New Rules in Texas Relating to Veterinary Compounding

The Texas State Board of Veterinary Medical Examiners have adopted rules impacting veterinarian compounding in Texas.  A complete set of all the new rules adopted in Texas can be found here.  The following rule was adopted in the Spring of 2012 and became effective June 14, 2012.  The rules are intended to limit veterinarians from compounding significant quantities of drugs in advance of diagnosis for business profit reason without having established a veterinarian-client relationship  for the patient and diagnosing a condition or disease in that patient.  The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs.  The new rule 573.44 provides:

 RULE §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 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 prescribed. The amount of a drug that a veterinarian compounds or orders compounded 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 FDAapproved 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.
Source Note: The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229

Here are the boards comments, which can be found here,  on that new rules:

22 TAC §573.44

The Board adopts new §573.44, regarding Compounding Drugs, which sets out the limited circumstances in which a veterinarian can compound a drug.  The adopted new rule parallels current state and federal regulations on the compounding of drugs by veterinarians while emphasizing issues that are of particular significance for veterinarians, such as the importance of the veterinary-client-patient relationship and the limitations on drugs compounded for foodproducing animals. The adopted rule is structured by subject-area, to clarify the limitations that apply to all compounded products, the limitations on compounding for food producing animals, and the limitations on promotion and sale  of compounded drugs. The new adopted rule strengthens the requirement that a veterinarian must establish and maintain a veterinarian-client
-patient relationship with any animal for which the veterinarian compounds drugs. The Board intends the adopted rule to limit drug compounding by veterinarians only  to treat a specific occurrence of a disease or condition that the veterinarian has diagnosed in a specific patient, and to prohibit veterinarians from compounding on any other basis or in quantities greater than those needed for the treatment of the particular disease occurrence in the specific diagnosed patient.   The Board's concern is that some  veterinarians compound significant quantities of drugs in advance of diagnosis for business profit reasons without first diagnosing the condition or disease the compounded drug is designed to treat in a particular patient with whom the veterinarian has established and maintained a  veterinarian-client-patient relationship. Compounding drugs for
office use is allowed under the rule, but only in amounts that do not exceed the established historical need for specific compounded drugs  for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship. The adopted rule includes more detailed provisions requiring that a veterinarian only compound products made with FDA-approved drugs as active ingredients, and not promote or distribute compounds that are essentially the same as other FDA-approved drugs. The subsection of the adopted rule regarding compounding for food-producing animals parallels existing federal and state law on the subject by requiring that the veterinarian set withdrawal times that are based on scientific
information and note the method used to determine the withdrawal period in the patient records, and ensure that procedures are in place to maintain the identity of any food-producing animal that receives a compounded drug. With regard to labeling requirements for compounded drugs, the new adopted rule eliminates redundancies in the labeling information required for all drugs under §573.44, and requires that the label for  compounded drugs include both name and strength of medically active ingredients. 

RULE §573.45 EXTRA-LABEL OR OFF-LABEL USE OF DRUGS provides:

(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 e 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,

The board's comments about rule 573.45 are as follows.

22 TAC §573.45
The Board adopts new §573.45, regarding Extra-Label or Off-Label Use of Drugs, which sets out the conditions under which a veterinarian may prescribe a drug for an off-label use. The adopted new rule includes compounded drugs explicitly among the list of extra-label or offlabel uses for drugs. Although compounding is commonly considered an off-label use, some licensees have expressed confusion over whether the limitations on extra-label use applied to compounded drugs as well as approved drugs. The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs set out in adopted new §573.44.