Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
D6398-08 – Standard Test Method Technical Guide
ASTM D6398 – 08 (Reapproved 2014), formally titled Standard Practice to Enhance Identification of Drug Names on Labels, provides critical guidelines for the design of prescription drug container labels used in hospitals, pharmacies, and nursing centers. Developed under ASTM Committee D10 on Packaging, its primary objective is to reduce medication errors by enhancing label distinctiveness.
🎯 Scope and Applicability
This practice governs the design of prescription product labels, focusing on shape, size, color, layout, typeface, and barcoding (Section 1.1). It specifically excludes bulk shipping containers, in-process transfer containers, and finished goods containers (Section 1.1.1). Furthermore, it does not apply to over-the-counter (OTC) drug product labeling (Section 1.2) or retail product labeling (Section 1.3). Values stated in SI units are regarded as the standard (Section 1.4).
💡 Regulatory Context: For OTC drug labeling requirements, the standard directs users to 21 CFR 201.66. This practice focuses exclusively on the institutional and prescription environment where look-alike errors are most critical.
| 🟦 Scope Item | 📏 Coverage Specification |
|---|---|
| Target Environment | Prescription packaging in hospitals, pharmacies, nursing centers (1.1) |
| Unit Standard | SI units regarded as standard; inch-pound units for reference (1.4) |
| Exclusion Category 1 | Bulk shipping and finished goods containers (1.1.1) |
| Exclusion Category 2 | Over-the-counter (OTC) drug labeling (1.2) |
🏷️ Label Design Specifications
The core design mandate is found in Section 5. The standard requires that manufacturers use differing combinations of label shape and color, paired with distinct layouts and text faces, for drugs with different actions or potencies (Section 5.1). Additionally, high contrast must be provided both between the margin of the label and its surroundings, and crucially, between the drug name itself and the label background (Section 5.2).
⚠️ Design Pitfall: Section 4.1 explicitly warns that using a similar label design, color, and typeface throughout a product line makes identifying an individual drug more difficult and directly contributes to medication errors.
| 🎯 Label Element | ⚡ Design Requirement |
|---|---|
| Shape & Color | Must differ for
📥 Standard Documents Download |