Definitions

1.     Pharmaceutical Grade – A compound that is approved by the Food and Drug Administration (FDA) or for which United States Pharmacopeia/National Formulary has established a chemical purity standard and for which such standard is stated on the label. A certificate of analysis is usually available upon request.

2.     Non-pharmaceutical Grade – Any drug not meeting the above criteria. These compounds may have higher levels of impurities and can introduce unwanted variables or toxic effects. An example would be chemicals that are obtained through SIGMA. If a powder will be used and is scientifically justified, a description of sterile preparation for parenteral administration should be included in your IACUC Application for Vertebrate Animal Use (AVAU) protocol.

I: Background and Purpose

The use of pharmaceutical-grade substances in research animals ensures that those administered meet established and documentable purity and composition standards. This is an important measure to help ensure research animal health and welfare.

II: Related Policies

Policy#: 529-254 REQUIREMENTS FOR ANIMAL USERS: Expired Medical Material

529-268 Guidelines for Compounding and Secondary Container Use for Injectable Drugs

III: Policy

This policy applies to substances incorporated into the animal other than through voluntary ingestion (eating).  This includes, but is not limited to, any substance injected (i.e. intravenous, intraperitoneal, intramuscular and subcutaneous), introduced via gavage, or placed into any surgical opening.

1.  Investigators are expected to use pharmaceutical-grade medications whenever they are available, even in acute procedures.

2.  Non-pharmaceutical-grade- grade chemical compounds should only be used in live vertebrate animals after specific review and approval by the IACUC for reasons such as scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product. Note: Cost savings alone is not an adequate justification for using non-pharmaceutical-grade compounds in live vertebrate animals.
 
3.  The protocol/amendment will include details of the preparation of the compound, including the use of the highest-grade equivalent, chemical reagent, aseptic formulation, and use of a non-toxic vehicle, as appropriate for the proposed route of administration.
 
4.  This policy pertains to all components-active and inactive-contained in preparations to be administered to animals. Therefore, the vehicle used to facilitate the administration of a compound is just as important to consider as the active compound itself during preparation and must be pharmaceutical-grade.

5.  Dilutions and Combinations
Administering anesthetics, analgesics, or other drugs to very large or very small animals may necessitate dilution or adulteration of drugs that will cause them to be classified as non-pharmaceutical grade compounds. The combination of drugs, such as ketamine and xylazine, also qualifies as compounding, with the final solution being classified as non-pharmaceutical grade. The use of such agents for routine veterinary purposes, such as anesthesia, analgesia, or euthanasia, can be approved without scientific justification.

6.  Modifying non-pharmaceutical grade substances, including the combination of anesthetic/analgesic drugs, must be performed sterilely. Once modified, the expiration date must be clearly indicated. As a rule of thumb, the modified drug must not be used after 1 month and cannot exceed the expiration date of any of the individual components.  Solutions must be inspected visually for clarity before each use.

Approved 4/6/15, 9/11/2023