5.1 Medication errors by users sometimes occur due to difficulty in reading or understanding drug container labels. The objective of this specification is to facilitate correct drug product identification. It does not absolve the user from the duty to read the label and correctly identify the drug product prior to use.AbstractThis specification covers the requirements for labels used for small-volume parenteral drug containers, in particular, the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers. The label shall contain the proprietary name of the drug (optional), established or generic name of the drug (required), amount of drug per unit, and, for liquids, the total volume of the contents-all of which shall be printed in conformity with the type size (as large as possible), orientation (parallel to the long axis of the container), and legibility (provide contrast between the type used for proprietary and established names of the drug and amount of drug per unit, and avoid the use of pastel shades for label background) requirements. Legibility test shall be performed to assess the conformance of the label with the requirements specified.1.1 This specification covers the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers having a volume of 100 mL or less.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
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 201.66.1.1 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.
5.1 This practice is provided to develop and maintain uniformity in practices for use, selection, location, placement, and content of labels on treestands and climbing sticks, particularly with regard to quality assurance and safety.5.2 It is emphasized that the use of these practices will not alter the validity of data determined with specific tests, but provides guidance in the interpretation of test results (valid or invalid) and guidance in the selection of a reasonable general provision in those instances where no standard exists today.1.1 This practice provides guidance for providing user labels on treestands.1.2 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.