Amended in Senate April 10, 2014

Amended in Senate March 28, 2014

Senate Bill No. 1039

Introduced by Senator Hernandez

February 18, 2014

An act to amend Sections 4052.6 begin delete , 4059, 4059.5, end delete begin insert and end insert 4115 begin delete , and 4142 end delete of, and to add Sections 4119.6 and 4119.7 to, the Business and Professions Code, and to amend Sections 11150 and 11210 of the Health and Safety Code, relating to pharmacies.

LEGISLATIVE COUNSEL’S DIGEST

SB 1039, as amended, Hernandez. Pharmacies: furnishing drugs.

(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensure and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes an intern pharmacist to perform all functions of a pharmacist, and authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks, in each case under supervision of a pharmacist, as specified.

This bill would authorize a pharmacy technician to perform packaging, including emergency supply packaging and sealing in or for hospitals, hospital unit inspections, and other physical, manipulative, repetitive, or other nondiscretionary tasks under supervision of a pharmacist, as specified.

(2) Existing law authorizes a pharmacy to furnish a dangerous drug or dangerous device to a licensed health care facility for storage in a secured emergency pharmaceutical supplies container maintained within the facility in accordance with facility regulations of the State Department of Public Health and other existing law requirements, as specified.

This bill would authorize a pharmacy to furnish a dangerous drug or dangerous device to the emergency medical services system of a licensed general acute care hospital, as defined, for storage in a secured emergency pharmaceutical supplies container maintained within the hospital in accordance with the hospital’s policies and procedures. The bill would require both the hospital and the dispensing pharmacy to maintain records pertaining to the dangerous drugs or dangerous devices furnished to the hospital’s emergency medical services system for at least 3 years. The bill would also authorize a pharmacy to furnish a dangerous drug or dangerous device to a licensed general acute care hospital pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of a licensed general acute care hospital under specified conditions. The bill would require a pharmacist, begin delete or end delete a pharmacy technician begin insert , end insert or an intern pharmacist begin insert , end insert under the direct supervision and control of a pharmacist, to inspect the drugs maintained in the hospital at least once per month, and to report any irregularities, as specified. The bill would also require a hospital to adopt polices and procedures for ensuring proper methods for repackaging and labeling of specified substances.

Because a violation of certain provisions of the bill would be a crime, the bill would create a state-mandated local program.

(3) Existing law authorizes a pharmacist recognized by the board as an advanced practice pharmacist to perform specified functions, including performing patient assessments.

This bill would also authorize a pharmacist recognized by the board as an advanced practice pharmacist to order patient assessments.

(4) Existing law authorizes a pharmacist to initiate or adjust the drug regimen of a patient under specified circumstances. begin delete Existing law authorizes specified practitioners to order a dangerous drug or device and prohibits a person from furnishing a dangerous drug or device, except upon the prescription of those practitioners. end delete begin insert Existing law authorizes specified practitioners, including a pharmacist acting within the scope of an authorized pilot project, to prescribe, furnish, or administer controlled substances to a patient suffering from a disease, ailment, injury, or infirmity, but only when in good faith he or she believes the disease, ailment, injury, or infirmity requires the treatment, and only in the quantity and for the length of time as reasonably necessary. end insert

This bill would modify that list of practitioners to include a pharmacist initiating or adjusting the drug regimen of a patient as authorized under existing law begin delete and would make related conforming changes. end delete

(5) 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.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

SECTION 1.  

Section 4052.6 of the Business and Professions
Code is amended to read:

4052.6.  

(a) A pharmacist recognized by the board as an
advanced practice pharmacist may do all of the following:

(1) Order and perform patient assessments.

(2) Order and interpret drug therapy-related tests.

(3) Refer patients to other health care providers.

(4) Participate in the evaluation and management of diseases
and health conditions in collaboration with other health care
providers.

(5) Initiate, adjust, or discontinue drug therapy in the manner
specified in paragraph (4) of subdivision (a) of Section 4052.2.

(b) A pharmacist who adjusts or discontinues drug therapy shall
promptly transmit written notification to the patient’s diagnosing
prescriber or enter the appropriate information in a patient record
system shared with the prescriber, as permitted by that prescriber.
A pharmacist who initiates drug therapy shall promptly transmit
written notification to, or enter the appropriate information into,
a patient record system shared with the patient’s primary care
provider or diagnosing provider, as permitted by that provider.

(c) This section shall not interfere with a physician’s order to
dispense a prescription drug as written, or other order of similar
meaning.

(d) Prior to initiating or adjusting a controlled substance therapy
pursuant to this section, a pharmacist shall personally register with
the federal Drug Enforcement Administration.

(e) A pharmacist who orders and interprets tests pursuant to
paragraph (2) of subdivision (a) shall ensure that the ordering of
those tests is done in coordination with the patient’s primary care
provider or diagnosing prescriber, as appropriate, including
promptly transmitting written notification to the patient’s
diagnosing prescriber or entering the appropriate information in a
patient record system shared with the prescriber, when available
and as permitted by that prescriber.

begin delete

SEC. 2.  

Section 4059 of the Business and Professions Code is
amended to read:

4059.  

(a) A person shall not furnish a dangerous drug, except
upon the prescription of a physician, dentist, podiatrist, optometrist,
veterinarian, naturopathic doctor pursuant to Section 3640.7, or
pharmacist pursuant to Section 4052.1, 4052.2, or 4052.6. A person
shall not furnish a dangerous device, except upon the prescription
of a physician, dentist, podiatrist, optometrist, veterinarian,
naturopathic doctor pursuant to Section 3640.7, or pharmacist
pursuant to Section 4052.1, 4052.2, or 4052.6.

(b) This section does not apply to the furnishing of a dangerous
drug or dangerous device by a manufacturer, wholesaler, or
pharmacy to each other or to a physician, dentist, podiatrist,
optometrist, veterinarian, or naturopathic doctor pursuant to Section
3640.7, or to a laboratory under sales and purchase records that
correctly give the date, the names and addresses of the supplier
and the buyer, the drug or device, and its quantity. This section
does not apply to the furnishing of a dangerous device by a
manufacturer, wholesaler, or pharmacy to a physical therapist
acting within the scope of his or her license under sales and
purchase records that correctly provide the date the device is
provided, the names and addresses of the supplier and the buyer,
a description of the device, and the quantity supplied.

(c) A pharmacist, or a person exempted pursuant to Section
4054, may distribute dangerous drugs and dangerous devices
directly to dialysis patients pursuant to regulations adopted by the
board. The board shall adopt any regulations as are necessary to
ensure the safe distribution of these drugs and devices to dialysis
patients without interruption thereof. A person who violates a
regulation adopted pursuant to this subdivision shall be liable upon
order of the board to surrender his or her personal license. These
penalties shall be in addition to penalties that may be imposed
pursuant to Section 4301. If the board finds any dialysis drugs or
devices distributed pursuant to this subdivision to be ineffective
or unsafe for the intended use, the board may institute immediate
recall of any or all of the drugs or devices distributed to individual
patients.

(d) Home dialysis patients who receive any drugs or devices
pursuant to subdivision (c) shall have completed a full course of
home training given by a dialysis center licensed by the State
Department of Public Health. The physician prescribing the dialysis
products shall submit proof satisfactory to the manufacturer or
wholesaler that the patient has completed the program.

(e) A pharmacist may furnish a dangerous drug authorized for
use pursuant to Section 2620.3 to a physical therapist. A record
containing the date, name and address of the buyer, and name and
quantity of the drug shall be maintained. This subdivision shall
not be construed to authorize the furnishing of a controlled
substance.

(f) A pharmacist may furnish electroneuromyographic needle
electrodes or hypodermic needles used for the purpose of placing
wire electrodes for kinesiological electromyographic testing to
physical therapists who are certified by the Physical Therapy Board
of California to perform tissue penetration in accordance with
Section 2620.5.

(g) Nothing in this section shall be construed as permitting a
licensed physical therapist to dispense or furnish a dangerous
device without a prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian, or a pharmacist acting within the scope
of his or her practice.

(h) A veterinary food-animal drug retailer shall dispense, furnish,
transfer, or sell veterinary food-animal drugs only to another
veterinary food-animal drug retailer, a pharmacy, a veterinarian,
or to a veterinarian’s client pursuant to a prescription from the
veterinarian for food-producing animals.

SEC. 3.  

Section 4059.5 of the Business and Professions Code
is amended to read:

4059.5.  

(a) Except as otherwise provided in this chapter,
dangerous drugs or dangerous devices may only be ordered by an
entity licensed by the board and shall be delivered to the licensed
premises and signed for and received by a pharmacist. When a
licensee is permitted to operate through a designated representative,
the designated representative shall sign for and receive the delivery.

(b) A dangerous drug or dangerous device transferred, sold, or
delivered to a person within this state shall be transferred, sold, or
delivered only to an entity licensed by the board, to a manufacturer,
or to an ultimate user or the ultimate user’s agent.

(c) Notwithstanding subdivisions (a) and (b), deliveries to a
hospital pharmacy may be made to a central receiving location
within the hospital. However, the dangerous drugs or dangerous
devices shall be delivered to the licensed pharmacy premises within
one working day following receipt by the hospital, and the
pharmacist on duty at that time shall immediately inventory the
dangerous drugs or dangerous devices.

(d) Notwithstanding any other law, a dangerous drug or
dangerous device may be ordered by and provided to a
manufacturer, physician, dentist, podiatrist, optometrist,
veterinarian, naturopathic doctor pursuant to Section 3640.7,
pharmacist pursuant to Section 4052.1, 4052.2, or 4052.6, or
laboratory, or a physical therapist acting within the scope of his
or her license. A person or entity receiving delivery of a dangerous
drug or dangerous device, or a duly authorized representative of
the person or entity, shall sign for the receipt of the dangerous drug
or dangerous device.

(e) A dangerous drug or dangerous device shall not be
transferred, sold, or delivered to a person outside this state, whether
foreign or domestic, unless the transferor, seller, or deliverer does
so in compliance with the laws of this state and of the United States
and of the state or country to which the dangerous drugs or
dangerous devices are to be transferred, sold, or delivered.
Compliance with the laws of this state and the United States and
of the state or country to which the dangerous drugs or dangerous
devices are to be delivered shall include, but not be limited to,
determining that the recipient of the dangerous drugs or dangerous
devices is authorized by law to receive the dangerous drugs or
dangerous devices.

(f) Notwithstanding subdivision (a), a pharmacy may take
delivery of dangerous drugs and dangerous devices when the
pharmacy is closed and no pharmacist is on duty if all of the
following requirements are met:

(1) The drugs are placed in a secure storage facility in the same
building as the pharmacy.

(2) Only the pharmacist-in-charge or a pharmacist designated
by the pharmacist-in-charge has access to the secure storage facility
after dangerous drugs or dangerous devices have been delivered.

(3) The secure storage facility has a means of indicating whether
it has been entered after dangerous drugs or dangerous devices
have been delivered.

(4) The pharmacy maintains written policies and procedures for
the delivery of dangerous drugs and dangerous devices to a secure
storage facility.

(5) The agent delivering dangerous drugs and dangerous devices
pursuant to this subdivision leaves documents indicating the name
and amount of each dangerous drug or dangerous device delivered
in the secure storage facility.

The pharmacy shall be responsible for the dangerous drugs and
dangerous devices delivered to the secure storage facility. The
pharmacy shall also be responsible for obtaining and maintaining
records relating to the delivery of dangerous drugs and dangerous
devices to a secure storage facility.

end delete

begin delete SEC. 4. end delete
begin insert SEC. 2. end insert   

Section 4115 of the Business and Professions Code is
amended to read:

4115.  

(a) A pharmacy technician may perform packaging,
including emergency supply packaging and sealing in or for
hospitals, hospital unit inspections, and other physical,
manipulative, repetitive, or other nondiscretionary tasks, only while
assisting, and while under the direct supervision and control of a
pharmacist.

(b) This section does not authorize the performance of any tasks
specified in subdivision (a) by a pharmacy technician without a
pharmacist on duty.

(c) This section does not authorize a pharmacy technician to
perform any act requiring the exercise of professional judgment
by a pharmacist.

(d) The board shall adopt regulations to specify tasks pursuant
to subdivision (a) that a pharmacy technician may perform under
the supervision of a pharmacist. Any pharmacy that employs a
pharmacy technician shall do so in conformity with the regulations
adopted by the board.

(e) No person shall act as a pharmacy technician without first
being licensed by the board as a pharmacy technician.

(f) (1) A pharmacy with only one pharmacist shall have no
more than one pharmacy technician performing the tasks specified
in subdivision (a). The ratio of pharmacy technicians performing
the tasks specified in subdivision (a) to any additional pharmacist
shall not exceed 2:1, except that this ratio shall not apply to
personnel performing clerical functions pursuant to Section 4116
or 4117. This ratio is applicable to all practice settings, except for
an inpatient of a licensed health facility, a patient of a licensed
home health agency, as specified in paragraph (2), an inmate of a
correctional facility of the Department of Corrections and
Rehabilitation, and for a person receiving treatment in a facility
operated by the State Department of State Hospitals, the State
Department of Developmental Services, or the Department of
Veterans Affairs.

(2) The board may adopt regulations establishing the ratio of
pharmacy technicians performing the tasks specified in subdivision
(a) to pharmacists applicable to the filling of prescriptions of an
inpatient of a licensed health facility and for a patient of a licensed
home health agency. Any ratio established by the board pursuant
to this subdivision shall allow, at a minimum, at least one pharmacy
technician for a single pharmacist in a pharmacy and two pharmacy
technicians for each additional pharmacist, except that this ratio
shall not apply to personnel performing clerical functions pursuant
to Section 4116 or 4117.

(3) A pharmacist scheduled to supervise a second pharmacy
technician may refuse to supervise a second pharmacy technician
if the pharmacist determines, in the exercise of his or her
professional judgment, that permitting the second pharmacy
technician to be on duty would interfere with the effective
performance of the pharmacist’s responsibilities under this chapter.
A pharmacist assigned to supervise a second pharmacy technician
shall notify the pharmacist in charge in writing of his or her
determination, specifying the circumstances of concern with respect
to the pharmacy or the pharmacy technician that have led to the
determination, within a reasonable period, but not to exceed 24
hours, after the posting of the relevant schedule. No entity
employing a pharmacist may discharge, discipline, or otherwise
discriminate against any pharmacist in the terms and conditions
of employment for exercising or attempting to exercise in good
faith the right established pursuant to this paragraph.

(g) Notwithstanding subdivisions (a) and (b), the board shall
by regulation establish conditions to permit the temporary absence
of a pharmacist for breaks and lunch periods pursuant to Section
512 of the Labor Code and the orders of the Industrial Welfare
Commission without closing the pharmacy. During these temporary
absences, a pharmacy technician may, at the discretion of the
pharmacist, remain in the pharmacy but may only perform
nondiscretionary tasks. The pharmacist shall be responsible for a
pharmacy technician and shall review any task performed by a
pharmacy technician during the pharmacist’s temporary absence.
Nothing in this subdivision shall be construed to authorize a
pharmacist to supervise pharmacy technicians in greater ratios
than those described in subdivision (f).

(h) The pharmacist on duty shall be directly responsible for the
conduct of a pharmacy technician supervised by that pharmacist.

begin delete SEC. 5. end delete
begin insert SEC. 3. end insert   

Section 4119.6 is added to the Business and Professions
Code, to read:

4119.6.  

(a) Notwithstanding any other law, a pharmacy may
furnish a dangerous drug or dangerous device to the emergency
medical services system of a licensed general acute care hospital,
as defined in subdivision (a) of Section 1250 of the Health and
Safety Code, for storage in a secured emergency pharmaceutical
supplies container maintained within the hospital in accordance
with the hospital’s policies and procedures. A pharmacy technician
or intern pharmacist under the direct supervision and control, as
defined in Section 4023.5, of a pharmacist may stock, replenish,
and inspect the hospital’s emergency pharmaceutical supplies
container.

(b) Both the hospital and the dispensing pharmacy acting under
this section shall maintain records of each request by, and
dangerous drugs or dangerous devices furnished to, the hospital’s
emergency medical services system, for at least three years.

(c) Controlled substances shall be furnished to the hospital’s
emergency medical services system under this section in
accordance with the California Uniform Controlled Substances
Act (Division 10 (commencing with Section 11000) of the Health
and Safety Code).

begin delete SEC. 6. end delete
begin insert SEC. 4. end insert   

Section 4119.7 is added to the Business and Professions
Code, to read:

4119.7.  

(a) Notwithstanding any other law, a pharmacy may
furnish a dangerous drug or dangerous device to a licensed general
acute care hospital, as defined in subdivision (a) of Section 1250
of the Health and Safety Code, pursuant to preprinted or electronic
standing orders, order sets, and protocols established under the
policies and procedures of the hospital, as approved according to
the policies of the hospital’s governing body, if the order is
promptly dated, timed, and authenticated in the medical record of
the patient to whom the dangerous drug or dangerous device is
dispensed by the ordering practitioner or another practitioner
responsible for the care of that patient and authorized by the
hospital’s policies and procedures to write orders.

(b) The hospital shall store and maintain drugs in accordance
with national standards regarding the storage area and refrigerator
or freezer temperature, and otherwise pursuant to the
manufacturer’s guidelines.

(c) (1) A pharmacist, pharmacy technician, or an intern
pharmacist under the direct supervision and control, as defined in
Section 4023.5, of a pharmacist, shall inspect the drugs maintained
in the hospital at least once per month. The hospital shall establish
specific written policies and procedures for inspections pursuant
to this paragraph.

(2) The person conducting the inspection pursuant to paragraph
(1) shall report any irregularities to the director or chief executive
officer of the hospital, or other person holding an equivalent
position, and in accordance with the hospital’s policy.

(d) The hospital shall adopt policies and procedures regarding
the responsibility for ensuring proper methods for repackaging
and labeling of bulk cleaning agents, solvents, chemicals, and
nondrug hazardous substances used throughout the hospital
according to state and federal law and standards.

begin delete

SEC. 7.  

Section 4142 of the Business and Professions Code is
amended to read:

4142.  

Except as otherwise provided by this article, no
hypodermic needle or syringe shall be sold at retail except upon
the prescription of a physician, dentist, veterinarian, podiatrist,
naturopathic doctor pursuant to Section 3640.7, or pharmacist
pursuant to Section 4052.1, 4052.2, or 4052.6.

end delete

begin delete SEC. 8. end delete
begin insert SEC. 5. end insert   

Section 11150 of the Health and Safety Code is
amended to read:

11150.  

No person other than a physician, dentist, podiatrist,
or veterinarian, or naturopathic doctor acting pursuant to Section
3640.7 of the Business and Professions Code, or pharmacist acting
within the scope of a project authorized under Article 1
(commencing with Section 128125) of Chapter 3 of Part 3 of
Division 107 or within the scope of Section 4052.1, 4052.2, or
4052.6 of the Business and Professions Code, a registered nurse
acting within the scope of a project authorized under Article 1
(commencing with Section 128125) of Chapter 3 of Part 3 of
Division 107, a certified nurse-midwife acting within the scope of
Section 2746.51 of the Business and Professions Code, a nurse
practitioner acting within the scope of Section 2836.1 of the
Business and Professions Code, a physician assistant acting within
the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107 or
Section 3502.1 of the Business and Professions Code, a
naturopathic doctor acting within the scope of Section 3640.5 of
the Business and Professions Code, or an optometrist acting within
the scope of Section 3041 of the Business and Professions Code,
or an out-of-state prescriber acting pursuant to Section 4005 of the
Business and Professions Code shall write or issue a prescription.

begin delete SEC. 9. end delete
begin insert SEC. 6. end insert   

Section 11210 of the Health and Safety Code is
amended to read:

11210.  

A physician, surgeon, dentist, veterinarian, naturopathic
doctor acting pursuant to Section 3640.7 of the Business and
Professions Code, or podiatrist, or pharmacist acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, or registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107, or naturopathic doctor acting within the scope
of Section 3640.5 of the Business and Professions Code, or an
optometrist acting within the scope of Section 3041 of the Business
and Professions Code may prescribe for, furnish to, or administer
controlled substances to his or her patient when the patient is
suffering from a disease, ailment, injury, or infirmities attendant
upon old age, other than addiction to a controlled substance.

The physician, surgeon, dentist, veterinarian, naturopathic doctor
acting pursuant to Section 3640.7 of the Business and Professions
Code, or podiatrist, or pharmacist acting within the scope of a
project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107 or within the scope
of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, or registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107, or naturopathic doctor acting within the scope
of Section 3640.5 of the Business and Professions Code, or an
optometrist acting within the scope of Section 3041 of the Business
and Professions Code shall prescribe, furnish, or administer
controlled substances only when in good faith he or she believes
the disease, ailment, injury, or infirmity requires the treatment.

The physician, surgeon, dentist, veterinarian, or naturopathic
doctor acting pursuant to Section 3640.7 of the Business and
Professions Code, or podiatrist, or pharmacist acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, or registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107, or a naturopathic doctor acting within the scope
of Section 3640.5 of the Business and Professions Code, or an
optometrist acting within the scope of Section 3041 of the Business
and Professions Code shall prescribe, furnish, or administer
controlled substances only in the quantity and for the length of
time as are reasonably necessary.

begin delete SEC. 10. end delete
begin insert SEC. 7. end insert   

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.