ASTM D4267-07

Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers

ABSTRACT
This 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.
SCOPE
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2007
• ICS: 55.100 - Bottles. Pots. Jars
• Technical Committee: D10 - Packaging

Relations

• Replaces: ASTM D4267-95(2001) - Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
• Effective Date: 01-Oct-2007

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:D4267 −07
StandardSpecification for
Labels for Small-Volume (100 mL or Less) Parenteral Drug
1
Containers
This standard is issued under the fixed designation D4267; 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 3.1.5 proprietary name—manufacturer’s trade or brand
name.
1.1 This specification covers the orientation, the size of type
used, and the contrast of the copy with the label background on
4. Label Requirements
immediate drug containers having a volume of 100 mLor less.
4.1 Contents of Label—The label shall consist of the fol-
1.2 The values stated in SI units are to be regarded as the
lowing:
standard. The values given in parentheses are for information
4.1.1 Proprietary name of drug (optional).
only.
4.1.2 Established name of drug (required). Printing the
active moiety of the established name in accordance with 6.1
2. Referenced Documents
shall suffice, example, GENTAMICIN Sulfate Inj).
2
2.1 ASTM Standards:
4.1.3 Amount of drug per unit (for example, milligrams per
D7298 Test Method for Measurement of Comparative Leg-
millilitre (mg per mL) or quantity of drug per container as
ibility by Means of Polarizing Filter Instrumentation
appropriate).
4.1.4 For liquids, the total volume of the contents shall be
3. Terminology
marked in a legible manner.
3.1 Definitions: 4.1.5 Other information as required by regulation and the
manufacturer.
3.1.1 established name—the designated name or official
name (commonly referred to as generic name).
4.2 General—Manufacturers are encouraged to use accept-
3.1.2 immediate container—that which is in direct contact
able abbreviations (for example, HCl for hydrochloride) and
3
with the article at all times.
minimize the use or size of other copy (for example, brand of,
USP solution, injection) or unrequired punctuation (such as
3.1.3 label—a display of written, printed, or graphic matter
4
mg. versus mg) where label space is critical.
upon the immediate container of any article.
3.1.4 labeling—all labels and other written, printed, or
5. Significance and Use
graphic matter (1) upon any article or any of its containers or
5
wrappers, or (2) accompanying such article 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
1 product identification. It does not absolve the user from the
This specification is under the jurisdiction of ASTM Committee D10 on
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer, duty to read the label and correctly identify the drug product
Pharmaceutical, Medical, and Child Resistant Packaging.
prior to use.
Current edition approved Oct. 1, 2007. Published October 2007. Originally
approved in 1983. Last previous edition approved in 2001 as D4267 – 95 (2001).
6. Type Size Requirements
DOI: 10.1520/D4267-07.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
6.1 The type size of the print used for the proprietary name
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on or established name of the drug and the numerals indicating the
the ASTM website.
amount of drug per unit shall be as large as possible.
3
United States Pharmacopeia, U.S. Pharmaceutical Convention, Inc. (USPC),
6.1.1 On containers larger than 2 mL, the vertical height of
Order Processing Dept., 12601 Twinbrook Parkway, Rockville, MD, 20852, USP
capitals and numerals used for these items should be at least
23/NF 18, 1995, p. 10.
4
Federal Food, Drug, and Cosmetic Act, Section 201(k); and USP 23/NF 18,
2.5-mm (10-point or larger) type.
1995, p. 11. Available from U.S. Government Printing Office, Washington, DC
6.1.2 On containers of 2 mL or less, the vertical height of
20402.
5
capitals and numerals for these items should be at least 1.5-mm
Federal Food, Drug, and Cosmetic Act, Section 201(m); and USP 23/NF 18,
1995, p. 11. (6-point or larger) type.
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D4267−07
6.2 Legibility—In all cases the type used for these items
shall be bold enough to satisfy the legibility test (see 9.1).
7. Orientation Requirements
FIG. 2Copy Printed From Needle End of Syringe
7.1 The copy required for proprietary name, or established
name of drug, and amount of drug per unit (4.1.1, 4.1.2, and
4.1.3) shall be printed parallel to the long axis
...