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Article 15.
Veterinary Food-Animal Drug Retailers
4196. License Required: Temporary Licenses; Persons
Authorized in Storage Area; Other Requirements; Board
Approval of Designated Representative-in-Charge
(a) No person shall conduct a veterinary food-animal drug
retailer in the State of California unless he or she has obtained a
license from the board. A license shall be required for each
veterinary food-animal drug retailer owned or operated by a
specific person. A separate license shall be required for each of
the premises of any person operating a veterinary food-animal
drug retailer in more than one location. The license shall be
renewed annually and shall not be transferable.
(b) The board may issue a temporary license, upon conditions
and for periods of time as the board determines to be in the
public interest. A temporary license fee shall be fixed by the
board at an amount not to exceed the annual fee for renewal of a
license to conduct a veterinary food-animal drug retailer.
(c) No person other than a pharmacist, an intern pharmacist, a
designated representative, an authorized officer of the law, or a
person authorized to prescribe, shall be permitted in that area,
place, or premises described in the permit issued by the board
pursuant to Section 4041, wherein veterinary food-animal drugs
are stored, possessed, or repacked. A pharmacist or designated
representative shall be responsible for any individual who enters
the veterinary food-animal drug retailer for the purpose of
performing clerical, inventory control, housekeeping, delivery,
maintenance, or similar functions relating to the veterinary food-
animal drug retailer.
(d) Every veterinary food-animal drug retailer shall be
supervised or managed by a designated representative-in-charge.
The designated representative-in-charge shall be responsible for
the veterinary food-animal drug retailer's compliance with state
and federal laws governing veterinary food-animal drug retailers.
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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. Minimum Standards: Security; Sanitation; Board
Regulations; Waivers
(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.
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(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. Written Policies and Procedures Required: Contents;
Training of Personnel; Quality Assurance; Consulting Pharmacist
(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:
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(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. Labeling Requirements; Maintaining Prescription Records
(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.
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Article 16. Applications
4200. Pharmacist License Requirements: Age; Education;
Experience; Examination; Proof of Qualifications; Fees
(a) The board may license as a pharmacist an applicant who
meets all the following requirements:
(1) Is at least 18 years of age.
(2) (A) Has graduated from a college of pharmacy or department
of pharmacy of a university recognized by the board; or
(B) If the applicant graduated from a foreign pharmacy school,
the foreign-educated applicant has been certified by the Foreign
Pharmacy Graduate Examination Committee.
(3) Has completed at least 150 semester units of collegiate study
in the United States, or the equivalent thereof in a foreign
country. No less than 90 of those semester units shall have been
completed while in resident attendance at a school or college of
pharmacy.
(4) Has earned at least a baccalaureate degree in a course of
study devoted to the practice of pharmacy.
(5) Has completed 1,500 hours of pharmacy practice experience
or the equivalent in accordance with Section 4209.
(6) Has passed a version of the California Practice Standards and
Jurisprudence Examination for Pharmacists that, at the time of
application for licensure, was based on an occupational analysis
that is either current or that was replaced by another
occupational analysis no more than one year before the
application for licensure and the applicant meets either of the
following requirements:
(A) Has passed the North American Pharmacist Licensure
Examination on or after January 1, 2004, and holds an active
pharmacist license in another state or territory of the United
States.
(B) Has passed the North American Pharmacist Licensure
Examination that, at the time of application for licensure, was
based on an occupational analysis that is either current or that
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was replaced by another occupational analysis no more than one
year before the application for licensure..
(b) Proof of the qualifications of an applicant for licensure as a
pharmacist shall be made to the satisfaction of the board and
shall be substantiated by affidavits or other evidence as may be
required by the board.
(c) Each person, upon application for licensure as a pharmacist
under this chapter, shall pay to the executive officer of the board
the fees provided by this chapter. The fees shall be compensation
to the board for investigation or examination of the applicant.
4200.1. Multiple Failures of License Examination; Additional
Education Requirements
(a) Notwithstanding Section 135, an applicant may take the
North American Pharmacist Licensure Examination four times,
and may take the California Practice Standards and Jurisprudence
Examination for Pharmacists four times.
(b) Notwithstanding Section 135, an applicant may take the
North American Pharmacist Licensure Examination and the
California Practice Standards and Jurisprudence Examination for
Pharmacists four additional times each if he or she successfully
completes, at minimum, 16 additional semester units of
education in pharmacy as approved by the board.
(c) The applicant shall comply with the requirements of Section
4200 for each application for reexamination made pursuant to
subdivision (b).
(d) An applicant may use the same coursework to satisfy the
additional educational requirement for each examination under
subdivision (b), if the coursework was completed within 12
months of the date of his or her application for reexamination.
(e) For purposes of this section, the board shall treat each failing
score on the pharmacist licensure examination administered by
the board prior to January 1, 2004, as a failing score on both the
North American Pharmacist Licensure Examination and the
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California Practice Standards and Jurisprudence Examination for
Pharmacists.
4200.2. California Practice Standards and Jurisprudence
Examination for Pharmacists; Required Inclusions
When developing the California Practice Standards and
Jurisprudence Examination for Pharmacists, the board shall
include all of the following:
(a) Examination items to demonstrate the candidate's
proficiency in patient communication skills.
(b) Aspects of contemporary standards of practice for
pharmacists in California, including, but not limited to, the
provision of pharmacist care and the application of clinical
knowledge to typical pharmacy practice situations that are not
evaluated by the North American Pharmacy Licensure
Examination.
4200.3. Examination Process to be Reviewed Regularly;
Required Standards
(a) The examination process shall be regularly reviewed
pursuant to Section 139.
(b) The examination process shall meet the standards and
guidelines set forth in the Standards for Educational and
Psychological Testing and the Federal Uniform Guidelines for
Employee Selection Procedures. The board shall work with the
Office of Professional Examination Services of the department or
with an equivalent organization who shall certify at minimum
once every five years that the examination process meets these
national testing standards. If the department determines that
the examination process fails to meet these standards, the board
shall terminate its use of the North American Pharmacy Licensure
Examination and shall use only the written and practical
examination developed by the board.
(c) The examination shall meet the mandates of subdivision (a)
of Section 12944 of the Government Code.
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(d) The board shall work with the Office of Professional
Examination Services or with an equivalent organization to
develop the state jurisprudence examination to ensure that
applicants for licensure are evaluated on their knowledge of
applicable state laws and regulations.
(e) The board shall annually publish the pass and fail rates for
the pharmacist's licensure examination administered pursuant to
Section 4200, including a comparison of historical pass and fail
rates before utilization of the North American Pharmacist
Licensure Examination.
(f) The board shall report to the Joint Committee on Boards,
Commissions, and Consumer Protection and the department as
part of its next scheduled review, the pass rates of applicants
who sat for the national examination compared with the pass
rates of applicants who sat for the prior state examination. This
report shall be a component of the evaluation of the examination
process that is based on psychometrically sound principles for
establishing minimum qualifications and levels of competency.
4200.4. Retaking National Examination After Failure; Waiting
Period
An applicant who fails either the North American Pharmacist
Licensure Examination or the California Practice Standards and
Jurisprudence Examination for Pharmacists may not retake that
examination for at least 45 days. The board may, in consultation
with the Office of Professional Examination Services of the
department, adopt a regulation establishing a different waiting
period to retake the examination.
4200.5. Retired Licensee: Eligibility; Bar on Practice;
Requirement for Restoration to Active Status
(a) The board shall issue, upon application and payment of the
fee established by Section 4400, a retired license to a pharmacist
who has been licensed by the board. The board shall not issue a
retired license to a pharmacist whose license has been revoked.
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(b) The holder of a retired license issued pursuant to this section
shall not engage in any activity for which an active pharmacist's
license is required. A pharmacist holding a retired license shall
be permitted to use the titles "retired pharmacist" or
"pharmacist, retired."
(c) The holder of a retired license shall not be required to renew
that license.
(d) In order for the holder of a retired license issued pursuant to
this section to restore his or her license to active status, he or she
shall pass the examination that is required for initial licensure
with the board.
4201. Application Form: Required Information; Authority
Granted by License; Reporting Changes in Beneficial Ownership
(a) Each application to conduct a pharmacy, wholesaler, third-
party logistics provider, veterinary food-animal drug retailer, or
outsourcing facility 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 other than a natural person, the application shall
state the information as to each person beneficially interested
therein or any person with management or control over the
license.
(b) As used in this section, and subject to subdivision (c), 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 a natural person shall
not be deemed to be beneficially interested in a nonprofit
corporation.
(3) If the applicant is a limited liability company, each officer,
manager, or member.
(c) If the applicant is a partnership or other unincorporated
association, a limited liability company, or a corporation, and the
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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 (a) as to each of the
five partners, members, or stockholders who own the five largest
interests in the applicant entity. Upon request by the executive
officer, the applicant shall furnish the board with the information
required by subdivision (a) as to partners, members, or
stockholders not named in the application, or shall refer the
board to an appropriate source of that information.
(d) The application shall contain a statement to the effect that
the applicant has not been convicted of a felony and has 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.
(e) Upon the approval of the application by the board and
payment of the fee required by this chapter for each pharmacy,
wholesaler, third-party logistics provider, or veterinary food-
animal drug retailer, the executive officer of the board shall issue
a license to conduct a pharmacy, wholesaler, third-party logistics
provider, veterinary food-animal drug retailer, or outsourcing
facility if all of the provisions of this chapter have been complied
with.
(f) Notwithstanding any other law, the pharmacy license shall
authorize the holder to conduct a pharmacy. The license shall be
renewed annually and shall not be transferable.
(g) Notwithstanding any other law, the wholesaler license shall
authorize the holder to wholesale dangerous drugs and
dangerous devices. The license shall be renewed annually and
shall not be transferable.
(h) Notwithstanding any other law, the third-party logistics
provider license shall authorize the holder to provide or
coordinate warehousing, distribution, or other similar services of
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dangerous drugs and dangerous devices. The license shall be
renewed annually and shall not be transferable.
(i) Notwithstanding any other law, the veterinary food-animal
drug retailer license shall authorize the holder to conduct a
veterinary food-animal drug retailer and to sell and dispense
veterinary food-animal drugs as defined in Section 4042.
(j) For licenses referred to in subdivisions (f), (g), (h), and (i), any
change in the proposed beneficial ownership interest shall be
reported to the board within 30 days thereafter upon a form to
be furnished by the board.
(Amended by Stats. 2015, Ch. 303, Sec. 7. Effective January 1,
2016.)
4202. Pharmacy Technician: License Requirements for
Education, Experience; Board Regulations; Criminal Background
Check; Discipline
(a) The board may issue a pharmacy technician license to an
individual if he or she is a high school graduate or possesses a
general educational development certificate equivalent, and
meets any one of the following requirements:
(1) Has obtained an associate's degree in pharmacy technology.
(2) Has completed a course of training specified by the board.
(3) Has graduated from a school of pharmacy recognized by the
board.
(4) Is certified by a pharmacy technician certifying organization
offering a pharmacy technician certification program accredited
by the National Commission for Certifying Agencies that is
approved by the board.
(b) The board shall adopt regulations pursuant to this section for
the licensure of pharmacy technicians and for the specification of
training courses as set out in paragraph (2) of subdivision (a).
Proof of the qualifications of any applicant for licensure as a
pharmacy technician shall be made to the satisfaction of the
board and shall be substantiated by any evidence required by the
board.
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(c) The board shall conduct a criminal background check of the
applicant to determine if an applicant has committed acts that
would constitute grounds for denial of licensure, pursuant to this
chapter or Chapter 2 (commencing with Section 480) of Division
1.5.
(d) The board may suspend or revoke a license issued pursuant
to this section on any ground specified in Section 4301.
(e) Once an individual is licensed as a pharmacist, the pharmacy
technician registration is no longer valid and the pharmacy
technician license shall be returned to the board within 15 days.
4202.5. Designated Paramedic License; Fee
(a) The board may issue a designated paramedic license to an
individual if he or she holds a license as a paramedic in this state
and meets the criteria of this section.
(b) The board shall conduct a criminal background check of the
applicant to determine if the applicant has committed acts that
would constitute grounds for denial of licensure, pursuant to this
chapter or Chapter 2 (commencing with Section 480) of Division
1.5.
(c) The board may suspend or revoke a license issued pursuant
to this section on any ground specified in Section 4301.
(d) A license issued under this section is dependent on the
validity of the holder’s paramedic license and shall be
automatically suspended if the individual’s paramedic license is
expired, revoked, or otherwise invalidated by the issuing
authority.
(e) The fee for application and issuance of an initial license as a
designated paramedic shall be one hundred forty dollars ($140)
for a two-year license. The biennial renewal shall be one hundred
forty dollars ($140). The penalty fee for failure to renew an
authorized paramedic license shall be sixty-five dollars ($65).
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4202.6. Denial of Federal Registration to Distribute Controlled
Substances
Notwithstanding Section 480, the board may deny an application
for licensure under this chapter if the applicant has been
convicted of a crime or subjected to formal discipline that would
be grounds for denial of a federal registration to distribute
controlled substances.
4203. Non-Profit Clinic License Application: Form; Investigation
(a) Each application for a license under Section 4180 shall be
made on a form furnished by the board. The form of application
for a license under Section 4180 shall contain the name and
address of the applicant, whether the applicant is licensed as a
primary care clinic as defined in this code, the name of its
professional director, the name of its administrator, and the
name of its consulting pharmacist.
(b) Upon the filing of the application and payment of the fee
prescribed in subdivision (s) of Section 4400, the board shall
make a thorough investigation to determine whether the
applicant and the premises for which application for a permit is
made qualify for a license. The board shall also determine
whether this article has been complied with, and shall investigate
all matters directly related to the issuance of the license. The
board shall not, however, investigate any matters connected with
the operation of a premises, including operating hours, parking
availability, or operating noise, except those matters relating to
the furnishing, sale, or dispensing of drugs or devices. The board
shall deny an application for a license if either the applicant or
the premises for which application for a license is made do not
qualify for a license under this article.
(c) If the board determines that the applicant and the premises
for which application for a license is made qualify for a license
under this article, the executive officer of the board shall issue a
license authorizing the clinic to which it is issued to purchase
drugs at wholesale pursuant to Section 4180. The license shall be
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renewed annually on or before December 31 of each year upon
payment of the renewal fee prescribed in subdivision (s) of
Section 4400 and shall not be transferable.
4203.5. Clinic Application
(a) Notwithstanding any other law, when a clinic applicant
submits either type of application described in subdivision (b),
the board shall issue a license or incorporate the reported
changes, as appropriate, within 30 days of receipt of a completed
application and payment of any prescribed fees.
(b) This section applies to the following types of applications:
(1) A new clinic license application filed under Section 4180.
(2) Applications to report changes to an existing site licensed
under Section 4180, including, but not limited to, changes in
professional director, clinic administrator, corporate officers,
change of location, or change of address.
(c) This section shall not be construed to limit the board’s
authority to conduct an investigation to determine whether
applicants and the premises for which an application is made
qualify for a license.
4203.6. Correctional Clinics: License Application
(a) Each application for a license as a correctional clinic under
Article 13.5 (commencing with Section 4187) shall be made on a
form furnished by the board. The application form shall contain
the name and address of the applicant, the name of its chief
executive officer, as defined in Section 4187, and the name of the
pharmacist-in-charge of the correctional pharmacy that provides
drugs to the clinic.
(b) Upon the filing of the application and payment of the fee
prescribed in Section 4400, where applicable, the board shall
make a thorough investigation to determine whether the
applicant and the premises for which application for a license is
made qualify for licensure. The board shall also determine
whether this article has been complied with and shall investigate
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all matters directly related to the issuance of the license. The
board shall not, however, investigate any matters connected with
the operation of a premises, including, but not limited to,
operating hours, parking availability, or operating noise, except
those matters relating to the furnishing or dispensing of drugs or
devices. The board shall deny an application for a license if either
the applicant or the premises for which application for a license is
made does not qualify for a license under this article.
(c) If the board determines that the applicant and the premises
for which application for a license is made qualify for a license
under this article, the executive officer of the board shall issue a
license authorizing the correctional clinic to which it is issued to
obtain drugs pursuant to Article 13.5 (commencing with Section
4187). The license shall be renewed annually on or before
December 31 of each year upon payment of the renewal fee
prescribed in Section 4400, if applicable. A license shall not be
transferable.
4204. Surgical Clinic Application: Form; Investigation
(a) Each application for a license under Section 4190 shall be
made on a form furnished by the board. The form of application
for a license under this article shall contain the name and address
of the applicant, whether the applicant is licensed, the type of
services the facility will offer, the name of its professional
director, the name of its administrator, and the name of its
consulting pharmacist.
(b) Each initial application shall contain a statement from a
consulting pharmacist certifying that the policies and procedures
of the clinic's drug distribution service, relative to inventories,
security procedures, training, protocol development,
recordkeeping, packaging, labeling, dispensing, and patient
consultation are consistent with the promotion and protection of
health and safety of the public. Upon the filing of the application
and the payment of a fee in subdivision (s) of Section 4400, the
board shall make a thorough investigation to determine whether
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the applicant and the premises for which application for a license
is made qualify for a license. The board shall also determine
whether this article has been complied with, and shall investigate
all matters directly related to the issuance of the license. The
board shall not however, investigate any matters connected with
the operation of a premises, including operating hours, parking
availability, or operating noise, except those matters relating to
the furnishing, sale, or dispensing of drugs or devices. The board
shall deny an application for a license if either the applicant or
the premises for which application for a license is made do not
qualify for a license under this article.
(c) If the board determines that the applicant and the premises
for which application for a license is made qualify for a license
under Section 4190, the executive officer of the board shall issue
a license authorizing the clinic to which it is issued to purchase
drugs at wholesale pursuant to Section 4190. The license shall be
renewed annually upon payment of a renewal fee prescribed in
subdivision (s) of Section 4400 and shall not be transferable.
4205. Sale or Dispensing of Hypodermic Syringes and Needles:
When Separate License Required; Form and Content of
Application; Renewability; Discipline
(a) A license issued pursuant to Section 4110, 4120, 4160, or
4161 shall be considered a license within the meaning of Section
4141.
(b) The board may, in its discretion, issue a license to any person
authorizing the sale and dispensing of hypodermic syringes and
needles for animal use.
(c) The application for a license shall be made in writing on a
form to be furnished by the board. The board may require any
information as the board deems reasonably necessary to carry
out the purposes of Article 9 (commencing with Section 4140) of
this chapter.
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(d) A separate license shall be required for each of the premises
of any person who sells or dispenses hypodermic syringes or
needles at more than one location.
(e) A license shall be renewed annually and shall not be
transferable.
(f) The board may deny, revoke, or suspend any license issued
pursuant to this article for any violation of this chapter.
4207. Investigation by Board
(a) Upon receipt of an application for a license and the
applicable fee, the board shall make a thorough investigation to
determine whether the applicant is qualified for the license being
sought. The board shall also determine whether this article has
been complied with, and shall investigate all matters directly
related to the issuance of the license that may affect the public
welfare.
(b) The board shall not investigate matters connected with the
operation of a premises other than those matters solely related
to the furnishing of dangerous drugs or dangerous devices that
might adversely affect the public welfare.
(c) The board shall deny an application for a license if the
applicant does not qualify for the license being sought.
(d) Notwithstanding any other provision of law, the board may
request any information it deems necessary to complete the
application investigation required by this section, and a request
for information that the board deems necessary in carrying out
this section in any application or related form devised by the
board shall not be required to be adopted by regulation pursuant
to the Administrative Procedure Act (Chapter 3.5 (commencing
with Section 11340) of Part 1 of Division 3 of Title 2 of the
Government Code).
4208. Intern Pharmacist License
(a) At the discretion of the board, an intern pharmacist license
may be issued for a period of:
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(1) One to six years to a person who is currently enrolled in a
school of pharmacy recognized by the board.
(2) Two years to a person who is a graduate of a school of
pharmacy recognized by the board and who has applied to
become licensed as a pharmacist in California.
(3) Two years to a foreign graduate who has met educational
requirements described in paragraphs (1) and (2) of subdivision
(a) of Section 4200.
(4) One year to a person who has failed the pharmacist licensure
examination four times and has reenrolled in a school of
pharmacy to satisfy the requirements of Section 4200.1.
(b) The board may issue an intern pharmacist license to an
individual for the period of time specified in a decision of
reinstatement adopted by the board.
(c) An intern pharmacist shall notify the board within 30 days of
any change of address.
(d) An intern pharmacist whose license has been issued
pursuant to paragraph (1) or (4) of subdivision (a) shall return his
or her license, by registered mail, within 30 days of no longer
being enrolled in a school of pharmacy. The intern pharmacist
license shall be canceled by the board. Notwithstanding
subdivision (c), an intern pharmacist license may be reinstated if
the student reenrolls in a school of pharmacy recognized by the
board to fulfill the education requirements of paragraphs (1) to
(4), inclusive, of subdivision (a) of Section 4200.
(e) A person who has not completed the experience
requirements necessary to be eligible for the licensure
examination may have his or her intern license extended for a
period of up to two years at the discretion of the board if he or
she is able to demonstrate his or her inability to exercise the
privileges of the intern license during the initial license period.
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4209. Intern Pharmacist; Minimum Hours of Practice to Apply
for Pharmacist Exam
(a) (1) An intern pharmacist shall complete 1,500 hours of
pharmacy practice experience before applying for the pharmacist
licensure examination.
(2) This pharmacy practice experience shall comply with the
Standards of Curriculum established by the Accreditation Council
for Pharmacy Education (ACPE) or with regulations adopted by
the board.
(3) This pharmacy practice experience shall include 900 hours of
pharmacy practice experience in a pharmacy as a pharmacist and
shall include pharmacy practice experience in both a community
and institutional pharmacy practice setting.
(b) An intern pharmacist shall submit proof of his or her
pharmacy practice experience on board-approved affidavits, or
another form specified by the board, which shall be certified
under penalty of perjury by a pharmacist under whose
supervision the experience was obtained or by the pharmacist-in-
charge at the pharmacy while the pharmacist intern obtained the
experience. Pharmacy practice experience earned in another
state may be certified by the licensing agency of that state to
document proof of those hours.
(c) An applicant for the examination who has been licensed as a
pharmacist in any state for at least one year, as certified by the
licensing agency of that state, may submit this certification to
satisfy the required 1,500 hours of pharmacy practice experience,
provided that the applicant has obtained a minimum of 900
hours of pharmacy practice experience in a pharmacy as a
pharmacist and has pharmacy practice experience in both a
community and institutional pharmacy practice setting.
Certification of an applicant’s licensure in another state shall be
submitted in writing and signed, under oath, by a duly authorized
official of the state in which the license is held.
(d) An applicant for the examination who has graduated after
January 1, 2016, from an ACPE accredited college of pharmacy or
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school of pharmacy recognized by the board shall be deemed to
have satisfied the pharmacy practice experience requirements
specified in subdivisions (a) and (b).
(Amended by Stats. 2015, Ch. 147, Sec. 1. Effective January 1,
2016.)
4210. Advanced Practice Pharmacist License
(a) A person who seeks recognition as an advanced practice
pharmacist shall meet all of the following requirements:
(1) Hold an active license to practice pharmacy issued pursuant
to this chapter that is in good standing.
(2) (A) Satisfy any two of the following criteria:
(i) Earn certification in a relevant area of practice, including, but
not limited to, ambulatory care, critical care, geriatric pharmacy,
nuclear pharmacy, nutrition support pharmacy, oncology
pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric
pharmacy, from an organization recognized by the Accreditation
Council for Pharmacy Education or another entity recognized by
the board.
(ii) Complete a postgraduate residency through an accredited
postgraduate institution where at least 50 percent of the
experience includes the provision of direct patient care services
with interdisciplinary teams.
(iii) Have provided clinical services to patients for at least one
year under a collaborative practice agreement or protocol with a
physician, advanced practice pharmacist, pharmacist practicing
collaborative drug therapy management, or health system.
(B) For purposes of this paragraph, if, as a condition of
completion of one of the required criteria fulfillment of a second
criterion is also required, that completion shall be deemed to
satisfy this paragraph.
(3) File an application with the board for recognition as an
advanced practice pharmacist.
(4) Pay the applicable fee to the board.
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(b) An advanced practice pharmacist recognition issued pursuant
to this section shall be valid for two years, coterminous with the
certificate holder’s license to practice pharmacy.
(c) The board shall adopt regulations establishing the means of
documenting completion of the requirements in this section.
(d) The board shall, by regulation, set the fee for the issuance and
renewal of advanced practice pharmacist recognition at the
reasonable cost of regulating advanced practice pharmacists
pursuant to this chapter. The fee shall not exceed three hundred
dollars ($300).
4211. Advanced Practice Pharmacist; License Renewal; Placed
on Inactive Status by Board
(a) An applicant for renewal of an advanced practice pharmacist
recognition shall maintain a current and active pharmacist
license, and shall submit all of the following as part of the
renewal:
(1) Application and payment of the renewal fees.
(2) (A) Proof satisfactory to the board that the licensee has
completed 10 hours of continuing education pursuant to Section
4233.
(B) The 10 hours shall be in addition to the continuing education
requirements necessary for a pharmacist license renewal
pursuant to Section 4231.
(C) An advanced practice pharmacist shall retain documentation
of completion of continuing education for four years.
(b) Notwithstanding subdivision (a), the board shall not require
completion of continuing education for the first renewal cycle of
an advanced practice pharmacist recognition.
(c) The board may issue an inactive advanced practice
pharmacist recognition under any of the following conditions:
(1) The pharmacist’s license becomes inactive.
(2) The advanced practice pharmacist fails to provide
documentation of the completion of the required continuing
education.
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(3) As part of an investigation or audit conducted by the board,
the advanced practice pharmacist fails to provide documentation
substantiating the completion of continuing education.
(d) The board shall reactivate an inactive advanced practice
pharmacist recognition only if the advanced practice pharmacist
pays the required renewal fees pursuant to Section 4210,
submits satisfactory proof to the board of completion of the
continuing education requirements under Section 4233, and
meets all renewal requirements in this section.
Article 17. Continuing Education
4231. Requirements for Renewal of Pharmacist License: Clock
Hours; Exemption for New Licensee
(a) The board shall not renew a pharmacist license unless the
applicant submits proof satisfactory to the board that he or she
has successfully completed 30 hours of approved courses of
continuing pharmacy education during the two years preceding
the application for renewal.
(b) Notwithstanding subdivision (a), the board shall not require
completion of continuing education for the first renewal of a
pharmacist license.
(c) If an applicant for renewal of a pharmacist license submits
the renewal application and payment of the renewal fee but does
not submit proof satisfactory to the board that the licensee has
completed 30 hours of continuing pharmacy education, the
board shall not renew the license and shall issue the applicant an
inactive pharmacist license. A licensee with an inactive
pharmacist license issued pursuant to this section may obtain an
active pharmacist license by paying the renewal fees due and
submitting satisfactory proof to the board that the licensee has
completed 30 hours of continuing pharmacy education.
(d) If, as part of an investigation or audit conducted by the
board, a pharmacist fails to provide documentation
substantiating the completion of continuing education as
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required in subdivision (a), the board shall cancel the active
pharmacist license and issue an inactive pharmacist license in its
place. A licensee with an inactive pharmacist license issued
pursuant to this section may obtain an active pharmacist license
by paying the renewal fees due and submitting satisfactory proof
to the board that the licensee has completed 30 hours of
continuing pharmacy education.
4232. Content of Courses
(a) The courses shall be in the form of postgraduate studies,
institutes, seminars, lectures, conferences, workshops, extension
studies, correspondence courses, and other similar methods of
conveying continuing professional pharmacy education.
(b) The subject matter shall be pertinent to the socioeconomic
and legal aspects of health care, the properties and actions of
drugs and dosage forms and the etiology, and characteristics and
therapeutics of the disease state.
(c) The subject matter of the courses may include, but shall not
be limited to, the following: pharmacology, biochemistry,
physiology, pharmaceutical chemistry, pharmacy administration,
pharmacy jurisprudence, public health and communicable
diseases, professional practice management, anatomy, histology,
and any other subject matter as represented in curricula of
accredited colleges of pharmacy.
4232.5. Continuing Education Requirement for Prescribing
Schedule II Controlled Substances
(a) A pharmacist who, pursuant to any authority of this chapter,
prescribes a Schedule II controlled substance, shall have
completed an education course on the risks of addiction
associated with the use of Schedule II drugs.
(b) A pharmacist who has completed such a course within the last
four years shall be deemed to have satisfied this requirement.
(c) This section shall become operative July 1, 2022.
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4233. Advanced Practice Pharmacist; Continuing Education
Requirement
A pharmacist who is recognized as an advanced practice
pharmacist shall complete 10 hours of continuing education each
renewal cycle in addition to the requirements of Section 4231.
The subject matter shall be in one or more areas of practice
relevant to the pharmacist’s clinical practice.
4234. Exceptions: Emergencies; Hardship
The board may, in accordance with the intent of this article,
make exceptions from the requirements of this article in
emergency or hardship cases.
Article 18. Poisons
4240. California Hazardous Substances Act; Application of Act
(a) The California Hazardous Substances Act, Chapter 4
(commencing with Section 108100) of Part 3 of Division 104 of
the Health and Safety Code, applies to pharmacies and
pharmacists and any other person or place subject to the
jurisdiction of the board.
(b) The board may enforce that act when necessary for the
protection of the health and safety of the public if prior
regulatory notice is given in accordance with the rulemaking
provisions of the Administrative Procedure Act (Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2
of the Government Code). Board enforcement shall focus on
those hazardous substances that relate significantly to or overlap
the practice of pharmacy.
(c) "Poison" as used in this chapter refers to a category of
hazardous substances defined in Section 108125 of the Health
and Safety Code. The board may by regulation make the
category more specific.
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Article 19. Disciplinary Proceedings
4300. Revocation and Suspension: Authority; Conditions;
Issuance of Probationary License; Application of Administrative
Procedure Act; Judicial Review
(a) Every license issued may be suspended or revoked.
(b) The board shall discipline the holder of any license issued by
the board, whose default has been entered or whose case has
been heard by the board and found guilty, by any of the following
methods:
(1) Suspending judgment.
(2) Placing him or her upon probation.
(3) Suspending his or her right to practice for a period not
exceeding one year.
(4) Revoking his or her license.
(5) Taking any other action in relation to disciplining him or her
as the board in its discretion may deem proper.
(c) The board may refuse a license to any applicant guilty of
unprofessional conduct. The board may, in its sole discretion,
issue a probationary license to any applicant for a license who is
guilty of unprofessional conduct and who has met all other
requirements for licensure. The board may issue the license
subject to any terms or conditions not contrary to public policy,
including, but not limited to, the following:
(1) Medical or psychiatric evaluation.
(2) Continuing medical or psychiatric treatment.
(3) Restriction of type or circumstances of practice.
(4) Continuing participation in a board-approved rehabilitation
program.
(5) Abstention from the use of alcohol or drugs.
(6) Random fluid testing for alcohol or drugs.
(7) Compliance with laws and regulations governing the practice
of pharmacy.
(d) The board may initiate disciplinary proceedings to revoke or
suspend any probationary certificate of licensure for any
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violation of the terms and conditions of probation. Upon
satisfactory completion of probation, the board shall convert the
probationary certificate to a regular certificate, free of
conditions.
(e) The proceedings under this article shall be conducted in
accordance with Chapter 5 (commencing with Section 11500) of
Part 1 of Division 3 of the Government Code, and the board shall
have all the powers granted therein. The action shall be final,
except that the propriety of the action is subject to review by the
superior court pursuant to Section 1094.5 of the Code of Civil
Procedure.
4300.1. Board Authority to Render a Decision on a License
The expiration, cancellation, forfeiture, or suspension of a
board-issued license by operation of law or by order or decision
of the board or a court of law, the placement of a license on a
retired status, or the voluntary surrender of a license by a
licensee shall not deprive the board of jurisdiction to commence
or proceed with any investigation of, or action or disciplinary
proceeding against, the licensee or to render a decision
suspending or revoking the license.
4301. Obtaining License by Fraud or Misrepresentation;
Unprofessional Conduct
The board shall take action against any holder of a license who
is guilty of unprofessional conduct or whose license has been
issued by mistake. Unprofessional conduct shall include, but is
not limited to, any of the following:
(a) Procurement of a license by fraud or misrepresentation.
(b) Incompetence.
(c) Gross negligence.
(d) The clearly excessive furnishing of controlled substances in
violation of subdivision (a) of Section 11153 of the Health and
Safety Code.
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(e) The clearly excessive furnishing of controlled substances in
violation of subdivision (a) of Section 11153.5 of the Health and
Safety Code. Factors to be considered in determining whether
the furnishing of controlled substances is clearly excessive shall
include, but not be limited to, the amount of controlled
substances furnished, the previous ordering pattern of the
customer (including size and frequency of orders), the type and
size of the customer, and where and to whom the customer
distributes its product.
(f) The commission of any act involving moral turpitude,
dishonesty, fraud, deceit, or corruption, whether the act is
committed in the course of relations as a licensee or otherwise,
and whether the act is a felony or misdemeanor or not.
(g) Knowingly making or signing any certificate or other
document that falsely represents the existence or nonexistence
of a state of facts.
(h) The administering to oneself, of any controlled substance, or
the use of any dangerous drug or of alcoholic beverages to the
extent or in a manner as to be dangerous or injurious to oneself,
to a person holding a license under this chapter, or to any other
person or to the public, or to the extent that the use impairs the
ability of the person to conduct with safety to the public the
practice authorized by the license.
(i) Except as otherwise authorized by law, knowingly selling,
furnishing, giving away, or administering, or offering to sell,
furnish, give away, or administer, any controlled substance to an
addict.
(j) The violation of any of the statutes of this state, of any other
state, or of the United States regulating controlled substances
and dangerous drugs.
(k) The conviction of more than one misdemeanor or any felony
involving the use, consumption, or self-administration of any
dangerous drug or alcoholic beverage, or any combination of
those substances.
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(l) The conviction of a crime substantially related to the
qualifications, functions, and duties of a licensee under this
chapter. The record of conviction of a violation of Chapter 13
(commencing with Section 801) of Title 21 of the United States
Code regulating controlled substances or of a violation of the
statutes of this state regulating controlled substances or
dangerous drugs shall be conclusive evidence of unprofessional
conduct. In all other cases, the record of conviction shall be
conclusive evidence only of the fact that the conviction occurred.
The board may inquire into the circumstances surrounding the
commission of the crime, in order to fix the degree of discipline
or, in the case of a conviction not involving controlled substances
or dangerous drugs, to determine if the conviction is of an
offense substantially related to the qualifications, functions, and
duties of a licensee under this chapter. A plea or verdict of guilty
or a conviction following a plea of nolo contendere is deemed to
be a conviction within the meaning of this provision. The board
may take action when the time for appeal has elapsed, or the
judgment of conviction has been affirmed on appeal or when an
order granting probation is made suspending the imposition of
sentence, irrespective of a subsequent order under Section
1203.4 of the Penal Code allowing the person to withdraw his or
her plea of guilty and to enter a plea of not guilty, or setting aside
the verdict of guilty, or dismissing the accusation, information, or
indictment.
(m) The cash compromise of a charge of violation of Chapter 13
(commencing with Section 801) of Title 21 of the United States
Code regulating controlled substances or of Chapter 7
(commencing with Section 14000) of Part 3 of Division 9 of the
Welfare and Institutions Code relating to the Medi-Cal program.
(n) The revocation, suspension, or other discipline by another
state of a license to practice pharmacy, operate a pharmacy, or
do any other act for which a license is required by this chapter
that would be grounds for revocation, suspension, or other
discipline under this chapter. Any disciplinary action taken by the
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board pursuant to this section shall be coterminous with action
taken by another state, except that the term of any discipline
taken by the board may exceed that of another state, consistent
with the board’s enforcement guidelines. The evidence of
discipline by another state is conclusive proof of unprofessional
conduct.
(o) Violating or attempting to violate, directly or indirectly, or
assisting in or abetting the violation of or conspiring to violate
any provision or term of this chapter or of the applicable federal
and state laws and regulations governing pharmacy, including
regulations established by the board or by any other state or
federal regulatory agency.
(p) Actions or conduct that would have warranted denial of a
license.
(q) Engaging in any conduct that subverts or attempts to subvert
an investigation of the board.
(r) The selling, trading, transferring, or furnishing of drugs
obtained pursuant to Section 256b of Title 42 of the United
States Code to any person a licensee knows or reasonably should
have known, not to be a patient of a covered entity, as defined in
paragraph (4) of subsection (a) of Section 256b of Title 42 of the
United States Code.
(s) The clearly excessive furnishing of dangerous drugs by a
wholesaler to a pharmacy that primarily or solely dispenses
prescription drugs to patients of long-term care facilities. Factors
to be considered in determining whether the furnishing of
dangerous drugs is clearly excessive shall include, but not be
limited to, the amount of dangerous drugs furnished to a
pharmacy that primarily or solely dispenses prescription drugs to
patients of long-term care facilities, the previous ordering
pattern of the pharmacy, and the general patient population to
whom the pharmacy distributes the dangerous drugs. That a
wholesaler has established, and employs, a tracking system that
complies with the requirements of subdivision (b) of Section
4164 shall be considered in determining whether there has been
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a violation of this subdivision. This provision shall not be
interpreted to require a wholesaler to obtain personal medical
information or be authorized to permit a wholesaler to have
access to personal medical information except as otherwise
authorized by Section 56 and following of the Civil Code. For
purposes of this section, “long-term care facility” has the same
meaning given the term in Section 1418 of the Health and Safety
Code.
(t) The acquisition of a nonprescription diabetes test device
from a person that the licensee knew or should have known was
not the nonprescription diabetes test device’s manufacturer or
the manufacturer’s authorized distributor as identified in Section
4160.5.
(u) The submission of a reimbursement claim for a
nonprescription diabetes test device to a pharmaceutical benefit
manager, health insurer, government agency, or other third-
party payor when the licensee knew or reasonably should have
known that the diabetes test device was not purchased either
directly from the manufacturer or from the nonprescription
diabetes test device manufacturer’s authorized distributors as
identified in Section 4160.5.
4301.1. Investigation Priority - Greatest Threat of Patient Harm
In order to ensure that the board’s resources are maximized for
the protection of the public health and safety, the board shall
prioritize its investigative and prosecutorial resources to ensure
that pharmacists representing the greatest threat of patient
harm are identified and disciplined expeditiously.
4301.3. Workgroup and Report to Legislature on Standard of
Care Enforcement Model
(a) On or before July 1, 2023, the board shall convene a
workgroup of interested stakeholders to discuss whether moving
to a standard of care enforcement model would be feasible and
appropriate for the regulation of pharmacy and make
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recommendations to the Legislature about the outcome of these
discussions through a report submitted pursuant to Section 9795
of the Government Code.
(b) This section shall remain in effect only until January 1, 2024,
and as of that date is repealed.
4301.5. Pharmacist License; Out-of-State Suspension or
Revocation to Apply to California License
(a) If a pharmacist possesses a license or is otherwise authorized
to practice pharmacy in any other state or by an agency of the
federal government, and that license or authority is suspended or
revoked, the pharmacist's license shall be suspended
automatically for the duration of the suspension or revocation,
unless terminated or rescinded as provided in subdivision (c). The
board shall notify the pharmacist of the license suspension and of
his or her right to have the issue of penalty heard as provided in
this section.
(b) Upon its own motion or for good cause shown, the board
may decline to impose or may set aside the suspension when it
appears to be in the interest of justice to do so, with due regard
to maintaining the integrity of and confidence in the pharmacy
profession.
(c) The issue of penalty shall be heard by an administrative law
judge sitting alone, by a committee of the board sitting with an
administrative law judge, or by the board sitting with an
administrative law judge, at the board's discretion. A pharmacist
may request a hearing on the penalty and that hearing shall be
held within 90 days from the date of the request. If the order
suspending or revoking the pharmacist's license or authority to
practice pharmacy is overturned on appeal, any discipline
ordered pursuant to this section shall automatically cease. Upon
the showing to the administrative law judge, board, or
committee of the board by the pharmacist that the out-of-state
action is not a basis for discipline in California, the suspension
shall be rescinded.
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If an accusation for permanent discipline is not filed within
90 days of the suspension imposed pursuant to this section, the
suspension shall automatically terminate.
(d) The record of the proceedings that resulted in the
suspension or revocation of the pharmacist's license or authority
to practice pharmacy, including a transcript of the testimony
therein, may be received in evidence.
(e) If a summary suspension has been issued pursuant to this
section, the pharmacist may request that the hearing on the
penalty conducted pursuant to subdivision (c) be held at the
same time as a hearing on the accusation.
4302. Discipline of Corporate Licensee for Conduct of Officer,
Director, Shareholder
The board may deny, suspend, or revoke any license where
conditions exist in relation to any person holding 10 percent or
more of the ownership interest, or where conditions exist in
relation to any officer, director, or other person with
management or control of the license that would constitute
grounds for disciplinary action against a licensee.
4303. Nonresident Pharmacy: Grounds for Discipline
(a) The board may report any violation by a nonresident
pharmacy of the laws and regulations of this state, any other
state, or of the United States, including, but not limited to, any
violation of this chapter or of the regulations established by the
board, to any appropriate state or federal regulatory or licensing
agency, including, but not limited to, the regulatory or licensing
agency of the state in which the nonresident pharmacy is a
resident or in which the pharmacist is licensed.
(b) The board may cancel, deny, revoke, or suspend a
nonresident pharmacy registration, issue a citation or letter of
admonishment to a nonresident pharmacy, or take any other
action against a nonresident pharmacy that the board may take
against a resident pharmacy license, on any of the same grounds
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upon which such action might be taken against a resident
pharmacy, provided that the grounds for the action are also
grounds for action in the state in which the nonresident
pharmacy is permanently located.
(c) If the home state pharmacy license of a nonresident
pharmacy is canceled, revoked, or suspended for any reason, any
license issued pursuant to Section 4112 or 4127.2 shall be
immediately canceled, revoked, or suspended by operation of
law.
4303.1. Outsourcing Facility - License Canceled, Revoked or
Suspended by Operation of Law
If the federal Food and Drug Administration (FDA) cancels,
revokes, or suspends an outsourcing facility’s registration for any
reason, any license issued pursuant to Section 4129.2 shall be
immediately canceled, revoked, or suspended by operation of
law.
4304. Nonresident Wholesaler; Authority to Discipline
The board may deny, revoke, or suspend any license issued
pursuant to Section 4161 for any violation of this chapter or for
any violation of Part 5 (commencing with Section 109875) of
Division 104 of the Health and Safety Code.
4305. Disciplinary Grounds: Failure of Pharmacy or Pharmacist
to Notify Board of Termination of Pharmacist-in-Charge;
Continuing to Operate Without Pharmacist
(a) Failure by any pharmacist to notify the board in writing that
he or she has ceased to act as the pharmacist-in-charge of a
pharmacy, or by any pharmacy to notify the board in writing that
a pharmacist-in-charge is no longer acting in that capacity, within
the 30-day period specified in Sections 4101 and 4113 shall
constitute grounds for disciplinary action.
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(b) Operation of a pharmacy for more than 30 days without
supervision or management by a pharmacist-in-charge shall
constitute grounds for disciplinary action.
(c) Any person who has obtained a license to conduct a
pharmacy, who willfully fails to timely notify the board that the
pharmacist-in-charge of the pharmacy has ceased to act in that
capacity, and who continues to permit the compounding or
dispensing of prescriptions, or the furnishing of drugs or poisons,
in his or her pharmacy, except by a pharmacist subject to the
supervision and management of a responsible pharmacist-in-
charge, shall be subject to summary suspension or revocation of
his or her license to conduct a pharmacy.
4305.5. Disciplinary Grounds: Failure of Wholesaler, Veterinary
Food-Animal Drug Retailer or Third-Party Logistics Provider to
Notify Board of Termination of Designated Representative-in-
Charge or Responsible Manager; Continuing to Operate Without
Designated Representative-in-Charge or Responsible Manager
(a) A person that is licensed as a wholesaler, third-party logistics
provider, or veterinary food-animal drug retailer, shall notify the
board within 30 days of the termination of employment of the
designated representative-in-charge or responsible manager.
Failure to notify the board within the 30-day period shall
constitute grounds for disciplinary action.
(b) A person that is licensed as a wholesaler, third-party logistics
provider, or veterinary food-animal drug retailer, that willfully
fails to notify the board of the termination of employment of the
designated representative-in-charge or responsible manager at
its licensed place of business, and that continues to operate the
place of business in the absence of the designated
representative-in-charge or responsible manager for that place of
business shall be subject to summary suspension or revocation of
its license as a wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer at that place of business.
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(c) A designated representative-in-charge of a wholesaler or
veterinary food-animal drug retailer, or a responsible manager of
a third-party logistics provider, who terminates his or her
employment at the licensed place of business, shall notify the
board within 30 days of the termination of employment. Failure
to notify the board within the 30-day period shall constitute
grounds for disciplinary action.
4306. Violation of Professional Corporation Act as
Unprofessional Conduct
It shall constitute unprofessional conduct and a violation of this
chapter for any person licensed under this chapter to violate,
attempt to violate, directly or indirectly, or assist in or abet the
violation of, or conspire to violate, any provision or term of this
article, the Moscone-Knox Professional Corporation Act, or any
regulations duly adopted under those laws.
4306.5. Acts or Omissions by Pharmacist: Unprofessional
Conduct
Unprofessional conduct for a pharmacist may include any of the
following:
(a) Acts or omissions that involve, in whole or in part, the
inappropriate exercise of his or her education, training, or
experience as a pharmacist, whether or not the act or omission
arises in the course of the practice of pharmacy or the
ownership, management, administration, or operation of a
pharmacy or other entity licensed by the board.
(b) Acts or omissions that involve, in whole or in part, the failure
to exercise or implement his or her best professional judgment or
corresponding responsibility with regard to the dispensing or
furnishing of controlled substances, dangerous drugs, or
dangerous devices, or with regard to the provision of services.
(c) Acts or omissions that involve, in whole or in part, the failure
to consult appropriate patient, prescription, and other records
pertaining to the performance of any pharmacy function.
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(d) Acts or omissions that involve, in whole or in part, the failure
to fully maintain and retain appropriate patient-specific
information pertaining to the performance of any pharmacy
function.
4306.6. Mitigating Factors for Pharmacist-in-Charge Reporting
Violations of Others
If the board disciplines a pharmacist-in-charge for the violation
of a state or federal law or regulation committed by another
person and the pharmacist-in-charge reported to the board that
violation or suspected violation, the board shall use the report as
a mitigating factor if all of the following conditions are met:
(a) The pharmacist-in-charge did not engage, either directly or
indirectly, in any conduct that violated any state or federal law or
regulation pertaining to the practice of pharmacy.
(b) The pharmacist-in-charge did not permit, encourage,
approve of, either tacitly or implicitly or through willful
ignorance, any conduct committed by another person that
violated state or federal law or regulation pertaining to the
practice of pharmacy.
(c) The pharmacist-in-charge reported the violation, or
suspected violation, of any state or federal law or regulation
pertaining to the practice of pharmacy to the board as soon as
reasonably possible following the discovery of the violation.
(d) The pharmacist-in-charge took all actions reasonably
necessary to stop and remedy the violation, or suspected
violation, of any state or federal law or regulation pertaining to
the practice of pharmacy as soon as reasonably possible
following the discovery of the violation.
4307. Individuals with Denied, Revoked, Suspended, etc.
Licenses Prohibited From Pharmacy Ownership or Association
with Board Licensed Entities
(a) Any person who has been denied a license or whose license
has been revoked or is under suspension, or who has failed to
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renew his or her license while it was under suspension, or who
has been a manager, administrator, owner, member, officer,
director, associate, partner, or any other person with
management or control of any partnership, corporation, trust,
firm, or association whose application for a license has been
denied or revoked, is under suspension or has been placed on
probation, and while acting as the manager, administrator,
owner, member, officer, director, associate, partner, or any other
person with management or control had knowledge of or
knowingly participated in any conduct for which the license was
denied, revoked, suspended, or placed on probation, shall be
prohibited from serving as a manager, administrator, owner,
member, officer, director, associate, partner, or in any other
position with management or control of a licensee as follows:
(1) Where a probationary license is issued or where an existing
license is placed on probation, this prohibition shall remain in
effect for a period not to exceed five years.
(2) Where the license is denied or revoked, the prohibition shall
continue until the license is issued or reinstated.
(b) "Manager, administrator, owner, member, officer, director,
associate, partner, or any other person with management or
control of a license” as used in this section and Section 4308, may
refer to a pharmacist or to any other person who serves in such
capacity in or for a licensee.
(c) The provisions of subdivision (a) may be alleged in any
pleading filed pursuant to Chapter 5 (commencing with Section
11500) of Part 1 of Division 3 of the Government Code. However,
no order may be issued in that case except as to a person who is
named in the caption, as to whom the pleading alleges the
applicability of this section, and where the person has been given
notice of the proceeding as required by Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of the Government
Code. The authority to proceed as provided by this subdivision
shall be in addition to the board's authority to proceed under
Section 4339 or any other provision of law.
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4308. Prohibited Association: Notification of Affected Licensees
Known to Board
Whenever a person is prohibited from serving as a manager,
administrator, owner, member, officer, director, associate,
partner, or in any other position of management or control of a
licensee as provided by Section 4307, the board shall, in each
case where it has that information, notify in writing each licensee
for whom the person is a manager, administrator, owner,
member, officer, director, associate, partner, or in any other
position with management or control of the prohibition. The
board shall send the notification to the licensee's address of
record. The licensee shall have 30 days from the date that the
notice is sent to remove and replace the prohibited person and,
where appropriate, file a change of permit to reflect that change.
4309. Petition for Reinstatement, etc. of Disciplined License:
Time for Filing; Contents; Investigation; Hearing; Factors to be
Considered; Effect of Ongoing Criminal Sentence, Accusation, or
Petition to Revoke Probation
(a) A person whose license has been revoked or suspended or
who has been placed on probation may petition the board for
reinstatement or modification of penalty, including modification
or termination of probation, after not less than the following
minimum periods have elapsed from the effective date of the
decision ordering disciplinary action:
(1) At least three years for reinstatement of a revoked license.
(2) At least two years for early termination of probation of three
years or more.
(3) At least one year for modification of a condition, or
reinstatement of a license revoked for mental or physical illness,
or termination of probation of less than three years.
(b) The petition shall state any facts required by the board, and
the petition shall be accompanied by two or more verified
recommendations from holders of licenses issued by the board to
which the petition is addressed, and two or more
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recommendations from citizens, each having personal knowledge
of the disciplinary penalty imposed by the board and the
activities of the petitioner since the disciplinary penalty was
imposed.
(c) The petition may be heard by the board sitting with an
administrative law judge, or a committee of the board sitting
with an administrative law judge, or the board may assign the
petition to an administrative law judge. Where the petition is
heard by a committee of the board sitting with an administrative
law judge or by an administrative law judge sitting alone, the
decision shall be subject to review by the board pursuant to
Section 11517 of the Government Code.
(d) In considering reinstatement or modification of penalty, the
board, committee of the board, or the administrative law judge
hearing the petition may consider factors including, but not
limited to, all of the following:
(1) All the activities of the petitioner since the disciplinary action
was taken.
(2) The offense for which the petitioner was disciplined.
(3) The petitioner's activities during the time the license was in
good standing.
(4) The petitioner's documented rehabilitative efforts.
(5) The petitioner's general reputation for truth and professional
ability.
(e) The hearing may be continued from time to time as the
board, committee of the board, or the administrative law judge
designated in Section 11371 of the Government Code finds
necessary.
(f) The board, committee of the board, or administrative law
judge may impose necessary terms and conditions on the
licensee in reinstating the license.
(g) No petition under this section shall be considered while the
petitioner is under sentence for any criminal offense, including
any period during which the petitioner is on court-imposed
probation or parole. No petition shall be considered while there
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is an accusation or petition to revoke probation pending against
the person. The board may deny without a hearing or argument
any petition filed pursuant to this section within a period of two
years from the effective date of the prior decision following a
hearing under this section.
(h) Nothing in this section shall be deemed to amend or
otherwise change the effect or application of Sections 822 and
823.
(i) The board may investigate any and all matters pertaining to
the petition and documents submitted with or in connection with
the application.
4310. Notice of Denial of Application: Petition for Licensure;
Application of Administrative Procedure Act
Immediately upon the denial of any application for a license the
board shall notify the applicant in writing. Within 10 days after
the board mails the notice, the applicant may present his or her
written petition for a license to the board. Upon receipt by the
board of the written petition, proceedings shall be conducted in
accordance with Chapter 5 (commencing with Section 11500) of
Part 1 of Division 3 of Title 2 of the Government Code.
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