ASTM D6398-08

Standard Practice to Enhance Identification of Drug Names on Labels

SIGNIFICANCE AND USE
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.
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 the standard. The values given in parentheses are for information only.

General Information

• Status: Historical
• Publication Date: 31-Jan-2008
• ICS: 11.120.10 - Medicaments
• ICS: 35.040 - Information coding
• Technical Committee: D10 - Packaging

Relations

• Replaces: ASTM D6398-01e1 - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Designation:D6398 −08
StandardPractice to
1
Enhance Identification of Drug Names on Labels
This standard is issued under the fixed designation D6398; 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 (´) indicates an editorial change since the last revision or reapproval.
4
1. Scope ISO 3864 Safety Colors and Safety Signs
1.1 This practice covers the shape, size, color, layout,
3. Terminology
typeface, and barcoding on drug container labels intended for
3.1 General definitions for packaging and distribution envi-
prescription product packaging such as might be used in
ronments are in accordance with Terminology D996.
hospitals, pharmacies, and nursing centers.
1.1.1 This practice does not apply to bulk product shipping
3.2 Definitions of Terms Specific to This Standard:
containers; in-process transfer containers; or primary,
3.2.1 shape of label—shape of the label wherein is written
secondary, or tertiary finished goods containers.
the name of the drug, the dosage, and the total contents of the
drug in its final form.
1.2 This practice does not apply to over-the-counter drug
product labeling.
4. Significance and Use
1.3 This practice does not apply to retail product labeling.
4.1 Medication errors occur when users are confused by the
1.4 The values stated in SI units are to be regarded as
similarsize,shape,color,typeface,andlayoutoflabelsthatare
standard. The values given in parentheses are for information
used for a range of a manufacturer’s drugs with widely
only.
dissimilar actions or potencies. The human visual system uses
shape, size, color, and typeface in the initial recognition of a
2. Referenced Documents
labeled drug. (See 9.1-9.3.) The use of this human visual
2
systemhasbeendescribedin21CFR429.12forthelabelingof
2.1 ASTM Standards:
insulin. Using the similar label design, color, and typeface
D996 Terminology of Packaging and Distribution Environ-
throughout a product line makes identifying an individual drug
ments
more difficult.
D4267 Specification for Labels for Small-Volume (100 mL
or Less) Parenteral Drug Containers
4.2 The objective of this practice is to provide guidance for
D4774 Specification for UserApplied Drug Labels inAnes-
the design of drug labels which will enable users to easily
thesiology
distinguish between drugs of differing action or potency. See
D7298 Test Method for Measurement of Comparative Leg-
Note 1.
ibility by Means of Polarizing Filter Instrumentation
NOTE1—Forspecificrequirementsfortheselabelsandotherfeaturesof
2.2 Other Documents:
labels for OTC human drugs, see 21 CFR 201.66.
3
21 CFR 429.12 Packaging and Labeling of Insulin
21 CFR 201.66 Format and Content Requirements for Over- 5. Label Requirements—Panel Shape, Color, and
3
the-Counter (OTC) Drug Product Labeling Contrast
5.1 Differing combinations of label shape and color, with
differing layouts and text face should be used to provide a
1
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 Feb. 1, 2008. Published March 2008. Originally
ϵ1
approved in 2001. Last previous edition approved in 2001 as D6398 – 01 . DOI:
5.2 High contrast between the margin of the label and its
10.1520/D6398-08.
surroundings and between the drug name and background
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
should be provided.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
4
Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http:// Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.dodssp.daps.mil. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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D6398−08
FIG. 1Labels to Distinguish Three Different Concentrations of a Local Anesthetic
6. Color 7.2.3 To facilitate legibility, extra space should be provided
around the drug name to separate the name from the rest of the
6.1 If applicable, manufacturers should use the colors speci-
label copy.
fied for the specific drug groups in accordance with Specifica-
tionD4774orrefertoISO3864forguidanceconcerningsafety 7.3 Where different st
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
e1
Designation:D6398–01 Designation: D 6398 – 08
Standard Practice to
1
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
e NOTE—Figure 1 was corrected editorially in August 2001.
1. Scope
1.1 Thispracticecoverstheshape,size,color,layout,typeface,andbarcodingondrugcontainerlabelsintendedforprescription
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 the standard. The values given in parentheses are for information only.
2. Referenced Documents
2
2.1 ASTM Standards:
D 996 Terminology of Packaging and Distribution Environments
D 4267 Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
D 4774Specification for User Applied Drug Labels in Anesthesiology Specification for User Applied Drug Labels in
Anesthesiology
D 7298 Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
2.2 Other Documents:
3
21 CFR 429.12 Packaging and Labeling of Insulin
3
21 CFR 201.66 Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labeling
4
ISO 3864 Safety Colors and Safety Signs
3. Terminology
3.1 General definitions for packaging and distribution environments are in accordance with Terminology D 996.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 shape of label—shape of the label wherein is written the name of the drug, the dosage, and the total contents of the drug
in its final form.
4. 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.
4.2Theobjectiveofthispracticeistoprovideguidanceforthedesignofdruglabelswhichwillenableuserstoeasilydistinguish
between drugs of differing action or potency.
1
This practice is under the jurisdiction of ASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer, Pharmaceutical
and Medical Packaging.
Current edition approved April 10, 2001. Published June 2001.
e1
Current edition approved Feb. 1, 2008. Published March 2008. Originally approved in 2001. Last previous edition approved in 2001 as D 6398 – 01 .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.19111-5098,
http://www.dodssp.daps.mil.
4
Available from American National Standards Institute, 11 W. 42nd St., 13th Floor, New York, NY 10036.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
D6398–08
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.
5. Label Requirements—Panel Shape, Color, and Contrast
5.1 Differing combinations of label shape and color, with di
...