Veterinary Food-animal Drug Retailers - Pharmacy - Business & Professions - CA

Section § 4196

If you want to run a veterinary food-animal drug retail business in California, you need a license from the board, and this must be done for each location separately. These licenses need to be renewed every year and cannot be passed on to someone else. The board might give a temporary license under certain conditions, but it will cost the same or less than a regular renewal. Only certain professionals like pharmacists or those approved by the board can handle the drugs, and there's a need for a responsible person in charge, called a designated representative-in-charge, to make sure all rules are followed. If this person leaves their role, the business has to report it within 30 days and suggest a new person, who the board must approve. This process continues until the board approves a new designated representative-in-charge.

(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) Every veterinary food-animal drug retailer shall be supervised or managed by a designated representative-in-charge. 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. As part of its initial application for a license, and for each renewal, each veterinary food-animal drug retailer shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a veterinary food-animal drug retailer license without identification of an approved designated representative-in-charge for the veterinary food-animal drug retailer.

(e) Every veterinary food-animal drug retailer shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge who ceases to act as the designated representative-in-charge, and shall on the same form propose another designated representative or pharmacist to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the veterinary food-animal drug retailer shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.

(f) 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.

veterinary food-animal drug retailer license requirement temporary license

Section § 4197

This law sets the basic rules for businesses that sell medication for animals used in food production. These businesses must keep drugs in a secure, lockable area and maintain their premises clean and well-equipped. The board that oversees these retailers can create additional rules about how these drugs and stores are maintained and stored. If the board believes that an animal’s safety and care can still be maintained, they may allow some retailers to skip certain licensing requirements if they don't fully meet the usual standards.

(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.

veterinary drugs food-animal drug retailers secure storage

Section § 4198

This law requires veterinary food-animal drug retailers to have formal policies for handling and dispensing drugs. They must cover staff training, drug maintenance, recordkeeping, storage security, and quality assurance. Retailers need to keep training records for employees for three years and maintain a quality assurance program that checks staff performance and drug handling. All records must be available for inspection during business hours. Additionally, a consulting pharmacist must visit these retailers at least every three months to review and approve policies, ensuring compliance with state and federal laws. The pharmacist must certify the retailer's compliance twice a year, with the latest certification submitted during the license renewal process.

(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.

(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.

veterinary food-animal drugs staff training recordkeeping

Section § 4199

This law says that when a veterinary drug store gives out medication for animals we eat, based on a vet's prescription, the label on the drug must follow specific rules. Also, the store needs to keep these prescriptions for at least three years.

(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, 4076.6, 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.

veterinary prescription food-animal drug drug labeling requirements