ASTM D6398-01e1

Standard Practice to Enhance Identification of Drug Names on Labels

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.

General Information

• Status: Historical
• Publication Date: 09-Apr-2001
• ICS: 11.120.10 - Medicaments
• ICS: 35.040 - Information coding
• Technical Committee: D10 - Packaging

Relations

• Replaces: ASTM D6398-01 - Standard Practice to Enhance Identification of Drug Names on Labels
• Effective Date: 10-Apr-2001
• Replaced By: ASTM D6398-08 - Standard Practice to Enhance Identification of Drug Names on Labels
• Effective Date: 01-Feb-2008

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation: D 6398 – 01
Standard Practice to
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Enhance Identification of Drug Names on Labels
This standard is issued under the fixed designation D 6398; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
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e NOTE—Figure 1 was corrected editorially in August 2001.
1. Scope 3. Terminology
1.1 This practice covers the shape, size, color, layout, 3.1 General definitions for packaging and distribution envi-
typeface, and barcoding on drug container labels intended for ronments are in accordance with Terminology D 996.
prescription product packaging such as might be used in 3.2 Definitions of Terms Specific to This Standard:
hospitals, pharmacies, and nursing centers. 3.2.1 shape of label—shape of the label wherein is written
1.1.1 This practice does not apply to bulk product shipping the name of the drug, the dosage, and the total contents of the
containers; in-process transfer containers; or primary, second- drug in its final form.
ary, or tertiary finished goods containers.
4. Significance and Use
1.2 This practice does not apply to over-the-counter drug
product labeling. 4.1 Medication errors occur when users are confused by the
similarsize,shape,color,typeface,andlayoutoflabelsthatare
1.3 This practice does not apply to retail product labeling.
used for a range of a manufacturer’s drugs with widely
2. Referenced Documents
dissimilar actions or potencies. The human visual system uses
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2.1 ASTM Standards: shape, size, color, and typeface in the initial recognition of a
D 996 Terminology of Packaging and Distribution Environ- labeled drug. (See 9.1-9.3.) The use of this human visual
ments systemhasbeendescribedin21CFR429.12forthelabelingof
D 4267 Specification for Labels for Small-Volume (100 mL insulin. Using the similar label design, color, and typeface
or Less) Parenteral Drug Containers throughout a product line makes identifying an individual drug
D 4774 Specification for User Applied Drug Labels in more difficult.
Anesthesiology 4.2 The objective of this practice is to provide guidance for
2.2 Other Documents: the design of drug labels which will enable users to easily
3 5
21 CFR 429.12 Packaging and Labeling of Insulin distinguish between drugs of differing action or potency.
21 CFR 201.66 Format and Content Requirements for
3 5. Label Requirements—Panel Shape, Color, and
Over-the-Counter (OTC) Drug Product Labeling
4 Contrast
ISO 3864 Safety Colors and Safety Signs
5.1 Differing combinations of label shape and color, with
differing layouts and text face should be used to provide a
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This practice is under the jurisdiction ofASTM Committee D10 on Packaging
readily recognizable combination for each group of drugs with
and is the direct responsibility of Subcommittee D10.32 on Consumer, Pharmaceu-
different actions or potency within a manufacturer’s range of
tical and Medical Packaging.
products. (See Fig. 1.)
Current edition approved April 10, 2001. Published June 2001.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 5.2 High contrast between the margin of the label and its
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
surroundings and between the drug name and background
Standards volume information, refer to the standard’s Document Summary page on
should be provided.
the ASTM website.
3
AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
4 5
Available from American National Standards Institute, 11 W. 42nd St., 13th For specific requirements for these labels and other features of labels for OTC
Floor, New York, NY 10036. human drugs, see 21 CFR 201.66.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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e1
D6398–01
FIG. 1 Labels to Distinguish Three Different Concentrations of a Local Anesthetic
6. Color 7.4 Where groups of drugs have names with similar endings
that may cause confusion, the initial syllable of the name may
6.1 If applicable, manufacturers should use the colors speci-
be printed in 2 or 4-point larger-sized capital letters (see Fig.
fied for the specific drug groups in accordance with Specifica-
2).
tion D 4774 or refer to ISO 3864 for guidance concerning
safety colors.
8. Barcoding
6.2 Pastel colors should not be used for the identification of
drugs, since approximately 8 % of the male population have 8.1 Criticalinformation,forexample,nameofdrug,dosage,
congenital X-linked “color blindness” which diminishes their concentration per unit, or tot
...