(a) It is unprofessional conduct for a licensed veterinarian to prescribe, administer, dispense, deliver, or order delivered any prescription drug without first having established a veterinarian/client/patient relationship and determined that such prescription drug is therapeutically indicated for the health and/or well-being of the animal(s). Prescription drugs include all controlled substances in Schedules I - V and legend drugs which bear the federal legends, recognized as such by any law of the State of Texas or of the United States.

(b) It shall be unprofessional and a violation of the rules of professional conduct for a licensed veterinarian to prescribe, provide, obtain, order, administer, possess, dispense, give, or deliver to or for any person prescription drugs that are not necessary or required for the medical care of animals, or where the use or possession of such drugs would promote addiction thereto. Prescription drugs are defined in subsection (a) of this section.

Any licensed veterinarian who prescribes, provides, obtains, orders, administers, possesses, dispenses, gives or delivers scheduled drugs to or for any animal solely for training or racing purposes and not for a medically sound reason has violated the Veterinary Licensing Act.

(a) Subject to subsection (b) of this section, a licensed veterinarian may not prescribe, administer, dispense, deliver, or order delivered, any controlled substance unless the licensed veterinarian is currently registered with the federal Drug Enforcement Administration (DEA) and the Texas Department of Public Safety (DPS) to dispense controlled substances.

(b) The requirement for DEA registration is waived for a licensed veterinarian who is not registered with the DEA to dispense controlled if:

(1) a licensed veterinarian who is registered with the DEA to dispense controlled substances (registrant) supervises or employs the veterinarian who is not registered with the DEA to dispense controlled substances (non-registrant);

(2) the registrant has knowledge that the non-registrant is dispensing and/or administering controlled substances in the usual course of the non-registrant's duties;

(3) the registrant has given written permission for the non-registrant to dispense/administer under the registrant's license; and

(4) the registrant has actual knowledge that the non-registrant is currently registered with the DPS and holds a current DPS controlled substances certificate.

(c) A licensed veterinarian who is not registered with the DEA but is registered with the DPS to dispense controlled substances and holds a current DPS controlled substances certificate may dispense and administer controlled substances, but may not procure, purchase or issue a prescription for a controlled substance.

(a) A veterinarian may only compound drugs for a specific animal or herd with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.

(b) A veterinarian may only compound drugs to treat a specific occurrence of a disease or condition, which threatens the health of the animal or will cause suffering or death if left untreated, that the veterinarian has observed and diagnosed in the particular patient for whom the compounded drugs are prescribed. The scale of compounding must not exceed the established need for specific compounded drugs for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.

(c) Labeling Requirements.

(1) All compounded drugs must bear the labeling information required under §573.40 of this title (relating to Labeling of Medications Dispensed), as well as the following information:

(A) date on which the drug was compounded;

(B) name and strength of medically active ingredients;

(C) identity of treated animals;

(D) withdrawal/withholding times if needed; and

(E) condition or disease to be treated.

(2) In addition to the information listed in paragraph (1) of this subsection, compounded drugs dispensed to the client must also state a date dispensed and an expiration date, which should not exceed the length of the prescribed treatment.

(d) Limitations on Compounded Products.

(1) A veterinarian shall not compound if there is a FDA-approved, commercially available animal or human drug that, when used as labeled or in an extra-label fashion in its available dosage form and concentration, will appropriately treat the patient.

(2) A veterinarian shall only compound products made from FDA-approved commercially available animal or human drugs.

(3) A veterinarian shall not promote and/or distribute compounded drugs that are essentially similar to FDA-approved products.

(4) A veterinarian must ensure the safety and efficacy of a compounded drug, including but not limited to avoiding known drug incompatibilities and inappropriate combinations, and must use a pharmacist to perform drug compounding when the complexity of the compounding exceeds the veterinarian's knowledge, skill, facilities, or available equipment.

(e) Compounding for Food Producing Animals.

(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval for the compounded product sufficient to ensure food safety and may not compound from any drugs prohibited for use in food producing animals. 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 compound if the compounded drug results in violative food residue, or any residue that may present a risk to public health.

(3) Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for compounding.

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

(f) Limitations on Promotion and Sale of Compounded Drugs.

(1) A veterinarian shall not prepare for sale any compounded drugs which employ fanciful names or trade names, colorings or other additives, or that in any way imply that the compounds have some unique effectiveness or composition.

(2) A veterinarian shall not advertise, promote, display, resell , or in any other way market prepared compounded drugs.

(3) A veterinarian shall not offer compounded drugs to other state licensed veterinarians, pharmacists or other commercial entities for resale.

(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 and may not compound from any drugs prohibited for use in food producing animals. 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 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.