Amended in Assembly August 19, 2013

Amended in Assembly August 5, 2013

Amended in Senate May 28, 2013

Amended in Senate April 24, 2013

Amended in Senate April 1, 2013

Senate BillNo. 493


Introduced by Senator Hernandez

February 21, 2013


An act to amend Sections 733, 4040, 4050, 4051, 4052, 4052.3, 4060, 4076, 4111, and 4174 of, and to add Sections 4016.5, 4052.6, 4052.8, 4052.9, 4210, and 4233 to, the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

SB 493, as amended, Hernandez. Pharmacy practice.

The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. The law specifies the functions pharmacists are authorized to perform, including to administer, orally or topically, drugs and biologicals pursuant to a prescriber’s order, and to administer immunizations pursuant to a protocol with a prescriber. Pharmacists may also furnish emergency contraception drug therapy pursuant to standardized procedures if they have completed a training program. A violation of the Pharmacy Law is a crime.

This bill, instead, would authorize a pharmacist to administer drugs and biological products that have been ordered by a prescriber. The bill would authorize pharmacists to perform other functions, including, among other things, to furnish self-administered hormonal contraceptives, nicotine replacement products, and prescription medications not requiring a diagnosis that are recommended for international travelers, as specified. Additionally, the bill would authorize pharmacists to order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies, and to independently initiate and administer routine vaccinations, as specified. This bill also would establish board recognition for an advanced practice pharmacist, as defined, would specify the criteria for that recognition, and would specify additional functions that may be performed by an advanced practice pharmacist, including, among other things, performing patient assessments, and certain other functions, as specified. The bill would authorize the board, by regulation, to set the fee for the issuance and renewal of advanced practice pharmacist recognition at the reasonable cost of regulating advanced practice pharmacists pursuant to these provisions, not to exceed $300.begin delete The bill would make conforming changes.end delete

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

The bill would make other conforming and technical changes.

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:

P2    1

SECTION 1.  

Section 733 of the Business and Professions Code
2 is amended to read:

3

733.  

(a) A licentiate shall not obstruct a patient in obtaining
4a prescription drug or device that has been legally prescribed or
5ordered for that patient. A violation of this section constitutes
6unprofessional conduct by the licentiate and shall subject the
7licentiate to disciplinary or administrative action by his or her
8licensing agency.

9(b) Notwithstanding any other law, a licentiate shall dispense
10drugs and devices, as described in subdivision (a) of Section 4024,
P3    1pursuant to a lawful order or prescription unless one of the
2following circumstances exists:

3(1) Based solely on the licentiate’s professional training and
4judgment, dispensing pursuant to the order or the prescription is
5contrary to law, or the licentiate determines that the prescribed
6drug or device would cause a harmful drug interaction or would
7otherwise adversely affect the patient’s medical condition.

8(2) The prescription drug or device is not in stock. If an order,
9other than an order described in Section 4019, or prescription
10cannot be dispensed because the drug or device is not in stock, the
11licentiate shall take one of the following actions:

12(A) Immediately notify the patient and arrange for the drug or
13device to be delivered to the site or directly to the patient in a
14timely manner.

15(B) Promptly transfer the prescription to another pharmacy
16known to stock the prescription drug or device that is near enough
17to the site from which the prescription or order is transferred, to
18ensure the patient has timely access to the drug or device.

19(C) Return the prescription to the patient and refer the patient.
20The licentiate shall make a reasonable effort to refer the patient to
21a pharmacy that stocks the prescription drug or device that is near
22enough to the referring site to ensure that the patient has timely
23access to the drug or device.

24(3) The licentiate refuses on ethical, moral, or religious grounds
25to dispense a drug or device pursuant to an order or prescription.
26A licentiate may decline to dispense a prescription drug or device
27 on this basis only if the licentiate has previously notified his or
28her employer, in writing, of the drug or class of drugs to which he
29or she objects, and the licentiate’s employer can, without creating
30undue hardship, provide a reasonable accommodation of the
31licentiate’s objection. The licentiate’s employer shall establish
32protocols that ensure that the patient has timely access to the
33prescribed drug or device despite the licentiate’s refusal to dispense
34the prescription or order. For purposes of this section, “reasonable
35accommodation” and “undue hardship” shall have the same
36meaning as applied to those terms pursuant to subdivision (l) of
37Section 12940 of the Government Code.

38(c) For the purposes of this section, “prescription drug or device”
39has the same meaning as the definition in Section 4022.

P4    1(d) This section applies to emergency contraception drug therapy
2and self-administered hormonal contraceptives described in Section
34052.3.

4(e) This section imposes no duty on a licentiate to dispense a
5drug or device pursuant to a prescription or order without payment
6for the drug or device, including payment directly by the patient
7or through a third-party payer accepted by the licentiate or payment
8of any required copayment by the patient.

9(f) The notice to consumers required by Section 4122 shall
10include a statement that describes patients’ rights relative to the
11requirements of this section.

12

SEC. 2.  

Section 4016.5 is added to the Business and Professions
13Code
, to read:

14

4016.5.  

“Advanced practice pharmacist” means a licensed
15pharmacist who has been recognized as an advanced practice
16pharmacist by the board, pursuant to Section 4210. A
17board-recognized advanced practice pharmacist is entitled to
18practice advanced practice pharmacy, as described in Section
194052.6, within or outside of a licensed pharmacy as authorized by
20this chapter.

21

SEC. 3.  

Section 4040 of the Business and Professions Code is
22amended to read:

23

4040.  

(a) “Prescription” means an oral, written, or electronic
24transmission order that is both of the following:

25(1) Given individually for the person or persons for whom
26ordered that includes all of the following:

27(A) The name or names and address of the patient or patients.

28(B) The name and quantity of the drug or device prescribed and
29the directions for use.

30(C) The date of issue.

31(D) Either rubber stamped, typed, or printed by hand or typeset,
32the name, address, and telephone number of the prescriber, his or
33her license classification, and his or her federal registry number,
34if a controlled substance is prescribed.

35(E) A legible, clear notice of the condition or purpose for which
36the drug is being prescribed, if requested by the patient or patients.

37(F) If in writing, signed by the prescriber issuing the order, or
38the certified nurse-midwife, nurse practitioner, physician assistant,
39or naturopathic doctor who issues a drug order pursuant to Section
402746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
P5    1who issues a drug order pursuant to Section 4052.1, 4052.2, or
24052.6.

3(2) Issued by a physician, dentist, optometrist, podiatrist,
4veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
5if a drug order is issued pursuant to Section 2746.51, 2836.1,
63502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
7physician assistant, or naturopathic doctor licensed in this state,
8or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist
9licensed in this state.

10(b) Notwithstanding subdivision (a), a written order of the
11prescriber for a dangerous drug, except for any Schedule II
12controlled substance, that contains at least the name and signature
13of the prescriber, the name and address of the patient in a manner
14consistent with paragraph (2) of subdivision (a) of Section 11164
15of the Health and Safety Code, the name and quantity of the drug
16prescribed, directions for use, and the date of issue may be treated
17as a prescription by the dispensing pharmacist as long as any
18additional information required by subdivision (a) is readily
19retrievable in the pharmacy. In the event of a conflict between this
20subdivision and Section 11164 of the Health and Safety Code,
21Section 11164 of the Health and Safety Code shall prevail.

22(c) “Electronic transmission prescription” includes both image
23and data prescriptions. “Electronic image transmission
24prescription” means any prescription order for which a facsimile
25of the order is received by a pharmacy from a licensed prescriber.
26“Electronic data transmission prescription” means any prescription
27order, other than an electronic image transmission prescription,
28that is electronically transmitted from a licensed prescriber to a
29pharmacy.

30(d) The use of commonly used abbreviations shall not invalidate
31an otherwise valid prescription.

32(e) Nothing in the amendments made to this section (formerly
33Section 4036) at the 1969 Regular Session of the Legislature shall
34be construed as expanding or limiting the right that a chiropractor,
35while acting within the scope of his or her license, may have to
36prescribe a device.

37

SEC. 4.  

Section 4050 of the Business and Professions Code is
38amended to read:

P6    1

4050.  

(a) In recognition of and consistent with the decisions
2of the appellate courts of this state, the Legislature hereby declares
3the practice of pharmacy to be a profession.

4(b) Pharmacy practice is a dynamic, patient-oriented health
5service that applies a scientific body of knowledge to improve and
6promote patient health by means of appropriate drug use,
7drug-related therapy, and communication for clinical and
8consultative purposes. Pharmacy practice is continually evolving
9to include more sophisticated and comprehensive patient care
10activities.

11(c) The Legislature further declares that pharmacists are health
12care providers who have the authority to provide health care
13services.

14

SEC. 5.  

Section 4051 of the Business and Professions Code is
15amended to read:

16

4051.  

(a) Except as otherwise provided in this chapter, it is
17unlawful for any person to manufacture, compound, furnish, sell,
18or dispense a dangerous drug or dangerous device, or to dispense
19or compound a prescription pursuant to Section 4040 of a prescriber
20unless he or she is a pharmacist under this chapter.

21(b) Notwithstanding any other law, a pharmacist may authorize
22the initiation of a prescription, pursuant to Section 4052.1, 4052.2,
234052.3, or 4052.6, and otherwise provide clinical advice, services,
24information, or patient consultation, as set forth in this chapter, if
25all of the following conditions are met:

26(1) The clinical advice, services, information, or patient
27consultation is provided to a health care professional or to a patient.

28(2) The pharmacist has access to prescription, patient profile,
29or other relevant medical information for purposes of patient and
30clinical consultation and advice.

31(3) Access to the information described in paragraph (2) is
32secure from unauthorized access and use.

33

SEC. 6.  

Section 4052 of the Business and Professions Code is
34amended to read:

35

4052.  

(a) Notwithstanding any other law, a pharmacist may:

36(1) Furnish a reasonable quantity of compounded drug product
37to a prescriber for office use by the prescriber.

38(2) Transmit a valid prescription to another pharmacist.

39(3) Administer drugs and biological products that have been
40ordered by a prescriber.

P7    1(4) Perform procedures or functions in a licensed health care
2facility as authorized by Section 4052.1.

3(5) Perform procedures or functions as part of the care provided
4by a health care facility, a licensed home health agency, a licensed
5clinic in which there is a physician oversight, a provider who
6contracts with a licensed health care service plan with regard to
7the care or services provided to the enrollees of that health care
8service plan, or a physician, as authorized by Section 4052.2.

9(6) Perform procedures or functions as authorized by Section
104052.6.

11(7) Manufacture, measure, fit to the patient, or sell and repair
12dangerous devices, or furnish instructions to the patient or the
13patient’s representative concerning the use of those devices.

14(8) Provide consultation, training, and education to patients
15 about drug therapy, disease management, and disease prevention.

16(9) Provide professional information, including clinical or
17pharmacological information, advice, or consultation to other
18health care professionals, and participate in multidisciplinary
19review of patient progress, including appropriate access to medical
20records.

21(10) Furnish the following medications:

22(A) Emergency contraception drug therapy and self-administered
23hormonal contraceptives, as authorized by Section 4052.3.

24(B) Nicotine replacement products, as authorized by Section
254052.9.

26(C) Prescription medications not requiring a diagnosis that are
27recommended by the federal Centers for Disease Control and
28Prevention for individuals traveling outside of the United States.

29(D) The pharmacist shall notify the patient’s primary care
30provider of any drugs or devices furnished to the patient. If the
31patient does not have a primary care provider, the pharmacist shall
32provide the patient with a written record of the drugs or devices
33furnished and advise the patient to consult a physician of the
34patient’s choice.

35(11) Administer immunizations pursuant to a protocol with a
36prescriber.

37(12) Order and interpret tests for the purpose of monitoring and
38managing the efficacy and toxicity of drug therapies.begin insert A pharmacist
39who orders and interprets tests pursuant to this paragraph shall
40ensure that the ordering of those tests is done in coordination with
P8    1the patient’s primary care provider or diagnosing prescriber, as
2appropriate, including promptly transmitting written notification
3to the patient’s diagnosing prescriber or entering the appropriate
4information in a patient record system shared with the prescriber,
5when available and as permitted by that prescriber.end insert

6(b) A pharmacist who is authorized to issue an order to initiate
7or adjust a controlled substance therapy pursuant to this section
8shall personally register with the federal Drug Enforcement
9Administration.

10(c) This section does not affect the applicable requirements of
11law relating to either of the following:

12(1) Maintaining the confidentiality of medical records.

13(2) The licensing of a health care facility.

14

SEC. 7.  

Section 4052.3 of the Business and Professions Code
15 is amended to read:

16

4052.3.  

(a) (1) Notwithstanding any other law, a pharmacist
17may furnish self-administered hormonal contraceptives in
18accordance with standardized procedures or protocols developed
19and approved by both the board and the Medical Board of
20California in consultation with the American Congress of
21Obstetricians and Gynecologists, the California Pharmacists
22Association, and other appropriate entities. The standardized
23procedure or protocol shall require that the patient use a
24self-screening tool that willbegin delete identityend deletebegin insert identifyend insert patient risk factors
25for use of self-administered hormonal contraceptives, based on
26the current United States Medical Eligibility Criteria (USMEC)
27for Contraceptive Use developed by the federal Centers for Disease
28Control and Prevention, and that the pharmacist refer the patient
29to the patient’s primary care provider or, if the patient does not
30have a primary care provider, to nearby clinics, upon furnishing a
31self-administered hormonal contraceptive pursuant to this
32subdivision, or if it is determined that use of a self-administered
33hormonal contraceptive is not recommended.

34(2) The board and the Medical Board of California are both
35authorized to ensure compliance with this subdivision, and each
36board is specifically charged with the enforcement of this
37subdivision with respect to its respective licensees. This subdivision
38does not expand the authority of a pharmacist to prescribe any
39prescription medication.

P9    1(b) (1) Notwithstanding any other law, a pharmacist may furnish
2emergency contraception drug therapy in accordance with either
3of the following:

4(A) Standardized procedures or protocols developed by the
5pharmacist and an authorized prescriber who is acting within his
6or her scope of practice.

7(B) Standardized procedures or protocols developed and
8 approved by both the board and the Medical Board of California
9in consultation with the American Congress of Obstetricians and
10Gynecologists, the California Pharmacists Association, and other
11appropriate entities. The board and the Medical Board of California
12are both authorized to ensure compliance with this clause, and
13each board is specifically charged with the enforcement of this
14provision with respect to its respective licensees. This subdivision
15does not expand the authority of a pharmacist to prescribe any
16prescription medication.

17(2) Prior to performing a procedure authorized under this
18subdivision, a pharmacist shall complete a training program on
19emergency contraception that consists of at least one hour of
20approved continuing education on emergency contraception drug
21therapy.

22(3) A pharmacist, pharmacist’s employer, or pharmacist’s agent
23shall not directly charge a patient a separate consultation fee for
24emergency contraception drug therapy services initiated pursuant
25to this subdivision, but may charge an administrative fee not to
26exceed ten dollars ($10) above the retail cost of the drug. Upon an
27oral, telephonic, electronic, or written request from a patient or
28customer, a pharmacist or pharmacist’s employee shall disclose
29the total retail price that a consumer would pay for emergency
30contraception drug therapy. As used in this paragraph, total retail
31price includes providing the consumer with specific information
32regarding the price of the emergency contraception drugs and the
33price of the administrative fee charged. This limitation is not
34intended to interfere with other contractually agreed-upon terms
35between a pharmacist, a pharmacist’s employer, or a pharmacist’s
36agent, and a health care service plan or insurer. Patients who are
37insured or covered and receive a pharmacy benefit that covers the
38cost of emergency contraception shall not be required to pay an
39administrative fee. These patients shall be required to pay
40copayments pursuant to the terms and conditions of their coverage.
P10   1This paragraph shall become inoperative for dedicated emergency
2contraception drugs if these drugs are reclassified as
3over-the-counter products by the federal Food and Drug
4Administration.

5(4) A pharmacist shall not require a patient to provide
6individually identifiable medical information that is not specified
7in Section 1707.1 of Title 16 of the California Code of Regulations
8before initiating emergency contraception drug therapy pursuant
9to this subdivision.

10(c) For each emergency contraception drug therapy or
11self-administered hormonal contraception initiated pursuant to this
12section, the pharmacist shall provide the recipient of the drug with
13a standardized factsheet that includes, but is not limited to, the
14indications and contraindications for use of the drug, the
15appropriate method for using the drug, the need for medical
16followup, and other appropriate information. The board shall
17develop this form in consultation with the State Department of
18Public Health, the American Congress of Obstetricians and
19Gynecologists, the California Pharmacists Association, and other
20health care organizations. This section does not preclude the use
21of existing publications developed by nationally recognized
22medical organizations.

23

SEC. 8.  

Section 4052.6 is added to the Business and Professions
24Code
, to read:

25

4052.6.  

(a) A pharmacist recognized by the board as an
26advanced practice pharmacist may do all of the following:

27(1) Perform patient assessments.

28(2) Order and interpret drug therapy-related tests.

29(3) Refer patients to other health care providers.

30(4) Participate in the evaluation and management of diseases
31and health conditions in collaboration with other health care
32providers.

33(5) Initiate, adjust, or discontinue drug therapy in the manner
34specified in paragraph (4) of subdivision (a) of Section 4052.2.

35(b) A pharmacist who adjusts or discontinues drug therapy shall
36promptly transmit written notification to the patient’s diagnosing
37prescriber or enter the appropriate information in a patient record
38system shared with the prescriber, as permitted by that prescriber.
39A pharmacist who initiates drug therapy shall promptly transmit
40written notification to, or enter the appropriate information into,
P11   1a patient record system shared with the patient’s primary care
2provider or diagnosing provider, as permitted by that provider.

3(c) This section shall not interfere with a physician’s order to
4dispense a prescription drug as written, or other order of similar
5meaning.

6(d) Prior to initiating or adjusting a controlled substance therapy
7pursuant to this section, a pharmacist shall personally register with
8the federal Drug Enforcement Administration.

begin insert

9(e) A pharmacist who orders and interprets tests pursuant to
10paragraph (2) of subdivision (a) shall ensure that the ordering of
11those tests is done in coordination with the patient’s primary care
12provider or diagnosing prescriber, as appropriate, including
13promptly transmitting written notification to the patient’s
14diagnosing prescriber or entering the appropriate information in
15a patient record system shared with the prescriber, when available
16and as permitted by that prescriber.

end insert
17

SEC. 9.  

Section 4052.8 is added to the Business and Professions
18Code
, to read:

19

4052.8.  

(a) In addition to the authority provided in paragraph
20(11) of subdivision (a) of Section 4052, a pharmacist may
21independently initiate and administer vaccines listed on the routine
22immunization schedules recommended by the federal Advisory
23Committee on Immunization Practices (ACIP), in compliance with
24individual ACIP vaccine recommendations, and published by the
25federal Centers for Disease Control and Prevention (CDC) for
26persons three years of age and older.

27(b) In order to initiate and administer an immunization described
28in subdivision (a), a pharmacist shall do all of the following:

29(1) Complete an immunization training program endorsed by
30the CDC or the Accreditation Council for Pharmacy Education
31that, at a minimum, includes hands-on injection technique, clinical
32evaluation of indications and contraindications of vaccines, and
33the recognition and treatment of emergency reactions to vaccines,
34and shall maintain that training.

35(2) Be certified in basic life support.

36(3) Comply with all state and federal recordkeeping and
37reporting requirements, including providing documentation to the
38patient’s primary care provider and entering information in the
39appropriate immunization registry designated by the immunization
40branch of the State Department of Public Health.

P12   1(c) A pharmacist administering immunizations pursuant to this
2section, or paragraph (11) of subdivision (a) of Section 4052, may
3also initiate and administer epinephrine or diphenhydramine by
4injection for the treatment of a severe allergic reaction.

5

SEC. 10.  

Section 4052.9 is added to the Business and
6Professions Code
, to read:

7

4052.9.  

(a) A pharmacist may furnish nicotine replacement
8products approved by the federal Food and Drug Administration
9for use by prescription only in accordance with standardized
10procedures and protocols developed and approved by both the
11board and the Medical Board of California in consultation with
12other appropriate entities and provide smoking cessation services
13if all of the following conditions are met:

14(1) The pharmacist maintains records of all prescription drugs
15and devices furnished for a period of at least three years for
16purposes of notifying other health care providers and monitoring
17the patient.

18(2) The pharmacist notifies the patient’s primary care provider
19of any drugs or devices furnished to the patient. If the patient does
20not have a primary care provider, the pharmacist provides the
21patient with a written record of the drugs or devices furnished and
22 advises the patient to consult a physician of the patient’s choice.

23(3) The pharmacist is certified in smoking cessation therapy by
24an organization recognized by the board.

25(4) The pharmacist completes one hour of continuing education
26focused on smoking cessation therapy biennially.

27(b) The board and the Medical Board of California are both
28authorized to ensure compliance with this section, and each board
29is specifically charged with the enforcement of this section with
30respect to their respective licensees. Nothing in this section shall
31be construed to expand the authority of a pharmacist to prescribe
32any other prescription medication.

33

SEC. 11.  

Section 4060 of the Business and Professions Code
34 is amended to read:

35

4060.  

A person shall not possess any controlled substance,
36except that furnished to a person upon the prescription of a
37physician, dentist, podiatrist, optometrist, veterinarian, or
38naturopathic doctor pursuant to Section 3640.7, or furnished
39pursuant to a drug order issued by a certified nurse-midwife
40pursuant to Section 2746.51, a nurse practitioner pursuant to
P13   1Section 2836.1, a physician assistant pursuant to Section 3502.1,
2a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
3pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
4not apply to the possession of any controlled substance by a
5manufacturer, wholesaler, pharmacy, pharmacist, physician,
6podiatrist, dentist, optometrist, veterinarian, naturopathic doctor,
7certified nurse-midwife, nurse practitioner, or physician assistant,
8if in stock in containers correctly labeled with the name and address
9of the supplier or producer.

10This section does not authorize a certified nurse-midwife, a nurse
11practitioner, a physician assistant, or a naturopathic doctor, to order
12his or her own stock of dangerous drugs and devices.

13

SEC. 12.  

Section 4076 of the Business and Professions Code
14 is amended to read:

15

4076.  

(a) A pharmacist shall not dispense any prescription
16except in a container that meets the requirements of state and
17federal law and is correctly labeled with all of the following:

18(1) Except when the prescriber or the certified nurse-midwife
19who functions pursuant to a standardized procedure or protocol
20described in Section 2746.51, the nurse practitioner who functions
21pursuant to a standardized procedure described in Section 2836.1
22or protocol, the physician assistant who functions pursuant to
23Section 3502.1, the naturopathic doctor who functions pursuant
24to a standardized procedure or protocol described in Section
253640.5, or the pharmacist who functions pursuant to a policy,
26 procedure, or protocol pursuant to Section 4052.1, 4052.2, or
274052.6 orders otherwise, either the manufacturer’s trade name of
28the drug or the generic name and the name of the manufacturer.
29Commonly used abbreviations may be used. Preparations
30containing two or more active ingredients may be identified by
31the manufacturer’s trade name or the commonly used name or the
32principal active ingredients.

33(2) The directions for the use of the drug.

34(3) The name of the patient or patients.

35(4) The name of the prescriber or, if applicable, the name of the
36certified nurse-midwife who functions pursuant to a standardized
37procedure or protocol described in Section 2746.51, the nurse
38practitioner who functions pursuant to a standardized procedure
39described in Section 2836.1 or protocol, the physician assistant
40who functions pursuant to Section 3502.1, the naturopathic doctor
P14   1who functions pursuant to a standardized procedure or protocol
2described in Section 3640.5, or the pharmacist who functions
3pursuant to a policy, procedure, or protocol pursuant to Section
44052.1, 4052.2, or 4052.6.

5(5) The date of issue.

6(6) The name and address of the pharmacy, and prescription
7number or other means of identifying the prescription.

8(7) The strength of the drug or drugs dispensed.

9(8) The quantity of the drug or drugs dispensed.

10(9) The expiration date of the effectiveness of the drug
11dispensed.

12(10) The condition or purpose for which the drug was prescribed
13if the condition or purpose is indicated on the prescription.

14(11) (A) Commencing January 1, 2006, the physical description
15of the dispensed medication, including its color, shape, and any
16identification code that appears on the tablets or capsules, except
17as follows:

18(i) Prescriptions dispensed by a veterinarian.

19(ii) An exemption from the requirements of this paragraph shall
20be granted to a new drug for the first 120 days that the drug is on
21the market and for the 90 days during which the national reference
22file has no description on file.

23(iii) Dispensed medications for which no physical description
24exists in any commercially available database.

25(B) This paragraph applies to outpatient pharmacies only.

26(C) The information required by this paragraph may be printed
27on an auxiliary label that is affixed to the prescription container.

28(D) This paragraph shall not become operative if the board,
29prior to January 1, 2006, adopts regulations that mandate the same
30labeling requirements set forth in this paragraph.

31(b) If a pharmacist dispenses a prescribed drug by means of a
32unit dose medication system, as defined by administrative
33regulation, for a patient in a skilled nursing, intermediate care, or
34other health care facility, the requirements of this section will be
35satisfied if the unit dose medication system contains the
36aforementioned information or the information is otherwise readily
37available at the time of drug administration.

38(c) If a pharmacist dispenses a dangerous drug or device in a
39facility licensed pursuant to Section 1250 of the Health and Safety
40Code, it is not necessary to include on individual unit dose
P15   1containers for a specific patient, the name of the certified
2nurse-midwife who functions pursuant to a standardized procedure
3or protocol described in Section 2746.51, the nurse practitioner
4who functions pursuant to a standardized procedure described in
5Section 2836.1 or protocol, the physician assistant who functions
6pursuant to Section 3502.1, the naturopathic doctor who functions
7pursuant to a standardized procedure or protocol described in
8Section 3640.5, or the pharmacist who functions pursuant to a
9policy, procedure, or protocol pursuant to Section 4052.1, 4052.2,
10or 4052.6.

11(d) If a pharmacist dispenses a prescription drug for use in a
12facility licensed pursuant to Section 1250 of the Health and Safety
13Code, it is not necessary to include the information required in
14paragraph (11) of subdivision (a) when the prescription drug is
15administered to a patient by a person licensed under the Medical
16Practice Act (Chapter 5 (commencing with Section 2000)), the
17Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
18or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
19with Section 2840)), who is acting within his or her scope of
20 practice.

21

SEC. 13.  

Section 4111 of the Business and Professions Code
22 is amended to read:

23

4111.  

(a) Except as otherwise provided in subdivision (b), (d),
24or (e), the board shall not issue or renew a license to conduct a
25pharmacy to any of the following:

26(1) A person or persons authorized to prescribe or write a
27prescription, as specified in Section 4040, in the State of California.

28(2) A person or persons with whom a person or persons specified
29in paragraph (1) shares a community or other financial interest in
30the permit sought.

31(3) Any corporation that is controlled by, or in which 10 percent
32or more of the stock is owned by a person or persons prohibited
33from pharmacy ownership by paragraph (1) or (2).

34(b) Subdivision (a) shall not preclude the issuance of a permit
35for an inpatient hospital pharmacy to the owner of the hospital in
36which it is located.

37(c) The board may require any information the board deems is
38reasonably necessary for the enforcement of this section.

39(d) Subdivision (a) shall not preclude the issuance of a new or
40renewal license for a pharmacy to be owned or owned and operated
P16   1by a person licensed on or before August 1, 1981, under the
2Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2
3(commencing with Section 1340) of Division 2 of the Health and
4Safety Code) and qualified on or before August 1, 1981, under
5subsection (d) of Section 1310 of Title XIII of the federal Public
6Health Service Act, as amended, whose ownership includes persons
7defined pursuant to paragraphs (1) and (2) of subdivision (a).

8(e) Subdivision (a) shall not preclude the issuance of a new or
9renewal license for a pharmacy to be owned or owned and operated
10by a pharmacist authorized to issue a drug order pursuant to Section
114052.1, 4052.2, or 4052.6.

12

SEC. 14.  

Section 4174 of the Business and Professions Code
13 is amended to read:

14

4174.  

Notwithstanding any other law, a pharmacist may
15dispense drugs or devices upon the drug order of a nurse
16practitioner functioning pursuant to Section 2836.1 or a certified
17nurse-midwife functioning pursuant to Section 2746.51, a drug
18order of a physician assistant functioning pursuant to Section
193502.1 or a naturopathic doctor functioning pursuant to Section
203640.5, or the order of a pharmacist acting under Section 4052.1,
214052.2, 4052.3, or 4052.6.

22

SEC. 15.  

Section 4210 is added to the Business and Professions
23Code
, to read:

24

4210.  

(a) A person who seeks recognition as an advanced
25practice pharmacist shall meet all of the following requirements:

26(1) Hold an active license to practice pharmacy issued pursuant
27to this chapter that is in good standing.

28(2) Satisfy any two of the following criteria:

29(A) Earn certification in a relevant area of practice, including,
30but not limited to, ambulatory care, critical care, nuclear pharmacy,
31nutrition support pharmacy, oncology pharmacy, pediatric
32pharmacy, pharmacotherapy, or psychiatric pharmacy, from an
33organization recognized by the Accreditation Council for Pharmacy
34Education or another entity recognized by the board.

35(B) Complete a postgraduate residency through an accredited
36postgraduate institution where at least 50 percent of the experience
37includes the provision of direct patient care services with
38interdisciplinary teams.

39(C) Have provided clinical services to patients for at least one
40year under a collaborative practice agreement or protocol with a
P17   1physician, advanced practice pharmacist, pharmacist practicing
2collaborative drug therapy management, or health system.

3(3) File an application with the board for recognition as an
4advanced practice pharmacist.

5(4) Pay the applicable fee to the board.

6(b) An advanced practice pharmacist recognition issued pursuant
7to this section shall be valid for two years, coterminous with the
8certificate holder’s license to practice pharmacy.

9(c) The board shall adopt regulations establishing the means of
10documenting completion of the requirements in this section.

11(d) The board shall, by regulation, set the fee for the issuance
12and renewal of advanced practice pharmacist recognition at the
13reasonable cost of regulating advanced practice pharmacists
14pursuant to this chapter. The fee shall not exceed three hundred
15dollars ($300).

16

SEC. 16.  

Section 4233 is added to the Business and Professions
17Code
, to read:

18

4233.  

A pharmacist who is recognized as an advanced practice
19pharmacist shall complete 10 hours of continuing education each
20renewal cycle in addition to the requirements of Section 4231. The
21subject matter shall be in one or more areas of practice relevant to
22the pharmacist’s clinical practice.

23

SEC. 17.  

No reimbursement is required by this act pursuant to
24Section 6 of Article XIII B of the California Constitution because
25the only costs that may be incurred by a local agency or school
26district will be incurred because this act creates a new crime or
27infraction, eliminates a crime or infraction, or changes the penalty
28for a crime or infraction, within the meaning of Section 17556 of
29the Government Code, or changes the definition of a crime within
30the meaning of Section 6 of Article XIII B of the California
31Constitution.



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