ASTM D4267-95

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

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: 09-Sep-1995
• Technical Committee: D10 - Packaging

Relations

• Replaced By: ASTM D4267-95(2001) - Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
• Effective Date: 10-Sep-1995

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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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 4267 – 95
Standard Specification for
Labels for Small-Volume (100 mL or Less) Parenteral Drug
Containers
This standard is issued under the fixed designation D 4267; 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 3.1.4 For liquids, the total volume of the contents shall be
marked in a legible manner.
1.1 This specification covers the orientation, the size of type
3.1.5 Other information as required by regulation and the
used, and the contrast of the copy with the label background on
manufacturer.
immediate drug containers having a volume of 100 mL or less.
3.2 General—Manufacturers are encouraged to use accept-
1.2 The values stated in SI units are to be regarded as the
able abbreviations (for example, HCl for hydrochloride) and
standard. The values given in parentheses are for information
minimize the use or size of other copy (for example, brand of,
only.
USP solution, injection) or unrequired punctuation (such as
2. Terminology mg. versus mg) where label space is critical.
2.1 Definitions:
4. Significance and Use
2.1.1 established name—the designated name or official
4.1 Medication errors by users sometimes occur due to
name (commonly referred to as generic name).
difficulty in reading or understanding drug container labels.
2.1.2 immediate container—that which is in direct contact
2 The objective of this specification is to facilitate correct drug
with the article at all times.
product identification. It does not absolve the user from the
2.1.3 label—a display of written, printed, or graphic matter
3 duty to read the label and correctly identify the drug product
upon the immediate container of any article.
prior to use.
2.1.4 labeling—all labels and other written, printed, or
graphic matter (1) upon any article or any of its containers or
5. Type Size Requirements
wrappers, or (2) accompanying such article
5.1 The type size of the print used for the proprietary name
2.1.5 proprietary name—manufacturer’s trade or brand
or established name of the drug and the numerals indicating the
name.
amount of drug per unit shall be as large as possible.
3. Label Requirements 5.1.1 On containers larger than 2 mL, the vertical height of
capitals and numerals used for these items should be at least
3.1 Contents of Label—The label shall consist of the fol-
2.5-mm (10-point or larger) type.
lowing:
5.1.2 On containers of 2 mL or less, the vertical height of
3.1.1 Proprietary name of drug (optional).
capitals and numerals for these items should be at least 1.5-mm
3.1.2 Established name of drug (required). Printing the
(6-point or larger) type.
active moiety of the established name in accordance with 5.1
5.2 Legibility—In all cases the type used for these items
shall suffice, example, GENTAMICIN Sulfate Inj).
shall be bold enough to satisfy the legibility test (see 8.1).
3.1.3 Amount of drug per unit (for example, milligrams per
millilitre (mg per mL) or quantity of drug per container as
6. Orientation Requirements
appropriate).
6.1 The copy required for proprietary name, or established
name of drug, and amount of drug per unit (3.1.1, 3.1.2, and
This specification is under the jurisdiction of ASTM Committee D-10 on
3.1.3) shall be printed parallel to the long axis of the container.
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer
The left-hand margin of the copy shall start from the base end
Packages.
Current edition approved Sept. 10, 1995. Published November 1995
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