visual system uses shape, size, color, and typeface in the initial recognition of a labeled drug. (See 9.1 – 9.3.) The use of this human visual system has been described in 21 CFR 429.12 for the labeling of insulin. Using the similar label design, color, and typeface throughout a product line makes identifying an individual drug more difficult.
4.2 The objective of this practice is to provide guidance for the design of drug labels which will enable users to easily distinguish between drugs of differing action or potency. See Note 1.
Note 1—For specific requirements for these labels and other features of labels for OTC human drugs, see 21 CFR 201.66.
Scope
1.1 This practice covers the shape, size, color, layout, typeface, and barcoding on drug container labels intended for prescription product packaging such as might be used in hospitals, pharmacies, and nursing centers.
1.1.1 This practice does not apply to bulk product shipping containers; in-process transfer containers; or primary, secondary, or tertiary finished goods containers.
1.2 This practice does not apply to over-the-counter drug product labeling.
1.3 This practice does not apply to retail product labeling.
1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.
