Bill Text: CA SB1039 | 2013-2014 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Pharmacy.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2014-09-15 - Chaptered by Secretary of State. Chapter 319, Statutes of 2014. [SB1039 Detail]

Download: California-2013-SB1039-Amended.html

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BILL NUMBER: SB 1039	AMENDED
	BILL TEXT

	AMENDED IN SENATE  APRIL 10, 2014
	AMENDED IN SENATE  MARCH 28, 2014

INTRODUCED BY   Senator Hernandez

                        FEBRUARY 18, 2014

   An act to amend Sections 4052.6  , 4059, 4059.5, 
 and  4115  , and 4142 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,  or  a pharmacy technician  , 
or an intern pharmacist  ,  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. 
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.
  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. 
   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  and would make related
conforming changes. 
   (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. 
  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. 
   SEC. 4.   SEC. 2.   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.
   SEC. 5.  SEC. 3.   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).
   SEC. 6.   SEC. 4.   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. 
  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.
   SEC. 8.   SEC. 5.   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.
   SEC. 9.  SEC. 6.   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.
   SEC. 10.   SEC. 7.   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.