453.068 Drugs for animal use.
453.068
453.068 Drugs for animal use.453.068(1)
(1) Prescribing; dispensing.453.068(1)(a)
(a) Extra-label use on animal; prescription required. No person may make extra-label use of a drug on an animal without a prescription or in any manner not authorized by that prescription.453.068(1)(b)
(b) Form of prescription. A prescription shall include all of the following:453.068(1)(b)1.
1. The name and address of the veterinarian and, if the prescription is a written order, the signature of the veterinarian.453.068(1)(b)2.
2. The name and address of the client.453.068(1)(b)3.
3. The species and identity of the patient for which the prescription is issued.453.068(1)(b)4.
4. The name, strength and quantity of the drug prescribed.453.068(1)(b)5.
5. The date on which the prescription is issued.453.068(1)(b)6.
6. The directions for administering the drug.453.068(1)(b)7.
7. If the patient is a food-producing animal, the withdrawal time for the veterinary drug.453.068(1)(b)8.
8. If the prescription authorizes extra-label use, the manner in which the client may use the drug.453.068(1)(b)9.
9. Any cautionary statements required by law.453.068(1)(c)
(c) Prescribing, dispensing and administering requirements for veterinarian. A veterinarian may not do any of the following:453.068(1)(c)1.
1. Prescribe for or dispense to a client a veterinary prescription drug or a drug for extra-label use without personally examining the patient unless a veterinary-client-patient relationship exists between the veterinarian, client and patient and the veterinarian determines that the client has sufficient knowledge to administer the drug properly.453.068(1)(c)2.
2. Prescribe or dispense a veterinary prescription drug to a client unless the veterinarian indicates in the appropriate records described under sub. (3), within 72 hours after the prescription is issued or the drug is dispensed, that the prescription has been issued or that the drug has been dispensed.453.068(1)(c)3.
3. Prescribe a drug to a client for extra-label use on a patient unless all of the following apply:453.068(1)(c)3.a.
a. A veterinary-client-patient relationship exists between the veterinarian, client and patient and the veterinarian has made a careful medical diagnosis of the condition of the patient within the context of that veterinarian-client-patient relationship.453.068(1)(c)3.b.
b. The veterinarian determines that there is no drug that is marketed specifically to treat the patient's diagnosed condition, or determines that all of the drugs that are marketed for that purpose are clinically ineffective.453.068(1)(c)3.c.
c. The veterinarian recommends procedures for the client to follow to ensure that the identity of the patient will be maintained.453.068(1)(c)3.d.
d. If the patient is a food-producing animal, the veterinarian prescribes a sufficient time period for drug withdrawal before the food from the patient may be marketed.453.068(1)(c)4.
4. Transmit a prescription electronically unless the client approves the transmission and the prescription is transmitted to a pharmacist or veterinarian designated by the client.453.068(2)
(2) Labeling. A veterinarian or pharmacist may not dispense a drug that has been prepared, mixed, formulated or packaged by the veterinarian or pharmacist unless the veterinarian or pharmacist affixes to the container in which the drug is dispensed a label containing all of the information specified in sub. (1) (b), except the address of the client. A veterinarian or pharmacist may not dispense a veterinary prescription drug that has been prepackaged by its manufacturer for dispensing unless the veterinarian or pharmacist affixes to the container in which the drug is dispensed a label containing all of the information specified in sub. (1) (b), except the address of the client. A veterinarian or pharmacist may dispense a veterinary over-the-counter drug without affixing any information to the container in which the drug is dispensed if a label that has been affixed to the container by its manufacturer provides adequate information for its use.453.068(3)
(3) Prescription records. A veterinarian shall maintain complete records of each veterinary prescription drug that the veterinarian receives, prescribes, dispenses or administers, and of each prescription issued by the veterinarian that authorizes extra-label use. Records of each veterinary prescription drug shall include the name of each veterinary prescription drug that is received, the name and address of the person from whom the drug is received and the date and quantity received, the name and address of the person to whom the drug is dispensed and the date and quantity dispensed and, if the veterinarian prescribes or administers the drug, the information specified in sub. (1) (b). Records of each prescription authorizing extra-label use shall include the information specified in sub. (1) (b). A veterinarian shall maintain records of each veterinary prescription drug under this subsection for not less than 3 years after the date on which the veterinarian prescribes, dispenses or administers the drug or extra-label use.453.068(4)
(4) Enforcement.453.068(4)(a)
(a) Inspections. Except as provided in par. (b), if the examining board has reason to believe that a person is violating or has violated this section, the examining board, the attorney general or the district attorney of the proper county may do any of the following:453.068(4)(a)1.
1. Inspect the premises on which the person possesses, prescribes, dispenses, labels or administers veterinary drugs.453.068(4)(a)2.
2. Inspect pertinent records, equipment, materials, containers or facilities that are relevant to determining whether the person is violating or has violated this section.453.068(4)(a)3.
3. Collect relevant samples of veterinary drugs.453.068(4)(b)
(b) Records exempt from inspection. The examining board, attorney general or district attorney may not inspect a person's financial, pricing, personnel or sales records under this subsection, other than the records described under sub. (3).453.068 - ANNOT.
History: 1991 a. 306; 1997 a. 27.