ASTM D6398-01

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
• Technical Committee: D10 - Packaging

Relations

• Replaced By: ASTM D6398-01e1 - Standard Practice to Enhance Identification of Drug Names on Labels
• Effective Date: 10-Apr-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: D 6398 – 01
Standard Practice to
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.
1. Scope 4. Significance and Use
1.1 This practice covers the shape, size, color, layout, 4.1 Medication errors occur when users are confused by the
typeface, and barcoding on drug container labels intended for similar size, shape, color, typeface, and layout of labels that are
prescription product packaging such as might be used in used for a range of a manufacturer’s drugs with widely
hospitals, pharmacies, and nursing centers. dissimilar actions or potencies. The human visual system uses
1.1.1 This practice does not apply to bulk product shipping shape, size, color, and typeface in the initial recognition of a
containers; in-process transfer containers; or primary, second- labeled drug. (See 9.1-9.3.) The use of this human visual
ary, or tertiary finished goods containers. system has been described in 21 CFR 429.12 for the labeling of
1.2 This practice does not apply to over-the-counter drug insulin. Using the similar label design, color, and typeface
product labeling. throughout a product line makes identifying an individual drug
1.3 This practice does not apply to retail product labeling. more difficult.
4.2 The objective of this practice is to provide guidance for
2. Referenced Documents
the design of drug labels which will enable users to easily
2.1 ASTM Standards:
distinguish between drugs of differing action or potency.
D 996 Terminology of Packaging and Distribution Environ-
2 5. Label Requirements—Panel Shape, Color, and
ments
Contrast
D 4267 Specification for Labels for Small-Volume (100 mL
or Less) Parenteral Drug Containers 5.1 Differing combinations of label shape and color, with
D 4774 Specification for User Applied Drug Labels in differing layouts and text face should be used to provide a
Anesthesiology readily recognizable combination for each group of drugs with
2.2 Other Documents: different actions or potency within a manufacturer’s range of
21 CFR 429.12 Packaging and Labeling of Insulin products. (See Fig. 1.)
21 CFR 201.66 Format and Content Requirements for 5.2 High contrast between the margin of the label and its
Over-the-Counter (OTC) Drug Product Labeling surroundings and between the drug name and background
ISO 3864 Safety Colors and Safety Signs should be provided.
3. Terminology 6. Color
3.1 General definitions for packaging and distribution envi- 6.1 If applicable, manufacturers should use the colors speci-
ronments are in accordance with Terminology D 996. fied for the specific drug groups in accordance with Specifica-
3.2 Definitions of Terms Specific to This Standard: tion D 4774 or refer to ISO 3864 for guidance concerning
3.2.1 shape of label—shape of the label wherein is written safety colors.
the name of the drug, the dosage, and the total contents of the 6.2 Pastel colors should not be used for the identification of
drug in its final form. drugs, since approximately 8 % of the male population have
congenital X-linked “color blindness” which diminishes their
ability to distinguish between pastel shades of red, green, and
beige (see 9.4).
6.3 Color contrasts with bright saturated colors contrasting
This practice is under the jurisdiction of ASTM Committee D10 on Packaging
with the text and the background should be used.
and is the direct responsibility of Subcommittee D10.32 on Consumer, Pharmaceu-
6.3.1 Suggested color contrasts are as follows:
tical and Medical Packaging.
Current edition approved April 10, 2001. Published June 2001.
Annual Book of ASTM Standards, Vol 15.09.
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 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, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
D 6398
FIG. 1 Labels to Distinguish Three Different Concentrations of a Local Anesthetic
Text Background
Black White
Blue Yellow
White Blue
Blue White
7. Copy Legibility
7.1 Label copy shall be in accordance with Section 8 of
Specification D 4267.
7.2 Recognition of the drug name:
7.2.1 Upper and lower case lettering for the drug name
should be used.
7.2.2 The initial capital letter of the drug name may be given
added emphasis in bold type.
7.2.3 To facilitate legibility, extra space should be provided
a
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