Multi-puncture Drug and Fluid Administration

IACUC Policy #056-00, Effective Date: 10/18/2012, Approved 02/18/2026

Overview/Purpose

To define requirements to minimize the likelihood of contamination with multi-puncture drug and fluid administration in animal research, testing, and teaching.

According to the Center for Disease Control, the FDA (21CFR 211.137) and Ohio law (Rule 4729:5-16-02(L)) multi-dose vials are to be dated when they are first opened and discarded within 28 days, unless the manufacturer specifies a different date for the opened vial. This rule involves products that are intended to be administered to human patients and since the use of these products can vary significantly in animal research, it does not apply when multi-use drugs are administered to animals used in research, teaching, and testing. Appropriate handling of drugs is critical to performing sound research. Animal Researchers must ensure the use of multi-use drug vials and fluid bags are managed in a way that maintains sterility and efficacy of injectable compounds.

Use of all injectable compounds must adhere to the IACUC approved policy #045 "The Use of Pharmaceutical and Nonpharmaceutical Grade Compounds in Animals and Labeling Expectations".

Definitions

• Multi-use containers – Vials and bags with a membrane that can be punctured and drawn from multiple times for injection.
• Stock product – A drug in a commercially manufactured pharmaceutical dosage that has been evaluated for safety and efficacy by the FDA. A stock solution serves as an initial base for preparing other solutions. Sterile saline solutions are considered a stock product.
• Compounded drug – For the purposes of this policy, compounding is the process of combining, mixing, diluting, or otherwise altering a drug or bulk drug substance in-house. 'Compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

Requirements

The following procedures must be adhered to when using multi-use containers for injection:

• The surface of the vial stopper or diaphragm must be wiped with 70% alcohol or appropriate disinfectant before each penetration. Exceptions to this requirement may only occur during treatment of food animals, under the direction of the Office of the Attending Veterinarian or OSU farm manager, or according to an IACUC approved Standard Management Plan (SMP).
• A sterile needle and syringe must be used for each vial entry. Exceptions to this requirement may only occur during treatment of food animals, under the direction of the Office of the Attending Veterinarian or OSU farm manager, or according to IACUC approved SMPs.
• If the content of a multi-use drug vial or bag shows evidence of abnormal turbidity, discoloration, particulates, or other changes suggesting compromised sterility, it must not be administered and must be disposed of appropriately.
• Unanticipated injection site reactions suggesting possible contamination should be reported to Office of the Attending Veterinarian or the IACUC as an adverse event.

The following standards apply to injectable stock products:

• Injectable medications will be dated when first punctured, stored according to the manufacturer's recommendations, and disposed of based on the labeled expiration date.
• Once medications are first opened (punctured), they will continue to be used until the medication is gone, the product expires per manufacturer's label date, or visible contamination/discoloration is noted in medication, at which point it will be discarded.
• Injectable medications used in animals will not be discarded solely on first puncture use date, while still within manufacturer label expiration, as long as there is no evidence of safety or efficacy concerns months beyond initial puncture date. This exception is performance-based and will continue to be monitored by the Office of the Attending Veterinarian.
• Extended-release formulations must follow the manufacturer's use by date after puncture. If an end user has a method for validating efficacy of an extended-release product beyond the puncture date, or if published data regarding stability is available, an exception can be requested in the IACUC protocol or facility SMP citing this justification.
• If handled as described above, stock medications that are divided into aliquots using sterile technique, but are not diluted or mixed with other compounds, expire at the same time as the original stock medication. The expiration date must be written on the aliquot along with the drug name and concentration.

The following standards apply to injectable compounded drugs:

• Compounded drugs must be created and labeled according to the IACUC policy #045 "The Use of Pharmaceutical and Nonpharmaceutical Grade Compounds in Animals and Labeling Expectations".
• If handled as described above, compounded drugs expire 30 days from compounding or on the expiration date of the original drug(s), if that is earlier than 30 days. This includes mixtures of ketamine/xylazine. If the solution turns cloudy or discolored or becomes ineffective, it must be discarded prior to the expiration date. If an end user has a method for validating efficacy of a diluted or compounded drug beyond the 30-day standard, or if published data regarding stability is available, an exception from the policy can be requested in the IACUC protocol or facility SMP citing this justification. The 30-day expiration date must be adhered to unless an exception is approved by the IACUC.

The following standards apply to injectable multi-use fluids:

• The open date must be written on the vial or bag when first punctured.
• If handled as described above, multi-use fluid bags or vials (such as 0.9% saline or Lactated Ringer's solution) used for subcutaneous fluid administration or drug dilution must be discarded at the expiration date or within 30 days of puncture, whichever is earlier.

Article ID: 128
Created: February 27, 2026
Last Updated: February 27, 2026

Online URL: https://ohiostateresearch.knowledgebase.co/article/multi-puncture-drug-and-fluid-administration-128.html