Section 573.44 - Compounding Drugs(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 prescribe, administer, or dispense compounded 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 intended. The amount of a drug that a veterinarian compounds or orders compounded for dispensing or office use 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 or order a drug compounded 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 or order compounded products with FDA-approved commercially available animal or human drugs as the active ingredients.(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 or order a drug compounded 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.22 Tex. Admin. Code § 573.44
The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229; Amended by Texas Register, Volume 41, Number 34, August 19, 2016, TexReg 6204, eff. 8/22/2016; Amended by Texas Register, Volume 44, Number 07, February 15, 2019, TexReg 707, eff. 2/24/2019