Packaging and Labeling

Label Information: The label on a parenteral solution must provide the physician or other user with all necessary information to ensure safe and proper use of the therapeutic agent. This information is crucial for preventing administration errors and ensuring patient safety.
Label Orientation: The label should be pasted upside-down so that the information can be easily read when the bottle is inverted in a hanging position. This ensures that health care providers can quickly access critical information without needing to reposition the container.
Label Size Requirements: For Large Volume Parenterals (LVPs) and Small Volume Parenterals (SVPs), the size of the label must cover a major portion of the manufacturer's label while leaving only the name of the original solution visible. This practice helps differentiate compounded solutions from commercially available products, thus minimizing confusion.
Key Labeling Requirements for Compounded Sterile Preparations: Specific requirements often include:
- Ingredient List: Name and amounts or concentrations of all ingredients used in the preparation.
- Total Volume: Indication of the total volume of the compounded sterile preparation to ensure accurate dosing.
- Beyond-Use Date: Clearly stated beyond-use date to inform users of the preparation's shelf life and safety.
- Route of Administration: Appropriate details on the route of administration to avoid improper administration methods.
- Storage Conditions: Guidelines on how to properly store the preparation to maintain its potency and safety.
- Additional Safety Information: Any other relevant information for safe use of the preparation, ensuring that healthcare providers have access to all necessary details.
Patient Safety Labeling: This may include additional information to assure proper drug administration, such as:
- Patient's Information: Patient name and identification number to prevent mix-ups and ensure correct administration.
- Patient's Location: Indication of where the patient is located within the healthcare setting for swift access.
- Drug Information: Name and amount of drugs added, as well as the name of the admixture solution, providing clarity on the components of the IV admixture.
- Administration Schedule: Time and date of scheduled administration, ensuring timely dosing for the patient.
- Preparation Date and Time: Time and date when the preparation was made, aiding in compliance and accountability.
- Administration Instructions: Clear instructions on how to administer the preparation safely and effectively.
- Preparation Initials: Initials of the personnel who prepare and check the IV admixture, adding a layer of accountability and traceability.