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2005 California Business and Professions Code Sections 4196-4199 Article 15. Veterinary Food-Animal Drug Retailers
BUSINESS AND PROFESSIONS CODESECTION 4196-4199
4196. (a) No person shall conduct a veterinary food-animal drug retailer in the State of California unless he or she has obtained a license from the board. A license shall be required for each veterinary food-animal drug retailer owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a veterinary food-animal drug retailer in more than one location. The license shall be renewed annually and shall not be transferable. (b) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be fixed by the board at an amount not to exceed the annual fee for renewal of a license to conduct a veterinary food-animal drug retailer. (c) No person other than a pharmacist, an intern pharmacist, a designated representative, an authorized officer of the law, or a person authorized to prescribe, shall be permitted in that area, place, or premises described in the permit issued by the board pursuant to Section 4041, wherein veterinary food-animal drugs are stored, possessed, or repacked. A pharmacist or designated representative shall be responsible for any individual who enters the veterinary food-animal drug retailer for the purpose of performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the veterinary food-animal drug retailer. (d) The board shall not issue or renew a veterinary food-animal retailer license until the veterinary food-animal drug retailer identifies a designated representative-in-charge and notifies the board in writing of the identity and license number of that designated representative. The designated representative-in-charge shall be responsible for the veterinary food-animal drug retailer's compliance with state and federal laws governing veterinary food-animal drug retailers. Each veterinary food-animal drug retailer shall identify, and notify the board of, a new designated representative-in-charge within 30 days of the date that the prior designated representative-in-charge ceases to be the designated representative-in-charge. A pharmacist may be identified as the designated representative-in-charge. (e) For purposes of this section, designated representative-in-charge means a person granted a designated representative license pursuant to Section 4053, or a registered pharmacist, who is the supervisor or manager of the facility. (f) This section shall become operative on January 1, 2006. 4197. (a) The following minimum standards shall apply to all veterinary food-animal drug retailers licensed by the board: (1) Each retailer shall store veterinary food-animal drugs in a secure, lockable area. (2) Each retailer shall maintain on the premises fixtures and equipment in a clean and orderly condition. The premises shall be dry, well-ventilated, and have adequate lighting. (b) The board may, by regulation, impose any other minimum standards pertaining to the acquisition, storage, and maintenance of veterinary food-animal drugs, or other goods, or to the maintenance or condition of the licensed premises of any veterinary food-animal drug retailer as the board determines are reasonably necessary. (c) When, in the opinion of the board, a high standard of patient safety consistent with good animal safety and care in the case of an animal patient can be provided by the licensure of a veterinary food-animal drug retailer that does not meet all of the requirements for licensure as a veterinary food-animal drug retailer, the board may waive any licensing requirements. 4198. (a) Each veterinary food-animal drug retailer shall have written policies and procedures related to the handling and dispensing of veterinary food-animal drugs by veterinary food-animal drug retailers. These written policies and procedures shall include, but not be limited to, the following: (1) Training of staff. (2) Cleaning, storage, and maintenance of veterinary food-animal drugs and equipment. (3) Recordkeeping requirements. (4) Storage and security requirements. (5) Quality assurance. (b) Each retailer shall prepare and maintain records of training and demonstrated competence for each individual employed or retained by the retailer. These records shall be maintained for three years from and after the last date of employment. (c) Each retailer shall have an ongoing, documented quality assurance program which includes, but is not limited to: (1) Monitoring personnel performance. (2) Storage, maintenance, and dispensing of veterinary food-animal drugs. (d) The records and documents specified in subdivisions (a) and (b) shall be maintained for three years from the date of making. The records and documents in subdivisions (a), (b), and (c) shall be, at all times during business hours, open to inspection by authorized officers of the law. (e) To assure compliance with the requirements of this chapter regarding operations of the veterinary food-animal drug retailer, a consulting pharmacist shall visit the veterinary food-animal drug retailer regularly and at least quarterly. The consulting pharmacist shall be retained either on a volunteer or paid basis to review, approve, and revise the policies and procedures of the veterinary food-animal drug retailer, and assure compliance with California and federal law regarding the labeling, storage, and dispensing of veterinary food-animal drugs. The consulting pharmacist shall certify in writing at least twice a year whether or not the veterinary food-animal drug retailer is operating in compliance with the requirements of this chapter. The most recent of the written certifications shall be submitted with the annual renewal application of a veterinary food-animal drug retailer license. 4199. (a) Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076 and 4077. (b) All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333.
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