To provide a basic introduction on the legal classifications of pharamceuticals and what the basic recording and storage requirements are.
These are drugs can be purchased without a prescription and are not controlled. Examples include acetaminophen which can be purchased at a drug store. Some animal drugs are also classified as over-the-counter and may be purchased at pharmacies or feed stores. An example is amprolium (Corid®), an OTC drug used as a coccidiostat.
These drugs are only available for use in animals by a prescription written by a graduate veterinarian licensed to practice within the state. Human medical doctors cannot prescribe drugs for animals, nor can a veterinarian prescribe for humans. Xylazine, phenothiazine tranquilizers and inhalant anesthetics are not scheduled but are considered prescription!
Controlled /Scheduled Substances
The Drug Enforcement Agency (DEA) has scheduled substances 1 though 5 depending on their potential for abuse.
Schedule
Description
Examples
I
Compounds with a high potential for abuse. Licensing for obtaining schedule I substances requires a special application. These cannot currently be obtained at UAF.
LSD, heroin
II
Includes the main opioids used in wildlife capture work and some of the barbiturates. Note that although carfentanil and etorphine are schedule II, DEA maintains a list of approved individuals who may obtain these potent narcotics. Therefore, having a DEA license for schedule II drugs is not enough to purchase these 2 drugs. Use of a scheduled II drugs necessitates the recording of each and every dose taken from a bottle. At UAF we provide a record sheet with each of the bottles containing a schedule II substance.
pentobarbital, carfentanil, amphetamine, morphine, phencyclidine
III
Contains several barbiturates, narcotics as well as ketamine and Telazol. Anabolic steroids also are within this schedule.
ketamine, Telazol®, some euthanasia solutions containing pentobarbital, buprenorphine, anabolic steroids
IV
Includes the benzodiazepine tranquilizers and some other opioids, primarily the agonist-antagonists.
diazepam, midazolam, butorphanol, chloral hydrate, pentazocine
V
Contains a small number of narcotic drugs. Not of much relevance to use in research animals at UAF
cough medications containing codeine, lomotil
21CFR1300-end contains the regulations governing scheduled substances.
Code of Federal Regulations can be accessed here.
Drug Enforcement Administration Diversion Control Program
- This website provides some excellent information including listings of all controlled substances as well as links to 21CFR1300-end plus online informational documents, brochures and forms.
- If you need to apply for a DEA registration this is the site to obtain forms. Be sure to review University policy first.
- UAA policy is available online
There is a remarkable amount of information located on the labeling of drugs and within the package insert. The package insert is the folded up piece of paper inside the box or affixed to the bottle. Most people throw this away without realizing that it contains a LOT of basic information about the drug.
ALWAYS READ THE LABEL BEFORE USING A DRUG!! Be sure you actually have what you think you have and double check the concentration. Remember that xylazine is available in 2% and 10% formulations. Using the wrong bottle can be disastrous!
All commercially available pharmaceuticals have been licensed for specific purposes in one or more species. All this is clearly identified on the labeling of the drug and in the package insert.
Any deviation from the labeled use of the drug is considered "extra-label" use. This includes administration of the drug at higher doses, with different frequencies, and on different species. Extra-label use of drugs is technically illegal. However, it is commonly done in veterinary medicine, particularly for zoological and wildlife medicine.
Animal Medicinal Drug Classification Act of 1994 was enacted by the 103rd Congress to clarify this issue.
Since the Act itself is not particularly clear, please read Dr Mark Drew's abstract: Update on the Animal Medicinal Drug Classification Act of 1994 Regulations for Wildlife Veterinarians. You need Adobe Acrobat to read this. This is from the 1998 Proceedings of the joint meeting of the American Association of Zoo Veterinarians and the American Association of Wildlife Veterinarians.
For additional information of compliance of various regulations including AMDUCA you should read the paper presented at this same meeting by Drs D. Mulcahy and D. Jessup, Compliance with DEA, FDA, and the Animal Welfare Act: A Challenge for Natural Resource Agency Veterinarians. Keep in mind that the authors are wildlife veterinarians working for agencies. They have presented a useful paper but they have left out the most relevant act covering research on live vertebrates in the wild. If you do not know what it is you better go back to Module 1!
Use of live vertebrates at the University of Alaska Anchorage is under the oversight of the UAA Institutional Animal Care and Use Committee. No use of animals may be undertaken without an approved Assurance of Animal Care form on file with the IACUC. Any administration of pharmaceuticals to animals, regardless of legal classification, must be described in this protocol.
A principal investigator may obtain scheduled pharmaceuticals for use on animals in research or teaching only if the acquisition, storage, and use has been described in an approved protocol. Controlled substances can only be used if the PI has a DEA registration (see University Controlled substances Policy).
Use of pharmaceuticals is limited to IACUC approved experimental or teaching protocols only. Animal medications or treatments must be performed under the supervision of a veterinarian licensed to practice in the state of Alaska. The practice of veterinary medicine by anyone but a licensed veterinary practitioner is a violation of the state practice act.
Each investigator must also maintain accurate records of the use of pharmaceuticals. These records must be made available to the IACUC upon request and, for controlled substances, to the DEA.
All administration of pharmaceuticals to live vertebrates must be recorded in research and animal management records. Pharmaceuticals will not be dispensed except to the PI or his/her designate.
Scheduled II substances require more detailed record keeping. Every vial of a schedule II drug will have a record sheet where every individual dose must be recorded.
Pharmaceuticals must be stored under proper conditions. Scheduled substances can not be purchased in any quantity unless they can be stored in a locked cabinet with access restricted to the principle investigator and the attending veterinarian.
Pharmaceuticals taken into the field must be stored under appropriate conditions with restricted or limited access.