SECTIONS 4196-4199 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 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) 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.

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.