SECTIONS 4190-4195 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 4190-4195

4190. (a) Notwithstanding any provision of this chapter, a surgical
clinic, as defined in paragraph (1) of subdivision (b) of Section
1204 of the Health and Safety Code may purchase drugs at wholesale
for administration or dispensing, under the direction of a physician,
to patients registered for care at the clinic, as provided in
subdivision (b). The clinic shall keep records of the kind and
amounts of drugs purchased, administered, and dispensed, and the
records shall be available and maintained for a minimum of three
years for inspection by all properly authorized personnel.
(b) The drug distribution service of a surgical clinic shall be
limited to the use of drugs for administration to the patients of the
surgical clinic and to the dispensing of drugs for the control of
pain and nausea for patients of the clinic. Drugs shall not be
dispensed in an amount greater than that required to meet the patient'
s needs for 72 hours. Drugs for administration shall be those drugs
directly applied, whether by injection, inhalation, ingestion, or any
other means, to the body of a patient for his or her immediate
needs.
(c) No surgical clinic shall operate without a license issued by
the board nor shall it be entitled to the benefits of this section
until it has obtained a license from the board. A separate license
shall be required for each clinic location. A clinic shall notify the
board of any change in the clinic's address on a form furnished by
the board.
(d) Any proposed change in ownership or beneficial interest in the
licensee shall be reported to the board, on a form to be furnished
by the board, at least 30 days prior to the execution of any
agreement to purchase, sell, exchange, gift or otherwise transfer any
ownership or beneficial interest or prior to any transfer of
ownership or beneficial interest, whichever occurs earlier.

4191. (a) Prior to the issuance of a clinic license authorized
under this article, the clinic shall comply with all applicable laws
and regulations of the State Department of Public Health and the
board relating to drug distribution to ensure that inventories,
security procedures, training, protocol development, recordkeeping,
packaging, labeling, dispensing, and patient consultation are carried
out in a manner that is consistent with the promotion and protection
of the health and safety of the public. The policies and procedures
to implement the laws and regulations shall be developed and approved
by the consulting pharmacist, the professional director, and the
clinic administrator.
(b) The dispensing of drugs in a clinic that has received a
license under this article shall be performed only by a physician, a
pharmacist, or other person lawfully authorized to dispense drugs,
and only in compliance with all applicable laws and regulations.

4192. (a) Each clinic that makes an application for a license under
this article shall show evidence that the professional director is
responsible for the safe, orderly, and lawful provision of pharmacy
services. In carrying out the professional director's
responsibilities, a consulting pharmacist shall be retained to
approve the policies and procedures in conjunction with the
professional director and the administrator. In addition, the
consulting pharmacist shall be required to visit the clinic regularly
and at least quarterly. However, nothing in this section shall
prohibit the consulting pharmacist from visiting more than quarterly
to review the application of policies and procedures based on the
agreement of all the parties approving the policies and procedures.
(b) The consulting pharmacist shall certify in writing quarterly
that the clinic is, or is not, operating in compliance with the
requirements of this article. Each completed written certification
shall be kept on file in the clinic for three years and shall include
recommended corrective actions, if appropriate.
(c) For the purposes of this article, "professional director"
means a physician and surgeon acting in his or her capacity as
medical director or a dentist or podiatrist acting in his or her
capacity as a director in a clinic where only dental or podiatric
services are provided.
(d) Licensed clinics shall notify the board within 30 days of any
change in professional director on a form furnished by the board.

4193. No clinic holding a license pursuant to this article shall be
eligible for any professional dispensing fee that may be authorized
under the Medi-Cal program (Chapter 7 (commencing with Section 14000)
of Part 3 of Division 9 of the Welfare and Institutions Code). No
clinic holding a license pursuant to this article shall offer drugs
for sale or shall charge or bill for professional services for the
dispensing or administering of drugs.

4194. No Schedule II controlled substance shall be dispensed in the
clinic. This limitation does not prohibit a physician from
dispensing a Schedule II drug to the extent permitted by subdivision
(b) of Section 11158 of the Health and Safety Code and all other
provisions of law, nor does it prevent the lawful administration of
Schedule II drugs on the premises of the clinic.

4195. The board shall have the authority to inspect a clinic at any
time in order to determine whether a clinic is, or is not, operating
in compliance with this article and all other provisions of the law.