| (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.
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| Source Note: The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229; amended to be effective August 22, 2016, 41 TexReg 6203; amended to be effective February 24, 2019, 44 TexReg 707 |
