2022 LAWBOOK FOR PHARMACY - page 8

 

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2022 LAWBOOK FOR PHARMACY - page 8

 

 

4311. Suspension of License for Felony Conviction: Automatic
Suspension; Summary Suspension; Other Suspensions;
Applicable Proceedings
(a) Any license issued by the board, or the holder thereof, shall
be suspended automatically during any time that the person is
incarcerated after conviction of a felony, regardless of whether
the conviction has been appealed. The board, immediately upon
receipt of a certified copy of a record of a criminal conviction,
shall determine whether the person has been automatically
suspended by virtue of incarceration pursuant to a felony
conviction and, if so, the duration of that suspension. The board
shall notify the person so suspended of the suspension and that
the person has a right to request a hearing, solely as to whether
he or she is incarcerated pursuant to a felony conviction, in
writing at that person's address of record with the board and at
the facility in which the person is incarcerated.
(b) In addition to any suspension under subdivision (a), the
board shall summarily suspend any license issued by the board
where a conviction of the holder of the license meets the
requirements of paragraphs (1) and (2).
(1) A felony that was either of the following:
(A) Committed in the course of a business or practice for which
the board issues a license.
(B) Committed in a manner that a client, customer, or patient of
the licensee was a victim.
(2) Where an element of the offense involves either of the
following:
(A) The specific intent to deceive, defraud, steal, or make a false
statement.
(B) The illegal sale or possession for sale of or trafficking in any
controlled substance.
(3) The suspension shall continue until the time for appeal has
elapsed, if no appeal is taken, or until the judgment of conviction
has been affirmed on appeal or has otherwise become final, and
until further order of the board.
280
(4) The board shall immediately send notice in writing of the
suspension to the licensee, or the holder of any other board-
issued license, at his or her address of record and, if incarcerated
at the time, at the facility in which the person is incarcerated.
The notice shall include notification of that person's right to elect
to have the issue of penalty heard as provided in paragraph (2) of
subdivision (d), and of the right to request a hearing to contest
the summary suspension. Any request for a hearing under this
paragraph must be received by the board within 15 days
following receipt of the notice provided for by this paragraph.
(5) The hearing shall be before an administrative law judge, a
committee of the board sitting with an administrative law judge,
or the board sitting with an administrative law judge, at the
board's discretion, and shall be subject to review by the board, at
its discretion. The hearing shall be limited to
(A) whether there
has been a felony conviction as stated in the board's notice, and
(B) whether the conviction meets the criteria of this subdivision,
except where the licensee chooses to proceed as provided by
paragraph (2) of subdivision (d), or where the board has also filed
and served an accusation as provided in Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code and given notice of the hearing as required by
that chapter; provided that if an accusation under Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2
of the Government Code is also to be heard, only an
administrative law judge sitting alone or the board, sitting with
an administrative law judge, may hear the case.
(c) In addition to any suspension under subdivision (a), the
board shall also suspend any license issued by the board, or the
holder thereof, if the board determines that the felony conviction
of the holder of the license is substantially related to the
qualifications, functions, or duties of the licensee.
(1) Notice of the board's determination shall be sent to the
licensee, or the holder thereof, at that person's address of record
with the board and, if the person is incarcerated at the time, the
281
facility in which the person is incarcerated. The notice shall
advise the person that the license shall be suspended without
hearing unless, within 15 days following receipt of the notice, a
written request for hearing is delivered to the board.
(2) Upon receipt of a timely request for hearing, a notice of
hearing shall be sent to the person at least 10 days before the
date scheduled for the hearing. The notice of hearing shall
include notification of that person's right to elect to have the
issue of penalty heard as provided in paragraph (2) of subdivision
(d).
(3) The hearing to determine whether a felony conviction is
substantially related for purposes of an interim suspension under
this subdivision shall be separate from any hearing on an
accusation under the Administrative Procedure Act, except
where the licensee elects to proceed under paragraph (2) of
subdivision (d), or where the board has filed and served an
accusation as provided by Chapter 5 (commencing with Section
11500) of Part 1 of Division 3 of Title 2 of the Government Code
and given notice of hearing as required by that chapter. The
hearing on whether the felony conviction is substantially related
shall be heard either 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, and shall be subject to review by the
board, at its discretion. However, if an accusation under Chapter
5 (commencing with Section 11500) of Part 1 of Division 3 of Title
2 of the Government Code is also to be heard, only an
administrative law judge sitting alone or the board, sitting with
an administrative law judge, may hear the case. Except where a
person proceeds under paragraph (2) of subdivision (d), or the
board proceeds with an accusation at the same time, any
suspension imposed under this subdivision shall continue until an
accusation is filed under Chapter 5 (commencing with Section
11500) of Part 1 of Division 3 of Title 2 of the Government Code
and a final decision is rendered by the board.
282
(4) A conviction of any crime referred to in Section 4301, or for
violation of Section 187, 261, or 288 of the Penal Code, shall be
conclusively presumed to be substantially related to the
qualifications, functions, or duties of a licensee of the board.
Upon its own motion or for good cause shown the board may
decline to impose a suspension under this subdivision or may set
aside a suspension previously imposed 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 practice of pharmacy and
the handling of dangerous drugs and devices.
(d) (1) Discipline may be ordered in accordance with Section
4300 or an application denied when the time for appeal has
elapsed, the judgment of conviction has been affirmed on
appeal, or 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, setting aside the verdict of guilty, or dismissing the
accusation, complaint, information, or indictment.
(2) The issue of penalty shall be heard by an administrative law
judge sitting alone or with a committee of the board or with the
board itself, at the board's discretion, and any decision shall be
subject to review by the board, at its discretion. The hearing
shall not be held until the judgment of conviction has become
final or, irrespective of a subsequent order under Section 1203.4
of the Penal Code, an order granting probation has been made
suspending the imposition of sentence, provided that a licensee
may, at his or her option, elect to have the issue of penalty
decided before those time periods have elapsed. Where the
licensee so elects, the issue of penalty shall be heard in the
manner described in this section at the hearing to determine
whether the conviction was substantially related to the
qualifications, functions, or duties of the licensee. If the
conviction of a licensee who has made this election is overturned
on appeal, any discipline ordered pursuant to this section shall
283
automatically cease. Nothing in this subdivision shall prohibit the
board from pursuing disciplinary action based on any cause,
including the facts underlying the conviction, other than the
overturned conviction.
(3) The record of the proceedings resulting in the criminal
conviction, including a transcript of any testimony taken in
connection with the proceeding, may be received in evidence in
any administrative proceeding to the extent the testimony would
otherwise be admissible under Chapter 5 (commencing with
Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code. A certified copy of the criminal conviction
shall be conclusive proof of the fact of the conviction.
(e) Other provisions of this chapter setting forth procedures for
the suspension or revocation of a license issued by the board
shall not apply to proceedings conducted pursuant to this
section, except as specifically provided in this section.
(f) For purposes of this section, a crime is a felony if it is
specifically declared to be so or is made a felony by subdivision
(a) of Section 17 of the Penal Code, unless it is charged as a
misdemeanor pursuant to paragraph (4) or (5) of subdivision (b)
of Section 17 of the Penal Code, irrespective of whether in a
particular case the crime may be considered a misdemeanor as a
result of postconviction proceedings. For purposes of this
section, a felony also includes a conviction under federal law, or
the law of any other state of the United States, of the District of
Columbia, or of any territory or possession of the United States.
A conviction includes a plea or verdict of guilty or a conviction
following a plea of nolo contendere.
(g) The board may delegate the authority to issue a suspension
under subdivision (a) or (b) or a notice of suspension under
subdivision (c) to the executive officer of the board.
284
4312. Voiding License of Entity Remaining Closed: Notice;
Disposition of Stock; Distribution of Proceeds Where Board Sells
Stock
(a) The board may cancel the license of a facility that is licensed
by the board if the licensed premises remain closed, as defined in
subdivision (e), other than by order of the board. For good cause
shown, the board may cancel a license after a shorter period of
closure. To cancel a license pursuant to this subdivision, the
board shall make a diligent, good faith effort to give notice by
personal service on the licensee. If a written objection is not
received within 10 days after personal service is made or a
diligent, good faith effort to give notice by personal service on
the licensee has failed, the board may cancel the license without
the necessity of a hearing. If the licensee files a written objection,
the board shall file an accusation based on the licensee
remaining closed. 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, and the board shall
have all the powers granted in that chapter.
(b) If a facility license is canceled pursuant to subdivision (a) or
revoked pursuant to this article, or a facility notifies the board of
its intent to remain closed or to discontinue business, the
licensee shall, within 10 days thereafter, arrange for the transfer
of all dangerous drugs and controlled substances or dangerous
devices to another licensee authorized to possess the dangerous
drugs and controlled substances or dangerous devices. The
licensee transferring the dangerous drugs and controlled
substances or dangerous devices shall immediately confirm in
writing to the board that the transfer has taken place.
(c) If a licensed facility fails to comply with subdivision (b), the
board may seek and obtain an order from the superior court in
the county in which the facility licensed by the board is located,
authorizing the board to enter the facility and inventory and
store, transfer, sell, or arrange for the sale of, all dangerous drugs
285
and controlled substances and dangerous devices found in the
facility.
(d) If the board sells or arranges for the sale of any dangerous
drugs, controlled substances, or dangerous devices pursuant to
subdivision (c), the board may retain from the proceeds of the
sale an amount equal to the cost to the board of obtaining and
enforcing an order issued pursuant to subdivision (c), including
the cost of disposing of the dangerous drugs, controlled
substances, or dangerous devices. The remaining proceeds, if
any, shall be returned to the licensee from whose premises the
dangerous drugs or controlled substances or dangerous devices
were removed.
(1) The licensee shall be notified of the licensee’s right to the
remaining proceeds by personal service or by certified mail,
postage prepaid.
(2) If a statute or regulation requires the licensee to file with the
board the licensee’s address, and any change of address, the
notice required by this subdivision may be sent by certified mail,
postage prepaid, to the latest address on file with the board and
service of notice in this manner shall be deemed completed on
the 10th day after the mailing.
(3) If the licensee is notified as provided in this subdivision, and
the licensee fails to contact the board for the remaining proceeds
within 30 calendar days after personal service has been made or
service by certified mail, postage prepaid, is deemed completed,
the remaining proceeds shall be deposited by the board into the
Pharmacy Board Contingent Fund. These deposits shall be
deemed to have been received pursuant to Chapter 7
(commencing with Section 1500) of Title 10 of Part 3 of the Code
of Civil Procedure and shall be subject to claim or other
disposition as provided in that chapter.
(e) For the purposes of this section, “closed” means not engaged
in the ordinary activity for which a license has been issued for at
least one day each calendar week during any 120-day period.
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(f) Nothing in this section shall be construed as requiring a
pharmacy to be open seven days a week.
4313. Evidence of Rehabilitation; Priority of Public Protection
In determining whether to grant an application for licensure or
whether to discipline or reinstate a license, the board shall give
consideration to evidence of rehabilitation. However, public
protection shall take priority over rehabilitation and, where
evidence of rehabilitation and public protection are in conflict,
public protection shall take precedence.
4314. Orders of Abatement
(a) The board may issue citations containing fines and orders of
abatement for any violation of Section 733, for any violation of
this chapter or regulations adopted pursuant to this chapter, or
for any violation of Division 116 (commencing with Section
150200) of the Health and Safety Code, in accordance with
Sections 125.9, 148, and 4005 and the regulations adopted
pursuant to those sections.
(b) Where appropriate, a citation issued by the board, as
specified in this section, may subject the person or entity to
whom the citation is issued to an administrative fine.
(c) Notwithstanding any other provision of law, where
appropriate, a citation issued by the board may contain an order
of abatement. The order of abatement shall fix a reasonable time
for abatement of the violation. It may also require the person or
entity to whom the citation is issued to demonstrate how future
compliance with the Pharmacy Law, and the regulations adopted
pursuant thereto, will be accomplished. A demonstration may
include, but is not limited to, submission of a corrective action
plan, and requiring completion of up to six hours of continuing
education courses in the subject matter specified in the order of
abatement. Any continuing education courses required by the
order of abatement shall be in addition to those required for
license renewal.
287
(d) Nothing in this section shall in any way limit the board from
issuing a citation, fine, and order of abatement pursuant to
Section 4067 or Section
56.36 of the Civil Code, and the regulations adopted pursuant to
those sections.
(e) The issuance of a citation pursuant to subdivision (b) shall not
be construed as a disciplinary action or discipline for purposes of
licensure or the reporting of discipline for licensure.
4315. Letter of Admonishment
(a) The executive officer, or his or her designee, may issue a
letter of admonishment to a licensee for failure to comply with
Section 733, for failure to comply with this chapter or regulations
adopted pursuant to this chapter, or for failure to comply with
Division 116 (commencing with Section 150200) of the Health
and Safety Code, directing the licensee to come into compliance.
(b) The executive officer, or his or her designee, may issue a
letter of admonishment to an applicant for licensure who has
committed any violation of law that the board deems, in its
discretion, does not merit the denial of a license or require
probationary status under Section 4300. The letter of
admonishment may be issued concurrently with a license.
(c) The letter of admonishment shall be in writing and shall
describe in detail the nature and facts of the violation, including a
reference to the statutes or regulations violated.
(d) The letter of admonishment shall inform the licensee or
applicant that within 30 days of service of the order of
admonishment the licensee or applicant may do either of the
following:
(1) Submit a written request for an office conference to the
executive officer of the board to contest the letter of
admonishment.
(A) Upon a timely request, the executive officer, or his or her
designee, shall hold an office conference with the licensee or
applicant or his or her legal counsel or authorized representative.
288
Unless so authorized by the executive officer, or his or her
designee, no individual other than the legal counsel or authorized
representative of the licensee or applicant may accompany the
licensee or applicant to the office conference.
(B) Prior to or at the office conference, the licensee or applicant
may submit to the executive officer declarations and documents
pertinent to the subject matter of the letter of admonishment.
(C) The office conference is intended to be an informal
proceeding and shall not be subject to the Administrative
Procedure Act (Chapter 3.5 (commencing with Section 11340),
Chapter 4 (commencing with Section 11370), Chapter 4.5
(commencing with Section 11400), or Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code).
(D) The executive officer, or his or her designee, may affirm,
modify, or withdraw the letter of admonishment. Within 14
calendar days from the date of the office conference, the
executive officer, or his or her designee, shall personally serve or
send the board’s written decision by certified mail to the
licensee’s or applicant’s address of record. This decision shall be
deemed the final administrative decision concerning the letter of
admonishment.
(E) Judicial review of the decision may be had by filing a petition
for a writ of mandate in accordance with the provisions of
Section 1094.5 of the Code of Civil Procedure within 30 days of
the date the decision was personally served or sent by certified
mail. The judicial review shall extend to the question of whether
or not there was a prejudicial abuse of discretion in the issuance
of the letter of admonishment.
(2) Comply with the letter of admonishment and, if required,
submit a written corrective action plan to the executive officer
documenting compliance. If an office conference is not requested
pursuant to this section, compliance with the letter of
admonishment shall not constitute an admission of the violation
noted in the letter of admonishment.
289
(e) The letter of admonishment shall be served upon the
licensee or applicant personally or by certified mail at his or her
address of record with the board. If the licensee or applicant is
served by certified mail, service shall be effective upon deposit in
the United States mail.
(f) The licensee or applicant shall maintain and have readily
available a copy of the letter of admonishment and corrective
action plan, if any, for at least three years from the date of
issuance of the letter of admonishment.
(g) Nothing in this section shall in any way limit the board’s
authority or ability to do either of the following:
(1) Issue a citation pursuant to Section 125.9, 148, or 4067, or
pursuant to Section 1775 of Title 16 of the California Code of
Regulations.
(2) Institute disciplinary proceedings pursuant to this article.
(h) The issuance of a letter of admonishment pursuant to
subdivision (b) shall not be construed as a disciplinary action or
discipline for purposes of licensure or the reporting of discipline
for licensure.
4316. Board Authorized to Issue Cease and Desist Orders
(a) The board, through its executive officer, is authorized to issue
a cease and desist order for operating any facility under this
chapter that requires licensure or for practicing any activity
under this chapter that requires licensure without obtaining that
licensure.
(b) Whenever the board issues a cease and desist order pursuant
to subdivision (a), the board shall immediately issue the facility a
notice setting forth the acts or omissions with which it is charged,
specifying the pertinent code section or sections and any
regulations.
(c) The order shall provide that the facility, within 15 days of
receipt of the notice, may request a hearing before the president
of the board to contest the cease and desist order. Consideration
of the facility’s contest of the cease and desist order shall comply
290
with Section 11425.10 of the Government Code. The hearing
shall be held no later than five business days from the date the
request of the owner is received by the board. The president
shall render a written decision within five business days of the
hearing. In the absence of the president of the board, the vice
president of the board may conduct the hearing permitted by
this subdivision. The owner or person in possession or control of
the facility may seek review of the decision of the president of
the board pursuant to Section 1094.5 of the Code of Civil
Procedure.
4317. Action Against Chain Community Pharmacy for Violating
Prohibition on Quotas
The board may take an enforcement action against a chain
community pharmacy, as defined in subdivision (c) of Section
4001, that violates Section 4113.7 unless, by clear and convincing
evidence, the chain community pharmacy demonstrates that the
violation was contrary to its policy.
4317.5. Fines for Repeated Violations by Chain Pharmacies
(a) The board may bring an action for fines for repeated
violations of materially similar provisions of this chapter within
five years by three or more pharmacies operating under common
ownership or management within a chain community pharmacy,
as follows: a third and, or subsequent violation may be punished
by an administrative fine not to exceed one hundred thousand
dollars ($100,000) per violation.
(b) The board may bring an action against a chain community
pharmacy operating under common ownership or management
for fines not to exceed one hundred fifty thousand dollars
($150,000) for any violation of this chapter demonstrated to be
the result of a written policy or which was expressly encouraged
by the common owner or manager.
(c) The board shall not bring an action for fines pursuant to
subdivision (a) until at least six months have elapsed from the
291
date the board determines that a violation has occurred unless
the violation giving rise to the action resulted in actual harm to
any consumer or serious potential harm to the public.
(d) In an action brought by the board pursuant to subdivision (a),
it shall be a defense for any pharmacy to establish either of the
following:
(1) That the violation was contrary to a written policy that was
communicated by the common owner or manager to all
employees of the pharmacies where the violation occurred.
(2) That, within six months after the violation, the common
owner or manager corrected all unlawful policies, communicated
the change in policy or policies in writing to all pharmacies under
its ownership or management, and provided proof of abatement
of the violation to the board, so long as the violation did not
result in actual harm to any consumer or serious potential harm
to the public.
(e) In determining the amount of the fine sought in an action
brought pursuant to this section, the board shall consider
relevant mitigating and aggravating factors, including, but not
limited to, the good faith of the licensee, the communication of
written changes to unlawful policies, the gravity of the violation,
the potential harm to patients, whether the violation affects the
professional judgment or independence of pharmacists and
pharmacy technicians, and the history of previous violations by
the common owner or manager.
(f) The authority granted by this section is in addition to the
authority of the board to institute any other administrative, civil,
or criminal action.
(g) For purposes of this section, “chain community pharmacy”
shall have the same meaning as defined in Section 4001.
(h) The fines in subdivisions (a) and (b) shall be imposed in
accordance with Section 4314.
(i) In connection with the board’s first Joint Sunset Review
Oversight Hearing pursuant to Section 9147.7 of the Government
Code occurring after this section becomes operative, the board
292
shall provide to the appropriate committees of the Legislature all
of the following information:
(1) The number of actions brought pursuant to this section.
(2) The number of actions brought pursuant to this section that
did not result in any fines.
(3) The types of violations giving rise to actions brought
pursuant to this section.
Article 20. Prohibitions and Offenses
4320. Penalties for Violation of Pharmacy Law: Actions
Authorized; Who May File Actions
(a) The penalties prescribed in this chapter may be recovered in
any court having jurisdiction, by a civil action instituted by the
board in the name of the State of California, or by criminal
prosecution upon complaint being made.
(b) The district attorney of the county wherein violations of this
chapter occur shall conduct all felony prosecutions at the request
of the board. The district attorney of the county or city attorney
of the city wherein violations of this chapter occur shall conduct
all other actions and prosecutions at the request of the board.
4321. Penalties: Misdemeanors; Infractions
(a) Any person who knowingly violates any of the provisions of
this chapter, when no other penalty is provided, is guilty of a
misdemeanor, and upon conviction thereof shall be punished by
a fine of not less than two hundred dollars ($200), and not more
than two thousand dollars ($2,000), or by imprisonment of not
less than 30 days nor exceeding six months, or by both that fine
and imprisonment.
(b) In all other instances, any person who violates any of the
provisions of this chapter, when no other penalty is provided, is
guilty of an infraction, and upon conviction thereof may be
punished by a fine not to exceed one thousand dollars ($1,000).
293
4322. Misdemeanor or Infraction: False Representations to
Secure License for Self or Others; False Representation of
Licensure; Penalties
Any person who attempts to secure or secures licensure for
himself or herself or any other person under this chapter by
making or causing to be made any false representations, or who
fraudulently represents himself or herself to be registered, is
guilty of a misdemeanor, and upon conviction thereof shall be
punished by a fine not exceeding five thousand dollars ($5,000),
or by imprisonment not exceeding 50 days, or by both that fine
and imprisonment.
4323. Misdemeanor; False Representation of Self as a
Physician, Agent of Physician, etc. to Obtain Drug
Every person who, in order to obtain any drug, falsely
represents himself or herself to be a physician or other person
who can lawfully prescribe the drug, or falsely represents that he
or she is acting on behalf of a person who can lawfully prescribe
the drug, in a telephone or electronic communication with a
pharmacist, shall be punished by imprisonment in the county jail
for not more than one year.
4324. Felony or Misdemeanor: Forgery of Prescription;
Possession of Drugs Obtained Through Forged Prescription
(a) Every person who signs the name of another, or of a
fictitious person, or falsely makes, alters, forges, utters,
publishes, passes, or attempts to pass, as genuine, any
prescription for any drugs is guilty of forgery and upon conviction
thereof shall be punished by imprisonment pursuant to
subdivision (h) of Section 1170 of the Penal Code, or by
imprisonment in a county jail for not more than one year.
(b) Every person who has in his or her possession any drugs
secured by a forged prescription shall be punished by
imprisonment pursuant to subdivision (h) of Section 1170 of the
294
Penal Code, or by imprisonment in the county jail for not more
than one year.
4325. Misdemeanor: Manufacture, Possession, etc. of False
Prescription Blank
(a) No person other than a physician, dentist, podiatrist,
veterinarian, pharmacist, or other person authorized by law to
dispense, administer, or prescribe controlled substances, or the
person's agent acting under authorization by the person to print
prescription blanks, and acting in the regular practice of the
person's profession, shall knowingly and willfully manufacture,
copy, reproduce, or possess, or cause to be manufactured,
copied, reproduced, or possessed, any prescription blank that
purports to bear the name, address, and federal registry or other
identifying information of a physician, dentist, podiatrist,
veterinarian, or other person authorized by law to dispense,
administer, or prescribe controlled substances.
(b) Every person who violates this section shall be guilty of a
misdemeanor.
4327. Misdemeanor: Sale, Dispensing, or Compounding While
Under the Influence of Drugs or Alcoholic Beverages
Any person who, while on duty, sells, dispenses or compounds
any drug while under the influence of any dangerous drug or
alcoholic beverages shall be guilty of a misdemeanor.
4328. Misdemeanor: Permitting Compounding, Dispensing, or
Furnishing by Non-Pharmacist
Except as otherwise provided in this chapter, any person who
permits the compounding or dispensing of prescriptions, or the
furnishing of dangerous drugs in his or her pharmacy, except by a
pharmacist, is guilty of a misdemeanor.
295
4329. Misdemeanor: Non-Pharmacist Acting as Manager,
Compounding, Dispensing or Furnishing Drugs
Any non-pharmacist who takes charge of or acts as supervisor,
manager, or pharmacist-in-charge of any pharmacy, or who
compounds or dispenses a prescription or furnishes dangerous
drugs except as otherwise provided in this chapter, is guilty of a
misdemeanor.
4330. Misdemeanor: Non-Pharmacist Owner Failing to Place
Pharmacist in Charge, Dispensing or Compounding Except by
Pharmacist, Interfering with Pharmacist-in-Charge
(a) Any person who has obtained a license to conduct a
pharmacy, who fails to place in charge of the pharmacy a
pharmacist, or any person, who by himself or herself, or by any
other person, permits the compounding or dispensing of
prescriptions, or the furnishing of dangerous drugs, in his or her
pharmacy, except by a pharmacist, or as otherwise provided in
this chapter, is guilty of a misdemeanor.
(b) Any pharmacy owner who commits any act that would
subvert or tend to subvert the efforts of the pharmacist-in-
charge to comply with the laws governing the operation of the
pharmacy is guilty of a misdemeanor.
4331. Misdemeanor: Wholesaler, Veterinary Food-Animal Drug
Retailer Failing to Place Pharmacist or Designated
Representative in Charge, Permitting Dispensing or
Compounding Except by Pharmacist or Designated
Representative
(a) A person not authorized under this chapter who takes charge
of a wholesaler or veterinary food-animal drug retailer or who
dispenses a prescription or furnishes dangerous devices, except
as otherwise provided in this chapter, is guilty of a misdemeanor.
(b) A person who is not a responsible manager or a designated
representative-3PL who takes charge of a third-party logistics
provider or coordinates the warehousing or distribution of
296
dangerous drugs or dangerous devices within a third-party
logistics provider, except as otherwise provided in this chapter, is
guilty of a misdemeanor.
(c) A person licensed as a veterinary food-animal drug retailer
that fails to place in charge of that veterinary food-animal drug
retailer a pharmacist or designated representative, or any person
who, by himself or herself, or by any other person, permits the
dispensing of prescriptions, except by a pharmacist or designated
representative, or as otherwise provided in this chapter, is guilty
of a misdemeanor.
(d) A person licensed as a wholesaler that fails to place in charge
of that wholesaler a pharmacist or designated representative, or
any person who, by himself or herself, or by any other person,
permits the furnishing of dangerous drugs or dangerous devices,
except by a pharmacist or designated representative, or as
otherwise provided in this chapter, is guilty of a misdemeanor.
(e) A person licensed as a third-party logistics provider that fails
to place in charge of a licensed place of business of the third-
party logistics provider a responsible manager, or any person
who, by himself or herself, or by any other person, permits the
furnishing of dangerous drugs or dangerous devices, except by a
facility manager, or as otherwise provided in this chapter, is
guilty of a misdemeanor.
4332. Misdemeanor: Failure or Refusal to Maintain or Produce
Required Drug or Device Records; Willful Production of False
Reports
Any person who fails, neglects, or refuses to maintain the
records required by Section 4081 or who, when called upon by an
authorized officer or a member of the board, fails, neglects, or
refuses to produce or provide the records within a reasonable
time, or who willfully produces or furnishes records that are
false, is guilty of a misdemeanor.
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4333. Maintaining Prescriptions, Other Drug Records on
Premises, Open to Inspection; Waiver; Willful Failure to Keep or
Permit Inspection of Records of Prescriptions, Other Records is
Misdemeanor
(a) All prescriptions filled by a pharmacy and all other records
required by Section 4081 shall be maintained on the premises
and available for inspection by authorized officers of the law for a
period of at least three years. In cases where the pharmacy
discontinues business, these records shall be maintained in a
board-licensed facility for at least three years.
(b) Any person who willfully fails to comply with subdivision (a)
is guilty of a misdemeanor, and upon conviction thereof, shall be
punished by a fine not exceeding two hundred dollars ($200).
Any person convicted of a second or subsequent offense shall be
punished by a fine of not less than two hundred dollars ($200)
and not more than four hundred dollars ($400).
(c) (1) Notwithstanding subdivisions (a) and (b), the board may,
upon written request, grant a waiver of the requirement that the
records described in subdivisions (a) and (b) be maintained on
the licensed premises or, in the event the pharmacy discontinues
business, that the records be maintained in a board licensed
facility. A person who maintains records in compliance with that
waiver is not subject to the penalties set forth in subdivision (b).
(2) A waiver granted pursuant to this subdivision shall not affect
the board's authority under this section or any other provision of
this chapter.
4335. Knowingly Failing to Arrange for Disposition of Stock of
Closed or Discontinued Business: Misdemeanor
Any person who knowingly violates subdivision (b) of Section
4312 is guilty of a misdemeanor.
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4336. Felony: Knowing or Willful Use of Minor to Violate
Specified Sections of Pharmacy Law: Exception for Pharmacist
Furnishing Pursuant to a Prescription
(a) Every person who knowingly or willfully violates Section
4055, 4059, 4060, 4061, 4062, 4063, 4064, 4065, 4077, 4080,
4081, 4083, or 4332 with respect to dangerous drugs by use of a
minor as an agent is guilty of a felony.
(b) Nothing contained in this section shall apply to a pharmacist
furnishing dangerous drugs pursuant to a prescription.
4337. Distribution of Fines Collected
Except as otherwise specified, all fines collected for violations of
this chapter shall be paid as follows: one-half into the State
Treasury to the credit of the Contingent Fund of the Board of
Pharmacy of the State of California and one-half to the treasurer
of the jurisdiction in which the misdemeanor is prosecuted, to be
deposited in the same fund as fines for other misdemeanors
occurring in that jurisdiction are deposited.
4338. Additional Fines May be Assessed
In addition to any fine assessed under Section 4321, the judge
may assess a fine not to exceed seventy dollars ($70) against any
person who violates Section 4140 or 4142, with the proceeds of
this fine to be used in accordance with Section 1463.23 of the
Penal Code. The court shall, however, take into consideration
the defendant's ability to pay and no defendant shall be denied
probation because of his or her inability to pay the fine permitted
under this section.
4339. Board Action to Enjoin Violation of Pharmacy Law;
Exception for Certain Drugs and Devices
(a) The board may bring an action to enjoin the violation of any
provision of this chapter in any superior court in and for the
county in which the violation has occurred. Any action shall
conform to the requirements of Chapter 3 (commencing with
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Section 525) of Title 7 of Part 2 of the Code of Civil Procedure,
except that the board shall not be required to allege facts
necessary to show or tending to show lack of adequate remedy
at law or irreparable damage or loss. The action shall be brought
in the name of the people of the State of California.
(b) Nothing in this section shall permit the bringing of any action
with respect to any drug or product not subject to Section 4022
that is packaged or bottled in the manufacturer's or distributor's
container and labeled in accordance with applicable federal and
state drug labeling requirements.
(c) The authority granted by this section is in addition to the
authority of the board to institute any other administrative, civil,
or criminal action.
4340. Unlawful Advertising by Nonresident Pharmacy Not
Registered with Board
It is unlawful for any nonresident pharmacy that is not
registered pursuant to Section 4112 or for any person who is a
resident of this state to advertise the pharmacy services of any
pharmacy, with the knowledge that the advertisement will or is
likely to induce members of the public in this state to use the
pharmacy to fill prescriptions.
4341. Advertisement of Prescription Drugs or Devices
Notwithstanding any other provision of law, prescription drugs or
devices may be advertised if the advertisement conforms with
the requirements of Section 651.
4342. Actions by Board to Prevent Sales of Preparations or
Drugs Lacking Quality of Strength; Penalties for Knowing or
Willful Violation of Regulations Governing Those Sales
(a) The board may institute any action or actions as may be
provided by law and that, in its discretion, are necessary, to
prevent the sale of pharmaceutical preparations and drugs that
do not conform to the standard and tests as to quality and
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strength, provided in the latest edition of the United States
Pharmacopoeia or the National Formulary, or that violate any
provision of the Sherman Food, Drug, and Cosmetic Law (Part 5
(commencing with Section 109875) of Division 104 of the Health
and Safety Code).
(b) Any knowing or willful violation of any regulation adopted
pursuant to Section 4006 shall be subject to punishment in the
same manner as is provided in Sections 4321 and 4336.
4343. Buildings: Prohibition Against the Use of Certain Signs
Unless Licensed Pharmacy Within
No building shall have upon it or displayed within it or affixed to
or used in connection with it a sign bearing the word or words
"Pharmacist," "Pharmacy," "Apothecary," "Drugstore,"
"Druggist," "Drugs," "Medicine," "Medicine Store," "Drug
Sundries," "Remedies," or any word or words of similar or like
import; or the characteristic symbols of pharmacy; or the
characteristic prescription sign (Rx) or similar design, unless there
is upon or within the building a pharmacy holding a license issued
by the board pursuant to Section 4110.
Article 21. Pharmacists Recovery Program
4360. Impaired Pharmacists: Legislative Intent
The board shall operate a pharmacists recovery program to
rehabilitate pharmacists and intern pharmacists whose
competency may be impaired due to abuse of alcohol, drug use,
or mental illness. The intent of the pharmacists recovery program
is to return these pharmacists and intern pharmacists to the
practice of pharmacy in a manner that will not endanger the
public health and safety.
4361. Definitions
(a) "Participant" means a pharmacist or intern pharmacist who
has entered the pharmacists recovery program.
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(b) "Pharmacists recovery program" means the rehabilitation
program created by this article for pharmacists and intern
pharmacists.
4362. Function of Program: Board Referrals; Voluntary,
Confidential Participation
(a) A pharmacist or intern pharmacist may enter the
pharmacists recovery program if:
(1) The pharmacist or intern pharmacist is referred by the board
instead of, or in addition to, other means of disciplinary action.
(2) The pharmacist or intern pharmacist voluntarily elects to
enter the pharmacists recovery program.
(b) A pharmacist or intern pharmacist who enters the
pharmacists recovery program pursuant to paragraph (2) of
subdivision (a) shall not be subject to discipline or other
enforcement action by the board solely on his or her entry into
the pharmacists recovery program or on information obtained
from the pharmacist or intern pharmacist while participating in
the program unless the pharmacist or intern pharmacist would
pose a threat to the health and safety of the public. However, if
the board receives information regarding the conduct of the
pharmacist or intern pharmacist, that information may serve as a
basis for discipline or other enforcement by the board.
4364. Criteria for Participation to be Established by Board
(a) The board shall establish criteria for the participation of
pharmacists and intern pharmacists in the pharmacists recovery
program.
(b) The board may deny a pharmacist or intern pharmacist who
fails to meet the criteria for participation entry into the
pharmacists recovery program.
(c) The establishment of criteria for participation in the
pharmacists recovery program shall not be subject to the
requirements of Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code.
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4365. Contracting with Employee Assistance Program: Selection
The board shall contract with one or more qualified contractors
to administer the pharmacists recovery program.
4366. Function of the Employee Assistance Program
The functions of the contractor administering the pharmacists
recovery program shall include, but not be limited to, the
following:
(a) To evaluate those pharmacists and intern pharmacists who
request participation in the program.
(b) To develop a treatment contract with each participant in the
pharmacists recovery program.
(c) To monitor the compliance of each participant with their
treatment contract.
(d) To prepare reports as required by the board.
(e) To inform each participant of the procedures followed in the
program.
(f) To inform each participant of their rights and responsibilities
in the program.
(g) To inform each participant of the possible consequences of
noncompliance with the program.
4369. Board Referrals to Program: Written Information
Provided to Licensee; Termination for Non-Compliance; Report
to Board of Termination; Authority to Discipline
(a) Any failure to comply with the treatment contract,
determination that the participant is failing to derive benefit
from the program, or other requirements of the pharmacists
recovery program may result in the termination of the
pharmacist's or intern pharmacist's participation in the
pharmacists recovery program. The name and license number of
a pharmacist or intern pharmacist who is terminated from the
pharmacists recovery program and the basis for the termination
shall be reported to the board.
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(b) Participation in the pharmacists recovery program shall not
be a defense to any disciplinary action that may be taken by the
board.
(c) No provision of this article shall preclude the board from
commencing disciplinary action against a licensee who is
terminated from the pharmacists recovery program.
4371. Review of Program Activities
(a) The executive officer of the board shall designate a program
manager of the pharmacists recovery program. The program
manager shall have background experience in dealing with
substance abuse issues.
(b) The program manager shall review the pharmacists recovery
program on a quarterly basis. As part of this evaluation, the
program manager shall review files of all participants in the
pharmacists recovery program.
(c) The program manager shall work with the contractor
administering the pharmacists recovery program to evaluate
participants in the program according to established guidelines
and to develop treatment contracts and evaluate participant
progress in the program.
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4372. Confidential Records; Exception for Disciplinary
Proceeding
All board records and records of the pharmacists recovery
program pertaining to the treatment of a pharmacist or intern
pharmacist in the program shall be kept confidential and are not
subject to discovery, subpoena, or disclosure pursuant to Chapter
3.5
(commencing with Section 6250) of Division 7 of Title 1 of the
Government Code. However, board records and records of the
pharmacists recovery program may be disclosed and testimony
provided in connection with participation in the pharmacists
recovery program, but only to the extent those records or
testimony are relevant to the conduct for which the pharmacist
or intern pharmacist was terminated from the pharmacists
recovery program.
4373. Immunity from Civil Liability
No member of the board shall be liable for any civil damages
because of acts or omissions that may occur while acting in good
faith pursuant to this article.
Article 22. Unfair Trade Practices
4380. Resale of Preferentially Priced Drugs: Prohibition;
Exceptions
(a) The resale, by any person, of drugs acquired at preferentially
low prices permitted under federal law only because of the
Nonprofit Institutions Act (15 U.S.C. Sec. 13c) is prohibited except
in any of the following instances:
(1) When for the person's own use, as defined by the federal
courts in Abbott Labs. v. Portland Retail Druggists (425 U.S. 1, 47
L. Ed. 2d 537) and DeModena v. Kaiser Foundation Health Plan,
Inc. (743 F. 2d 1388).
(2) When sold to a purchaser also eligible for those prices under
the Nonprofit Institutions Act, that controls, is controlled by, or is
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under common control with, the seller, and that purchases the
products for its own use, as defined in paragraph (1).
(3) When sold to a walk-in customer pursuant to a prescription,
provided that those sales represent less than 1 percent of the
drugs purchased by the seller for its own use in this state.
(b) Nothing in this article prohibits the resale of drugs to any
person in the occasional emergency situation where no other
sources are readily available in the community to meet the
emergency need.
4381. Violation of Article as Unfair Competition; Private Actions
Authorized; Triple Damages and Attorneys’ Fees; Proof
Required
(a) A violation of this article is an act of unfair competition
within the meaning of Chapter 5 (commencing with Section
17200) of Part 2 of Division 7, and this article is enforceable as
provided in that chapter.
(b) In addition thereto, any person or trade association may
bring an action to enjoin and restrain any violation of this article
and to recover actual damages, if any.
(c) In an action for injunctive relief under this article, it is not
necessary to allege or prove actual damages or the threat
thereof, or actual injury or the threat thereof, to the plaintiff. In
addition to injunctive relief, the plaintiff in any action shall
recover three times the amount of his or her actual damages, if
any, as well as three times the actual damages, if any, sustained
by any person who has assigned to the plaintiff a claim for
damages resulting from a violation of this section. In any action
under this article in which judgment is entered against the
defendant, the plaintiff shall be awarded reasonable attorneys'
fees together with the costs of suit.
(d) In issuing an injunction against a violation under this article,
the court may, in its discretion, include any other restraint it
deems expedient in order to deter the defendant from and
ensure against future violations of this article.
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(e) Proof of malice or intent to harm competition is immaterial
to sustain a cause of action under this article.
4382. Board May Audit Sales to Walk-In Customers
The board may audit persons for compliance with the limits
established in paragraph (3) of subdivision (a) of Section 4380
except that in the case of a facility or pharmacy that
predominately serves members of a prepaid group practice
health care service plan, those audits may be undertaken solely
by the Department of Managed Health Care pursuant to its
authority to audit those plans.
Article 23. Revenue and Renewal
4400. Fees
The amount of fees and penalties prescribed by this chapter,
except as otherwise provided, is that fixed by the board
according to the following schedule:
(a) The fee for a pharmacy license shall be five hundred twenty
dollars ($520) and may be increased to five hundred seventy
dollars ($570). The fee for the issuance of a temporary pharmacy
permit shall be two hundred fifty dollars ($250) and may be
increased to three hundred twenty-five dollars ($325).
(b) The fee for a pharmacy license annual renewal shall be six
hundred sixty-five dollars ($665) and may be increased to nine
hundred thirty dollars ($930).
(c) The fee for the pharmacist application and examination shall
be two hundred sixty dollars ($260) and may be increased to two
hundred eighty-five dollars ($285).
(d) The fee for regrading an examination shall be ninety dollars
($90) and may be increased to one hundred fifteen dollars
($115). If an error in grading is found and the applicant passes
the examination, the regrading fee shall be refunded.
(e) The fee for a pharmacist license shall be one hundred
ninety-five dollars ($195) and may be increased to two hundred
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fifteen dollars ($215). The fee for a pharmacist biennial renewal
shall be three hundred sixty dollars ($360) and may be increased
to five hundred five dollars ($505).
(f) The fee for a wholesaler or third-party logistics provider
license and annual renewal shall be seven hundred eighty dollars
($780) and may be increased to eight hundred twenty dollars
($820). The application fee for any additional location after
licensure of the first 20 locations shall be three hundred dollars
($300) and may be decreased to no less than two hundred
twenty-five dollars ($225). A temporary license fee shall be seven
hundred fifteen dollars ($715) and may be decreased to no less
than five hundred fifty dollars ($550).
(g) The fee for a hypodermic license shall be one hundred
seventy dollars ($170) and may be increased to two hundred
forty dollars ($240). The fee for a hypodermic license renewal
shall be two hundred dollars ($200) and may be increased to two
hundred eighty dollars ($280).
(h) (1) The fee for application, investigation, and issuance of a
license as a designated representative pursuant to Section 4053,
as a designated representative-3PL pursuant to Section 4053.1,
or as a designated representative-reverse distributor pursuant to
Section 4053.2 shall be one hundred fifty dollars ($150) and may
be increased to two hundred ten dollars ($210).
(2) The fee for the annual renewal of a license as a designated
representative, designated representative-3PL, or designated
representative-reverse distributor shall be two hundred fifteen
dollars ($215) and may be increased to three hundred dollars
($300).
(i) (1) The fee for the application, investigation, and issuance of
a license as a designated representative for a veterinary food-
animal drug retailer pursuant to Section 4053 shall be one
hundred fifty dollars ($150) and may be increased to two
hundred ten dollars ($210).
(2) The fee for the annual renewal of a license as a designated
representative for a veterinary food-animal drug retailer shall be
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two hundred fifteen dollars ($215) and may be increased to three
hundred dollars ($300).
(j) (1) The application fee for a nonresident wholesaler or third-
party logistics provider license issued pursuant to Section 4161
shall be seven hundred eighty dollars ($780) and may be
increased to eight hundred twenty dollars ($820).
(2) For nonresident wholesalers or third-party logistics providers
that have 21 or more facilities operating nationwide the
application fees for the first 20 locations shall be seven hundred
eighty dollars ($780) and may be increased to eight hundred
twenty dollars ($820). The application fee for any additional
location after licensure of the first 20 locations shall be three
hundred dollars ($300) and may be decreased to no less than two
hundred twenty-five dollars ($225). A temporary license fee shall
be seven hundred fifteen dollars ($715) and may be decreased to
no less than five hundred fifty dollars ($550).
(3) The annual renewal fee for a nonresident wholesaler license
or third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
increased to eight hundred twenty dollars ($820).
(k) The fee for evaluation of continuing education courses for
accreditation shall be set by the board at an amount not to
exceed forty dollars ($40) per course hour.
(l) The fee for an intern pharmacist license shall be one hundred
sixty-five dollars ($165) and may be increased to two hundred
thirty dollars ($230). The fee for transfer of intern hours or
verification of licensure to another state shall be twenty-five
dollars ($25) and may be increased to thirty dollars ($30).
(m) The board may waive or refund the additional fee for the
issuance of a license where the license is issued less than 45 days
before the next regular renewal date.
(n) The fee for the reissuance of any license, or renewal thereof,
that has been lost or destroyed or reissued due to a name change
shall be thirty-five dollars ($35) and may be increased to forty-
five dollars ($45).
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(o) The fee for processing an application to change information
on a premises license record shall be one hundred dollars ($100)
and may be increased to one hundred thirty dollars ($130).
(p) It is the intent of the Legislature that, in setting fees
pursuant to this section, the board shall seek to maintain a
reserve in the Pharmacy Board Contingent Fund equal to
approximately one year’s operating expenditures.
(q) The fee for any applicant for a clinic license shall be five
hundred twenty dollars ($520) for each license and may be
increased to five hundred seventy dollars ($570). The annual fee
for renewal of the license shall be three hundred twenty-five
dollars ($325) for each license and may be increased to three
hundred sixty dollars ($360).
(r) The fee for the issuance of a pharmacy technician license
shall be one hundred forty dollars ($140) and may be increased
to one hundred ninety-five dollars ($195). The fee for renewal of
a pharmacy technician license shall be one hundred forty dollars
($140) and may be increased to one hundred ninety-five dollars
($195).
(s) The fee for a veterinary food-animal drug retailer license
shall be four hundred thirty-five dollars ($435) and may be
increased to six hundred ten dollars ($610). The annual renewal
fee for a veterinary food-animal drug retailer license shall be
three hundred thirty dollars ($330) and may be increased to four
hundred sixty dollars ($460).
(t) The fee for issuance of a retired license pursuant to Section
4200.5 shall be thirty-five dollars ($35) and may be increased to
forty-five dollars ($45).
(u) The fee for issuance of a sterile compounding pharmacy
license or a hospital satellite compounding pharmacy shall be
one thousand six hundred forty-five dollars ($1,645) and may be
increased to two thousand three hundred five dollars ($2,305).
The fee for a temporary license shall be five hundred fifty dollars
($550) and may be increased to seven hundred fifteen dollars
($715). The annual renewal fee of the license shall be one
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thousand three hundred twenty-five dollars ($1,325) and may be
increased to one thousand eight hundred fifty-five dollars
($1,855).
(v) The fee for the issuance of a nonresident sterile
compounding pharmacy license shall be two thousand three
hundred eighty dollars ($2,380) and may be increased to three
thousand three hundred thirty-five dollars ($3,335). The annual
renewal of the license shall be two thousand two hundred
seventy dollars ($2,270) and may be increased to three thousand
one hundred eighty dollars ($3,180). In addition to paying that
application fee, the nonresident sterile compounding pharmacy
shall deposit, when submitting the application, a reasonable
amount, as determined by the board, necessary to cover the
board’s estimated cost of performing the inspection required by
Section 4127.2. If the required deposit is not submitted with the
application, the application shall be deemed to be incomplete. If
the actual cost of the inspection exceeds the amount deposited,
the board shall provide to the applicant a written invoice for the
remaining amount and shall not take action on the application
until the full amount has been paid to the board. If the amount
deposited exceeds the amount of actual and necessary costs
incurred, the board shall remit the difference to the applicant.
(w) The fee for the issuance of an outsourcing facility license
shall be two thousand two hundred seventy dollars ($2,270) and
may be increased to up to three thousand one hundred eighty
dollars ($3,180) by the board. The fee for the renewal of an
outsourcing facility license shall be one thousand three hundred
twenty-five dollars ($1,325) and may be increased to up to one
thousand eight hundred fifty-five dollars ($1,855) by the board.
The fee for a temporary outsourcing facility license shall be seven
hundred fifteen dollars ($715).
(x) The fee for the issuance of a nonresident outsourcing facility
license shall be two thousand three hundred eighty dollars
($2,380) and may be increased to up to three thousand three
hundred thirty-five dollars ($3,335) by the board. The fee for the
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renewal of a nonresident outsourcing facility license shall be two
thousand two hundred seventy dollars ($2,270) and may be
increased to up to three thousand one hundred eighty dollars
($3,180) by the board. In addition to paying that application fee,
the nonresident outsourcing facility shall deposit, when
submitting the application, a reasonable amount, as determined
by the board, necessary to cover the board’s estimated cost of
performing the inspection required by Section 4129.2. If the
required deposit is not submitted with the application, the
application shall be deemed to be incomplete. If the actual cost
of the inspection exceeds the amount deposited, the board shall
provide to the applicant a written invoice for the remaining
amount and shall not take action on the application until the full
amount has been paid to the board. If the amount deposited
exceeds the amount of actual and necessary costs incurred, the
board shall remit the difference to the applicant.
(y) The fee for the issuance of a centralized hospital packaging
license shall be eight hundred twenty dollars ($820) and may be
increased to one thousand one hundred fifty dollars ($1,150).
The annual renewal of the license shall be eight hundred five
dollars ($805) and may be increased to one thousand one
hundred twenty-five dollars ($1,125).
(z) The fee for the issuance of a license to a correctional clinic
pursuant to Article 13.5 (commencing with Section 4187) that is
not owned by the state shall be five hundred twenty dollars
($520) and may be increased to five hundred seventy dollars
($570). The annual renewal fee for that correctional clinic license
shall be three hundred twenty-five dollars ($325) and may be
increased to three hundred sixty dollars ($360).
(aa) Beginning on and after July 1, 2019, the fee for an ADDS
license shall be two hundred dollars ($200) and may be increased
to two hundred fifty dollars ($250). The fee for the annual
renewal of the license shall be two hundred dollars ($200) and
may be increased to two hundred fifty dollars ($250).
(ab) This section shall become operative on July 1, 2021.
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4401. Pharmacist: Biennial Renewal
Every pharmacist who desires to retain his or her license on the
books of the board shall biennially pay to the executive officer of
the board the renewal fee, established by the board, within the
limits prescribed by this chapter. In return for the payment of
the renewal fee, a certificate of renewal shall be issued.
4402. Cancellation: Of Pharmacist after Non-Renewal for Three
Years; All Other Licenses after 60 Days
(a) Any pharmacist license that is not renewed within three
years following its expiration may not be renewed, restored, or
reinstated and shall be canceled by operation of law at the end of
the three-year period.
(b) (1) Any pharmacist whose license is canceled pursuant to
subdivision (a) may obtain a new license if he or she takes and
passes the examination that is required for initial license with the
board.
(2) The board may impose conditions on any license issued
pursuant to this section, as it deems necessary.
(c) A license that has been revoked by the board under former
Section 4411 shall be deemed canceled three years after the
board's revocation action, unless the board has acted to reinstate
the license in the interim.
(d) This section shall not affect the authority of the board to
proceed with any accusation that has been filed prior to the
expiration of the three-year period.
(e) Any other license issued by the board may be canceled by
the board if the license is not renewed within 60 days after its
expiration. Any license canceled under this subdivision may not
be reissued. Instead, a new application will be required.
4403. Reissuance without Payment of Fees Prohibited
The board shall not reissue or renew any license without the
payment of the fees required by this chapter and the payment of
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all fees that are delinquent at the time that the application is
made.
4404. Reissuance of Lost or Destroyed License; Proof of Loss,
etc.
If any license issued under this chapter is lost or destroyed, or if
any person desires a reissuance of his or her license, the board
may reissue it, subject to Section 4403, upon application
therefor, and the submission of satisfactory proof, if required by
the board, that the license has been lost or destroyed, or if the
license has not been lost or destroyed, upon the surrender of the
old license.
4405. Disposition of Fines
All fines recoverable under this chapter shall be paid by the
magistrate receiving the same to the board, except where other
provision is made in this chapter for the disposition thereof.
4406. Report of Fees Collected
All fees collected on behalf of the board and all receipts of every
kind and nature shall be reported each month for the month
preceding to the Controller and at the same time the entire
amount shall be paid into the State Treasury and shall be
credited to the Pharmacy Board Contingent Fund which is hereby
created. This contingent fund shall be available, upon
appropriation of the Legislature, for the use of the board.
4407. Compensation of Members
All compensation of members and all other expenses of the
board shall be paid out of the examination and registration fees
and fines.
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4409. Contribution to California Pharmacist Scholarship and
Repayment Program at License Renewal
At the time a pharmacy license is renewed pursuant to
subdivision (a) of Section 4110 or a pharmacist license is renewed
pursuant to Section 4401, the pharmacy or pharmacist may make
a contribution of at least twenty-five dollars ($25), to be
submitted to the board, for the sole purpose of funding the
California Pharmacist Scholarship and Loan Repayment Program
established pursuant to Article 2 (commencing with Section
128198) of Chapter 3 of Part 3 of Division 107 of the Health and
Safety Code. The contribution submitted pursuant to this section
shall be paid into the State Treasury and credited to the
California Pharmacist Scholarship and Loan Repayment Program
Fund established pursuant to Section 128198.5 of the Health and
Safety Code.
Article 24. Prescription Rates for Medicare
Beneficiaries
4425. Pharmacy Participation in Medi-Cal Program; Conditions;
Department of Health Care Services Utilization Review and
Monitoring
(a) As a condition for the participation of a pharmacy in the
Medi-Cal program pursuant to Chapter 7 (commencing with
Section 14000) of Division 9 of the Welfare and Institutions Code,
the pharmacy, upon presentation of a valid prescription for the
patient and the patient’s Medicare card, shall charge Medicare
beneficiaries a price that does not exceed the Medi-Cal
reimbursement rate for prescription medicines, and an amount,
as set by the State Department of Health Care Services to cover
electronic transmission charges. However, Medicare beneficiaries
shall not be allowed to use the Medi-Cal reimbursement rate for
over-the-counter medications or compounded prescriptions.
(b) The State Department of Health Care Services shall provide a
mechanism to calculate and transmit the price to the pharmacy,
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but shall not apply the Medi-Cal drug utilization review process
for purposes of this section.
(c) The State Department of Health Care Services shall monitor
pharmacy participation with the requirements of subdivision (a).
(d) The State Department of Health Care Services shall conduct
an outreach program to inform Medicare beneficiaries of their
right to participate in the program described in subdivision (a),
including, but not limited to, the following:
(1) Including on its Internet Web site the Medi-Cal
reimbursement rate for, at minimum, 200 of the most commonly
prescribed medicines and updating this information monthly.
(2) Providing a sign to participating pharmacies that the
pharmacies shall prominently display at the point of service and
at the point of sale, reminding the Medicare beneficiaries to ask
that the charge for their prescription be the same amount as the
Medi-Cal reimbursement rate and providing the department’s
telephone number, e-mail address, and Internet Web site
address to access information about the program.
€ If prescription drugs are added to the scope of benefits
available under the federal Medicare program, the Senate Office
of Research shall report that fact to the appropriate committees
of the Legislature. It is the intent of the Legislature to evaluate
the need to continue the implementation of this article under
those circumstances.
(f) This section shall not apply to a prescription that is covered
by insurance.
4426. Department of Public Health to Study Reimbursement
Rates
The State Department of Public Health shall conduct a study of
the adequacy of Medi-Cal pharmacy reimbursement rates
including the cost of providing prescription drugs and services.
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Article 25. Automated Drug Delivery System
4427. Definitions of Drugs and Devices
As used in this article, “drugs” or “dangerous drugs” shall have
the same meaning as “dangerous drug” as provided in Section
4022 and “devices” or “dangerous devices” shall have the same
meaning as “dangerous device” as provided in Section 4022.
4427.1. Requirements for Installation or Operation
An ADDS shall not be installed or operated in California unless it
meets the requirements of this article.
4427.2. Licensing Requirements
(a) An ADDS installed, leased, owned, or operated in California
shall be licensed by the board.
(b) An ADDS license shall only be issued to the holder of a
current, valid, and active pharmacy license of a pharmacy located
and licensed in California.
(c) A separate application and license shall be required for each
ADDS.
(d) An ADDS license shall only be issued when the following
conditions are met:
(1) Use of the ADDS is consistent with legal requirements.
(2) The proposed location for installation of the ADDS meets the
requirements of Section 4427.3 and the ADDS is secure from
access and removal by unauthorized individuals.
(3) The pharmacy’s policies and procedures related to the ADDS
include appropriate security measures and monitoring of the
inventory to prevent theft and diversion.
(4) The pharmacy’s policies and procedures include provisions
for reporting to the board drug losses from the ADDS inventory,
as required by law.
(e) Prior to issuance of the license, the board shall conduct a
prelicensure inspection, within 30 days of a completed
application for an ADDS license, at the proposed location of the
ADDS. Relocation of the ADDS shall require a new application for
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licensure. Replacement of an ADDS shall require notification to
the board within 30 days.
(f) The ADDS license shall be canceled by operation of law if the
underlying pharmacy license is not current, valid, and active.
Upon reissuance or reinstatement of the underlying pharmacy
license, a new application for an ADDS license may be submitted
to the board.
(g) The holder of an ADDS license shall advise the board in
writing within 30 days if use of the ADDS is discontinued.
(h) The ADDS license shall be renewed annually, and the
renewal date shall be the same as the underlying pharmacy
license.
(i) An AUDS operated by a licensed hospital pharmacy, as
defined in Section 4029, and used solely to provide doses
administered to patients while in a licensed general acute care
hospital facility or a licensed acute psychiatric hospital facility, as
defined in subdivisions (a) and (b) of Section 1250 of the Health
and Safety Code, shall be exempt from the requirement of
obtaining an ADDS license pursuant to this section if the licensed
hospital pharmacy owns or leases the AUDS and owns the
dangerous drugs and dangerous devices in the AUDS. The AUDS
shall comply with all other requirements for an ADDS in this
article. The licensed hospital pharmacy shall maintain a list of the
locations of each AUDS it operates and shall make the list
available to the board upon request.
(j) An ADDS license is not required for technology, installed
within the secured licensed premises area of a pharmacy, used in
the selecting, counting, packaging, and labeling of dangerous
drugs and dangerous devices.
4427.3. Location Requirements
(a) An ADDS shall be placed and operated inside an enclosed
building, with a premises address, at a location approved by the
board.
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(b) An ADDS shall be placed and operated in one of the following
locations:
(1) Adjacent to the secured pharmacy area of the pharmacy
holding the ADDS license.
(2) A health facility licensed pursuant to Section 1250 of the
Health and Safety Code that complies with Section 1261.6 of the
Health and Safety Code.
(3) A clinic licensed pursuant to Section 1204 or 1204.1 of the
Health and Safety Code, or Section 4180 or 4190 of this code.
(4) A correctional clinic licensed pursuant to Section 4187.1.
(5) If the ADDS is an APDS, in a location as provided in Section
4427.6.
(6) If the ADDS is an AUDS, in a location as provided in
subdivision (a) of Section 4427.65.
(c) Prior to installation, the pharmacy holding the ADDS license
and the location where the ADDS is placed pursuant to
subdivision (b) shall jointly develop and implement written
policies and procedures to ensure safety, accuracy,
accountability, security, patient confidentiality, and maintenance
of the ADDS, as well as quality, potency, and purity of the drugs
and devices. These policies and procedures shall be maintained
at the location of the ADDS and at the pharmacy holding the
ADDS license.
4427.4. Ownership and Operation by Pharmacy
(a) The ADDS shall be owned or leased by the pharmacy holding
the license for the ADDS.
(b) Each ADDS shall only be operated under the supervision of
the pharmacy holding the ADDS license.
(c) An ADDS shall be considered an extension and part of the
pharmacy holding the ADDS license, regardless of the ADDS
location, and shall be subject to inspection pursuant to Section
4008.
(d) Drugs and devices stored in an ADDS shall be deemed part of
the inventory and the responsibility of the pharmacy holding the
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