BILL NUMBER: AB 2408 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 31, 2006
PASSED THE ASSEMBLY AUGUST 31, 2006
AMENDED IN SENATE AUGUST 28, 2006
AMENDED IN SENATE JUNE 1, 2006
AMENDED IN ASSEMBLY MAY 4, 2006
AMENDED IN ASSEMBLY MARCH 27, 2006
INTRODUCED BY Assembly Member Negrete McLeod
FEBRUARY 23, 2006
An act to amend Sections 4036, 4050, 4052, 4301, and 4306.5 of, to
amend, renumber, and add Section 4052.1 of, to add Sections 4052.2
and 4052.3 to, and to repeal and add Section 4303 of, the Business
and Professions Code, relating to pharmacies.
LEGISLATIVE COUNSEL'S DIGEST
AB 2408, Negrete McLeod Pharmacies.
Existing law, the Pharmacy Law, provides for the licensing and
regulation of pharmacists and pharmacies by the Board of Pharmacy in
the Department of Consumer Affairs. A violation of the Pharmacy Law
is a crime.
Existing law defines a pharmacist and a pharmacy, requires
pharmacists and pharmacies to be licensed by the board, and
authorizes a licensee to engage in certain activities. Existing law
also sets forth activities that constitute unprofessional conduct for
a pharmacist to engage in.
This bill would require a pharmacist to be a natural person, and
would entitle a licensed pharmacist to practice pharmacy within or
outside of a licensed pharmacy. The bill would revise the activities
in which a pharmacist may engage, including the adjustment of
prescriptions, would revise the pharmacist's responsibilities and
requirements with regard to certain activities, and would make
certain additional acts or omissions unprofessional conduct.
Existing law defines a nonresident pharmacy and requires a
nonresident pharmacy to meet certain criteria, including registration
with the board. Existing law authorizes the board to deny, revoke,
or suspend a nonresident registration for failure to comply with
specified requirements or for conduct that causes serious bodily or
psychological injury to a California resident, in specified
circumstances.
This bill would delete the authorization for the board to deny,
revoke, or suspend a nonresident registration for failure to comply
with specified requirements or for conduct causing serious bodily
harm or psychological injury to a California resident, and would
instead authorize the board to deny, revoke, or suspend a nonresident
pharmacy registration, issue a citation or letter of admonishment,
or take any other action against a nonresident pharmacy that it may
take against a resident pharmacy on any of the same grounds upon
which the action might be taken against a resident pharmacy, if
action may be taken against the nonresident pharmacy in its own state
for the conduct. The bill would also authorize the board to report
violations of laws or regulations by a nonresident pharmacy to any
appropriate state or federal regulatory or licensing agency.
This bill would revise and recast related provisions of the
Pharmacy Law.
Because this bill would create new requirements and prohibitions
under the Pharmacy Law, the violation of which would be a crime, it
would impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4036 of the Business and Professions Code is
amended to read:
4036. "Pharmacist" means a natural person to whom a license has
been issued by the board, under Section 4200, except as specifically
provided otherwise in this chapter. The holder of an unexpired and
active pharmacist license issued by the board is entitled to practice
pharmacy as defined by this chapter, within or outside of a licensed
pharmacy as authorized by this chapter.
SEC. 2. Section 4050 of the Business and Professions Code is
amended to read:
4050. (a) In recognition of and consistent with the decisions of
the appellate courts of this state, the Legislature hereby declares
the practice of pharmacy to be a profession.
(b) Pharmacy practice is a dynamic patient-oriented health service
that applies a scientific body of knowledge to improve and promote
patient health by means of appropriate drug use, drug-related
therapy, and communication for clinical and consultative purposes.
Pharmacy practice is continually evolving to include more
sophisticated and comprehensive patient care activities.
SEC. 3. Section 4052 of the Business and Professions Code is
amended to read:
4052. (a) Notwithstanding any other provision of law, a
pharmacist may:
(1) Furnish a reasonable quantity of compounded drug product to a
prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
(4) Perform procedures or functions in a licensed health care
facility as authorized by Section 4052.1.
(5) Perform procedures or functions as part of the care provided
by a health care facility, a licensed home health agency, a licensed
clinic in which there is a physician oversight, a provider who
contracts with a licensed health care service plan with regard to the
care or services provided to the enrollees of that health care
service plan, or a physician, as authorized by Section 4052.2.
(6) Manufacture, measure, fit to the patient, or sell and repair
dangerous devices or furnish instructions to the patient or the
patient's representative concerning the use of those devices.
(7) Provide consultation to patients and professional information,
including clinical or pharmacological information, advice, or
consultation to other health care professionals.
(8) Furnish emergency contraception drug therapy as authorized by
Section 4052.3.
(9) Administer immunizations pursuant to a protocol with a
prescriber.
(b) A pharmacist who is authorized to issue an order to initiate
or adjust a controlled substance therapy pursuant to this section
shall personally register with the federal Drug Enforcement
Administration.
(c) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.
(d) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.
SEC. 4. Section 4052.1 of the Business and Professions Code is
amended and renumbered to read:
4052.4. Notwithstanding Section 2038 or any other provision of
law, a pharmacist may perform skin puncture in the course of
performing routine patient assessment procedures or in the course of
performing any procedure authorized under Section 1206.5. For
purposes of this section, "routine patient assessment procedures"
means: (a) procedures that a patient could, with or without a
prescription, perform for himself or herself, or (b) clinical
laboratory tests that are classified as waived pursuant to the
federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C.
Sec. 263a) and the regulations adopted thereunder by the federal
Health Care Financing Administration, as authorized by paragraph (11)
of subdivision (a) of Section 1206.5. A pharmacist performing these
functions shall report the results obtained from a test to the
patient and any physician designated by the patient. Any pharmacist
who performs the service authorized by this section shall not be in
violation of Section 2052.
SEC. 5. Section 4052.1 is added to the Business and Professions
Code, to read:
4052.1. (a) Notwithstanding any other provision of law, a
pharmacist may perform the following procedures or functions in a
licensed health care facility in accordance with policies,
procedures, or protocols developed by health professionals, including
physicians, pharmacists, and registered nurses, with the concurrence
of the facility administrator:
(1) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.
(2) Ordering drug therapy-related laboratory tests.
(3) Administering drugs and biologicals by injection pursuant to a
prescriber's order.
(4) Initiating or adjusting the drug regimen of a patient pursuant
to an order or authorization made by the patient's prescriber and in
accordance with the policies, procedures, or protocols of the
licensed health care facility.
(b) Prior to performing any procedure authorized by this section,
a pharmacist shall have received appropriate training as prescribed
in the policies and procedures of the licensed health care facility.
SEC. 6. Section 4052.2 is added to the Business and Professions
Code, to read:
4052.2. (a) Notwithstanding any other provision of law, a
pharmacist may perform the following procedures or functions as part
of the care provided by a health care facility, a licensed home
health agency, a licensed clinic in which there is a physician
oversight, a provider who contracts with a licensed health care
service plan with regard to the care or services provided to the
enrollees of that health care service plan, or a physician, in
accordance with the policies, procedures, or protocols of that
facility, home health agency, licensed clinic, health care service
plan, or physician, and in accordance with subdivision (c):
(1) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.
(2) Ordering drug therapy-related laboratory tests.
(3) Administering drugs and biologicals by injection pursuant to a
prescriber's order.
(4) Initiating or adjusting the drug regimen of a patient pursuant
to a specific written order or authorization made by the individual
patient's treating prescriber, and in accordance with the policies,
procedures, or protocols of the health care facility, home health
agency, licensed clinic, health care service plan, or physician.
Adjusting the drug regimen does not include substituting or selecting
a different drug, except as authorized by the protocol. The
pharmacist shall provide written notification to the patient's
treating prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this paragraph within 24 hours.
(b) A patient's treating prescriber may prohibit, by written
instruction, any adjustment or change in the patient's drug regimen
by the pharmacist.
(c) The policies, procedures, or protocols referred to in this
subdivision shall be developed by health care professionals,
including physicians, pharmacists, and registered nurses, and shall,
at a minimum, do all of the following:
(1) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses. The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
(2) Require that the medical records of the patient be available
to both the patient's treating prescriber and the pharmacist.
(3) Require that the procedures to be performed by the pharmacist
relate to a condition for which the patient has first been seen by a
physician.
(4) Except for procedures or functions provided by a health care
facility, a licensed clinic in which there is physician oversight, or
a provider who contracts with a licensed health care plan with
regard to the care or services provided to the enrollees of that
health care service plan, require the procedures to be performed in
accordance with a written, patient-specific protocol approved by the
treating or supervising physician. Any change, adjustment, or
modification of an approved preexisting treatment or drug therapy
shall be provided in writing to the treating or supervising physician
within 24 hours.
(d) Prior to performing any procedure authorized by this section,
a pharmacist shall have done either of the following:
(1) Successfully completed clinical residency training.
(2) Demonstrated clinical experience in direct patient care
delivery.
SEC. 7. Section 4052.3 is added to the Business and Professions
Code, to read:
4052.3. (a) Notwithstanding any other provision of law, a
pharmacist may furnish emergency contraception drug therapy in
accordance with either of the following:
(1) Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.
(2) Standardized procedures or protocols developed and approved by
both the board and the Medical Board of California in consultation
with the American College of Obstetricians and Gynecologists, the
California Pharmacist Association, and other appropriate entities.
Both the board and the Medical Board of California shall have
authority to ensure compliance with this clause, and both boards are
specifically charged with the enforcement of this provision with
respect to their respective licensees. Nothing in this clause shall
be construed to expand the authority of a pharmacist to prescribe any
prescription medication.
(b) Prior to performing a procedure authorized under this
paragraph, a pharmacist shall complete a training program on
emergency contraception that consists of at least one hour of
approved continuing education on emergency contraception drug
therapy.
(c) A pharmacist, pharmacist's employer, or pharmacist's agent may
not directly charge a patient a separate consultation fee for
emergency contraception drug therapy services initiated pursuant to
this paragraph, but may charge an administrative fee not to exceed
ten dollars ($10) above the retail cost of the drug. Upon an oral,
telephonic, electronic, or written request from a patient or
customer, a pharmacist or pharmacist's employee shall disclose the
total retail price that a consumer would pay for emergency
contraception drug therapy. As used in this subparagraph, total
retail price includes providing the consumer with specific
information regarding the price of the emergency contraception drugs
and the price of the administrative fee charged. This limitation is
not intended to interfere with other contractually agreed-upon terms
between a pharmacist, a pharmacist's employer, or a pharmacist's
agent, and a health care service plan or insurer. Patients who are
insured or covered and receive a pharmacy benefit that covers the
cost of emergency contraception shall not be required to pay an
administrative fee. These patients shall be required to pay
copayments pursuant to the terms and conditions of their coverage.
The provisions of this subparagraph shall cease to be operative for
dedicated emergency contraception drugs when these drugs are
reclassified as over-the-counter products by the federal Food and
Drug Administration.
(d) A pharmacist may not require a patient to provide individually
identifiable medical information that is not specified in Section
1707.1 of Title 16 of the California Code of Regulations before
initiating emergency contraception drug therapy pursuant to this
section.
(e) For each emergency contraception drug therapy initiated
pursuant to this section, the pharmacist shall provide the recipient
of the emergency contraception drugs with a standardized factsheet
that includes, but is not limited to, the indications for use of the
drug, the appropriate method for using the drug, the need for medical
followup, and other appropriate information. The board shall develop
this form in consultation with the State Department of Health
Services, the American College of Obstetricians and Gynecologists,
the California Pharmacists Association, and other health care
organizations. The provisions of this section do not preclude the use
of existing publications developed by nationally recognized medical
organizations.
SEC. 8. Section 4301 of the Business and Professions Code, as
added by Section 44 of Chapter 857 of the Statutes of 2004, is
amended to read:
4301. The board shall take action against any holder of a license
who is guilty of unprofessional conduct or whose license has been
procured by fraud or misrepresentation or issued by mistake.
Unprofessional conduct shall include, but is not limited to, any of
the following:
(a) Gross immorality.
(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.
(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.
(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. The record of the
compromise is conclusive evidence of unprofessional conduct.
(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.
(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 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.
(t) This section shall become operative on January 1, 2006.
SEC. 9. Section 4303 of the Business and Professions Code is
repealed.
SEC. 10. Section 4303 is added to the Business and Professions
Code, to read:
4303. (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 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 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.
SEC. 11. Section 4306.5 of the Business and Professions Code is
amended to read:
4306.5. 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.
(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.
SEC. 12. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.