Last Updated 16 August 2017
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Pharmaceutical Grade: A drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) for use in humans or animals or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF), or British Pharmacopeia (BP). These standards are used by manufacturers to help ensure the products are of the appropriate chemical purity and quality, in the appropriate solution or compound, to ensure stability, safety, and efficacy. The FDA maintains a database listing approved commercial formulations for human drugs (the Orange Book) and veterinary drugs (the Green Book). For chemicals, a certificate of analysis is usually available upon request.
Non-pharmaceutical Grade: Chemicals or compounds that do not meet or exceed requirements of USP/NF/BP and may have higher levels of impurities that can introduce unwanted variables or toxic effects. Sterile pharmaceutical grade preparations that are reconstituted, diluted, mixed or have other substances added are also considered non-pharmaceutical grade.
Diluent: An agent that dilutes or renders an active compound less potent or irritant. Example – 0.9% sterile saline or sterile water.
Dose: The quantity to be administered at one time, as a specified amount of medication.
Parenteral: Includes intravenous, intraperitoneal, subcutaneous, intradermal, intramuscular, intrathecal, intracranial and intraosseous. Medications are formulated for particular routes and can have decreased efficacy or be toxic if given by another route. The approved routes indicated by the manufacture MUST be used, unless it is stated otherwise in an IACUC approved protocol. Example: Oral tablets cannot be injected
Standards for the Preparation of Injectable Medications
Pharmaceutical Grade drugs should be purchased in sterile, rubber topped vials in the smallest volume available that is appropriate for the intended use.
Calculate the weight of the chemical needed to prepare the desired volume of drug at the necessary concentration. See Appendix A for example pharmaceutical calculations.
Dissolve the measured amount of drug in the appropriate volume of diluent in a sterile container. Whenever possible, use a sterile, pH balanced (6.8 – 7.2), osmotically balanced (approx. 300 mOsm, e.g. 0.9% Sodium Chloride, Phosphate Buffered Saline, Balanced Salt Solution), pyrogen-free diluent. Non-aqueous formulations may require addition information describing assurances for sterility, potential adverse consequences, etc. during IACUC review.
If needed, adjust pH close to physiologic pH (7.4).
Once the drug is fully dissolved and no particulates are visible, while working in a clean bio-safety cabinet or laminar flow hood, filter through a 0.2 ul filter into a sterile glass vial with a crimped sterile rubber closure.
Label the container with the name of the drug, the concentration, and a beyond use date as defined below.
Prior to removal of any medication from the vial, swab the rubber port of the vial with 70% alcohol and allow to dry completely.
Standards for the Storage of Injectable Medications
It is a best practice to open or prepare the smallest quantity of drug required for that day’s work; to discard any remaining drug at the end of the day; or prepare a stock solution that is aliquoted and frozen such that a single day’s requirements can be thawed when needed.
Expiration and beyond use dates:
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 manufacturer recommends a beyond use date for a reconstituted drug, that date is the expiration date.
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, for example subcutaneous fluids, may be utilized for up to 30 days after opening. Label fluid bag or vial with date when first accessed.
If controlled substance formulations must be stored in the refrigerator or frozen, please contact Controlled Substance Monitors (CSemail@example.com) for additional security and storage information.
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Matthews, K. and Taylor, D., Assessment of Sterility in Fluid Bags Maintained For Chronic Use; J. American Association for Laboratory Animal Science, Vol. 50, No. 5, Pages 708-712, September 2001.
Plumb DC. 2005. Plumb's veterinary drug handbook. Stockholm, Wis. Ames, Iowa: PharmaVet ; Distributed by Blackwell Pub.
Office for Animal Care and Use, NIH. Updated February 19, 2009. (http://oacu.od.nih.gov/)