ASTM D4774-11

Standard Specification for User Applied Drug Labels in Anesthesiology

ABSTRACT
This specification covers the size, color and pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer. The size and background color requirements of drug labels are presented in details. The type and color requirements of printing for drug labels are presented in details.
SIGNIFICANCE AND USE
The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly identify the drug prior to use.
The user may alternatively use black and white labels rather than these colored labels.
SCOPE
1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer.
1.2 The values stated in SI units are to be regarded as the recommended values. The use of inch-pound system values, not being exact equivalents, may result in nonconformance with the 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.

General Information

• Status: Historical
• Publication Date: 31-Mar-2011
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: D10 - Packaging

Relations

• Replaces: ASTM D4774-06 - Standard Specification for User Applied Drug Labels in Anesthesiology
• Effective Date: 01-Apr-2011
• Replaced By: ASTM D4774-11e1 - Standard Specification for User Applied Drug Labels in Anesthesiology
• Effective Date: 01-Apr-2011

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: D4774 – 11
Standard Specification for
1
User Applied Drug Labels in Anesthesiology
This standard is issued under the fixed designation D4774; 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.
1. Scope D996 Terminology of Packaging and Distribution Environ-
ments
1.1 This specification covers the size, color, pattern, and
2.2 Other Standard:
type used on labels applied to unlabeled syringes filled by the
3
Pantone Matching System
users or their agents to identify the drug content. This speci-
fication is not intended to cover labels applied by the drug
3. Terminology
manufacturer.
3.1 Definitions—General definitions for packaging and dis-
1.2 The values stated in SI units are to be regarded as the
tribution environments are found in Terminology D996.
recommended values. The use of inch-pound system values,
not being exact equivalents, may result in nonconformance
4. Size and Background Color Requirements
with the standard.
4.1 Label Size—The labels shall have a nominal length of
1.3 This standard does not purport to address all of the
25 to 35 mm and a width of 10 to 13 mm.
safety concerns, if any, associated with its use. It is the
4.2 Label Background Color—The colors and patterns
responsibility of the user of this standard to establish appro-
given in Fig. 1 shall be used to distinguish these groups of
priate safety and health practices and determine the applica-
drugs. The background color shall not interfere with the ability
bility of regulatory limitations prior to use.
of the user to write information on the label.
2. Referenced Documents 4.2.1 Antagonists— To denote an antagonist, 1-mm wide
2 diagonal stripes of the agonist color alternating with a 1-mm
2.1 ASTM Standards:
wide white stripe shall be used. The stripes shall run from the
lower left to the upper right at an angle of approximately 45°
1
This specification is under the jurisdiction of ASTM Committee D10 on
to the long axis of the label. The name of an antagonist drug
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer,
shall appear in the center of the label and the striping shall be
Pharmaceutical and Medical Packaging.
omitted behind and below the name (see Fig. 2).
Current edition approved April 1, 2011. Published May 2011. Originally
approved in 1988. Last previous edition approved in 2006 as D4774 – 06. DOI:
10.1520/D4774-11.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ
the ASTM website. 07072–3098.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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D4774 – 11
A
Drugs that do not fit into the above classes should be labeled with black printing on a white background. The examples shown are representative, not restrictive.
B
All printing is to be in black boldtype, with the exception that “succinylcholine’’and “epinephrine’’shall be printed against the background color as reversed plate letters
within a black bar running from edge to edge of the label.
FIG. 1 Standard Background Colors for User Applied Syringe Drug Labels
2

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D4774 – 11
FIG. 2 Label for an Antagonist Drug
5. Significance and Use optional. The initial syllable, or initial two syllables, of the
drugnamemaybeemphasizedbybeingprintedinaboldupper
5.1 The objective of this specification is to facilitate iden-
case type a minimum of 2 points larger than the remainder of
tification of drugs in syringes filled by the user. The use of
the drug name, which is typed in lower case (see Fig. 4).
colorsisintendedonlyasanaidinidentificationofdruggroups
and does not absolve the user from the duty to read the label to
6.1.2 Except for antagonists, the name of the drug and
correctly identify the drug prior to use.
concentration (for example, “mg/mL,” “meq/mL,” or “mcg/
5.2 The user may alternatively use black and white labels
mL”; see Fig. 3 and Fig. 5) should be printed on the upper half
rather than these colored labels.
ofthelabeltoleavespacebelowforentryofthedate,time,and
initials of user).
6. Type and Color Requirements
6.1.3 For induction agents and local anesthetics the concen-
6.1 The type should be as large as possible (minimum
tration of the solution (as “%’’ or “mg/mL’’) and the date of
10-point) using bold type. Upper
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation:D4774–06 Designation: D4774 – 11
Standard Specification for
1
User Applied Drug Labels in Anesthesiology
This standard is issued under the fixed designation D4774; 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.
1. Scope
1.1This specification covers the size, color and pattern, and type used on labels applied to unlabeled syringes filled by the users
or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer.
1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users
or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer.
1.2 The values stated in SI units are to be regarded as the recommended values.The use of inch-pound system values, not being
exact equivalents, may result in nonconformance with the 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D996 Terminology of Packaging and Distribution Environments
2.2 Other Standard:
3
Pantone Matching System
3. Terminology
3.1 Definitions—General definitions for packaging and distribution environments are found in Terminology D996.
4. Size and Background Color Requirements
4.1 Label Size—The labels shall have a nominal length of 25 to 35 mm and a width of 10 to 13 mm.
4.2 Label Background Color—The colors and patterns given in TableFig. 1shall be used to distinguish these groups of drugs.
The background color shall not interfere with the ability of the user to write information on the label.
4.2.1 Antagonists— To denote an antagonist, 1-mm wide diagonal stripes of the agonist color alternating with a 1-mm wide
white stripe shall be used. The stripes shall run from the lower left to the upper right at an angle of approximately 45° to the long
axis of the label. The name of an antagonist drug shall appear in the center of the label and the striping shall be omitted behind
and below the name (see Fig. 1Fig. 2).
1
This specification is under the jurisdiction ofASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer, Pharmaceutical
and Medical Packaging.
Current edition approved Dec. 1, 2006. Published January 2007. Originally approved in 1988. Last previous edition approved in 2000 as D4774–94 (2000). DOI:
10.1520/D4774-06.
Current edition approved April 1, 2011. Published May 2011. Originally approved in 1988. Last previous edition approved in 2006 as D4774 – 06. DOI:
10.1520/D4774-11.
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 Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ 07072–3098.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
D4774 – 11
A
Drugs that do not fit into the above classes should be labeled with black printing on a white background. The examples shown are representative, not restrictive.
B
All printing is to be in black boldtype, with the exception that “succinylcholine’’and “epinephrine’’shall be printed against the background color as reversed plate letters
within a black bar running from edge to edge of the label.
FIG. 1 Standard Background Colors for User Applied Syringe Drug Labels
2

---------------------- Page: 2 ----------------------
D4774 – 11
FIG. 2 Label for an Antagonist Drug
5. Significance and Use
5.1 The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is
intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly
identify the drug prior to use.
5.2The user may alternatively use black and white labels rather than these
...