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D4267-07 – Standard Test Method Technical Guide
📋 Label Contents and Requirements
ASTM D4267-07 specifies the orientation, type size, and contrast for labels on immediate parenteral drug containers with a volume of 100 mL or less. The label must include the proprietary name (optional), established name (required) with the active moiety printed legibly, drug amount per unit (e.g., mg per mL), total volume for liquids, and other required information. Manufacturers are encouraged to use acceptable abbreviations like HCl for hydrochloride and minimize unrequired punctuation (e.g., mg versus mg.) to optimize space.
💡 Tip: The established name and drug amount should be the most prominent elements, as they are critical for correct drug identification. Use the largest possible type size for these items.
🔤 Type Size Specifications
The type size for the proprietary or established name and the numerals indicating drug amount must be as large as possible. The standard provides minimum requirements based on container volume:
| 🟦 Container Volume | 📏 Minimum Type Size (points) | 📐 Minimum Type Height (mm) |
|---|---|---|
| >2 mL | 10 | 2.5 |
| ≤2 mL | 6 | 1.5 |
These minimums apply to the vertical height of capitals and numerals. Manufacturers should always aim for larger sizes when possible.
📏 Significance and Use
The primary objective of this specification is to reduce medication errors by facilitating correct drug product identification through legible labels. Users are not relieved from the responsibility of reading labels carefully before use.
⚠️ This specification does not absolve users from the duty to read the label and correctly identify the drug product prior to use.
❓ Frequently Asked Questions
🔍 What is the scope of ASTM D4267-07?
This specification covers orientation, type size, and contrast of labels on immediate parenteral drug containers with a volume of 100 mL or less.
💡 What are the required elements on the label?
The label must include the proprietary name (optional), established name (required), drug amount per unit, total volume for liquids, and other regulatory information.
⚡ How are type sizes specified based on container volume?
For containers larger than 2 mL, type height must be at least 2.5 mm (10-point). For containers of 2 mL or less, type height must be at least 1.5 mm (6-point).
📌 Why is this standardization important for patient safety?
It ensures labels are legible and clear, reducing the risk of medication errors and facilitating correct drug identification by users.