ASTM D6398-01 - 10.4.2001
 
1. Scope

1.1 This practice covers the shape, size, color, layout, typeface, and barcoding on drug container labels intended for prescription product packaging such as might be used in hospitals, pharmacies, and nursing centers.

1.1.1 This practice does not apply to bulk product shipping containers; in-process transfer containers; or primary, secondary, or tertiary finished goods containers.

1.2 This practice does not apply to over-the-counter drug product labeling.

1.3 This practice does not apply to retail product labeling.

 
2. Referenced Documents

ISO 3864

Safety Colors and Safety Signs Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

D4267-07

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

D996-23

Standard Terminology of Packaging and Distribution Environments

D7298-06(2024)

Standard Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation

D4774-24

Standard Specification for User Applied Drug Labels in Anesthesiology

21 CFR 429.12

Packaging and Labeling of Insulin Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://www.dodssp.daps.mil.

21 CFR 201.66

Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labeling