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,begin insert 4040,end insert 4050, 4051, 4052, 4052.3,begin delete and 4060end deletebegin insert 4060, 4076, 4111, and 4174 end insertof, 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 wouldbegin delete expand other functionsend deletebegin insert authorizeend insert pharmacistsbegin delete are authorizedend delete to performbegin insert other functionsend insert, including, among other things, to furnish self-administered hormonal contraceptives,begin delete prescription smoking cessation drugsend deletebegin insert nicotine replacement productsend insert, 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 Becauseend deletebegin insert The bill would make conforming changes.end insert

begin insert Becauseend insert 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.

21begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 4040 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
22amended to read:end insert

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
33 her 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 tobegin delete eitherend delete Sectionbegin delete 4052.1 or 4052.2end delete
2begin insert 4052.1, 4052.2, or 4052.6end insert.

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 tobegin delete eitherend delete Sectionbegin delete 4052.1 or 4052.2end deletebegin insert 4052.1, 4052.2, or
94052.6end insert
by a pharmacist licensed 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

begin deleteSEC. 3.end delete
38begin insertSEC. 4.end insert  

Section 4050 of the Business and Professions Code is
39amended 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

begin deleteSEC. 4.end delete
15begin insertSEC. 5.end insert  

Section 4051 of the Business and Professions Code is
16amended to read:

17

4051.  

(a) Except as otherwise provided in this chapter, it is
18unlawful for any person to manufacture, compound, furnish, sell,
19or dispense a dangerous drug or dangerous device, or to dispense
20or compound a prescription pursuant to Section 4040 of a prescriber
21unless he or she is a pharmacist under this chapter.

22(b) Notwithstanding any other law, a pharmacist may authorize
23the initiation of a prescription, pursuant to Section 4052.1, 4052.2,
244052.3, or 4052.6, and otherwise provide clinical advice, services,
25information, or patient consultation, as set forth in this chapter, if
26all of the following conditions are met:

27(1) The clinical advice, services, information, or patient
28consultation is provided to a health care professional or to a patient.

29(2) The pharmacist has access to prescription, patient profile,
30or other relevant medical information for purposes of patient and
31clinical consultation and advice.

32(3) Access to the information described in paragraph (2) is
33secure from unauthorized access and use.

34

begin deleteSEC. 5.end delete
35begin insertSEC. 6.end insert  

Section 4052 of the Business and Professions Code is
36amended to read:

37

4052.  

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

38(1) Furnish a reasonable quantity of compounded drug product
39to a prescriber for office use by the prescriber.

40(2) Transmit a valid prescription to another pharmacist.

P7    1(3) Administer drugs and biological products that have been
2ordered by a prescriber.

3(4) Perform procedures or functions in a licensed health care
4facility as authorized by Section 4052.1.

5(5) Perform procedures or functions as part of the care provided
6by a health care facility, a licensed home health agency, a licensed
7clinic in which there is a physician oversight, a provider who
8contracts with a licensed health care service plan with regard to
9the care or services provided to the enrollees of that health care
10service plan, or a physician, as authorized by Section 4052.2.

11(6) Perform procedures or functions as authorized by Section
124052.6.

13(7) Manufacture, measure, fit to the patient, or sell and repair
14dangerous devices, or furnish instructions to the patient or the
15patient’s representative concerning the use of those devices.

16(8) Provide consultation, training, and education to patients
17 about drug therapy, disease management, and disease prevention.

18(9) Provide professional information, including clinical or
19pharmacological information, advice, or consultation to other
20health care professionals, and participate in multidisciplinary
21review of patient progress, including appropriate access to medical
22records.

23(10) Furnish the following medications:

24(A) Emergency contraception drug therapy and self-administered
25hormonal contraceptives, as authorized by Section 4052.3.

26(B) begin deletePrescription smoking cessation drugs and devices, end deletebegin insertNicotine
27 replacement products, end insert
as authorized by Section 4052.9.

28(C) Prescription medications not requiring a diagnosis that are
29recommended by the federal Centers for Disease Control and
30Prevention for individuals traveling outside of the United States.

begin insert

31(D) The pharmacist shall notify the patient’s primary care
32provider of any drugs or devices furnished to the patient. If the
33patient does not have a primary care provider, the pharmacist
34shall provide the patient with a written record of the drugs or
35devices furnished and advise the patient to consult a physician of
36the patient’s choice.

end insert

37(11) Administer immunizations pursuant to a protocol with a
38prescriber.

39(12) Order and interpret tests for the purpose of monitoring and
40managing the efficacy and toxicity of drug therapies.

P8    1(b) A pharmacist who is authorized to issue an order to initiate
2or adjust a controlled substance therapy pursuant to this section
3shall personally register with the federal Drug Enforcement
4Administration.

5(c) This section does not affect the applicable requirements of
6law relating to either of the following:

7(1) Maintaining the confidentiality of medical records.

8(2) The licensing of a health care facility.

9

begin deleteSEC. 6.end delete
10begin insertSEC. 7.end insert  

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

12

4052.3.  

(a) (1) Notwithstanding any other law, a pharmacist
13may furnish self-administered hormonal contraceptives in
14accordance with standardized procedures or protocols developed
15and approved by both the board and the Medical Board of
16California in consultation with the American Congress of
17Obstetricians and Gynecologists, the California Pharmacists
18Association, and other appropriate entities. The standardized
19procedure or protocol shall require that the patient use a
20self-screening toolbegin insert that will identity patient risk factors for use of
21self-administered hormonal contraceptivesend insert
, based on thebegin insert currentend insert
22 United States Medical Eligibility Criteria (USMEC) for
23Contraceptive Use developed by the federal Centers for Disease
24Control and Prevention, and that the pharmacist refer the patient
25to the patient’s primary care provider or, if the patient does not
26have a primary care provider, to nearby clinicsbegin insert, upon furnishing
27a self-administered hormonal contraceptive pursuant to this
28subdivision, or if it is determined that use of a self-administered
29hormonal contraceptive is not recommendedend insert
.

30(2) The board and the Medical Board of California are both
31authorized to ensure compliance with this subdivision, and each
32board is specifically charged with the enforcement of this
33subdivision with respect to its respective licensees. This subdivision
34does not expand the authority of a pharmacist to prescribe any
35prescription medication.

36(b) (1) Notwithstanding any other law, a pharmacist may furnish
37emergency contraception drug therapy in accordance with either
38of the following:

P9    1(A) Standardized procedures or protocols developed by the
2pharmacist and an authorized prescriber who is acting within his
3or her scope of practice.

4(B) Standardized procedures or protocols developed and
5 approved by both the board and the Medical Board of California
6in consultation with the American Congress of Obstetricians and
7Gynecologists, the California Pharmacists Association, and other
8appropriate entities. The board and the Medical Board of California
9are both authorized to ensure compliance with this clause, and
10each board is specifically charged with the enforcement of this
11provision with respect to its respective licensees. This subdivision
12does not expand the authority of a pharmacist to prescribe any
13prescription medication.

14(2) Prior to performing a procedure authorized under this
15subdivision, a pharmacist shall complete a training program on
16emergency contraception that consists of at least one hour of
17approved continuing education on emergency contraception drug
18therapy.

19(3) A pharmacist, pharmacist’s employer, or pharmacist’s agent
20shall not directly charge a patient a separate consultation fee for
21emergency contraception drug therapy services initiated pursuant
22to this subdivision, but may charge an administrative fee not to
23exceed ten dollars ($10) above the retail cost of the drug. Upon an
24oral, telephonic, electronic, or written request from a patient or
25customer, a pharmacist or pharmacist’s employee shall disclose
26the total retail price that a consumer would pay for emergency
27contraception drug therapy. As used in this paragraph, total retail
28price includes providing the consumer with specific information
29regarding the price of the emergency contraception drugs and the
30price of the administrative fee charged. This limitation is not
31intended to interfere with other contractually agreed-upon terms
32between a pharmacist, a pharmacist’s employer, or a pharmacist’s
33agent, and a health care service plan or insurer. Patients who are
34insured or covered and receive a pharmacy benefit that covers the
35cost of emergency contraception shall not be required to pay an
36administrative fee. These patients shall be required to pay
37copayments pursuant to the terms and conditions of their coverage.
38This paragraph shall become inoperative for dedicated emergency
39contraception drugs if these drugs are reclassified as
P10   1over-the-counter products by the federal Food and Drug
2Administration.

3(4) A pharmacist shall not require a patient to provide
4individually identifiable medical information that is not specified
5in Section 1707.1 of Title 16 of the California Code of Regulations
6before initiating emergency contraception drug therapy pursuant
7to this subdivision.

8(c) For each emergency contraception drug therapy or
9self-administered hormonal contraception initiated pursuant to this
10section, the pharmacist shall provide the recipient of the drug with
11a standardized factsheet that includes, but is not limited to, the
12indications and contraindications for use of the drug, the
13appropriate method for using the drug, the need for medical
14followup, and other appropriate information. The board shall
15develop this form in consultation with the State Department of
16Public Health, the American Congress of Obstetricians and
17Gynecologists, the California Pharmacists Association, and other
18health care organizations. This section does not preclude the use
19of existing publications developed by nationally recognized
20medical organizations.

21

begin deleteSEC. 7.end delete
22begin insertSEC. 8.end insert  

Section 4052.6 is added to the Business and Professions
23Code
, to read:

24

4052.6.  

(a) A pharmacist recognized by the board as an
25advanced practice pharmacist may do all of the following:

26(1) Perform patient assessments.

27(2) Order and interpret drug therapy-related tests.

28(3) Refer patients to other health care providers.

29(4) Participate in the evaluation and management of diseases
30and health conditions in collaboration with other health care
31providers.

32(5) Initiate, adjust, or discontinue drug therapy in the manner
33specified in paragraph (4) of subdivision (a) of Section 4052.2.

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

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.

9

begin deleteSEC. 8.end delete
10begin insertSEC. 9.end insert  

Section 4052.8 is added to the Business and Professions
11Code
, to read:

12

4052.8.  

(a) In addition to the authority provided in paragraph
13begin delete (9)end deletebegin insert (11)end insert of subdivision (a) of Section 4052, a pharmacist may
14independently initiate and administer vaccines listed on the routine
15immunization schedules recommended by the federal Advisory
16Committee on Immunization Practices (ACIP), in compliance with
17individual ACIP vaccine recommendations, and published by the
18federal Centers for Disease Control and Prevention (CDC) for
19persons three years of age and older.

20(b) In order to initiate and administer an immunization described
21in subdivision (a), a pharmacist shall do all of the following:

22(1) Complete an immunization training program endorsed by
23the CDC or the Accreditation Council for Pharmacy Education
24that, at a minimum, includes hands-on injection technique, clinical
25evaluation of indications and contraindications of vaccines, and
26the recognition and treatment of emergency reactions to vaccines,
27and shall maintain that training.

28(2) Be certified in basic life support.

29(3) Comply with all state and federal recordkeeping and
30reporting requirements, including providing documentation to the
31patient’s primary care provider and entering information in the
32appropriate immunization registry designated by the immunization
33branch of the State Department of Public Health.

34(c) A pharmacist administering immunizations pursuant to this
35section, or paragraphbegin delete (9)end deletebegin insert (11)end insert of subdivision (a) of Section 4052,
36may also initiate and administer epinephrine or diphenhydramine
37by injection for the treatment of a severe allergic reaction.

38

begin deleteSEC. 9.end delete
39begin insertSEC. 10.end insert  

Section 4052.9 is added to the Business and
40Professions Code
, to read:

P12   1

4052.9.  

begin insert(a)end insertbegin insertend insert A pharmacist may furnishbegin delete prescription smoking
2cessation drugs and devices,end delete
begin insert nicotine replacement products
3approved by the federal Food and Drug Administration for use by
4prescription only in accordance with standardized procedures and
5protocols developed and approved by both the board and the
6Medical Board of California in consultation with other appropriate
7entitiesend insert
and provide smoking cessation services if all of the
8following conditions are met:

begin delete

9(a)

end delete

10begin insert(1)end insert The pharmacist maintains records of all prescription drugs
11and devices furnished for a period of at least three years for
12purposes of notifying other health care providers and monitoring
13the patient.

begin delete

14(b)

end delete

15begin insert(2)end insert The pharmacist notifies the patient’s primary care provider
16of any drugs or devices furnished to the patient. If the patient does
17not have a primary care provider, the pharmacist provides the
18patient with a written record of the drugs or devices furnished and
19 advises the patient to consult a physician of the patient’s choice.

begin delete

20(c)

end delete

21begin insert(3)end insert The pharmacist is certified in smoking cessation therapy by
22an organization recognized by the board.

begin delete

23(d)

end delete

24begin insert(4)end insert The pharmacist completes one hour of continuing education
25focused on smoking cessation therapy biennially.

begin delete

26(e) The pharmacist shall consult with the patient’s primary care
27provider before furnishing a smoking cessation drug to the patient
28that may produce serious neuropsychiatric events.

end delete
begin insert

29(b) The board and the Medical Board of California are both
30authorized to ensure compliance with this section, and each board
31is specifically charged with the enforcement of this section with
32respect to their respective licensees. Nothing in this section shall
33be construed to expand the authority of a pharmacist to prescribe
34any other prescription medication.

end insert
35

begin deleteSEC. 10.end delete
36begin insertSEC. 11.end insert  

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

38

4060.  

A person shall not possess any controlled substance,
39except that furnished to a person upon the prescription of a
40physician, dentist, podiatrist, optometrist, veterinarian, or
P13   1naturopathic doctor pursuant to Section 3640.7, or furnished
2pursuant to a drug order issued by a certified nurse-midwife
3pursuant to Section 2746.51, a nurse practitioner pursuant to
4Section 2836.1, a physician assistant pursuant to Section 3502.1,
5a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
6pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
7not apply to the possession of any controlled substance by a
8manufacturer, wholesaler, pharmacy, pharmacist, physician,
9podiatrist, dentist, optometrist, veterinarian, naturopathic doctor,
10certified nurse-midwife, nurse practitioner, or physician assistant,
11if in stock in containers correctly labeled with the name and address
12of the supplier or producer.

13This section does not authorize a certified nurse-midwife, a nurse
14practitioner, a physician assistant, or a naturopathic doctor, to order
15his or her own stock of dangerous drugs and devices.

16begin insert

begin insertSEC. 12.end insert  

end insert

begin insertSection 4076 of the end insertbegin insertBusiness and Professions Codeend insert
17begin insert is amended to read:end insert

18

4076.  

(a) A pharmacist shall not dispense any prescription
19except in a container that meets the requirements of state and
20federal law and is correctly labeled with all of the following:

21(1) Exceptbegin delete whereend deletebegin insert whenend insert the prescriber or the certified
22nurse-midwife who functions pursuant to a standardized procedure
23or protocol described in Section 2746.51, the nurse practitioner
24who functions pursuant to a standardized procedure described in
25Section 2836.1 or protocol, the physician assistant who functions
26pursuant to Section 3502.1, the naturopathic doctor who functions
27pursuant to a standardized procedure or protocol described in
28Section 3640.5, or the pharmacist who functions pursuant to a
29policy, procedure, or protocol pursuant to begin delete either Section 4052.1
30or 4052.2end delete
begin insert Section 4052.1, 4052.2, or 4052.6end insert orders otherwise,
31either the manufacturer’s trade name of the drug or the generic
32name and the name of the manufacturer. Commonly used
33abbreviations may be used. Preparations containing two or more
34active ingredients may be identified by the manufacturer’s trade
35name or the commonly used name or the principal active
36ingredients.

37(2) The directions for the use of the drug.

38(3) The name of the patient or patients.

39(4) The name of the prescriber or, if applicable, the name of the
40certified nurse-midwife who functions pursuant to a standardized
P14   1procedure or protocol described in Section 2746.51, the nurse
2practitioner who functions pursuant to a standardized procedure
3described in Section 2836.1 or protocol, the physician assistant
4who functions pursuant to Section 3502.1, the naturopathic doctor
5who functions pursuant to a standardized procedure or protocol
6described in Section 3640.5, or the pharmacist who functions
7pursuant to a policy, procedure, or protocol pursuant tobegin delete either
8Section 4052.1 or 4052.2end delete
begin insert Section 4052.1, 4052.2, or 4052.6end insert.

9(5) The date of issue.

10(6) The name and address of the pharmacy, and prescription
11number or other means of identifying the prescription.

12(7) The strength of the drug or drugs dispensed.

13(8) The quantity of the drug or drugs dispensed.

14(9) The expiration date of the effectiveness of the drug
15dispensed.

16(10) The condition or purpose for which the drug was prescribed
17if the condition or purpose is indicated on the prescription.

18(11) (A) Commencing January 1, 2006, the physical description
19of the dispensed medication, including its color, shape, and any
20identification code that appears on the tablets or capsules, except
21as follows:

22(i) Prescriptions dispensed by a veterinarian.

23(ii) An exemption from the requirements of this paragraph shall
24be granted to a new drug for the first 120 days that the drug is on
25the market and for the 90 days during which the national reference
26file has no description on file.

27(iii) Dispensed medications for which no physical description
28exists in any commercially available database.

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

30(C) The information required by this paragraph may be printed
31on an auxiliary label that is affixed to the prescription container.

32(D) This paragraph shall not become operative if the board,
33prior to January 1, 2006, adopts regulations that mandate the same
34labeling requirements set forth in this paragraph.

35(b) If a pharmacist dispenses a prescribed drug by means of a
36unit dose medication system, as defined by administrative
37regulation, for a patient in a skilled nursing, intermediate care, or
38other health care facility, the requirements of this section will be
39satisfied if the unit dose medication system contains the
P15   1aforementioned information or the information is otherwise readily
2available at the time of drug administration.

3(c) If a pharmacist dispenses a dangerous drug or device in a
4facility licensed pursuant to Section 1250 of the Health and Safety
5Code, it is not necessary to include on individual unit dose
6containers for a specific patient, the name of the certified
7nurse-midwife who functions pursuant to a standardized procedure
8or protocol described in Section 2746.51, the nurse practitioner
9who functions pursuant to a standardized procedure described in
10Section 2836.1 or protocol, the physician assistant who functions
11pursuant to Section 3502.1, the naturopathic doctor who functions
12pursuant to a standardized procedure or protocol described in
13Section 3640.5, or the pharmacist who functions pursuant to a
14policy, procedure, or protocol pursuant tobegin delete either Section 4052.1
15or 4052.2end delete
begin insert Section 4052.1, 4052.2, or 4052.6end insert.

16(d) If a pharmacist dispenses a prescription drug for use in a
17facility licensed pursuant to Section 1250 of the Health and Safety
18Code, it is not necessary to include the information required in
19paragraph (11) of subdivision (a) when the prescription drug is
20administered to a patient by a person licensed under the Medical
21Practice Act (Chapter 5 (commencing with Section 2000)), the
22Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
23or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
24with Section 2840)), who is acting within his or her scope of
25 practice.

26begin insert

begin insertSEC. 13.end insert  

end insert

begin insertSection 4111 of the end insertbegin insertBusiness and Professions Codeend insert
27begin insert is amended to read:end insert

28

4111.  

(a) Except as otherwise provided in subdivision (b), (d),
29or (e), the board shall not issue or renew a license to conduct a
30pharmacy to any of the following:

31(1) A person or persons authorized to prescribe or write a
32prescription, as specified in Section 4040, in the State of California.

33(2) A person or persons with whom a person or persons specified
34in paragraph (1) shares a community or other financial interest in
35the permit sought.

36(3) Any corporation that is controlled by, or in which 10 percent
37or more of the stock is owned by a person or persons prohibited
38from pharmacy ownership by paragraph (1) or (2).

P16   1(b) Subdivision (a) shall not preclude the issuance of a permit
2for an inpatient hospital pharmacy to the owner of the hospital in
3which it is located.

4(c) The board may require any information the board deems is
5reasonably necessary for the enforcement of this section.

6(d) Subdivision (a) shall not preclude the issuance of a new or
7renewal license for a pharmacy to be owned or owned and operated
8by a person licensed on or before August 1, 1981, under the
9Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2
10(commencing with Section 1340) of Division 2 of the Health and
11Safety Code) and qualified on or before August 1, 1981, under
12subsection (d) of Section 1310 of Title XIII of the federal Public
13Health Service Act, as amended, whose ownership includes persons
14defined pursuant to paragraphs (1) and (2) of subdivision (a).

15(e) Subdivision (a) shall not preclude the issuance of a new or
16renewal license for a pharmacy to be owned or owned and operated
17by a pharmacist authorized to issue a drug order pursuant tobegin delete eitherend delete
18 Sectionbegin delete 4052.1 or 4052.2end deletebegin insert 4052.1, 4052.2, or 4052.6end insert.

19begin insert

begin insertSEC. 14.end insert  

end insert

begin insertSection 4174 of the end insertbegin insertBusiness and Professions Codeend insert
20begin insert is amended to read:end insert

21

4174.  

Notwithstanding any otherbegin delete provision ofend delete law, a pharmacist
22may dispense drugs or devices upon the drug order of a nurse
23practitioner functioning pursuant to Section 2836.1 or a certified
24nurse-midwife functioning pursuant to Section 2746.51, a drug
25order of a physician assistant functioning pursuant to Section
263502.1 or a naturopathic doctor functioning pursuant to Section
273640.5, or the order of a pharmacist acting under Section 4052.1,
284052.2,begin delete or 4052.3end deletebegin insert 4052.3, or 4052.6end insert.

29

begin deleteSEC. 11.end delete
30begin insertSEC. 15.end insert  

Section 4210 is added to the Business and Professions
31Code
, to read:

32

4210.  

(a) A person who seeks recognition as an advanced
33practice pharmacist shall meet all of the following requirements:

34(1) Hold an active license to practice pharmacy issued pursuant
35to this chapter that is in good standing.

36(2) Satisfy any two of the following criteria:

37(A) Earn certification in a relevant area of practice, including,
38but not limited to, ambulatory care, critical care, nuclear pharmacy,
39nutrition support pharmacy, oncology pharmacy, pediatric
40pharmacy, pharmacotherapy, or psychiatric pharmacy, from an
P17   1organization recognized by the Accreditation Council for Pharmacy
2Education or another entity recognized by the board.

3(B) Complete abegin delete one-yearend delete postgraduate residency through an
4accredited postgraduate institution where at least 50 percent of the
5experience includes the provision of direct patient care services
6with interdisciplinary teams.

7(C) Havebegin delete actively managedend deletebegin insert provided clinical services toend insert patients
8for at least one year under a collaborative practice agreement or
9protocol with a physician, advanced practice pharmacist,
10pharmacist practicing collaborative drug therapy management, or
11health system.

12(3) File an application with the board for recognition as an
13advanced practice pharmacist.

14(4) Pay the applicable fee to the board.

15(b) An advanced practice pharmacist recognition issued pursuant
16to this section shall be valid for two years, coterminous with the
17certificate holder’s license to practice pharmacy.

18(c) The board shall adopt regulations establishing the means of
19documenting completion of the requirements in this section.

20(d) The board shall, by regulation, set the fee for the issuance
21and renewal of advanced practice pharmacist recognition at the
22reasonable cost of regulating advanced practice pharmacists
23pursuant to this chapter. The fee shall not exceed three hundred
24dollars ($300).

25

begin deleteSEC. 12.end delete
26begin insertSEC. 16.end insert  

Section 4233 is added to the Business and Professions
27Code
, to read:

28

4233.  

A pharmacist who is recognized as an advanced practice
29pharmacist shall complete 10 hours of continuing education each
30renewal cycle in addition to the requirements of Section 4231. The
31subject matter shall be in one or more areas of practice relevant to
32the pharmacist’s clinical practice.

33

begin deleteSEC. 13.end delete
34begin insertSEC. 17.end insert  

No reimbursement is required by this act pursuant to
35Section 6 of Article XIII B of the California Constitution because
36the only costs that may be incurred by a local agency or school
37district will be incurred because this act creates a new crime or
38infraction, eliminates a crime or infraction, or changes the penalty
39for a crime or infraction, within the meaning of Section 17556 of
40the Government Code, or changes the definition of a crime within
P18   1the meaning of Section 6 of Article XIII B of the California
2Constitution.



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