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Article 10. Pharmacy Corporations
4150. Definitions
(a) A pharmacy corporation means a corporation that is
authorized to render professional services, as defined in Section
13401 of the Corporations Code, so long as that corporation and
its shareholders, officers, directors, and employees rendering
professional services who are pharmacists are in compliance with
the Moscone-Knox Professional Corporation Act, this article, and
all other statutes and regulations now or hereafter enacted or
adopted pertaining to the corporation and the conduct of its
affairs.
(b) With respect to a pharmacy corporation, the governmental
agency referred to in the Moscone-Knox Professional
Corporation Act is the Board of Pharmacy of the State of
California.
4151. Licensure Requirements
Each shareholder, director, and officer of a pharmacy
corporation, except an assistant secretary and an assistant
treasurer, shall be a licensed person as defined in Section 13401
of the Corporations Code.
4152. Corporate Name Requirements
The name of a pharmacy corporation and any name or names
under which it may render professional services shall contain the
word "pharmacist," "pharmacy," or "pharmaceutical" and
wording or abbreviations denoting corporate existence.
4153. Shareholder Income While Disqualified
The income of a pharmacy corporation attributable to
professional services rendered while a shareholder is a
disqualified person, as defined in Section 13401 of the
Corporations Code, shall not in any manner accrue to the benefit
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of the shareholder or his or her shares in the pharmacy
corporation.
4154. Regulations Authorized
The board may adopt and enforce regulations to carry out the
purposes and objectives of this article, including regulations
requiring (a) that the bylaws of a pharmacy corporation shall
include a provision whereby the capital stock of the corporation
owned by a disqualified person, as defined in Section 13401 of
the Corporations Code, or a deceased person, shall be sold to the
corporation or to the remaining shareholders of the corporation
within the time as the regulations may provide, and (b) that a
pharmacy corporation shall provide adequate security by
insurance or otherwise for claims against it by its patients or
clients arising out of the rendering of professional services.
4155. Corporate Form Not Required
Nothing in this article shall be construed as requiring the
applicant or holder of a pharmacy permit pursuant to Section
4110 to be a pharmacy corporation.
4156. Unprofessional Conduct by Corporation
A pharmacy corporation shall not do, or fail to do, any act where
doing or failing to do the act would constitute unprofessional
conduct under any statute or regulation. In the conduct of its
practice, a pharmacy corporation shall observe and be bound by
the laws and regulations that apply to a person licensed under
this chapter.
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Article 11. Wholesalers, Third-Party Logistics Providers
and Manufacturers
4160. Wholesaler or Third-Party Logistics Provider: License
Required
(a) A person shall not act as a wholesaler or third-party logistics
provider of any dangerous drug or dangerous device unless he or
she has obtained a license from the board.
(b) Upon approval by the board and the payment of the
required fee, the board shall issue a license to the applicant.
(c) (1) A separate license shall be required for each place of
business owned or operated by a wholesaler or third-party
logistics provider. Each place of business may only be issued a
single license by the board, except as provided in paragraph (2).
Each license shall be renewed annually and shall not be
transferable. At all times during which a place of business is open
for business, at least one designated representative, in the case
of a wholesaler, or designated representative-3PL in the case of a
third-party logistics provider, shall be present. A wholesaler that
only acts as a reverse distributor may use either a designated
representative or a designated representative-reverse distributor
to fulfill this requirement.
(2) A wholesaler and a third-party logistics provider under
common ownership may be licensed at the same place of
business provided that all of the following requirements are
satisfied:
(A) The wholesaler and the third-party logistics provider each
separately maintain the records required under Section 4081.
(B) Dangerous drugs and dangerous devices owned by the
wholesaler are not commingled with the dangerous drugs and
dangerous devices handled by the third-party logistics provider.
(C) Any individual acting as a designated representative for the
wholesaler is not concurrently acting as a designated
representative-3PL on behalf of the third-party logistics provider.
Nothing in this subparagraph shall be construed to prohibit an
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individual from concurrently holding a license to act as a
designated representative and to act as a designated
representative-3PL.
(D) The wholesaler has its own designated representative-in-
charge responsible for the operations of the wholesaler and the
third-party logistics provider has its own responsible manager
responsible for the operations of the third-party logistics
provider. The same individual shall not concurrently serve as the
responsible manager and the designated representative-in-
charge for a wholesaler and a third-party logistics provider
licensed at the same place of business.
(E) The third-party logistics provider does not handle the
prescription drugs or prescription devices owned by a prescriber.
(F) The third-party logistics provider is not a reverse third-party
logistics provider.
(G) The wholesaler is not acting as a reverse distributor.
(d) Every wholesaler shall be supervised or managed by a
designated representative-in-charge. The designated
representative-in-charge shall be responsible for the wholesaler’s
compliance with state and federal laws governing wholesalers. As
part of its initial application for a license, and for each renewal,
each wholesaler 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 wholesaler
license without identification of an approved designated
representative-in-charge for the wholesaler. The designated
representative-in-charge shall maintain an active license as a
designated representative with the board at all times during
which he or she is designated as the designated representative-
in-charge. A wholesaler that only acts as a reverse distributor
may identify and allow a designated representative-reverse
distributor to perform in this capacity. That individual shall
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maintain an active license as a designated representative-reverse
distributor.
(e) Each place of business of a third-party logistics provider shall
be supervised and managed by a responsible manager. The
responsible manager shall be responsible for the compliance of
the place of business with state and federal laws governing third-
party logistics providers and with the third-party logistics
provider’s customer specifications, except where the customer’s
specifications conflict with state or federal laws. As part of its
initial application for a license, and for each renewal, each third-
party logistics provider shall, on a form designated by the board,
provide identifying information and the California license number
for a designated representative-3PL proposed to serve as the
responsible manager. The proposed responsible manager shall be
subject to approval by the board. The board shall not issue or
renew a third-party logistics provider license without
identification of an approved responsible manager for the third-
party logistics provider. The responsible manager shall maintain
an active license as a designated representative-3PL with the
board at all times during which he or she is designated as the
responsible manager.
(f) A wholesaler 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 ceases to act as the
designated representative-in-charge, and shall on the same form
propose another authorized licensee 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 wholesaler 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.
(g) A third-party logistics provider shall notify the board in
writing, on a form designed by the board, within 30 days of the
date when a responsible manager ceases to act as the
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responsible manager, and shall on the same form propose
another designated representative-3PL to take over as the
responsible manager. The proposed replacement responsible
manager shall be subject to approval by the board. If
disapproved, the third-party logistics provider shall propose
another replacement within 15 days of the date of disapproval,
and shall continue to name proposed replacements until a
responsible manager is approved by the board.
(h) A drug manufacturer premises licensed by the Food and
Drug Administration or licensed pursuant to Section 111615 of
the Health and Safety Code that only distributes dangerous drugs
and dangerous devices of its own manufacture is exempt from
this section and Section 4161.
(i) 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 required in an
amount established by the board as specified in subdivision (f) of
Section 4400. When needed to protect public safety, a temporary
license may be issued for a period not to exceed 180 days,
subject to terms and conditions that the board deems necessary.
If the board determines that a temporary license was issued by
mistake or denies the application for a permanent license, the
temporary license shall terminate upon either personal service of
the notice of termination upon the licenseholder or service by
certified mail, return receipt requested, at the licenseholder’s
address of record with the board, whichever occurs first. For
purposes of retaining a temporary license, or for purposes of any
disciplinary or license denial proceeding before the board, the
temporary licenseholder shall not be deemed to have a vested
property right or interest in the license.
4160.5. Nonprescription Diabetes Test Devices - Authorized
Distributors Posted on Board Website
Within 30 days of the effective date of the act adding this
section, a manufacturer of a nonprescription diabetes test device
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shall make the names of its authorized distributors available on
its Internet Web site and shall provide the board with the names
of its authorized distributors. Within 30 days of receiving that
information from a manufacturer of a nonprescription diabetes
test device, the board shall post the names of authorized
distributors of nonprescription diabetes test devices on the
board’s Internet Web site. A manufacturer of a nonprescription
diabetes test device shall, within 30 days of making changes to its
authorized distributors, update its Internet Web site and inform
the board of changes to its authorized distributors. Within 30
days of receiving notice of any change from a manufacturer of a
nonprescription diabetes test device, the board shall post the
updated list of the manufacturer’s authorized distributors on its
Internet Web site.
4161. Nonresident Wholesaler or Nonresident Third-Party
Logistics Provider; Requirements
(a) A person located outside this state that (1) ships, sells, mails,
warehouses, distributes, or delivers dangerous drugs or
dangerous devices into this state or (2) sells, brokers,
warehouses, or distributes dangerous drugs or devices within this
state shall be considered a nonresident wholesaler or a
nonresident third-party logistics provider.
(b) A nonresident wholesaler or nonresident third-party logistics
provider shall be licensed by the board prior to shipping, selling,
mailing, warehousing, distributing, or delivering dangerous drugs
or dangerous devices to a site located in this state or selling,
brokering, warehousing, or distributing dangerous drugs or
devices within this state.
(c) (1) A separate license shall be required for each place of
business owned or operated by a nonresident wholesaler or
nonresident third-party logistics provider from or through which
dangerous drugs or dangerous devices are shipped, sold, mailed,
warehoused, distributed, or delivered to a site located in this
state or sold, brokered, warehoused, or distributed within this
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state. Each place of business may only be issued a single license
by the board, except as provided in paragraph (2). A license shall
be renewed annually and shall not be transferable.
(2) A nonresident wholesaler and a nonresident third-party
logistics provider under common ownership may be licensed at
the same place of business provided that all of the following
requirements are satisfied:
(A) The wholesaler and the third-party logistics provider each
separately maintain the records required under Section 4081.
(B) Dangerous drugs and dangerous devices owned by the
wholesaler are not commingled with the dangerous drugs and
dangerous devices handled by the third-party logistics provider.
(C) Any individual acting as a designated representative for the
wholesaler is not concurrently acting as a designated
representative-3PL on behalf of the third-party logistics provider.
Nothing in this subparagraph shall be construed to prohibit an
individual from concurrently holding a license to act as a
designated representative and to act as a designated
representative-3PL.
(D) The wholesaler has its own designated representative-in-
charge responsible for the operations of the wholesaler and the
third-party logistics provider has its own responsible manager
responsible for the operations of the third-party logistics
provider. The same individual shall not concurrently serve as the
responsible manager and the designated representative-in-
charge for a wholesaler and a third-party logistics provider
licensed at the same place of business.
(E) The third-party logistics provider does not handle the
prescription drugs or prescription devices owned by a prescriber.
(F) The third-party logistics provider is not a reverse third-party
logistics provider.
(G) The wholesaler is not acting as a reverse distributor.
(d) The following information shall be reported, in writing, to the
board at the time of initial application for licensure by a
nonresident wholesaler or a nonresident third-party logistics
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provider, on renewal of a nonresident wholesaler or nonresident
third-party logistics provider license, or within 30 days of a
change in that information:
(1) Its agent for service of process in this state.
(2) Its principal corporate officers, as specified by the board, if
any.
(3) Its general partners, as specified by the board, if any.
(4) Its owners if the applicant is not a corporation or
partnership.
(e) A report containing the information in subdivision (d) shall be
made within 30 days of any change of ownership, office,
corporate officer, or partner.
(f) A nonresident wholesaler or nonresident third-party logistics
provider shall comply with all directions and requests for
information from the regulatory or licensing agency of the state
in which it is licensed, as well as with all requests for information
made by the board.
(g) A nonresident wholesaler or nonresident third-party logistics
provider shall maintain records of dangerous drugs and
dangerous devices sold, traded, transferred, warehoused, or
distributed to persons in this state or within this state, so that the
records are in a readily retrievable form.
(h) A nonresident wholesaler or nonresident third-party logistics
provider shall at all times maintain a valid, unexpired license,
permit, or registration to conduct the business of the wholesaler
or nonresident third-party logistics provider in compliance with
the laws of the state in which it is a resident. An application for a
nonresident wholesaler or nonresident third-party logistics
provider license in this state shall include a license verification
from the licensing authority in the applicant’s state of residence.
The board may waive the home state licensure requirement for a
nonresident third-party logistics provider if the board inspects
the location and finds it to be in compliance with this article and
any regulations adopted by the board or the applicant provides
evidence of its accreditation by the Drug Distributor
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Accreditation program of the National Association of Boards of
Pharmacy. The nonresident third-party logistics provider shall
reimburse the board for all actual and necessary costs incurred
by the board in conducting an inspection of the location,
pursuant to subdivision (v) of Section 4400.
(i) (1) The board shall not issue or renew a nonresident
wholesaler license until the nonresident wholesaler identifies a
designated representative-in-charge and notifies the board in
writing of the identity and license number of the designated
representative-in-charge.
(2) The board shall not issue or renew a nonresident third-party
logistics provider license until the nonresident third-party
logistics provider identifies a responsible manager and notifies
the board in writing of the identity and license number of the
designated representative-3PL who will be the responsible
manager.
(j) The designated representative-in-charge shall be responsible
for the compliance of the nonresident wholesaler with state and
federal laws
governing wholesalers. The responsible manager shall be
responsible for the compliance of the nonresident third-party
logistics provider’s place of business with state and federal laws
governing third-party logistics providers. A nonresident
wholesaler or nonresident third-party logistics provider shall
identify and notify the board of a new designated representative-
in-charge or responsible manager within 30 days of the date that
the prior designated representative-in-charge or responsible
manager ceases to be the designated representative-in-charge or
responsible manager.
(k) 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 five hundred fifty
dollars ($550) or another amount established by the board not to
exceed the annual fee for renewal of a license to compound
sterile drug products. When needed to protect public safety, a
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temporary license may be issued for a period not to exceed 180
days, subject to terms and conditions that the board deems
necessary. If the board determines that a temporary license was
issued by mistake or denies the application for a permanent
license, the temporary license shall terminate upon either
personal service of the notice of termination upon the
licenseholder or service by certified mail, return receipt
requested, at the licenseholder’s address of record with the
board, whichever occurs first. Neither for purposes of retaining a
temporary license, nor for purposes of any disciplinary or license
denial proceeding before the board, shall the temporary
licenseholder be deemed to have a vested property right or
interest in the license.
(l) The registration fee shall be the fee specified in subdivision (f)
of Section 4400.
4161.5. Nonresident Wholesaler or Nonresident Third-Party
Logistics Provider
At such time as federal regulations are promulgated to
implement Section 584 of the federal Food, Drug, and Cosmetic
Act (21 U.S.C. Sec. 360eee-3), the board shall immediately
identify any standard, requirement, or regulation in California
law governing interstate commerce that is in conflict with the
federal regulations and act to remove the conflict in the manner
permitted by law.
4162. Wholesaler or Third-Party Logistics Provider; Surety Bond
Requirements
(a) (1) An applicant for the issuance or renewal of a wholesaler
license, which is not government owned and operated, shall
submit a surety bond of one hundred thousand dollars
($100,000) or other equivalent means of security acceptable to
the board payable to the Pharmacy Board Contingent Fund. The
purpose of the surety bond is to secure payment of any
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administrative fine imposed by the board and any cost recovery
ordered pursuant to Section 125.3.
(2) An applicant for the issuance or renewal of a third-party
logistics provider license, which is not government owned and
operated, shall submit a surety bond of ninety thousand dollars
($90,000) or other equivalent means of security acceptable to the
board payable to the Pharmacy Board Contingent Fund. The
purpose of the surety bond is to secure payment of any
administrative fine imposed by the board and any cost recovery
ordered pursuant to Section 125.3.
(3) For purposes of paragraphs (1) and (2), the board may
accept a surety bond less than the amount required under
paragraph (1) or (2) if the annual gross receipts of the previous
tax year for the wholesaler or third-party logistics provider is ten
million dollars ($10,000,000) or less, in which case the surety
bond shall be twenty-five thousand dollars ($25,000).
(4) A person to whom an approved new drug application has
been issued by the United States Food and Drug Administration
who engages in the wholesale distribution of only the dangerous
drug specified in the new drug application, and is licensed or
applies for licensure as a wholesaler or third-party logistics
provider, shall not be required to post a surety bond as provided
in paragraph (1) or (2).
(5) For licensees subject to paragraph (3) or (4), the board may
require a bond up to one hundred thousand dollars ($100,000)
for any licensee who has been disciplined by any state or federal
agency or has been issued an administrative fine pursuant to this
chapter.
(b) The board may make a claim against the bond if the licensee
fails to pay a fine within 30 days after the order imposing the
fine, or costs become final.
(c) A single surety bond or other equivalent means of security
acceptable to the board shall satisfy the requirement of
subdivision (a) for all licensed sites under common control as
defined in Section 4126.5.
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4162.5. Nonresident Wholesaler or Nonresident Third-Party
Logistics Provider; Surety Bond Requirements
(a) (1) An applicant for the issuance or renewal of a nonresident
wholesaler license shall submit a surety bond of one hundred
thousand dollars ($100,000), or other equivalent means of
security acceptable to the board, such as an irrevocable letter of
credit, or a deposit in a trust account or financial institution,
payable to the Pharmacy Board Contingent Fund. The purpose of
the surety bond is to secure payment of any administrative fine
imposed by the board and any cost recovery ordered pursuant to
Section 125.3.
(2) An applicant for the issuance or renewal of a nonresident
third-party logistics provider license shall submit a surety bond of
ninety thousand dollars ($90,000), or other equivalent means of
security acceptable to the board, such as an irrevocable letter of
credit, or a deposit in a trust account or financial institution,
payable to the Pharmacy Board Contingent Fund. The purpose of
the surety bond is to secure payment of any administrative fine
imposed by the board and any cost recovery ordered pursuant to
Section 125.3.
(3) For purposes of paragraphs (1) and (2), the board may
accept a surety bond less than the amount required under
paragraph (1) or (2) if the annual gross receipts of the previous
tax year for the nonresident wholesaler or the nonresident third-
party logistics provider is ten million dollars ($10,000,000) or less,
in which case the surety bond shall be twenty-five thousand
dollars ($25,000).
(4) For applicants who satisfy paragraph (3), the board may
require a bond up to one hundred thousand dollars ($100,000)
for any nonresident wholesaler or nonresident third-party
logistics provider who has been disciplined by any state or
federal agency or has been issued an administrative fine
pursuant to this chapter.
(5) A person to whom an approved new drug application or a
biologics license application has been issued by the United States
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Food and Drug Administration who engages in the wholesale
distribution of only the dangerous drug specified in the new drug
application or biologics license application, and is licensed or
applies for licensure as a nonresident wholesaler or a
nonresident third-party logistics provider, shall not be required
to post a surety bond as provided in this section.
(b) The board may make a claim against the bond if the licensee
fails to pay a fine within 30 days of the issuance of the fine or
when the costs become final.
(c) A single surety bond or other equivalent means of security
acceptable to the board shall satisfy the requirement of
subdivision (a) for all licensed sites under common control as
defined in Section 4126.5.
4163. Unauthorized Furnishing by Manufacturer or Wholesaler
(a) A manufacturer, wholesaler, repackager, or pharmacy shall
not furnish a dangerous drug or dangerous device to an
unauthorized person.
(b) Except as provided in subdivision (c), drugs or dangerous
devices shall be acquired from a person authorized by law to
possess or furnish dangerous drugs or dangerous devices. If the
person acquiring the dangerous drugs or dangerous devices is a
wholesaler, the obligation of the wholesaler shall be limited to
obtaining confirmation of licensure of those sources from whom
it has not previously acquired dangerous drugs or dangerous
devices.
(c) Upon approval of the board, a reverse distributor licensed as
a wholesaler may acquire a dangerous drug or dangerous device
from an unlicensed source that was previously licensed with the
board for the sole purpose of destruction of the dangerous drug
or dangerous device.
4164. Reports Required
(a) A wholesaler or third-party logistics provider licensed by the
board that distributes controlled substances, dangerous drugs, or
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dangerous devices within or into this state shall report to the
board all distributions of dangerous drugs and controlled
substances that are subject to abuse, as determined by the
board.
(b) Each wholesaler shall develop and maintain a system for
tracking individual sales of dangerous drugs at preferential or
contract prices to pharmacies that primarily or solely dispense
prescription drugs to patients of long-term care facilities. The
system shall be capable of identifying purchases of any
dangerous drug at preferential or contract prices by customers
that vary significantly from prior ordering patterns for the same
customer, including by identifying purchases in the preceding 12
calendar months by that customer or similar customers and
identifying current purchases that exceed prior purchases by
either that customer or similar customers by a factor of 20
percent.
(c) Upon written, oral, or electronic request by the board, a
wholesaler shall furnish data tracked pursuant to subdivision (b)
to the board in written, hardcopy, or electronic form. The board
shall specify the dangerous drugs, the customers, or both the
dangerous drugs and customers for which data are to be
furnished, and the wholesaler shall have 30 calendar days to
comply with the request.
(d) As used in this section, “preferential or contract prices”
means and refers to purchases by contract of dangerous drugs at
prices below the market wholesale price for those drugs.
4165. Sale or Transfer of Dangerous Drug or Device Into State:
Furnishing Records to Authorized Officer on Demand
A wholesaler or third-party logistics provider licensed by the
board who sells or transfers any dangerous drug or dangerous
device into this state or who receives, by sale or otherwise, any
dangerous drug or dangerous device from any person in this
state shall, on request, furnish an authorized officer of the law
with all records or other documentation of that sale or transfer.
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4166. Shipping of Dangerous Drugs or Devices - Wholesaler or
Distributor Liable for Security and Integrity Until Delivery
(a) A wholesaler that uses the services of a third-party logistics
provider or carrier, including, but not limited to, the United
States Postal Service or a common carrier, shall be liable for the
security and integrity of any dangerous drugs or dangerous
devices through that provider or carrier until the drugs or devices
are delivered to the transferee at its board-licensed premises.
(b) A third-party logistics provider that uses the services of a
carrier, including, but not limited to, the United States Postal
Service or a common carrier, shall have in place and comply with
written policies and procedures that provide for both of the
following:
(1) Verification that the third-party logistics provider, or the
owner of the dangerous drugs or dangerous devices stored at the
third-party logistics provider, has imposed obligations on the
carrier that provide for the security and integrity of any
dangerous drugs or dangerous devices transported by the carrier
until the drugs or devices are delivered to the transferee at its
premises.
(2) Confirmation, prior to shipping a dangerous drug or
dangerous device, that the intended recipient is legally
authorized to receive the dangerous drug or dangerous device.
(c) Nothing in this section is intended to affect the liability of a
wholesaler, third-party logistics provider, or other distributor for
dangerous drugs or dangerous devices after their delivery to the
transferee.
4167. Wholesaler or Third-Party Logistics Provider: Bar on
Obtaining Dangerous Drugs or Devices it Cannot Securely
Maintain on Licensed Premises
A wholesaler or third-party logistics provider shall not obtain, by
purchase or otherwise, any dangerous drugs or dangerous
devices that it cannot maintain, in a secure manner, at the place
of business licensed by the board.
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4168. Board License Required for Local Business License
A county or municipality shall not issue a business license for
any establishment that requires a wholesaler or third-party
logistics provider license unless the establishment possesses a
current wholesaler or third-party logistics provider license issued
by the board. For purposes of this section, an “establishment” is
the licensee’s physical location in California.
4169. Prohibited Acts
(a) A person or entity shall not do any of the following:
(1) Purchase, trade, sell, warehouse, distribute, or transfer
dangerous drugs or dangerous devices at wholesale with a
person or entity that is not licensed with the board as a
wholesaler, third-party logistics provider, or pharmacy.
(2) Purchase, trade, sell, or transfer dangerous drugs that the
person knew or reasonably should have known were adulterated,
as set forth in Article 2 (commencing with Section 111250) of
Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
(3) Purchase, trade, sell, or transfer dangerous drugs that the
person knew or reasonably should have known were
misbranded, as defined in Section 111335 of the Health and
Safety Code.
(4) Purchase, trade, sell, or transfer dangerous drugs or
dangerous devices after the beyond use date on the label.
(5) Fail to maintain records of the acquisition or disposition of
dangerous drugs or dangerous devices for at least three years.
(b) Notwithstanding any other law, a violation of this section
may subject the person or entity that has committed the
violation to a fine not to exceed the amount specified in Section
125.9 for each occurrence, pursuant to a citation issued by the
board.
(c) Amounts due from any person under this section shall be
offset as provided under Section 12419.5 of the Government
Code. Amounts received by the board under this section shall be
deposited into the Pharmacy Board Contingent Fund.
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(d) This section shall not apply to a pharmaceutical
manufacturer licensed by the Food and Drug Administration or
by the State Department of Public Health.
4169.1. Wholesaler Obligation to Report Suspicious Orders to
Board
A wholesaler, upon discovery, shall notify the board in writing of
any suspicious orders of controlled substances placed by a
California-licensed pharmacy or wholesaler by providing the
board a copy of the information that the wholesaler provides to
the United States Drug Enforcement Administration. Suspicious
orders include, but are not limited to, orders of unusual size,
orders deviating substantially from a normal pattern, and orders
of unusual frequency.
Article 11.5. Surplus Medication Collection and
Distribution Intermediaries
4169.5. Surplus medication Collection and Distribution
Intermediary; License
(a) A surplus medication collection and distribution intermediary
established for the purpose of facilitating the donation of
medications to or transfer of medications between participating
entities under a program established pursuant to Division 116
(commencing with Section 150200) of the Health and Safety
Code shall be licensed by the board. The board shall enforce the
requirements set forth in Section 150208 of the Health and
Safety Code. The license shall be renewed annually.
(b) An application for licensure as a surplus medication
collection and distribution intermediary shall be made on a form
furnished by the board, and shall state the name, address, usual
occupation, and professional qualifications, if any, of the
applicant. If the applicant is an entity other than a natural
person, the application shall state the information as to each
person beneficially interested in that entity.
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(c) As used in this section, and subject to subdivision (e), the
term “person beneficially interested” means and includes:
(1) If the applicant is a partnership or other unincorporated
association, each partner or member.
(2) If the applicant is a corporation, each of its officers,
directors, and stockholders, provided that no natural person shall
be deemed to be beneficially interested in a nonprofit
corporation.
(3) If the applicant is a limited liability company, each officer,
manager, or member.
(d) If the applicant is a charitable organization described in
Section 501(c)(3) of the Internal Revenue Code, the applicant
shall furnish the board with the organization’s articles of
incorporation. The applicant shall also furnish the board with the
names of the controlling members.
(e) If the applicant is a partnership or other unincorporated
association, a limited liability company, or a corporation, and if
the number of partners, members, or stockholders, as the case
may be, exceeds five, the application shall so state, and shall
further state the information required by subdivision (b) as to
each of the five partners, members, or stockholders who own the
five largest interests in the applicant’s entity. Upon request by
the executive officer of the board, the applicant shall furnish the
board with the information required by subdivision (b) as to
partners, members, or stockholders not named in the
application, or shall refer the board to an appropriate source of
that information.
(f) The application shall contain a statement to the effect that
the applicant or persons beneficially interested have not been
convicted of a felony and have not violated any of the provisions
of this chapter. If the applicant cannot make this statement, the
application shall contain a statement of the violation, if any, or
reasons which will prevent the applicant from being able to
comply with the requirements with respect to the statement.
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(g) Upon the approval of the application by the board and
payment of a fee in the amount of three hundred dollars ($300),
the executive officer of the board shall issue or renew a license to
operate as a surplus medication collection and distribution
intermediary, if all of the provisions of this chapter have been
complied with. Fees received by the board pursuant to this
section shall be deposited into the Pharmacy Board Contingent
Fund. An applicant for licensure as a surplus medication
collection and distribution intermediary that is government
owned or is a nonprofit organization pursuant to subdivision (d)
is exempt from the fee requirement.
(h) A surplus medication collection and distribution
intermediary licensed pursuant to this section is exempt from
licensure as a wholesaler.
(i) A surplus medication collection and distribution intermediary
licensed pursuant to this section shall keep and maintain for
three years complete records for which the intermediary
facilitated the donation of medications to or transfer of
medications between participating entities.
Article 11.7 Cancer Medication Collection and
Distribution: Registry of Participating Practitioners
4169.7. Requirements for Participating in Registry
(a) A participating practitioner in the collection and distribution
of unused cancer medications pursuant to the program
established pursuant to Division 117 (commencing with Section
150400) of the Health and Safety Code shall be registered with a
surplus medication collection and distribution intermediary, as
defined in Section 150401 of the Health and Safety Code, in
accordance with this section. The registration shall be renewed
annually.
(b) An application for registration with a surplus medication
collection and distribution intermediary shall be made on a form,
which may be in an electronic format, furnished by the surplus
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medication collection and distribution intermediary, and shall
state the name, address, usual occupation, and professional
qualifications, if any, of the applicant.
(c) Upon the approval of an application by a surplus medication
collection and distribution intermediary, and payment of a fee in
an amount not to exceed three hundred dollars ($300) to the
surplus medication collection and distribution intermediary for
processing the application and issuing or renewing the
registration, the surplus medication collection and distribution
intermediary shall issue or renew a registration certificate to
operate as a participating practitioner, if the practitioner has
complied with all of the provisions of this chapter.
(d) A surplus medication collection and distribution intermediary
shall do all of the following:
(1) Create a registry, not to exceed 50 participating
practitioners.
(2) Develop a donor form that may be in an electronic format
and that shall include all of the following information:
(A) The date the medication was donated.
(B) The name, address, and telephone number of the donor.
(C) The name, strength, and quantity of the medication.
(D) The manufacturer and lot number, if applicable, of the
medication.
(E) The name and dated signature of the practitioner who is
accepting and inspecting the donated medication.
(F) An acknowledgment that the medication was handled and
stored in accordance with the physician’s order and per the
manufacturer’s recommendation.
(3) Develop a recipient form, which may be in an electronic
format, and which shall include all of the following:
(A) The date the recipient received the medication.
(B) The name, address, and telephone number of the recipient.
(C) The name, strength, and quantity of the medication.
(D) The manufacturer and the lot number, if applicable, of the
medication.
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(E) The name and dated signature of the practitioner who is
accepting and inspecting the donated medication.
(F) An acknowledgment that the donor is known to the
practitioner and is a patient of record, and that there is no reason
to believe that the donated prescription medication was
improperly handled or stored.
(G) An acknowledgment that by accepting the donated
prescription medication, the recipient accepts any risks that an
accidental mishandling could create.
(H) An acknowledgment that the donor, the participating
practitioner, and the surplus medication collection and
distribution intermediary are released from liability arising from
their participation pursuant to this article and the program
established pursuant to Division 117 (commencing with Section
150400) of the Health and Safety Code.
(I) An acknowledgment that the pharmaceutical manufacturer is
released from liability of any claims or injury arising from the
transfer of any prescription medication pursuant to this article
and the program established pursuant to Division 117
(commencing with Section 150400) of the Health and Safety
Code.
(J) An acknowledgment that the recipient is receiving donated
prescription medication and that the recipient is receiving the
donated prescription medication at no cost.
(e) A participating practitioner is exempt from licensure as a
wholesaler.
(f) A participating practitioner shall keep and maintain for three
years records created by the participating practitioner for
purposes of this article.
(g) The board may request records from the distribution
intermediary and participating practitioner to confirm
compliance with this section and Section 150400 of the Health
and Safety Code.
(h) The board may prohibit a participating practitioner from
participating in the program established pursuant to Division 117
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(commencing with Section 150400) of the Health and Safety
Code if the participating practitioner does not comply with the
requirements of the program or this article. If the board prohibits
a participating practitioner from participating in the program, it
shall, within 15 days of making that determination, provide
written notice to the participating practitioner and to the surplus
medication collection and distribution intermediary that issued
the participating practitioner a registration certificate to operate
as a participating practitioner.
(i) For purposes of this section, the following definitions apply:
(1) “Donor” means an individual who donates unused
prescription medications to a participating practitioner for the
purpose of redistribution to established patients of that
practitioner.
(2) “Ineligible drugs” means drugs that are not able to be
accepted for redistribution as part of the program established
pursuant to Division 117 (commencing with Section 150400) of
the Health and Safety Code. “Ineligible drugs” include all
controlled substances, including all opioids, all compounded
medications, injectable medications, drugs that have an
approved United States Food and Drug Administration Risk
Evaluation and Mitigation Strategy (REMS) requirement, and all
growth factor medications.
(3) “Participating practitioner” means a person who is licensed
to practice medicine by the Medical Board of California and is
board certified in medical oncology or hematology and is
registered with a surplus medication collection and distribution
intermediary.
(4) “Recipient” means an individual who voluntarily receives
donated prescription medications.
(5) “Unused cancer medication” or “medication” means a
medication or drug, including a “dangerous drug” as defined in
Section 4022 or a “drug” as defined in Section 4025, that is
prescribed as part of a cancer treatment plan and is in its original
unopened, tamper-evident dose unit packaging that includes the
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drug’s lot number and expiration date. A cancer drug packaged in
single-unit doses may be accepted and dispensed if the outside
packaging is opened but the single-unit dose packaging is
unopened.
4169.8. Article Repeal Date
This article shall remain in effect only until January 1, 2027, and
as of that date is repealed.
Article 12. Prescriber Dispensing
4170. Dispensing by Prescriber: Requirements and Restrictions;
Enforcement
(a) No prescriber shall dispense drugs or dangerous devices to
patients in his or her office or place of practice unless all of the
following conditions are met:
(1) The dangerous drugs or dangerous devices are dispensed to
the prescriber's own patient, and the drugs or dangerous devices
are not furnished by a nurse or physician attendant.
(2) The dangerous drugs or dangerous devices are necessary in
the treatment of the condition for which the prescriber is
attending the patient.
(3) The prescriber does not keep a pharmacy, open shop, or
drugstore, advertised or otherwise, for the retailing of dangerous
drugs, dangerous devices, or poisons.
(4) The prescriber fulfills all of the labeling requirements
imposed upon pharmacists by Section 4076, all of the
recordkeeping requirements of this chapter, and all of the
packaging requirements of good pharmaceutical practice,
including the use of childproof containers.
(5) The prescriber does not use a dispensing device unless he or
she personally owns the device and the contents of the device,
and personally dispenses the dangerous drugs or dangerous
devices to the patient packaged, labeled, and recorded in
accordance with paragraph (4).
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(6) The prescriber, prior to dispensing, offers to give a written
prescription to the patient that the patient may elect to have
filled by the prescriber or by any pharmacy.
(7) The prescriber provides the patient with written disclosure
that the patient has a choice between obtaining the prescription
from the dispensing prescriber or obtaining the prescription at a
pharmacy of the patient's choice.
(8) A certified nurse-midwife who functions pursuant to a
standardized procedure or protocol described in Section 2746.51,
a nurse practitioner who functions pursuant to a standardized
procedure described in Section 2836.1, or protocol, a physician
assistant who functions pursuant to Section 3502.1, or a
naturopathic doctor who functions pursuant to Section 3640.5,
may hand to a patient of the supervising physician and surgeon a
properly labeled prescription drug prepackaged by a physician
and surgeon, a manufacturer as defined in this chapter, or a
pharmacist.
(b) The Medical Board of California, the State Board of
Optometry, the Bureau of Naturopathic Medicine, the Dental
Board of California, the California Board of Podiatric Medicine,
the Osteopathic Medical Board of California, the Board of
Registered Nursing, the Veterinary Medical Board, and the
Physician Assistant Committee shall have authority with the
California State Board of Pharmacy to ensure compliance with
this section, and those boards are specifically charged with the
enforcement of this chapter with respect to their respective
licensees.
(c) "Prescriber," as used in this section, means a person, who
holds a physician's and surgeon's certificate, a license to practice
optometry, a license to practice naturopathic medicine, a license
to practice dentistry, a license to practice veterinary medicine, or
a certificate to practice podiatry, and who is duly registered by
the Medical Board of California, the Osteopathic Medical Board
of California, the State Board of Optometry, the Bureau of
Naturopathic Medicine, the Dental Board of California, the
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Veterinary Medical Board, or the California Board of Podiatric
Medicine.
4170.5. Veterinarian in Teaching Hospital May Dispense and
Administer Dangerous Drugs and Devices; Requirements
(a) Veterinarians in a veterinary teaching hospital operated by
an accredited veterinary medical school may dispense and
administer dangerous drugs and devices and controlled
substances from a common stock.
(b) The veterinary teaching hospital shall designate a pharmacist
to be responsible for ordering the drugs for the common stock
and the designated pharmacist-in-charge shall be professionally
responsible to insure that inventories, security procedures,
training, protocol development, recordkeeping, packaging,
labeling, and dispensing occur in a manner that is consistent with
the promotion and protection of the health and safety of the
public.
(c) The veterinary teaching hospital's pharmacist-in-charge shall
develop policies, procedures, and guidelines that recognize the
unique relationship between the institution's pharmacists and
veterinarians in the control, management, dispensation, and
administration of drugs.
(d) The board may inspect a veterinary teaching hospital
dispensing or administering drugs pursuant to this section.
4171. Exceptions to Section 4170: Samples; Clinics;
Veterinarians; Narcotic Treatment Programs; Certain Cancer
Medications
(a) Section 4170 shall not prohibit the furnishing of a limited
quantity of samples by a prescriber, if the prescriber dispenses
the samples to the patient in the package provided by the
manufacturer, no charge is made to the patient therefor, and an
appropriate record is entered in the patient's chart.
(b) Section 4170 shall not apply to clinics, as defined in
subdivision (a) of Section 1204 or subdivision (b) or (c) of Section
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1206 of the Health and Safety Code, to programs licensed
pursuant to Sections 11876, 11877, and 11877.5 of the Health
and Safety Code, or to a prescriber dispensing parenteral
chemotherapeutic agents, biologicals, or delivery systems used in
the treatment of cancer.
4172. Storage Requirements
A prescriber who dispenses drugs pursuant to Section 4170 shall
store all drugs to be dispensed in an area that is secure. The
Medical Board of California shall, by regulation, define the term
"secure" for purposes of this section.
4173. Dispensing by Registered Nurses
This chapter does not prevent the dispensing of drugs or devices
by registered nurses functioning pursuant to Section 2725.1.
4174. Dispensing by Pharmacist Upon Order of Nurse
Practitioner
Notwithstanding any other law, a pharmacist may dispense
drugs or devices upon the drug order of a nurse practitioner
functioning pursuant to Section 2836.1 or a certified nurse-
midwife functioning pursuant to Section 2746.51, a drug order of
a physician assistant functioning pursuant to Section 3502.1 or a
naturopathic doctor functioning pursuant to Section 3640.5, or
the order of a pharmacist acting under Section 4052.1, 4052.2,
4052.3, or 4052.6.
4175. Processing of Complaints
(a) The California State Board of Pharmacy shall promptly
forward to the appropriate licensing entity, including the Medical
Board of California, the Veterinary Medical Board, the Dental
Board of California, the State Board of Optometry, the California
Board of Podiatric Medicine, the Osteopathic Medical Board of
California, the Board of Registered Nursing, the Bureau of
Naturopathic Medicine, or the Physician Assistant Committee, all
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complaints received related to dangerous drugs or dangerous
devices dispensed by a prescriber, certified nurse-midwife, nurse
practitioner, naturopathic doctor, or physician assistant pursuant
to Section 4170.
(b) All complaints involving serious bodily injury due to
dangerous drugs or dangerous devices dispensed by prescribers,
certified nurse-midwives, nurse practitioners, naturopathic
doctors, or physician assistants pursuant to Section 4170 shall be
handled by the Medical Board of California, the Dental Board of
California, the State Board of Optometry, the California Board of
Podiatric Medicine, the Osteopathic Medical Board of California,
the Bureau of Naturopathic Medicine, the Board of Registered
Nursing, the Veterinary Medical Board, or the Physician Assistant
Committee as a case of greatest potential harm to a patient.
Article 13. Nonprofit or Free Clinics
4180. Purchase of Drugs at Wholesale Only with License:
Eligible Clinics
(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
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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.
(c) The board shall synchronize license renewal dates and
aggregate fees for multiple clinics under common nonprofit
ownership at the request of the parent organization.
4180.5. Independent Clinics Sharing Office Space; Licensing;
Separate Boards, Drug Stocks, Records; Reporting Losses;
Application Fee; Ownership Change; Review by Department of
Health Care Services and Department of Public Health
[Added Stats 2017 chap 548, section 9 (AB 401), effective January
1, 2018, repealed January 1, 2021]
4181. License Requirements; Policies and Procedures; Who
May Dispense
(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 Public Health relating to
the drug distribution service to ensure that inventories, security
procedures, training, protocol development, recordkeeping,
packaging, labeling, dispensing, and patient consultation occur in
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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. Duties of Professional Director; Consulting Pharmacist
Required
(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.
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(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 Professional Dispensing Fee
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. Dispensing Schedule II Substance by Clinic Prohibited
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. Inspection Permitted
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. Automated Drug Delivery Systems
(a) Automated drug delivery systems, as defined in Section
4017.3, 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
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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 and
with Section 1707.5 of Title 16 of the California Code of
Regulations.
(h) This section shall become operative on July 1, 2019.
Article 13.5. Correctional Clinics
4187. Correctional Clinics
For purposes of this article the following terms shall have the
following meanings:
(a) “Correctional clinic” means a primary care clinic, as referred
to in subdivision (b) of Section 1206 of the Health and Safety
Code, conducted, maintained, or operated by the state to
provide health care to eligible patients of the Department of
Corrections and Rehabilitation.
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(b) “Chief executive officer” means the highest ranking health
care administrator at a correctional institution.
(c) “Chief medical executive” means a physician and surgeon
acting in the capacity of medical director within the correctional
institution.
(d) “Chief nurse executive” means the highest ranking nurse
within the correctional institution.
(e) “Licensed correctional clinic” means a correctional clinic that
is licensed pursuant to this article.
(f) “Supervising dentist” means the highest ranking dentist
within the correctional institution.
4187.1. Correctional Clinics: Licensing; Dispensing and
Administering of Drugs
(a) Notwithstanding any other provision of this chapter, a
correctional clinic licensed by the board under this article may
obtain drugs from a licensed correctional pharmacy, the
Department of Correction and Rehabilitation’s Central Fill
Pharmacy, or from another correctional clinic licensed by the
board under this article within the same institution for the
administration or dispensing of drugs or devices to patients
eligible for care at the correctional facility if under either:
(1) The direction of a physician and surgeon, dentist, or other
person lawfully authorized to prescribe.
(2) An approved protocol as identified within the statewide
Inmate Medical Services Policies and Procedures.
(b) The dispensing or administering of drugs in a correctional
clinic may be performed pursuant to a chart order, as defined in
Section 4019, a valid prescription consistent with this chapter, or
pursuant to an approved protocol as identified within the
statewide Inmate Medical Services Policies and Procedures. The
dispensing of drugs in a correctional clinic shall only be
performed by a physician and surgeon, a dentist, a pharmacist, or
other person lawfully authorized to dispense drugs. Medications
dispensed to patients that are to be kept on the patient’s person
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for use shall meet the labeling requirements of Section 4076 and
all recordkeeping requirements of this chapter.
(c) A correctional clinic shall keep records of the kind and
amounts of drugs acquired, administered, transferred, and
dispensed. The records shall be available and maintained for a
minimum of three years for inspection by all properly authorized
personnel.
(d) (1) A correctional clinic shall not be entitled to the benefits
of this section until it has obtained a license from the board.
(2) A separate license shall be required for each correctional
clinic location and shall not be transferrable.
(3) A correctional clinic’s location and address shall be identified
by correctional institution and building within that correctional
institution.
(4) A clinic shall notify the board in advance of any change in the
clinic’s address on a form furnished by the board.
4187.2. Correctional Clinics: Policies and Procedures
(a) The policies and procedures to implement the laws and
regulations of this article within a correctional clinic shall be
developed and approved by the statewide Correctional Pharmacy
and Therapeutics Committee referenced in Section 5024.2 of the
Penal Code. Prior to the issuance of a correctional clinic license
by the board, an acknowledgment shall be signed by the
correctional facility pharmacist-in-charge servicing that
institution, the pharmacist-in-charge for the California
Department of Correction and Rehabilitation’s Central Fill
Pharmacy, and the correctional clinic’s chief medical executive,
supervising dentist, chief nurse executive, and chief executive
officer.
(b) (1) The chief executive officer shall be responsible for the
safe, orderly, and lawful provision of pharmacy services. The
pharmacist-in-charge of the correctional facility shall implement
the policies and procedures developed and approved by the
statewide Correctional Pharmacy and Therapeutics Committee
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referenced in Section 5024.2 of the Penal Code and the statewide
Inmate Medical Services Policies and Procedures in conjunction
with the chief executive officer, the chief medical executive, the
supervising dentist, and the chief nurse executive.
(2) A licensed correctional clinic shall notify the board within 30
days of any change in the chief executive officer on a form
furnished by the board.
(c) A correctional facility pharmacist shall be required to inspect
the clinic at least quarterly.
4187.3. Correctional Clinics: Administering Controlled
Substances
A Schedule II, III, IV, or V controlled substance may be
administered by health care staff of the licensed correctional
clinic lawfully authorized to administer pursuant to a chart order,
as defined in Section 4019, a valid prescription consistent with
this chapter, or pursuant to an approved protocol as identified
within the statewide Inmate Medical Services Policies and
Procedures.
4187.4. Correctional Clinics: Board Inspections
The board shall have the authority to inspect a correctional
clinic at any time in order to determine whether a correctional
clinic is, or is not, operating in compliance with this article.
4187.5 Correctional Clinics: Automated Drug Delivery Systems
(a) An automated drug delivery system, as defined in subdivision
(h), may be located in a correctional clinic licensed by the board
under this article. If an automated drug delivery system is located
in a correctional clinic, the correctional clinic shall implement the
statewide Correctional Pharmacy and Therapeutics Committee’s
policies and procedures and the statewide Inmate Medical
Services 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 either in electronic form or paper
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form at the location where the automated drug system is being
used.
(b) Drugs shall be removed from the automated drug delivery
system upon authorization by a pharmacist after the pharmacist
has reviewed the prescription and the patient profile for
potential contraindications and adverse drug reactions. If the
correctional pharmacy is closed and if, in the prescriber’s
professional judgment, delay in therapy may cause patient harm,
a medication may be removed from the automated drug delivery
system and administered or furnished to a patient under the
direction of the prescriber. Where the drug is otherwise
unavailable, a medication may be removed and administered or
furnished to the patient pursuant to an approved protocol as
identified within the statewide Inmate Medical Services Policies
and Procedures. Any removal of medication from an automated
drug delivery system shall be documented and provided to the
correctional pharmacy when it reopens.
(c) Drugs removed from the automated drug delivery system
shall be provided to the patient by a health professional licensed
pursuant to this division who is lawfully authorized to perform
that task.
(d) The stocking of an automated drug delivery system shall be
performed by either:
(1) A pharmacist.
(2) An intern pharmacist or pharmacy technician, acting under
the supervision of a pharmacist.
(e) Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be the
responsibility of the correctional 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.
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(f) The automated drug delivery system shall be operated by a
licensed correctional pharmacy. Any drugs within an automated
drug delivery system are considered owned by the licensed
correctional pharmacy until they are dispensed from the
automated drug delivery system.
(g) Drugs from the automated drug delivery system in a
correctional clinic shall only be removed by a person lawfully
authorized to administer or dispense the drugs.
(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.
Article 14. Clinics
4190. Clinic Defined; License Required; Purchase of Drugs at
Wholesale: Drug Distribution Service of a Clinic; Information
Reported to the Board
(a) For the purposes of this article, "clinic" means a surgical
clinic licensed pursuant to paragraph (1) of subdivision (b) of
Section 1204 of the Health and Safety Code, an outpatient setting
accredited by an accreditation agency, as defined in Section 1248
of the Health and Safety Code, or an ambulatory surgical center
certified to participate in the Medicare Program under Title XVIII
of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.).
(b) A clinic licensed by the board 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, as provided in subdivision (c). A separate license shall be
required for each clinic location. A clinic licensed by the board
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shall notify the board of any change in the clinic's address on a
form furnished by the board. 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.
(c) The drug distribution service of a clinic shall be limited to the
use of drugs for administration to the patients of the 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.
(d) No clinic shall be entitled to the benefits of this section until
it has obtained a license from the board.
(e) If a clinic is licensed by the board, 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.
(f) Nothing in this section shall limit the ability of a physician and
surgeon to prescribe, dispense, administer, or furnish drugs at a
clinic as provided in Sections 2241.5, 2242, and 4170.
4191. Compliance With Department of Public Health
Requirements; Who May Dispense Drugs
(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
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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. Duties of Professional Director; Providing Information to
Board
(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
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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. Clinic Not Eligible for Professional Dispensing Fee; Ban on
Offering Drugs for Sale
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. Dispensing of Schedule II Substance by Clinic Prohibited;
Physician May Dispense; Administration Authorized in Clinic
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. Inspection Authorized
The board shall have the authority to inspect a clinic that is
licensed pursuant to this article at any time in order to determine
whether the clinic is, or is not, operating in compliance with this
article and all other provisions of the law.
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