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RULE §573.45Extra-Label or Off-Label Use of Drugs

(a) Extra-label or off-label use is the actual or intended use of a drug in an animal that is not in accordance with the approved labeling, and includes, but is not limited to:

  (1) compounded drugs;

  (2) use in species not listed in the labeling;

  (3) use for diseases or other conditions not listed in the labeling;

  (4) use at dosage levels, frequencies, or routes of administration other than those stated in the labeling; and

  (5) deviation from the labeled withdrawal time based on these different uses.

(b) A veterinarian must use his or her discretion in the off-label use of drugs for animals. In exercising such discretion, a veterinarian shall consider, to the extent possible:

  (1) whether the off-label use of a drug meets the community standard of humane care and treatment set out in §573.22 of this title (relating to Professional Standard of Care);

  (2) the established safety of the off-label usage;

  (3) the inclusion of a drug in a standard veterinary formulary;

  (4) analyses of off-label usage in the veterinary medical literature and in articles and commentaries written by the veterinarian's peers in the veterinary medical profession;

  (5) information provided by the drug's manufacturer, vendor or the FDA as to whether off-label usage of a drug may present a risk to public health; and

  (6) any other sources of pertinent information.

(c) If anticipated off-label use of a drug is not commonly accepted or used by average veterinarians in the community in which the veterinarian practices or if the off-label usage does not have an established safety record, the veterinarian shall orally or in writing inform the client that the off-label usage is not commonly accepted or used in the veterinary community and that such usage could pose a risk to the health of the animal. Any oral notification shall be recorded in the patient records.

(d) Extra-Label Drug Use in Food-Producing Animals.

  (1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval sufficient to ensure food safety. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.

  (2) A veterinarian shall not prescribe an extra-label drug in a manner that will result in violative food residue, or any residue that may present a risk to public health.

  (3) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.

Source Note: The provisions of this §573.45 adopted to be effective June 14, 2012, 37 TexReg 4229; amended to be effective August 22, 2016, 41 TexReg 6203

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