Updated Guidelines on the Preparation, Storage and Expiration of Injectable Medications

August 24, 2017

Icon of laboratory beakers through a magnifying glassThe Guidelines on the Preparation, Storage and Expiration of Injectable Medications were recently updated. This update was largely focused on simplifying previous guideline language to provide clearer expectations for researchers and their laboratory staff in preparing, storing, and properly disposing of both pharmaceutical and non-pharmaceutical grade substances. Special emphasis was also given to the expectations for combined or diluted anesthetics and analgesics.

Critical elements of the revised Guidelines have been outlined below:

  • Best practice dictates that you do the following:
    • Only open or prepare the smallest quantity of drug(s) required for that day’s work;
    • Discard any remaining drug(s) at the end of the day; and/or
    • Prepare a stock solution that is aliquoted and frozen, such that a single day’s requirements can be thawed
      when needed
       
  • When mixing or diluting drugs, store the final preparation in a sterile glass vial with a crimped sterile rubber closure to minimize the risk of contamination
     
  • Label the container with the name of the drug, the concentration, and a beyond use date as defined below:
    • If the pharmaceutical grade drug is purchased as a sterile, ready-to-use formulation, and no diluents or other drugs are added to the container, the expiration date is as listed on the original packaging
    • If the pharmaceutical grade preparation is diluted, mixed, or has other substances added, it is considered non-pharmaceutical grade
      • If the mixed or diluted formulation is intended for therapeutic purposes, e.g. anesthetics, analgesics, or treatment of a clinical illness, and is aseptically prepared, stored, and accessed, it can be used for up to 7 days beyond initial opening
      • If a non-pharmaceutical grade formulation is not intended for therapeutic use, prepare and store as described in your IACUC approved protocol with a maximum expiration date as defined by the manufacturer
         
  • Sterile fluids used directly in patients to provide IV fluid support for therapeutic purposes, e.g. surgery, invasive blood pressure monitoring, or treatment of clinical illness, must be replaced at least every 24 hours. If accessed aseptically, sterile fluids used directly by other routes, such as subcutaneous fluids, may be utilized for up to 30 days after opening. Label fluid bag or vial with date when first accessed

Additional information, including a handout on Pharmaceutical Calculations for Diluting and Combining Drugs, can be found on the full Guidelines on the Preparation, Storage and Expiration of Injectable Medications page. Please take a moment to review this page to ensure that you and your staff are familiar with the new guidelines.

Questions or concerns should be directed to your ULAM Faculty Veterinarian. If you don’t know your faculty veterinarian, send an inquiry to ulam-questions@umich.edu and your question will be routed appropriately.