ASTM D4267-95(2001)

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
• ICS: 55.100 - Bottles. Pots. Jars
• Technical Committee: D10 - Packaging

Relations

• Replaces: ASTM D4267-95 - Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
• Effective Date: 10-Sep-1995
• Replaced By: ASTM D4267-07 - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: D 4267 – 95 (Reapproved 2001)
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 3.1.3 Amount of drug per unit (for example, milligrams per
millilitre (mg per mL) or quantity of drug per container as
1.1 This specification covers the orientation, the size of type
appropriate).
used, and the contrast of the copy with the label background on
3.1.4 For liquids, the total volume of the contents shall be
immediate drug containers having a volume of 100 mLor less.
marked in a legible manner.
1.2 The values stated in SI units are to be regarded as the
3.1.5 Other information as required by regulation and the
standard. The values given in parentheses are for information
manufacturer.
only.
3.2 General—Manufacturers are encouraged to use accept-
2. Terminology
able abbreviations (for example, HCl for hydrochloride) and
minimize the use or size of other copy (for example, brand of,
2.1 Definitions:
USP solution, injection) or unrequired punctuation (such as
2.1.1 established name—the designated name or official
mg. versus mg) where label space is critical.
name (commonly referred to as generic name).
2.1.2 immediate container—that which is in direct contact
4. Significance and Use
with the article at all times.
4.1 Medication errors by users sometimes occur due to
2.1.3 label—a display of written, printed, or graphic matter
difficulty in reading or understanding drug container labels.
upon the immediate container of any article.
The objective of this specification is to facilitate correct drug
2.1.4 labeling—all labels and other written, printed, or
product identification. It does not absolve the user from the
graphic matter (1) upon any article or any of its containers or
duty to read the label and correctly identify the drug product
wrappers, or (2) accompanying such article
prior to use.
2.1.5 proprietary name—manufacturer’s trade or brand
name.
5. Type Size Requirements
3. Label Requirements 5.1 The type size of the print used for the proprietary name
or established name of the drug and the numerals indicating the
3.1 Contents of Label—The label shall consist of the fol-
amount of drug per unit shall be as large as possible.
lowing:
5.1.1 On containers larger than 2 mL, the vertical height of
3.1.1 Proprietary name of drug (optional).
capitals and numerals used for these items should be at least
3.1.2 Established name of drug (required). Printing the
2.5-mm (10-point or larger) type.
active moiety of the established name in accordance with 5.1
5.1.2 On containers of 2 mL or less, the vertical height of
shall suffice, example, GENTAMICIN Sulfate Inj).
capitals and numerals for these items should be at least 1.5-mm
(6-point or larger) type.
This specification is under the jurisdiction of ASTM Committee D10 on
5.2 Legibility—In all cases the type used for these items
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer
shall be bold enough to satisfy the legibility test (see 8.1).
Packages.
Current edition approved Sept. 10, 1995. Published November 1995. Originally
6. Orientation Requirements
published as D 4267 – 83. Last previous edition D 4267 – 89.
United States Pharmacopeia, U.S. Pharmaceutical Convention, Inc. (USPC),
6.1 The copy required for proprietary name, or established
Order Processing Dept., 12601 T
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