Active Standard ASTM D4774 | Developed by Subcommittee: D10.32
Book of Standards Volume: 15.10
Historical (view previous versions of standard)
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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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.
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.
FIG. 1 Standard Background Colors for User Applied Syringe Drug Labels
FIG. 2 Label for an Antagonist Drug
FIG. 3 Reversed Plate Printing Used to Identify
"SUCCINYLcholine," "EPINEPHrine," and Beta Blockers,
"ESMOlol," "LABATolol," and "METOprolol"
FIG. 5 Drug Name and Dosage
FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D996 Terminology of Packaging and Distribution Environments
Other StandardPantone Matching System Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ 07072-3098.
ICS Number Code 11.040.20 (Transfusion, Infusion)