2009 California Business and Professions Code - Section 4180-4186 :: Article 13. Nonprofit Or Free Clinics

4180.  (a) (1) Notwithstanding any provision of this chapter, any of
the following clinics may purchase drugs at wholesale for
administration or dispensing, under the direction of a physician and
surgeon, to patients registered for care at the clinic:
   (A) A licensed nonprofit community clinic or free clinic as
defined in paragraph (1) of subdivision (a) of Section 1204 of the
Health and Safety Code.
   (B) A primary care clinic owned or operated by a county as
referred to in subdivision (b) of Section 1206 of the Health and
Safety Code.
   (C) A clinic operated by a federally recognized Indian tribe or
tribal organization as referred to in subdivision (c) of Section 1206
of the Health and Safety Code.
   (D) A clinic operated by a primary care community or free clinic,
operated on separate premises from a licensed clinic, and that is
open no more than 20 hours per week as referred to in subdivision (h)
of Section 1206 of the Health and Safety Code.
   (E) A student health center clinic operated by a public
institution of higher education as referred to in subdivision (j) of
Section 1206 of the Health and Safety Code.
   (F) A nonprofit multispecialty clinic as referred to in
subdivision (l) of Section 1206 of the Health and Safety Code.
   (2) 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) No clinic shall 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.

4181.  (a) Prior to the issuance of a clinic license authorized
under Section 4180, the clinic shall comply with all applicable laws
and regulations of the State Department of Health Services relating
to the drug distribution service to ensure that inventories, security
procedures, training, protocol development, recordkeeping,
packaging, labeling, dispensing, and patient consultation occur 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 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.

4182.  (a) Each clinic that makes an application for a license under
Section 4180 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.

4183.  No clinic dispensing drugs 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).

4184.  No Schedule II controlled substance shall be dispensed by the
clinic. This limitation shall not be construed to prohibit a
physician dispensing a Schedule II drug to the extent permitted by
law.

4185.  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.

4186.  (a) Automated drug delivery systems, as defined in
subdivision (h), may be located in any clinic licensed by the board
pursuant to Section 4180. If an automated drug delivery system is
located in a clinic, the clinic shall develop and implement written
policies and procedures to ensure safety, accuracy, accountability,
security, patient confidentiality, and maintenance of the quality,
potency, and purity of drugs. All policies and procedures shall be
maintained at the location where the automated drug system is being
used.
   (b) Drugs shall be removed from the automated drug delivery system
only upon authorization by a pharmacist after the pharmacist has
reviewed the prescription and the patient's profile for potential
contraindications and adverse drug reactions. Drugs removed from the
automated drug delivery system shall be provided to the patient by a
health professional licensed pursuant to this division.
   (c) The stocking of an automated drug delivery system shall be
performed by a pharmacist.
   (d) Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be the
responsibility of the clinic. The review shall be conducted on a
monthly basis by a pharmacist and shall include a physical inspection
of the drugs in the automated drug delivery system, an inspection of
the automated drug delivery system machine for cleanliness, and a
review of all transaction records in order to verify the security and
accountability of the system.
   (e) The automated drug delivery system used at the clinic shall
provide for patient consultation pursuant to Section 1707.2 of Title
16 of the California Code of Regulations with a pharmacist via a
telecommunications link that has two-way audio and video.
   (f) The pharmacist operating the automated drug delivery system
shall be located in California.
   (g) Drugs dispensed from the automated drug delivery system shall
comply with the labeling requirements in Section 4076.
   (h) For purposes of this section, an "automated drug delivery
system" means a mechanical system controlled remotely by a pharmacist
that performs operations or activities, other than compounding or
administration, relative to the storage, dispensing, or distribution
of prepackaged dangerous drugs or dangerous devices. An automated
drug delivery system shall collect, control, and maintain all
transaction information to accurately track the movement of drugs
into and out of the system for security, accuracy, and
accountability.