Monday, February 22, 2016

A few laws relating to Compounding Drugs, Extra-Label or Off-Label Use of Drugs, Controlled Substances Records Keeping for Drugs to be aware of in Texas

§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 FDAapproved, 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. 18 (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

§573.45 Extra-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 offlabel 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- 19 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

SUBCHAPTER F RECORDS KEEPING §573.50 Controlled Substances Records Keeping for Drugs on Hand Texas veterinarians shall maintain at their place of business records of all scheduled drugs listed in the Texas Controlled Substances Act in their possession. These records shall be maintained for a minimum of five years. A record shall be kept for each scheduled drug. The records shall be complete, contemporaneous, and legible. The record shall contain the following information in addition to the name of the drug: (1) date of acquisition; (2) quantity purchased; (3) date administered or dispensed; (4) quantity administered or dispensed; (5) name of client and patient receiving the drug(s); and (6) total balance on hand of the scheduled drug. Source Note: The provisions of this §573.50 adopted to be effective March 9, 1988, 13 TexReg 1028; amended to be effective July 6, 1990, 15 TexReg 3635; amended to be effective April 6, 2008, 33 TexReg 2695; amended to be effective December 23, 2013, 38 TexReg 9365; amended to be effective November 22, 2015, 40 TexReg 8027 §573.51 Rabies Control (a) Only the vaccinating veterinarian shall issue official rabies vaccination certificates. Each certificate shall contain the information required by 25 TAC §169.29 (relating to Vaccination Requirement) adopted by the Department of State Health Services, including: (1) owner's name, address and telephone number; (2) animal identification species, sex (including neutered if applicable), approximate age (three months to 12 months, 12 months or older), size (pounds), predominant breed, and colors; 20 (3) vaccine used product name, manufacturer, and serial number; (4) date vaccinated; (5) date vaccination expires (re-vaccination due date); (6) rabies tag number if a tag is issued; and (7) veterinarian's signature, or electronic signature, or signature stamp and license number, in accordance with §573.10 of this title (relating to Supervision of Non-Licensed Persons). (b) Each veterinarian that issues a rabies vaccination certificate, or the veterinary practice where the certificate was issued, shall retain a readily retrievable copy of the certificate for a period of not less than five years from the date of issuance. (c) A veterinarian having knowledge of an animal bite to a human shall immediately report the incident to the local health authority. A veterinarian preparing an animal's body for rabies diagnosis shall comply with all requirements of 25 TAC §169.33 (relating to Submission of Specimens for Laboratory Examination) adopted by the Department of State Health Services. (d) A veterinarian who ceases the practice of veterinary medicine shall deliver to the local health authority all duplicate rabies vaccination certificates issued by the veterinarian within the preceding five-year period. A veterinarian who sells or leases his practice to another veterinarian may transfer duplicate rabies certificates with the records of the practice which are transferred to a new owner. Source Note: The provisions of this §573.51 adopted to be effective June 14, 2012, 37 TexReg 4229; amended to be effective December 23, 2013, 38 TexReg 9365

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