2022 LAWBOOK FOR PHARMACY

collaborative practice agreement or protocol, including examples

of the clinical services the applicant provided to patients.

(B) A written statement from the supervising practitioner,

program director or health facility administrator attesting under

penalty of perjury that the applicant has completed at least 1,500

hours of experience providing clinical services to patients. For an

applicant who cannot satisfy this documentation requirement,

the board may, for good cause shown, grant a waiver for this

subsection.

(b) The experience an applicant offers to demonstrate

compliance with one of the three criteria in subsection (a) above

may not also be used to satisfy another of the criteria.

Authority cited: Sections 4005 and 4210, Business and

Professions Code. Reference: Sections 4052.1, 4052.2 and 4210,

Business and Professions Code

1730.2. Certification Programs

(a) For purposes of Business and Professions Code section 4210,

subdivision (a)(2)(A), general clinical pharmacy practice is among

the relevant areas of practice for which certification may be

earned.

(b) For a pharmacist seeking to demonstrate certification in

general clinical pharmacy as a criterion for advanced practice

pharmacist licensure by the board, the certification may be

earned from an organization recognized as a continuing

education provider by the Accreditation Council for Pharmacy

Education or accredited by the National Commission for

Certifying Agencies as a certification provider, so long as:

(1) The certification program includes specified learning

objectives in at least five sequentially-ordered education

modules, covering the following topics: performing patient

assessments; ordering and interpreting drug therapy-related

tests; referring patients to other health care providers;

participating in the evaluation and management of diseases and

health conditions in collaboration with other health care

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providers; and initiating, adjusting, modifying or discontinuing

drug therapy;

(2) The certification program requires assessment after

completion of each of the education modules in an examination

format or by other assessment methodology that confirms the

participant’s understanding, knowledge, and application of the

specified learning objectives for the module, where any failure to

successfully complete the assessment in any module prevents

advancement to the next module;

(3) The certification program requires that instruction and

assessments in each of the modules are developed and provided

by either:

(A) An advanced practice pharmacist licensed by the board or

(B) An expert with experience in the respective area(s) of focus

specified in subparagraph (1), where “expert” means a person

who qualifies to teach at a school of pharmacy recognized by the

board.

(4) The certification program requires that, upon successful

completion of all modules and their respective assessments, each

participant shall earn a passing score on a final overall

assessment before being awarded certification. The assessment

shall be either a final written examination or an objective

structured clinical examination developed and administered in

collaboration with an accredited school of pharmacy recognized

by the board; and

(5) The certification program require(s) a minimum of ten hours

of continuing education on the topics identified in (b)(1) every

two years to maintain certification.

Authority cited: Section 4005 and 4210, Business and Professions

Code.

Reference: Sections 4052.6, 4210, and 4233, Business and

Professions Code.

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1731. Experimental Programs

In order to enable any accredited school of pharmacy

recognized by the Board to experiment with new and innovative

methods for drug handling, teaching, research, or to develop new

and better methods or concepts involving the ethical practice of

pharmacy, the Board enacts the following:

(a) The application of particular provisions of the Pharmacy

Rules and Regulations contained in Title 16, California

Administrative Code, Chapter 17, may be waived as to an

accredited school of pharmacy recognized by the Board if the

Dean of said school has filed with the Board an experimental plan

or program which specifies the particular provisions to be

waived, and which has been approved by the Board.

(b) Any plan or program approved by the Board shall have:

definite time limitations; progress reports which shall be filed as

required by the Board.

program at its discretion, at any time it may deem the public

interest is not fully protected; nor shall any such plan or program

be approved by the Board if such proposal might jeopardize

public health or welfare or conflict with provisions of Chapter 9,

Div. 2, Business and Professions Code.

Authority cited: Section 4005, Business and Professions Code.

Reference: 5005, 4120, 4161, 4162, 4304 and 4400, Business and

Professions Code.

Article 4. Continuing Education

1732. Definitions.

As used in this article:

(a) “Accreditation agency” means an organization which

evaluates and accredits providers of continuing education for

pharmacists.

(b) “Hour” means at least 50 minutes of contact time.

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approved accreditation agency or accredited by the board to

provide a specific continuing education course.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4232, Business and Professions Code.

1732.05. Accreditation Agencies for Continuing Education.

(a) The following organizations are approved as accreditation

agencies:

(1) The Accreditation Council for Pharmacy Education.

(2) The California Pharmacists Association.

(b) Accreditation agencies shall:

(1) Evaluate each continuing education provider seeking

accreditation in accordance with the provider’s ability to comply

with the requirements of section 1732.1 of this Division.

(2) Maintain a list of the name and address of person

responsible for the provider's continuing education program. The

accreditation agency shall require that any change in the

responsible person's identity shall be reported to the

accreditation agency within 15 days of the effective date of the

change.

(3) Provide the board with the names, addresses and

responsible party of each provider, upon request.

(4) Respond to complaints from the board, providers or from

pharmacists concerning activities of any of its accredited

providers or their coursework.

(5) Review at least one course per year offered by each provider

accredited by the agency for compliance with the agency's

requirements and requirements of the board and, on request,

report the findings of such reviews to the board.

(6) Take such action as is necessary to assure that the continuing

education coursework offered by its providers meets the

continuing education requirements of the board; and

(7) Verify the completion of a specific continuing education

course by an individual pharmacist upon request of the board.

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evaluate continuing education providers as set forth in

subdivision (b) shall constitute cause for revocation of its

approval as an accreditation agency by the board.

Authority cited: section 4005, Business and Professions Code.

Reference: section 4232, Business and Professions Code.

1732.1. Requirements for Accredited Providers.

(a) No person shall provide continuing pharmacy education

without being accredited by an approved accreditation agency or

having the course accredited by the board pursuant to section

1732.2 of this Division.

(b) Providers shall ensure that each continuing education course

complies with the requirements of section 1732.3 of this Division.

that complete a continuing education course. The statement of

credit shall contain the name of the enrollee, name and number

of the provider, title of the course, number of completed hours,

date of completion, expiration date of the coursework, course

number, if applicable and the name of the accrediting agency.

(d) Each provider shall notify the accreditation agency at least

15 days in advance of the first time each new continuing

education course is offered or presented.

(e) Providers shall maintain records of completion of their

continuing education courses for four years.

(f) Providers shall include the following information in

promotional materials regarding continuing education courses:

(1) Provider's name.

(2) The number of hours awarded for completion of the course.

(3) The date when the course’s accreditation expires.

(4) The provider number assigned by the accreditation agency.

(5) The name of the provider’s accrediting agency.

(6) The learning objectives of the program.

(7) The nature of the targeted audiences that may best benefit

from participation in the program.

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(8) The speakers and their credentials.

(g) Providers shall have written procedures for determining the

credit hours awarded for the completion of continuing education

courses.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4232, Business and Professions Code.

1732.2. Board Accredited Continuing Education.

(a) Individuals may petition the board to allow continuing

education credit for specific coursework which is not offered by a

provider but meets the standards of Section 1732.3.

(b) Notwithstanding subdivision (a) of this section, coursework

which meets the standard of relevance to pharmacy practice and

has been approved for continuing education by the Medical

Board of California, the California Board of Podiatric Medicine,

the California Board of Registered Nursing or the Dental Board of

California shall, upon satisfactory completion, be considered

approved continuing education for pharmacists.

board for the purpose of developing the California Practice

Standards and Jurisprudence Examination for pharmacists

pursuant to section 4200.2 of the Business and Professions Code

may annually be awarded up to six (6) hours of continuing

education for conducting a review of exam test questions. A

subcommittee member shall not receive continuing education

hours pursuant to this subdivision if that subcommittee member

requests reimbursement from the board for time spent

conducting a review of exam test questions.

(d) A pharmacist or pharmacy technician who attends a full day

board meeting may be awarded six (6) hours of continuing

education per renewal period. The board shall designate on its

public agenda which day shall be eligible for continuing education

credit. A pharmacist or pharmacy technician requesting

continuing education pursuant to this subdivision must sign in

and out on an attendance sheet at the board meeting that

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requires the individual to provide his or her first and last name,

license number, time of arrival and time of departure from the

meeting.

(e) A pharmacist or pharmacy technician who attends a full

committee meeting of the board may be awarded two (2) hours

of continuing education per renewal period. A pharmacist or

pharmacy technician requesting continuing education hours

pursuant to this subdivision must sign in and out on an

attendance sheet at the committee meeting that requires the

individual to provide his or her first and last name, license

number, time of arrival and time of departure from the meeting.

(f) An individual may be awarded three (3) hours of continuing

education for successfully passing the examination administered

by the Commission for Certification in Geriatric Pharmacy.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4200.2, 4202, 4231 and 4232, Business and

Professions Code.

1732.3. Requirements for Continuing Education Courses.

(a) Unless denied by the accreditation agency upon audit, all

coursework offered by providers may be used to satisfy the

continuing education required by section 1732.5 of this Division.

(b) On a random basis or in response to a request by the board,

the accreditation agency shall review selected coursework. The

material shall be forwarded to a reviewer to judge the quality of

the program on the basis of factors established by the

accreditation agency in addition to the requirements of this

section.

three years following the initial presentation provided that the

information is still current.

(d) Continuing education courses shall comply with the

following:

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(1) Courses shall have specific, measurable learning objectives

which serve as a basis for an evaluation of the program's

effectiveness.

(2) Speakers, or those developing the content of the course,

shall be competent in the subject matter and shall be qualified by

education, training and/or experience.

(3) Courses shall have a syllabus which provides a general

outline of the course. The syllabus shall contain at a minimum,

the learning objectives for each course and a summary

containing the main points for each topic.

(4) Courses shall include a mechanism that allows all

participants to assess their achievement in accordance with the

program's learning objectives.

(e) (1) Continuing education courses shall be relevant to the

practice of pharmacy as provided in this section and in section

4232 of the Business and Professions Code and related to one or

more of the following:

(A) The scientific knowledge or technical skills required for the

practice of pharmacy.

(B) Direct and/or indirect patient care.

(2) Continuing education courses shall not reflect the

commercial views of the provider or of any person giving

financial assistance to the provider.

Authority cited: Section 4005 Business and Professions Code.

Reference: Section 4232, Business and Professions Code.

1732.4. Provider Audit Requirements.

Upon written request from the accreditation agency, relating to

an audit of continuing education course, each provider shall

submit such materials as are required by the accreditation

agency.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4232, Business and Professions Code.

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1732.5. Renewal Requirements for Pharmacist.

(a) Except as provided in section 4234 of the Business and

Professions Code and section 1732.6 of this Division, each

applicant for renewal of a pharmacist license shall submit proof

satisfactory to the board, that the applicant has completed 30

hours of continuing education in the prior 24 months.

(b) At least two (2) of the thirty (30) hours required for

pharmacist license renewal shall be completed by participation in

a Board provided CE course in Law and Ethics. Pharmacists

renewing their licenses which expire on or after July 1, 2019, shall

be subject to the requirements of this subdivision.

for four (4) years following completion of a continuing education

course.

Authority cited: Section 4005, Business and Professions Code.

Reference: Sections 4231 and 4232, Business and Professions

Code.

1732.6. Exemptions.

Pharmacists may seek exemption from the continuing education

requirements for renewal on the grounds of emergency or

hardship by applying to the board in writing, setting forth the

reasons why such exemption should be granted. Exemptions may

be granted for such reasons as illness or full-time enrollment in a

health professional school.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4234, Business and Professions Code.

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1732.7. Complaint Mechanism.

A provider may request reconsideration of any adverse action

taken against the provider or its coursework by an accreditation

agency. Following such reconsideration, the provider may

request review of the accreditation agency's decision by the

board.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4232, Business and Professions Code.

Article 4.5 Compounding

1735. Compounding in Licensed Pharmacies

(a) “Compounding” means any of the following activities

occurring in a licensed pharmacy, by or under the supervision of

a licensed pharmacist, pursuant to a prescription:

(1) Altering the dosage form or delivery system of a drug

(2) Altering the strength of a drug

(3) Combining components or active ingredients

(4) Preparing a compounded drug preparation from chemicals

or bulk drug substances

(b) “Compounding” does not include reconstitution of a drug

pursuant to a manufacturer’s direction(s), nor does it include the

sole act of tablet splitting or crushing, capsule opening, or the

addition of flavoring agent(s) to enhance palatability.

(Section 1735 et seq.) apply to all compounding practices.

Additional parameters and requirements applicable solely to

sterile compounding are stated by Article 7 (Section 1751 et

seq.).

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4036, 4037, 4051,

4052, and 4127, Business and Professions Code.

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1735.1. Compounding Definitions

(a) “Ante-area” means an area with ISO Class 8 or better air

quality where personnel hand hygiene and garbing procedures,

staging of components, and other high-particulate-generating

activities are performed, that is adjacent to the area designated

for sterile compounding. It is a transition area that begins the

systematic reduction of particles, prevents large fluctuations in

air temperature and pressures in the cleanroom, and maintains

air flows from clean to dirty areas. ISO Class 7 or better air quality

is required for ante-areas providing air to a negative pressure

room.

(b) “Beyond use date” means the date, or date and time, after

which administration of a compounded drug preparation shall

not begin, the preparation shall not be dispensed, and the

preparation shall not be stored (other than for quarantine

purposes).

for compounding sterile drug preparations, having an open front

with inward airflow for personnel protection, downward HEPA-

filtered laminar airflow for product protection, and HEPA-filtered

exhausted air for environmental protection. Where hazardous

drugs are prepared, the exhaust air from the biological safety

cabinet shall be appropriately removed by properly designed

external building exhaust. This external exhaust should be

dedicated to one BSC or CACI.

(d) “Bulk drug substance” means any substance that, when used

in the preparation of a compounded drug preparation,

processing, or packaging of a drug, is an active ingredient or a

finished dosage form of the drug, but the term does not include

any intermediate used in the synthesis of such substances.

(e) “Cleanroom or clean area or buffer area” means a room or

area with HEPA-filtered air that provides ISO Class 7 or better air

quality where the primary engineering control (PEC) is physically

located.

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(1) For nonhazardous compounding a positive pressure

differential of 0.02-to 0.05-inch water column relative to all

adjacent spaces is required.

(2) For hazardous compounding at least 30 air changes per hour

of HEPA-filtered supply air and a negative pressure of between

0.01 to 0.03 inches of water column relative to all adjacent

spaces is required.

(f) “Compounding Aseptic Containment Isolator (CACI)” means a

unidirectional HEPA-filtered airflow compounding aseptic isolator

(CAI) designed to provide worker protection from exposure to

undesirable levels of airborne drug throughout the compounding

and material transfer processes and to provide an aseptic

environment for compounding sterile preparations. Air exchange

with the surrounding environment should not occur unless the

air is first passed through a microbial retentive filter (HEPA

minimum) system capable of containing airborne concentrations

of the physical size and state of the drug being compounded.

Where hazardous drugs are prepared, the exhaust air from the

isolator shall be appropriately removed by properly designed

external building exhaust. This external exhaust should be

dedicated to one BSC or CACI. Air within the CACI shall not be

recirculated nor turbulent.

(g) “Compounding Aseptic Isolator (CAI)” means a form of

isolator specifically designed for nonhazardous compounding of

pharmaceutical ingredients or preparations while bathed with

unidirectional HEPA-filtered air. It is designed to maintain an

aseptic compounding environment within the isolator

throughout the compounding and material transfer processes.

Air exchange into the isolator from the surrounding environment

should not occur unless the air has first passed through a

microbial retentive filter (HEPA minimum) system capable of

containing airborne concentrations of the physical size and state

of the drug being compounded. Air within the CAI shall not be

recirculated nor turbulent.

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(h) “Controlled cold temperature” means 2 degrees to 8 degrees

C (35 degrees to 46 degrees F).

(i) “Controlled freezer temperature” means -25 degrees to -10

degrees C (-13 degrees to 14 degrees F) or at a range otherwise

specified by the pharmaceutical manufacturer(s) for that

product.

(j) “Controlled room temperature” means 20 degrees to 25

degrees C (68 degrees to 77 degrees F).

(k) “Copy or essentially a copy” of a commercially available drug

product includes all preparations that are comparable in active

ingredients to commercially available drug products, except that

it does not include any preparations in which there has been a

change, made for an identified individual patient, which produces

for that patient a clinically significant difference, as determined

by a prescribing practitioner, between that compounded

preparation and the comparable commercially available drug

product.

(l) “Daily” means occurring every day the pharmacy is operating,

except when daily monitoring of refrigerator and freezer

temperature are required, then daily means every 24 hours.

(m) “Displacement airflow method” means a concept which

utilizes a low pressure differential high airflow principle to

maintain segregation from the adjacent ante-area by means of

specific pressure differentials. This principle of displacement

airflow shall require an air velocity of 40 ft per minute or more,

from floor to ceiling and wall to wall, from the clean area across

the line of demarcation into the ante-area. The displacement

concept may not be used to maintain clean area requirements

for sterile compounds which originate from any ingredient that

was at any time non-sterile, regardless of intervening sterilization

of the ingredient, or for hazardous compounds.

(n) “Dosage unit” means a quantity sufficient for one

administration to one patient.

(o) “Equipment” means items that must be calibrated,

maintained or periodically certified.

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(p) “First air” means the air exiting the HEPA filter in a

unidirectional air stream that is essentially particle free.

(q) “Gloved fingertip sampling” means a process whereby

compounding personnel lightly press each fingertip and thumb of

each hand onto appropriate growth media, which are then

incubated at a temperature and for a time period conducive to

multiplication of microorganisms, and then examined for growth

of microorganisms.

(r) “Hazardous” means all anti-neoplastic agents identified by

the National Institute for Occupational Safety and Health (NIOSH)

as meeting the criteria for a hazardous drug and any other drugs,

compounds, or materials identified as hazardous by the

pharmacist-in-charge.

(s) “Integrity” means retention of potency until the beyond use

date provided on the label, so long as the preparation is stored

and handled according to the label directions.

(t) “Lot” means one or more compounded drug preparation(s)

prepared during one uninterrupted continuous cycle of

compounding from one or more common active ingredient(s).

(u) “Media-fill test” means a test used to measure the efficacy

of compounding personnel in aseptic techniques whereby

compounding procedures are mimicked using a growth-based

media and then the resulting preparation is evaluated for

sterility. The media-fill test must mimic the most complex

compounding procedures performed by the pharmacy.

(v) “Non-sterile-to-sterile batch” means any compounded drug

preparation containing two (2) or more dosage units with any

ingredient that was at any time non-sterile, regardless of

intervening sterilization of that ingredient.

(w) “Parenteral” means a preparation of drugs administered in a

manner other than through the digestive tract. It does not

include topical, sublingual, rectal or buccal routes of

administration.

(x) “Personal protective equipment” means clothing or devices

that protect the employee from exposure to compounding

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ingredients and/or potential toxins and minimize the

contamination of compounded preparations. These include shoe

covers, head and facial hair covers, face masks, gowns, and

gloves.

(y) “Potency” means active ingredient strength within +/-10%

(or the range specified in USP37NF32, 37th Revision, Through

2nd Supplement Effective December 1, 2014) of the labeled

amount. Sterile injectable products compounded solely from

commercially manufactured sterile pharmaceutical products in a

health care facility licensed under section 1250 of the Health and

Safety Code are exempt from this definition. For those exempt,

the range shall be calculated and defined in the master formula.

(z) “Preparation” means a drug or nutrient compounded in a

licensed pharmacy; the preparation may or may not be sterile.

(aa) "Prescriber's office" or "prescriber office" means an office

or suite of offices in which a prescriber regularly sees patients for

outpatient diagnosis and treatment. This definition does not

include any hospital, pharmacy, or other facility, whether or not

separately licensed, that may be affiliated with, adjacent to, or

co-owned by, the prescriber’s practice environment.

(ab) “Primary Engineering Control (PEC)” means a device that

provides an ISO Class 5 or better environment through the use of

non-turbulent, unidirectional HEPA-filtered first air for

compounding sterile preparations. Examples of PEC devices

include, but are not limited to, laminar airflow workbenches,

biological safety cabinets, sterile compounding automated

robots, compounding aseptic isolators, and compounding aseptic

containment isolators.

(ac) “Process validation” means demonstrating that when a

process is repeated within specified limits, the process will

consistently produce preparations complying with

predetermined requirements. If any aspect of the process is

changed, the process would need to be revalidated.

(ad) “Product” means a commercially manufactured drug or

nutrient evaluated for safety and efficacy by the FDA.

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(ae) “Quality” means the absence of harmful levels of

contaminants, including filth, putrid, or decomposed substances,

the absence of active ingredients other than those listed on the

label, and the absence of inactive ingredients other than those

listed on the master formula document.

(af) “Segregated sterile compounding area” means a designated

space for sterile-to-sterile compounding where a PEC is located

within either a demarcated area (at least three foot perimeter) or

in a separate room. Such area or room shall not contain and shall

be void of activities and materials that are extraneous to sterile

compounding. The segregated sterile compounding area shall not

be in a location that has unsealed windows or doors that connect

to the outdoors, in a location with high traffic flow, or in a

location that is adjacent to construction sites, warehouses, or

food preparation. The segregated sterile compounding area shall

not have a sink, other than an emergency eye-washing station,

located within three feet of a PEC. The segregated sterile

compounding area shall be restricted to preparation of sterile-to-

sterile compounded preparations.

(1) The BUD of a sterile drug preparation made in a segregated

sterile compounding area is limited to 12 hours or less as defined

by section 1751.8(d).

(2) When the PEC in the segregated sterile compounding area is

a CAI or a CACI and the documentation provided by the

manufacturer shows it meets the requirements listed in section

1751.4(f)(1)-(3), the assigned BUD shall comply with section

1751.8(a-b) or (d).

(ag) “Strength” means amount of active ingredient per unit of a

compounded drug preparation

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4029, 4036, 4037,

4051, 4052, and 4127, Business and Professions Code.

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1735.2. Compounding Limitations and Requirements; Self-

Assessment

(a) Except as specified in (b) and (c), no drug preparation shall

be compounded prior to receipt by a pharmacy of a valid

prescription for an individual patient where the prescriber has

approved use of a compounded drug preparation either orally or

in writing. Where approval is given orally, that approval shall be

noted on the prescription prior to compounding.

(b) A pharmacy may prepare and store a limited quantity of a

compounded drug preparation in advance of receipt of a patient-

specific prescription where and solely in such quantity as is

necessary to ensure continuity of care for an identified

population of patients of the pharmacy based on a documented

history of prescriptions for that patient population.

prescriber for office use by the prescriber as authorized by

Business and Professions Code section 4052, subdivision (a)(1),

means that amount of compounded drug preparation that:

(1) Is ordered by the prescriber or the prescriber’s agent using a

purchase order or other documentation received by the

pharmacy prior to furnishing that lists the number of patients

seen or to be seen in the prescriber’s office for whom the drug is

needed or anticipated, and the quantity for each patient that is

sufficient for office administration; and

(2) Is delivered to the prescriber’s office and signed for by the

prescriber or the prescriber’s agent; and

(3) Is sufficient for administration or application to patients

solely in the prescriber's office, or for furnishing of not more than

a 120-hour supply for veterinary medical practices, solely to the

prescriber's own veterinary patients seen as part of regular

treatment in the prescriber's office, as fairly estimated by the

prescriber and documented on the purchase order or other

documentation submitted to the pharmacy prior to furnishing;

and

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(4) That the pharmacist has a credible basis for concluding it is a

reasonable quantity for office use considering the intended use

of the compounded medication and the nature of the

prescriber’s practice; and

(5) With regard to any individual prescriber to whom the

pharmacy furnishes, and with regard to all prescribers to whom

the pharmacy furnishes, is an amount which the pharmacy is

capable of compounding in compliance with pharmaceutical

standards for integrity, potency, quality and strength of the

compounded drug preparation; and

(6) Does not exceed an amount the pharmacy can reasonably

and safely compound.

(d) No pharmacy or pharmacist shall compound a drug

preparation that:

(1) Is classified by the FDA as demonstrably difficult to

compound;

(2) Appears on an FDA list of drugs that have been withdrawn or

removed from the market because such drugs or components of

such drugs have been found to be unsafe or not effective; or

(3) Is a copy or essentially a copy of one or more commercially

available drug products, unless that drug product appears on an

ASHP (American Society of Health-System Pharmacists) or FDA

list of drugs that are in short supply at the time of compounding

and at the time of dispense, and the compounding of that drug

preparation is justified by a specific, documented medical need

made known to the pharmacist prior to compounding. The

pharmacy shall retain a copy of the documentation of the

shortage and the specific medical need in the pharmacy records

for three years from the date of receipt of the documentation.

(e) A drug preparation shall not be compounded until the

pharmacy has first prepared a written master formula document

that includes at least the following elements:

(1) Active ingredients to be used.

(2) Equipment to be used.

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(3) The maximum allowable beyond use date for the

preparation, and the rationale or reference source justifying its

determination.

(4) Inactive ingredients to be used.

(5) Specific and essential compounding steps used to prepare

the drug.

(6) Quality reviews required at each step in preparation of the

drug.

(7) Post-compounding process or procedures required, if any.

(8) Instructions for storage and handling of the compounded

drug preparation.

(f) Where a pharmacy does not routinely compound a particular

drug preparation, the master formula record for that preparation

may be recorded on the prescription document itself.

(g) The pharmacist performing or supervising compounding is

responsible for the integrity, potency, quality, and labeled

strength of a compounded drug preparation until the beyond use

date indicated on the label, so long as label instructions for

storage and handling are followed after the preparation is

dispensed.

(h) All chemicals, bulk drug substances, drug products, and

other components used for drug compounding shall be stored

and used according to compendia and other applicable

requirements to maintain their integrity, potency, quality, and

labeled strength.

(i) Every compounded drug preparation shall be given beyond

use date representing the date or date and time beyond which

the compounded drug preparation should not be used, stored,

transported or administered, and determined based on the

professional judgment of the pharmacist performing or

supervising the compounding.

(1) For non-sterile compounded drug preparation(s), the beyond

use date shall not exceed any of the following:

(A) the shortest expiration date or beyond use date of any

ingredient in the compounded drug preparation,

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(B) the chemical stability of any one ingredient in the

compounded drug preparation;

the compounded drug preparation,

(D) for non-aqueous formulations, 180 days or an extended date

established by the pharmacist’s research, analysis, and

documentation,

(E) for water-containing oral formulations, 14 days or an

extended date established by the pharmacist’s research, analysis,

and documentation, and

(F) for water-containing topical/dermal and mucosal liquid and

semisolid formulations, 30 days or an extended date established

by the pharmacist’s research, analysis, and documentation.

(G) A pharmacist, using his or her professional judgment may

establish an extended date as provided in (D), (E), and (F), if the

pharmacist researches by consulting and applying drug-specific

and general stability documentation and literature; analyzes such

documentation and literature as well as the other factors set

forth in this subdivision, and maintains documentation of the

research, analysis and conclusion. The factors the pharmacist

must analyze include:

(i) the nature of the drug and its degradation mechanism,

(ii) the dosage form and its components,

(iii) the potential for microbial proliferation in the preparation,

(iv) the container in which it is packaged,

(v) the expected storage conditions, and

(vi) the intended duration of therapy.

Documentation of the pharmacist’s research and analysis

supporting an extension must be maintained in a readily

retrievable format as part of the master formula.

(2) For sterile compounded drug preparations, the beyond use

date shall not exceed any of the following:

(A) The shortest expiration date or beyond use date of any

ingredient in the sterile compounded drug product preparation,

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(B) The chemical stability of any one ingredient in the sterile

compounded drug preparation,

the sterile compounded drug preparation, and

(D) The beyond use date assigned for sterility in section 1751.8.

(3) For sterile compounded drug preparations, extension of a

beyond use date is only allowable when supported by the

following:

(A) Method Suitability Test,

(B) Container Closure Integrity Test, and

(4) In addition to the requirements of paragraph three (3), the

drugs or compounded drug preparations tested and studied shall

be identical in ingredients, specific and essential compounding

steps, quality reviews, and packaging as the finished drug or

compounded drug preparation.

(5) Shorter dating than set forth in this subdivision may be used

if it is deemed appropriate in the professional judgment of the

responsible pharmacist.

(j) The pharmacist performing or supervising compounding is

responsible for the proper preparation, labeling, storage, and

delivery of the compounded drug preparation.

(k) Prior to allowing any drug product preparation to be

compounded in a pharmacy, the pharmacist-in-charge shall

complete a self-assessment for compounding pharmacies

developed by the board (Incorporated by reference is

“Community Pharmacy & Hospital Outpatient Pharmacy

Compounding Self-Assessment” Form 17M-39 Rev. 02/12.) as

required by Section 1715 of Title 16, Division 17, of the California

Code of Regulations. That form contains a first section applicable

to all compounding, and a second section applicable to sterile

injectable compounding. The first section must be completed by

the pharmacist-in-charge before any compounding is performed

in the pharmacy. The second section must be completed by the

pharmacist-in-charge before any sterile compounding is

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performed in the pharmacy. The applicable sections of the self-

assessment shall subsequently be completed before July 1 of

each odd-numbered year, within 30 days of the start date of a

new pharmacist-in-charge or change of location, and within 30

days of the issuance of a new pharmacy license. The primary

purpose of the self-assessment is to promote compliance

through self-examination and education.

(l) Packages of ingredients, both active and inactive, that lack a

supplier’s expiration date are subject to the following limitations:

(1) such ingredients cannot be used for any non-sterile

compounded drug preparation more than three (3) years after

the date of receipt by the pharmacy.

(2) such ingredients cannot be used for any sterile compounded

drug preparation more than one (1) year after the date of receipt

by the pharmacy.

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4029, 4036, 4037,

4051, 4052, and 4127, Business and Professions Code.

1735.3. Recordkeeping of Compounded Drug Preparations

(a) For each compounded drug preparation, pharmacy records

shall include:

(1) The master formula document.

(2) A compounding log consisting of a single document

containing all of the following:

(A) Name and Strength of the compounded drug preparation.

(B) The date the drug preparation was compounded.

compounding the drug preparation.

(D) The identity of the pharmacist reviewing the final drug

preparation.

(E) The quantity of each ingredient used in compounding the

drug preparation.

(F) The manufacturer, expiration date and lot number of each

component. If the manufacturer name is demonstrably

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unavailable, the name of the supplier may be substituted. If the

manufacturer does not supply an expiration date for any

component, the records shall include the date of receipt of the

component in the pharmacy, and the limitations of section

1735.2, subdivision (l) shall apply.

(i) Exempt from the requirements in this paragraph

(1735.3(a)(2)(F)) are sterile preparations compounded in a single

lot for administration within seventy-two (72) hours to a patient

in a health care facility licensed under section 1250 of the Health

and Safety Code and stored in accordance with standards for

“Redispensed CSPs” found in Chapter 797 of the United States

Pharmacopeia - National Formulary (USP37-NF32) Through 2nd

Supplement (37th Revision, Effective December 1, 2014), hereby

incorporated by reference.

(G) A pharmacy-assigned unique reference or lot number for the

compounded drug product preparation.

(H) The beyond use date or beyond use date and time of the

final compounded drug preparation, expressed in the

compounding document in a standard date and time format.

(I) The final quantity or amount of drug preparation

compounded for dispensing.

(J) Documentation of quality reviews and required post-

compounding process and procedures.

(b) Pharmacies shall maintain records of the proper acquisition,

storage, and destruction of chemicals, bulk drug substances, drug

products, and components used in compounding.

registered with the Food and Drug Administration (FDA). All

other chemicals, bulk drug substances, and drug products used to

compound drug preparations shall be obtained, whenever

possible, from FDA-registered suppliers. The pharmacy shall

acquire and retain certificates of purity or analysis, either written

in English or translated into English, for chemicals, bulk drug

substances, and drug products used in compounding. Certificates

of purity or analysis are not required for drug products that are

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approved by the FDA. Any certificates of purity or analysis

acquired by the pharmacy shall be matched to the corresponding

chemical, bulk drug substance, or drug products received.

(d) Pharmacies shall maintain and retain all records required by

this article in the pharmacy in a readily retrievable form for at

least three years from the date the record was last in effect. If

only recorded and stored electronically, on magnetic media, or in

any other computerized form, the records shall be maintained as

specified by Business and Professions Code section 4070

subsection (c).

Authority cited: Sections 4005, 4127, and 4169, Business and

Professions Code. Reference: Sections 4005, 4036, 4037, 4051,

4052, and 4127, Business and Professions Code.

1735.4. Labeling of Compounded Drug Preparations

(a) Each compounded drug preparation shall be affixed with a

container label prior to dispensing that contains at least:

(1) Name of the compounding pharmacy and dispensing

pharmacy (if different);

(2) Name (brand or generic) and strength, volume, or weight of

each active ingredient. For admixed IV solutions, the intravenous

solution utilized shall be included;

(3) Instructions for storage, handling, and administration. For

admixed IV solutions, the rate of infusion shall be included;

(4) The beyond use date for the drug preparation;

(5) The date compounded; and

(6) The lot number or pharmacy reference number.

(b) Any compounded drug preparation dispensed to a patient or

readied for dispensing to a patient shall also include on the label

the information required under Business and Professions Code

section 4076 and California Code of Regulations, title 16, section

1707.5.

readied for dispensing to a patient shall also include, on the

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container label or on a receipt provided to the patient, a

statement that the drug has been compounded by the pharmacy.

(d) Prior to dispensing drug preparations compounded into unit-

dose containers that are too small or otherwise impractical for

full compliance with subdivisions (a), (b), and (c) shall be labeled

with at least the name of the compounding pharmacy and

dispensing pharmacy, if different, the name(s) of the active

ingredient(s), strength, volume or weight of the preparation,

pharmacy reference or lot number, and beyond use date, and

shall not be subject to minimum font size requirements. Once

dispensed, outer packaging must comply with 1735.4(a) - (c).

(e) All hazardous agents shall bear a special label which states

“Chemotherapy -Dispose of Properly” or “Hazardous - Dispose of

Properly.”

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4036, 4037, 4051,

4052, 4076 and 4127, Business and Professions Code.

1735.5. Compounding Policies and Procedures

(a) Any pharmacy engaged in compounding shall maintain

written policies and procedures for compounding that

establishes procurement procedures, methodologies for the

formulation and compounding of drugs, facilities and equipment

cleaning, maintenance, operation, and other standard operating

procedures related to compounding. Any material failure to

follow the pharmacy’s written policies and procedures shall

constitute a basis for disciplinary action.

(b) The policies and procedures shall be reviewed and such

review shall be documented on an annual basis by the

pharmacist-in-charge. The policies and procedures shall be

updated whenever changes in policies and procedures are

implemented.

following:

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(1) Procedures for notifying staff assigned to compounding

duties of any changes in policies or procedures.

(2) A written plan for recall of a dispensed compounded drug

preparation where subsequent information demonstrates the

potential for adverse effects with continued use. The plan shall

ensure that all affected doses can be accounted for during the

recall and shall provide steps to identify which patients received

the affected lot or compounded drug preparation(s).

(3) Procedures for maintaining, storing, calibrating, cleaning,

and disinfecting equipment used in compounding, and for

training on these procedures as part of the staff training and

competency evaluation process.

(4) Procedures for evaluating, maintaining, certifying, cleaning,

and disinfecting the facility (physical plant) used for

compounding, and for training on these procedures as part of the

staff training and competency evaluation process.

(5) Documentation of the methodology used to validate

integrity, potency, quality, and labeled strength of compounded

drug preparations. The methodology must be appropriate to

compounded drug preparations.

(6) Documentation of the methodology and rationale or

reference source used to determine appropriate beyond use

dates for compounded drug preparations.

(7) Dates and signatures reflecting all annual reviews of the

policies and procedures by the pharmacist-in-charge.

(8) Dates and signatures accompanying any revisions to the

policies and procedures approved by the pharmacist-in-charge.

(9) Policies and procedures for storage of compounded drug

preparations in the pharmacy and daily documentation of all

room, refrigerator, and freezer temperatures within the

pharmacy.

(10) Policies and procedures regarding ensuring appropriate

functioning of refrigeration devices, monitoring refrigeration

device temperatures, and actions to take regarding any out of

range temperature variations within the pharmacy.

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(11) Policies and procedures for proper garbing when

compounding with hazardous products. This shall include when

to utilize double shoe covers.

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4036, 4037, 4051,

4052, 4127, and 4301, Business and Professions Code

1735.6. Compounding Facilities and Equipment

(a) Any pharmacy engaged in compounding shall maintain

written documentation regarding the facilities and equipment

necessary for safe and accurate compounding of compounded

drug preparations. This shall include records of maintenance and

cleaning of the facilities and equipment. Where applicable, this

shall also include records of certification(s) of facilities or

equipment.

(b) Any equipment used to compound drug preparations shall

be stored, used, maintained, and cleaned in accordance with

manufacturers' specifications.

ingredients used to compound drug preparations for which

calibration or adjustment is appropriate shall be calibrated prior

to use, on a schedule and by a method determined by the

manufacturer’s specifications, to ensure accuracy.

Documentation of each such calibration shall be recorded in a

form which is not alterable and these records of calibration shall

be maintained and retained in the pharmacy.

(d) Any pharmacy engaged in any hazardous drug compounding

shall maintain written documentation regarding appropriate

cleaning of facilities and equipment to prevent cross-

contamination with non-hazardous drugs.

(e) Hazardous drug compounding shall be completed in an

externally exhausted physically separate room with the following

requirements:

(1) Minimum of 30 air changes per hour except that 12 air

changes per hour are acceptable for segregated compounding

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areas with a BSC or CACI when products are assigned a BUD of 12

hours or less or when non sterile products are compounded; and

(2) Maintained at a negative pressure of 0.01 to 0.03 inches of

water column relative to all adjacent spaces (rooms, above

ceiling, and corridors); and

(3)(A) For sterile compounding, each BSC or CACI shall be

externally exhausted.

(B) For nonsterile compounding, a BSC, a CACI, or other

containment ventilated enclosure shall be used and shall either

use a redundant-HEPA filter in series or be externally exhausted.

For purposes of this paragraph, a containment ventilated

enclosure means a full or partial enclosure that uses ventilation

principles to capture, contain, and remove airborne

contaminants through high-efficiency particulate air (HEPA)

filtration and to prevent their release into the work environment

(4) All surfaces within the room shall be smooth, seamless,

impervious, and non-shedding.

(f) Where compliance with the January 1, 2017 amendments to

Article 4.5 or Article 7, requires physical construction or

alteration to a facility or physical environment, the board or its

designee may grant a waiver of such compliance for a period of

time to permit such physical change(s). Application for any

waiver shall be made by the licensee in writing, and the request

shall identify the provision(s) requiring physical construction or

alteration, and the timeline for any such change(s). The board or

its designee may grant the waiver when, in its discretion, good

cause is demonstrated for such waiver.

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4029, 4036, 4037,

4051, 4052 and 4127, Business and Professions Code.

1735.7. Training of Compounding Staff

(a) A pharmacy engaged in compounding shall maintain

documentation demonstrating that personnel involved in

compounding have the skills and training required to properly

467

and accurately perform their assigned responsibilities and

documentation demonstrating that all personnel involved in

compounding are trained in all aspects of policies and

procedures. This training shall include but is not limited to

support personnel (e.g. institutional environmental services,

housekeeping), maintenance staff, supervising pharmacist and all

others whose jobs are related to the compounding process.

(b) The pharmacy shall develop and maintain an ongoing

competency evaluation process for pharmacy personnel involved

in compounding, and shall maintain documentation of any and all

training related to compounding undertaken by pharmacy

personnel.

demonstrate knowledge about processes and procedures used in

compounding prior to compounding any drug preparation.

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4036, 4037, 4051,

4052 and 4127, Business and Professions Code

1735.8. Compounding Quality Assurance

(a) Any pharmacy engaged in compounding shall maintain, as

part of its written policies and procedures, a written quality

assurance plan designed to monitor and ensure the integrity,

potency, quality, and labeled strength of compounded drug

preparations.

(b) The quality assurance plan shall include written procedures

for verification, monitoring, and review of the adequacy of the

compounding processes and shall also include written

documentation of review of those processes by qualified

pharmacy personnel.

qualitative and quantitative analysis of compounded drug

preparations to ensure integrity, potency, quality, and labeled

strength, including the frequency of testing. All qualitative and

quantitative analysis reports for compounded drug preparations

468

shall be retained by the pharmacy and maintained along with the

compounding log and master formula document. The quality

assurance plan shall include a schedule for routine testing and

analysis of specified compounded drug preparations to ensure

integrity, potency, quality, and labeled strength, on at least an

annual basis.

(d) The quality assurance plan shall include a written procedure

for scheduled action in the event any compounded drug

preparation is ever discovered to be outside minimum standards

for integrity, potency, quality, or labeled strength.

(e) The quality assurance plan shall include a written procedure

for responding to out-of-range temperature variations within the

pharmacy and within patient care areas of a hospital where

furnished drug is returned for redispensing.

Authority cited: Sections 4005 and 4127, Business and

Professions Code. Reference: Sections 4005, 4036, 4037, 4051,

4052 and 4127, Business and Professions Code.

Article 5. Dangerous Drugs

1744. Drug Warnings.

Pursuant to Business and Professions Code Section 4074, a

pharmacist shall inform the patient or his or her representative

of the harmful effects of certain drugs dispensed by prescription.

(a) Because the following classes of drugs may impair a person's

ability to operate a vehicle or vessel, a pharmacist shall include a

written label on the drug container indicating that the drug may

impair a person’s ability to operate a vehicle or vessel:

(1) Muscle relaxants.

(2) Antipsychotic drugs with central nervous system depressant

effects.

(3) Antidepressants with central nervous system depressant

effects.

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(4) Antihistamines, motion sickness agents, antipruritics,

antinauseants, anticonvulsants and antihypertensive agents with

central nervous system depressant effects.

(5) All Schedule II, III, IV and V agents with central nervous

system depressant effects.

(6) Anticholinergic agents that may impair vision.

(7) Any other drug which, based on the pharmacist’s

professional judgment, may impair a patient’s ability to operate a

vehicle or vessel.

(b) Because the following classes of drugs pose a substantial risk

to the person consuming the drug when taken in combination

with alcohol, a pharmacist shall include a written label on the

drug container to alert the patient about possible potentiating

effects:

(1) Disulfiram and other drugs (e.g., chlorpropamide,

metronidazole) which may cause a disulfiram-like reaction.

(2) Mono amine oxidase inhibitors.

(3) Nitrates.

(4) Cycloserine.

(5) Antidiabetic agents including insulin and sulfonylureas (due

to risk of hypoglycemia).

(6) Any other drug which, based upon a pharmacist’s

professional judgment, may pose a substantial risk to the person

consuming the drug when taken in combination with alcohol.

Authority cited: Section 4005, Business and Professions Code.

Reference: Sections 4022, 4055 and 4074, Business and

Professions Code.

1745. Partial Filling of Schedule II Prescriptions.

(a) A prescription for a Schedule II controlled substance (as

defined in Health and Safety Code section 11055) may be

partially filled, as defined in paragraph (b), if:

(1) The prescription is for an inpatient of a skilled nursing facility

as defined in Health and Safety Code section 1250; or

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(2) The prescription is for a terminally ill patient. “Terminally ill”

as used herein means a patient for whom a licensed physician

and surgeon has made and documented a diagnosis of illness or

disease that will result in death.

(b) A “partially filled” prescription is a prescription from which

only a portion of the amount for which the prescription is written

is filled at any one time; provided that regardless of how many

times the prescription is partially filled, the total amount

dispensed shall not exceed that written on the face of the

prescription.

(a), all of the following conditions must be met:

(1) The prescription must be tendered and at least partially filled

within 60 days following the date of issue;

(2) The pharmacist records the date and amount of each partial

filling in a readily retrievable form and on the original

prescription, also recording the initials of the pharmacist

dispensing the prescription;

(3) No portion of the prescription is dispensed more than 60

days from the date of issuance of the prescription; and

(d) A pharmacist may partially fill a prescription for a controlled

substance listed in Schedule II, if the pharmacist is unable to

supply the full quantity ordered by the prescriber. The

pharmacist shall make a notation of the quantity supplied on the

face of the written prescription. The remaining portion of the

prescription may be filled within 72 hours of the first partial

filling. If the remaining portion is not filled within the 72-hour

period, the pharmacist shall notify the prescriber. The pharmacist

may not supply the drug after 72 hour period has expired without

a new prescription.

Authority cited: Section 4005, Business and Professions Code.

Reference: Section 4301, Business and Professions Code; and

Sections 11055, 11153, 11154, 11166, 11200, Health and Safety

Code.

471

1746. Emergency Contraception.

(a) A pharmacist furnishing emergency contraception pursuant

to Section 4052.3(a)(2) of the Business and Professions Code shall

follow the protocol specified in subdivision (b) of this section.

(b) Protocol for Pharmacists Furnishing Emergency

Contraception (EC).

(1) Authority: Section 4052.3(a)(2) of the California Business and

Professions Code authorizes a pharmacist to furnish emergency

contraception pursuant to a protocol approved by the California

State Board of Pharmacy and the Medical Board of California. Use

of the protocol specified in this section satisfies that

requirement.

(2) Purpose: To provide timely access to emergency

contraceptive medication and ensure that the patient receives

adequate information to successfully complete therapy.

(3) Procedure: When a patient requests emergency

contraception, the pharmacist will ask and communicate the

following:

Are you allergic to any medications?

Timing is an essential element of the product's effectiveness. EC

should be taken as soon as possible after unprotected

intercourse. Treatment may be initiated up to five days (120

hours) after unprotected intercourse.

EC use will not interfere with an established or implanted

pregnancy.

If more than 72 hours have elapsed since unprotected

intercourse, the use of ella™ (ulipristal) may be more effective

than levonorgestrel. For other options for EC, consult with your

health care provider.

Please follow up with your health care provider after the use of

EC.

(4) The pharmacist shall provide a fact sheet and review any

questions the patient may have regarding EC. In addition, the

472

pharmacist shall collect the information required for a patient

medication record required by Section 1707.1 of Title 16 of the

California Code of Regulations.

Fact Sheet: The pharmacist will provide the patient with a copy of

the current EC fact sheet approved by the Board of Pharmacy as

required by Business and Professions Code Section 4052.3(e).

(5) Referrals and Supplies: If emergency contraception services

are not immediately available at the pharmacy or the pharmacist

declines to furnish pursuant to conscience clause, the pharmacist

will refer the patient to another emergency contraception

provider. The pharmacist shall comply with all state mandatory

reporting laws, including sexual abuse laws.

(6) The pharmacist may provide up to 12 non-spermicidal

condoms to each Medi-Cal and Family PACT client who obtains

emergency contraception.

(7) Advanced provision: The pharmacist may dispense

emergency contraception medication for a patient in advance of

the need for emergency contraception.

(8) EC Product Selection: The pharmacist will provide emergency

contraception medication from the list of products specified in

this protocol. This list must be kept current and maintained in the

pharmacy. Along with emergency contraception products, the list

will include adjunctive medications indicated for nausea and

vomiting associated with taking EC containing estrogen. Patients

will be provided information concerning dosing and potential

adverse effects.

(9) Documentation: Each prescription authorized by a

pharmacist will be documented in a patient medication record as

required by law.

(10) Training: Prior to furnishing emergency contraception,

pharmacists who participate in this protocol must have

completed a minimum of one hour of continuing education

specific to emergency contraception.

(11) Medications Used for Emergency Contraception

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Dedicated Approved Products for Emergency Contraception

One Tablet Regimens

Ethinyl

Estradiol

One Tablet

Brand

Dose

per dose

Regimen

(mcg)

Plan B™

1.5mg

1 tablet

One-Step

levonorgestrel

30mg

ella™

1 tablet

ulipristal

1.5mg

Levonorgestrel

1 tablet

levonorgestrel

Two Tablet Regimens

Ethinyl

Estradiol

Two Tablet

Brand

Dose

per dose

Regimen

(mcg)

2 tablets

at once

(1.5mg

total

dose)

Each tablet is

1 tablet

Next Choice™

0.75 mg

(0.75mg)

levonorgestrel

followed

1 tablet

(0.75mg)

12 hours

later

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Ethinyl

Estradiol

Two Tablet

Brand

Dose

per dose

Regimen

(mcg)

2 tablets

at once

(1.5mg

total

dose)

Each tablet is

1 tablet

0.75 mg

Levonorgestrel

(0.75mg)

levonorgestrel

followed

1 tablet

(0.75mg)

12 hours

later

Oral Contraceptive Pills

Ethinyl

Estradiol

Levonorgestrel

Tablets per Dose

per dose

Brand

(two doses 12 hours apart*)

(mcg)

(mg)*

Alesse

5 pink tablets

100

0.50

Aviane

5 orange tablets

100

0.50

Levlen

4 light-orange tablets

120

0.60

Levlite

5 pink tablets

100

0.50

Levora

4 white tablets

0.60

120

Lo/Ovral

4 white tablets

120

0.50

475

Ethinyl

Estradiol

Levonorgestrel

Tablets per Dose

per dose

Brand

(two doses 12 hours apart*)

(mcg)

(mg)*

Low-

4 white tablets

0.60

120

Ogestrel

Nordette

4 light-orange tablets

120

0.60

Ogestrel

2 white tablets

100

0.50

Ovral

2 white tablets

100

0.50

Tri-

4 yellow tablets

0.50

100

Levlen

Triphasil

4 yellow tablets

120

0.50

Trivora

4 pink tablets

120

0.50

Ovrette

20 yellow tablets

0.75

*The progestin in Ovral, Lo/Ovral, and Ovrette is norgestrel,

which contains two isomers, only one of which (levonorgestrel) is

bioactive; the amount of norgestrel in each dose is twice the

amount of levonorgestrel.

In addition to the products specified in this paragraph, generic

equivalent products may be furnished. Estrogen containing

regimens are not preferred and should be used only when the

other options are not available.

(12) Anti-nausea Treatment Options for use with Emergency

Contraception

Non-Prescription

Timing of

Dose

Drugs

Administration

Meclizine

1 hour before first

hydrochloride

One or two 25 mg

EC dose;

(Dramamine II,

tablets

Repeat if needed in

Bonine)

24 hours

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Non-Prescription

Timing of

Dose

Drugs

Administration

1 hour before first

Diphenhydramine

One or two 25 mg

EC dose; repeat as

hydrochloride

tablets or capsules

needed every

(Benadryl)

4-6 hours

30 minutes to

One or two 50 mg

1 hour before first

Dimenhydrinate

tablets or 4-8

EC dose; repeat as

(Dramamine)

teaspoons liquid

needed every

4-6 hours

30 minutes before

Cyclizine

first EC dose;

hydrochloride

One 50 mg tablet

repeat as needed

(Marezine)

every 4-6 hours

Authority cited: Section 4005, Business and Professions Code.

Reference: Sections 4052 and 4052.3, Business and Professions

Code.

1746.1 Protocol for Pharmacists Furnishing Self-Administered

Hormonal Contraception.

(a) A pharmacist furnishing self-administered hormonal

contraception pursuant to Section

4052.3 of the Business and Professions Code shall follow the

protocol specified in subdivision (b) of this section.

(b) Protocol for Pharmacists Furnishing Self-Administered

Hormonal Contraception

(1) Authority: Section 4052.3(a)(1) of the California Business and

Professions Code authorizes a pharmacist to furnish self-

administered hormonal contraceptives in accordance with a

protocol approved by the California State Board of Pharmacy and

the Medical Board of California. Use of the protocol in this

section satisfies that requirement.

477

(2) Purpose: To provide timely access to self-administered

hormonal contraception medication and to ensure that the

patient receives adequate information to successfully comply

with therapy.

(3) Definition of Self-Administered Hormonal Contraception:

Hormonal contraception products with the following routes of

administration are considered self-administered:

(A) Oral;

(B) Transdermal;

(D) Depot Injection.

(4) Procedure: When a patient requests self-administered

hormonal contraception, the pharmacist shall complete the

following steps:

(A) Ask the patient to use and complete the self-screening tool;

(B) Review the self-screening answers and clarify responses if

needed;

combined hormonal contraceptives are requested or

recommended;

(D) Before furnishing self-administered hormonal contraception,

the pharmacist shall ensure that the patient is appropriately

trained in administration of the requested or recommended

contraceptive medication.

(E) When a self-administered hormonal contraceptive is

furnished, the patient shall be provided with appropriate

counseling and information on the product furnished, including:

1. Dosage;

2. Effectiveness;

3. Potential side effects;

4. Safety;

5. The importance of receiving recommended preventative

health screenings;

6. That self-administered hormonal contraception does not

protect against sexually transmitted infections (STIs).

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(5) Self-Screening Tool: The pharmacist shall provide the patient

with a self-screening tool containing the list of questions

specified in this protocol. The patient shall complete the self-

screening tool, and the pharmacist shall use the answers to

screen for all Category 3 and 4 conditions and characteristics for

self-administered hormonal contraception from the current

United States Medical Eligibility Criteria for Contraceptive Use

(USMEC) developed by the federal Centers for Disease Control

and Prevention (CDC). The patient shall complete the self-

screening tool annually, or whenever the patient indicates a

major health change.

A copy of the most recently completed self-screening tool shall

be securely stored within the originating pharmacy or health care

facility for a period of at least three years from the date of

dispense.

This self-screening tool should be made available in alternate

languages for patients whose primary language is not English.

(6) Fact Sheets:

(A) The pharmacist should provide the patient with a copy of a

current, consumer-friendly, comprehensive birth control guide

such as that created by the Food and Drug Administration (FDA).

Examples of appropriate guides are available on the Board of

Pharmacy’s website.

(B) The pharmacist shall provide the patient with the FDA-

required patient product information leaflet included in all self-

administered hormonal contraception products, as required by

Business and Professions Code Section 4052.3(c). The pharmacist

shall answer any questions the patient may have regarding self-

administered hormonal contraception.

administration- specific factsheet. Examples of appropriate

factsheets are available on the Board of Pharmacy’s website.

(7) Follow-Up Care: Upon furnishing a self-administered

hormonal contraceptive, or if it is determined that use of a self-

administered hormonal contraceptive is not recommended, the

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2022 LAWBOOK FOR PHARMACY - page 12