Updated July 2013
The NCSU IACUC follows both the NIH’s Guide for Care and Use of Laboratory Animals and USDA’s Policy on the Use of Non-Pharmaceutical Grade Compounds (see section 3.2) in research and teaching activities involving live vertebrate animals
NCSU IACUC Policy Statement (adapted from USDA Policy): Investigators are expected to use pharmaceutical-grade medications whenever they are available, even in acute procedures. Non-pharmaceutical- 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. Cost savings alone is not an adequate justification for using non-pharmaceutical-grade compounds in live vertebrate animals.
- Pharmaceutical Grade – A compound that is approved by the FDA or for which a chemical purity standard has been established by USP/NF or BP and for which such standard is stated on the label. A certificate of analysis is usually available upon request.
- Non-pharmaceutical Grade – Any drug that does not meet 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.
Dilutions and Combinations
Oftentimes 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 NCSU IACUC recognizes that such compounds may be preferable in certain circumstances and approves the use of the following agents without scientific justification for routine anesthesia, analgesia, or euthanasia:
- Anesthetic cocktails utilizing pharmaceutical grade compounds such as:
- Tiletamine/ketamine/xylazine combination for large swine
- Rodent “cocktails” that contain mixtures of ketamine, xylazine/dexmedetomidine, and/or acepromazine
- Other cocktail combinations that are considered standard veterinary practice and listed as a combination on your approved IACUC protocol.
- Cocktail combinations consistent with standard veterinary care used for veterinary care procedures
- Dilution of the analgesics such as:
- Carprofen, buprenorphine, and meloxicam or other analgesics with USP grade saline or water prior to administration to small rodents
- Dilution of sodium pentobarbital euthanasia solutions with USP grade saline or water prior to administration to small rodents
- Other dilutions consistent with standard veterinary care
In all of the above instances the adulteration of such substances must be performed sterilely and in accordance with appropriate dosages as dictated by standard of care. Once adulterated, expiration date must be clearly indicated and must account for stability in the altered conditions. As a rule of thumb, the adulterated drug must not be used after 3 months of initial dilution or sooner if indicated by the unadulterated formulation. Please note, scientific justification is not required only if the diluted or adulterated pharmaceutical is pharmaceutical grade. If any component of the adulterated or diluted product is not pharmaceutical grade, scientific justification is necessary for use of that product.