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pharmacist shall refer the patient for appropriate follow-up care
to the patient’s primary care provider or, if the patient does not
have a primary care provider, to nearby clinics. A patient who is
determined not to be an appropriate candidate for self-
administered hormonal contraception shall be advised of the
potential risk and referred to an appropriate health care provider
for further evaluation.
(8) Notifications: The pharmacist shall notify the patient’s
primary care provider of any drug(s) or device(s) furnished to the
patient, or enter the appropriate information in a patient record
system shared with the primary care provider, as permitted by
that primary care provider. If the patient does not have a primary
care provider, or is unable to provide contact information for his
or her primary care provider, the pharmacist shall provide the
patient with a written record of the drug(s) or device(s) furnished
and advise the patient to consult an appropriate health care
professional of the patient’s choice.
(9) Referrals and Supplies: If self-administered hormonal
contraception services are not immediately available or the
pharmacist declines to furnish pursuant to a conscience clause,
the pharmacist shall refer the patient to another appropriate
health care provider.
The pharmacist shall comply with all state mandatory reporting
laws, including sexual abuse laws.
(10) Product Selection: The pharmacist, in consultation with the
patient, may select any hormonal contraceptive listed in the
current version of the USMEC for individuals identified as
Category 1 or 2, based on the information reported in the self-
screening tool and the blood pressure (if recorded by the
pharmacist). The USMEC shall be kept current and maintained in
the pharmacy or health care facility, and shall be available on the
Board of Pharmacy’s website. Generic equivalent products may
be furnished.
(11) Documentation: Each self-administered hormonal
contraceptive furnished by a pharmacist pursuant to this
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protocol shall be documented in a patient medication record and
securely stored within the originating pharmacy or health care
facility for a period of at least three years from the date of
dispense. A patient medication record shall be maintained in an
automated data processing or manual record mode such that the
required information under title 16, sections 1717 and 1707.1 of
the California Code of Regulations is readily retrievable during
the pharmacy or facility’s normal operating hours.
(12) Training: Prior to furnishing self-administered hormonal
contraception, pharmacists who participate in this protocol must
have completed a minimum of one hour of a board-approved
continuing education program specific to self- administered
hormonal contraception, application of the USMEC, and other
CDC guidance on contraception. An equivalent, curriculum-based
training program completed on or after the year 2014 in an
accredited California school of pharmacy is also sufficient training
to participate in this protocol.
(13) Patient Privacy: All pharmacists furnishing self-administered
hormonal contraception in a pharmacy or health care facility
shall operate under the pharmacy or facility’s policies and
procedures to ensure that patient confidentiality and privacy are
maintained.
(14) Self-Screening Tool Questions
HORMONAL CONTRACEPTION SELF-SCREENING TOOL
QUESTIONS
1. What was the first date of your last menstrual period?
2a. Have you ever taken birth control pills or used a birth
control patch, ring, or shot/injection? Yes ☐ No ☐ (If no, go to
question 3.)
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2b. Did you ever experience a bad reaction to using hormonal
birth control? Yes ☐ No ☐
2c. Are you currently using birth control pills, or a birth control
patch, ring, or shot/injection? Yes ☐ No ☐
3. Have you ever been told by a medical professional not to
take hormones? Yes ☐ No ☐
4. Do you smoke cigarettes? Yes ☐ No ☐
5. Do you think you might be pregnant now? Yes ☐ No ☐
6. Have you given birth within the past 6 weeks? Yes ☐ No ☐
7. Are you currently breastfeeding an infant who is less than 1
month of age? Yes ☐ No ☐
8. Do you have diabetes? Yes ☐ No ☐
9. Do you get migraine headaches, or headaches so bad that
you feel sick to your stomach, you lose the ability to see, it
makes it hard to be in light, or it involves numbness?
Yes ☐ No ☐
10. Do you have high blood pressure, hypertension, or high
cholesterol? Yes ☐ No ☐
11. Have you ever had a heart attack or stroke, or been told you
had any heart disease? Yes ☐ No ☐
12. Have you ever had a blood clot in your leg or in your lung?
Yes ☐ No ☐
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13. Have you ever been told by a medical professional that you
are at a high risk of developing a blood clot in your leg or in
your lung? Yes ☐ No ☐
14. Have you had bariatric surgery or stomach reduction
surgery? Yes ☐ No ☐
15. Have you had recent major surgery or are you planning to
have surgery in the next 4 weeks? Yes ☐ No ☐
16. Do you have or have you ever had breast cancer?
Yes ☐ No ☐
17. Do you have or have you ever had hepatitis, liver disease,
liver cancer, or gall bladder disease, or do you have jaundice
(yellow skin or eyes)? Yes ☐ No ☐
18. Do you have lupus, rheumatoid arthritis, or any blood
disorders? Yes ☐ No ☐
19a. Do you take medication for seizures, tuberculosis (TB),
fungal infections, or human immunodeficiency virus (HIV)?
Yes ☐ No ☐
19b. If yes, list them here:
20a. Do you have any other medical problems or take regular
medication? Yes ☐ No ☐
20b. If yes, list them here:
Authority: Sections 4005 and 4052.3, Business and Professions
Code.
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Reference: Sections 733, 4052, 4052.3 and 4103, Business and
Professions Code.
1746.2. Protocol for Pharmacists Furnishing Nicotine
Replacement Products
(a) A pharmacist furnishing nicotine replacement products
pursuant to Section 4052.9 of the Business and Professions Code
shall follow the protocol specified in subdivision (b) of this
section.
(b) Protocol for Pharmacists Furnishing Nicotine Replacement
Products
(1) Authority: section 4052.9(a) of the California Business and
Professions Code authorizes a pharmacist to furnish nicotine
replacement products approved by the federal Food and Drug
Administration for use by prescription only 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.
(2) Purpose: To provide timely access to nicotine replacement
products and to ensure that the patient receives information to
appropriately initiate smoking cessation medication therapy.
(3) Explanation of Products Covered: Prescription nicotine
replacement products approved by the federal Food and Drug
Administration and provided by a pharmacist for smoking
cessation are covered under this protocol. Pharmacists may
continue to provide over-the-counter smoking cessation products
without use of this protocol.
(4) Procedure: When a patient requests nicotine replacement
therapy or other smoking cessation medication, or when a
pharmacist in his or her professional judgment decides to initiate
smoking cessation treatment and counseling, the pharmacist
shall complete the following steps:
(A) Review the patient's current tobacco use and past quit
attempts.
(B) Ask the patient the following screening questions:
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(i) Are you pregnant or plan to become pregnant? (If yes do not
furnish and refer to an appropriate health care provider)
(ii) Have you had a heart attack within the last 2 weeks? (If yes,
furnish with caution and refer to an appropriate health care
provider)
(iii) Do you have any history of heart palpitations, irregular
heartbeats, or have you been diagnosed with a serious
arrhythmia? (If yes, furnish with caution and refer to an
appropriate health care provider)
(iv) Do you currently experience frequent chest pain or have you
been diagnosed with unstable angina? (If yes, furnish with
caution and refer to an appropriate health care provider)
(v) Do you have any history of allergic rhinitis (e.g., nasal
allergies)? (If yes, avoid nasal spray)
(vi) Have you been diagnosed with temporal mandibular joint
(TMJ) dysfunction? (If yes, avoid nicotine gum)
These screening questions shall be made available in alternate
languages for patients whose primary language is not English.
(C) When a nicotine replacement product is furnished:
(i) The pharmacist shall review the instructions for use with
every patient using a nicotine replacement product.
(ii) Pharmacists should recommend the patient seek additional
assistance for behavior change, including but not limited to the
California Smokers' Helpline (1-800-NO-BUTTS), web-based
programs (e.g., http://smokefree.gov), apps, and local cessation
programs.
(D) The pharmacist shall answer any questions the patient may
have regarding smoking cessation therapy and/or nicotine
replacement products.
(5) Product Selection: The pharmacist, in consultation with the
patient, may select any nicotine replacement product (alone or in
combination) from the list of therapies specified in this protocol
in the Table “Nicotine Replacement Therapy Medications for
Smoking Cessation.” This list shall be kept current and
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maintained in the pharmacy or health care facility, and shall be
available on the Board of Pharmacy's website.
Generic equivalent products may be furnished.
(6) Notifications: The pharmacist shall notify the patient's
primary care provider of any prescription drug(s) and/or device(s)
furnished to the patient, or enter the appropriate information in
a patient record system shared with the primary care provider, as
permitted by that primary care provider. If the patient does not
have a primary care provider, or is unable to provide contact
information for his or her primary care provider, the pharmacist
shall provide the patient with a written record of the prescription
drug(s) and/or device(s) furnished and advise the patient to
consult an appropriate health care provider of the patient's
choice.
(7) Documentation: Each nicotine replacement product
provided for smoking cessation and furnished by a pharmacist
pursuant to this protocol shall be documented in a patient
medication record and securely stored within the originating
pharmacy or health care facility for a period of at least three
years from the date of dispense. A patient medication record
shall be maintained in an automated data processing or manual
record mode such that the required information under title 16,
sections 1717 and 1707.1 of the California Code of Regulations is
readily retrievable during the pharmacy or facility's normal
operating hours.
(8) Training: Prior to furnishing prescription nicotine
replacement products, pharmacists who participate in this
protocol must have completed a minimum of two hours of an
approved continuing education program specific to smoking
cessation therapy and nicotine replacement therapy, or an
equivalent curriculum-based training program completed within
the last two years in an accredited California school of pharmacy.
Additionally, pharmacists who participate in this protocol must
complete ongoing continuing education focused on smoking
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cessation therapy from an approved provider once every two
years.
(9) Patient Privacy: All pharmacists furnishing nicotine
replacement products in a pharmacy or health care facility shall
operate under the pharmacy's or facility's policies and
procedures to ensure that patient confidentiality and privacy are
maintained.
(10) Nicotine Replacement Therapy Medications for Smoking
Cessation
[See the charts of Nicotine Replacement Therapy Medication for
Smoking Cessation at the Board of Pharmacy website]
Note: Authority cited: Sections 4005, 4052(a)(10) and 4052.9,
Business and Professions Code. Reference: Sections 4052(a)(10)
and 4052.9, Business and Professions Code.
1746.3. Protocol for Pharmacists Furnishing Naloxone
Hydrochloride
A pharmacist furnishing naloxone hydrochloride pursuant to
section 4052.01 of the Business and Professions Code shall satisfy
the requirements of this section.
(a) As used in this section:
(1) “Opioid” means naturally derived opiates as well as synthetic
and semi- synthetic opioids.
(2) “Recipient” means the person to whom naloxone
hydrochloride is furnished.
(b) Training. Prior to furnishing naloxone hydrochloride,
pharmacists who use this protocol must have successfully
completed a minimum of one hour of an approved continuing
education program specific to the use of naloxone hydrochloride
in all routes of administration recognized in subsection (c)(4) of
this protocol, or an equivalent curriculum-based training program
completed in a board recognized school of pharmacy.
(c) Protocol for Pharmacists Furnishing Naloxone Hydrochloride.
Before providing naloxone hydrochloride, the pharmacist shall:
487
(1) Screen the potential recipient by asking the following
questions:
(A) Whether the potential recipient currently uses or has a
history of using illicit or prescription opioids. (If the recipient
answers yes, the pharmacist may skip screening question B.);
(B) Whether the potential recipient is in contact with anyone
who uses or has a history of using illicit or prescription opioids. (If
the recipient answers yes, the pharmacist may continue.);
(C) Whether the person to whom the naloxone hydrochloride
would be administered has a known hypersensitivity to naloxone.
(If the recipient answers yes, the pharmacist may not provide
naloxone. If the recipient responds no, the pharmacist may
continue.)
The screening questions shall be made available on the Board of
Pharmacy’s website in alternate languages for patients whose
primary language is not English.
(2) Provide the recipient training in opioid overdose prevention,
recognition, response, and administration of the antidote
naloxone.
(3) When naloxone hydrochloride is furnished:
(A) The pharmacist shall provide the recipient with appropriate
counseling and information on the product furnished, including
dosing, effectiveness, adverse effects, storage conditions, shelf---
life, and safety. The recipient is not permitted to waive the
required consultation.
(B) The pharmacist shall provide the recipient with any
informational resources on hand and/or referrals to appropriate
resources if the recipient indicates interest in addiction
treatment, recovery services, or medication disposal resources at
this time.
(C) The pharmacist shall answer any questions the recipient may
have regarding naloxone hydrochloride.
(4) Product Selection: A pharmacist shall advise the recipient on
how to choose the route of administration based on the
formulation available, how well it can likely be administered, the
488
setting, and local context. A pharmacist may supply naloxone
hydrochloride as an intramuscular injection, intranasal spray,
auto-injector or in another FDA- approved product form. A
pharmacist may also recommend optional items when
appropriate, including alcohol pads, rescue breathing masks, and
rubber gloves.
(5) Labeling: A pharmacist shall label the naloxone
hydrochloride consistent with law and regulations. Labels shall
include an expiration date for the naloxone hydrochloride
furnished. An example of appropriate labeling is available on the
Board of Pharmacy’s website.
(6) Fact Sheet: The pharmacist shall provide the recipient a copy
of the current naloxone fact sheet approved by the Board of
Pharmacy or a fact sheet approved by the executive officer. The
executive officer may only approve a fact sheet that has all the
elements and information that are contained in the current
board-approved fact sheet. The board-approved fact sheet shall
be made available on the Board of Pharmacy’s website in
alternate languages for patients whose primary language is not
English. Fact sheets in alternate languages must be the current
naloxone fact sheet approved by the Board of Pharmacy.
(7) Notifications: If the recipient of the naloxone hydrochloride
is also the person to whom the naloxone hydrochloride would be
administered, then the naloxone recipient is considered a patient
for purposes of this protocol and notification may be required
under this section.
If the patient gives verbal or written consent, then the
pharmacist shall notify the patient’s primary care provider of any
drug(s) and/or device(s) furnished, or enter the appropriate
information in a patient record system shared with the primary
care provider, as permitted by the patient and that primary care
provider.
If the patient does not have a primary care provider, or chooses
not to give notification consent, then the pharmacist shall
provide a written record of the drug(s) and/or device(s) furnished
489
and advise the patient to consult an appropriate health care
provider of the patient’s choice.
(8) Documentation: Each naloxone hydrochloride product
furnished by a pharmacist pursuant to this protocol shall be
documented in a medication record for the naloxone recipient,
and securely stored within the originating pharmacy or health
care facility for a period of at least three years from the date of
dispense. The medication record shall be maintained in an
automated data or manual record mode such that the required
information under title 16, sections 1707.1 and 1717 of the
California Code of Regulations is readily retrievable during the
pharmacy or facility’s normal operating hours.
(9) Privacy: All pharmacists furnishing naloxone hydrochloride in
a pharmacy or health care facility shall operate under the
pharmacy or facility’s policies and procedures to ensure that
recipient confidentiality and privacy are maintained.
Note: Authority: Section 4052.01, Business and Professions
Code. Reference: Section 4052.01, Business and Professions
Code.
1746.4. Pharmacists Initiating and Administering Vaccines.
(a) A pharmacist initiating and/or administering vaccines
pursuant to sections 4052 or 4052.8 of the Business and
Professions Code shall follow the requirements specified in
subdivisions (b) through (f) of this section.
(b) Training: A pharmacist who initiates and/or administers any
vaccine shall keep documentation of:
(1) Completion of an approved immunization training program,
and
(2) Basic life support certification.
This documentation shall be kept on site and available for
inspection.
(c) Continuing Education: Pharmacists must complete one hour
of ongoing continuing education focused on immunizations and
vaccines from an approved provider once every two years.
490
(d) Notifications: The pharmacist shall notify the patient’s
primary care provider of any vaccines administered to the
patient, or enter the appropriate information in a patient record
system shared with the primary care provider, as permitted by
the primary care provider. Primary care provider notification
must take place within 14 days of the administration of any
vaccine. If the patient does not have a primary care provider, or
is unable to provide contact information for his or her primary
care provider, the pharmacist shall advise the patient to consult
an appropriate health care provider of the patient’s choice. If
known, notification to the prenatal care provider of
immunizations provided to pregnant women must take place
within 14 days of the administration of any vaccine.
(e) Immunization Registry: A pharmacist shall fully report the
information described in Section 120440(c) of the Health and
Safety Code into one or more state and/or local immunization
information systems within 14 days of the administration of any
vaccine. The pharmacist shall inform the patient or the patient’s
guardian of immunization record sharing preferences, detailed in
Section 120440(e) of the Health and Safety Code.
(f) Documentation: For each vaccine administered by a
pharmacist, a patient vaccine administration record shall be
maintained in an automated data processing or manual record
mode such that the required information under title 42, section
300aa-25 of the United States Code is readily retrievable during
the pharmacy or facility’s normal operating hours. A pharmacist
shall provide the patient with a vaccine administration record,
which fully documents the vaccines administered by the
pharmacist. An example of an appropriate vaccine administration
record is available on the Board of Pharmacy’s website.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4052 and 4052.8, Business and Professions
Code, Section 120440, Health and Safety Code, and Sections
300aa - 25, Title 42, United States Code.
491
1746.5. Pharmacists Furnishing Travel Medications.
(a) A pharmacist furnishing prescription medications not
requiring a diagnosis that are recommended by the federal
Center for Disease Control and Prevention (CDC) for individuals
traveling outside the 50 states and the District of Columbia
pursuant to section 4052(a)(10)(A)(3) of the Business and
Professions Code (hereafter, “travel medications”) shall follow
the requirements of this section.
(b) For purposes of Business and Professions Code section
4052(a)(10)(A)(3), a prescription medication “not requiring a
diagnosis” means a prescription medication that is either:
(1) For treatment of a condition that is recognized as both self-
diagnosable and self-treatable by the CDC’s Health Information
for International Travel (commonly called the Yellow Book), or
(2) For prophylaxis of a condition.
(c) Training: A pharmacist who furnishes travel medications shall
keep documentation of the following on site and available for
inspection by the Board:
(1) Completion of an immunization training program that meets
the requirements of Business and Professions Code section
4052.8(b)(1),
(2) Completion of a travel medicine training program, which
must consist of at least 10 hours of training and cover each
element of the International Society of Travel Medicine’s Body of
Knowledge for the Practice of Travel Medicine (2012), hereby
incorporated by reference,
(3) Completion of the CDC Yellow Fever Vaccine Course, and
(4) Current basic life support certification.
(d) Continuing Education: Pharmacists must complete two hours
of ongoing continuing education focused on travel medicine,
separate from continuing education in immunizations and
vaccines, from an approved provider once every two years.
(e) Prior to furnishing travel medications, a pharmacist shall
perform a good faith evaluation of the patient, including
evaluation of the patient’s travel history using destination-
492
specific travel criteria. The travel history must include all the
information necessary for a risk assessment during pre-travel
consultation, as identified in the CDC Yellow Book. An example of
an appropriate and comprehensive travel history is available on
the Board’s website.
(f) Notifications: The pharmacist shall notify the patient’s
primary care provider of any drugs or devices furnished to the
patient within 14 days of the date of furnishing, or enter the
appropriate information in a patient record system shared with
the primary care provider, as permitted by the primary care
provider. If the patient does not have a primary care provider, or
is unable to provide contact information for his or her primary
care provider, the pharmacist shall provide the patient with a
written record of the drugs or devices furnished and advise the
patient to consult a physician of the patient’s choice.
(g) Documentation: For each travel medication furnished by a
pharmacist, a patient medication record shall be maintained and
securely stored in physical or electronic manner such that the
information required under section 300aa-25 of title 42 of the
United States Code is readily retrievable during the pharmacy or
facility’s normal operating hours. A pharmacist shall provide the
patient with a written document that reflects the clinical
assessment and travel medication plan.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4052 and 4052.8, Business and Professions
Code.
1747. Independent HIV Preexposure and Postexposure
Prophylaxis Furnishing.
(a) Prior to independently initiating and furnishing HIV
preexposure and/or postexposure prophylaxis to a patient pursuant
to Business and Professions Code sections 4052.02 and 4052.03, a
pharmacist shall successfully complete a training program approved
by the board, provided by a provider accredited by an approved
accreditation agency, or as part of an equivalent curriculum-based
493
training program completed from a recognized school of pharmacy.
The training program shall satisfy the following criteria:
(1) Each training program shall be specific to the use of HIV
preexposure and postexposure prophylaxis, and include at least 1.5
hours of instruction covering, at a minimum, the following areas:
(A) HIV preexposure and postexposure prophylaxis pharmacology.
(B) Requirements for independently initiating and furnishing HIV
preexposure and postexposure prophylaxis contained in Business
and Professions Code sections 4052.02 and 4052.03.
(C) Patient counseling information and appropriate counseling
techniques, including at least, counseling on sexually transmitted
diseases and sexual health.
(D) Patient referral resources and supplemental resources for
pharmacists.
(E) Financial assistance programs for preexposure and
postexposure prophylaxis, including the Office of AIDS’ PrEP
Assistance Program (PrEP-AP).
(F) Clinical eligibility recommendations provided in the federal
Centers for Disease Control and Prevention (CDC) guidelines defined
in Business and Professions Code sections 4052.02(c) and
4052.03(c).
(2) The training program shall require the passing of an
assessment based on the criteria of (a)(1) with a score of 70% or
higher to receive documentation of successful completion of the
training program.
(b) A pharmacist who independently initiates or furnishes HIV
preexposure and/or postexposure prophylaxis pursuant to Business
and Professions Code sections 4052.02 and 4052.03 shall maintain
documentation of their successful completion of the training
program for a period of four (4) years. Training obtained as part of
an equivalent curriculum-based training program, as identified in
(a), can be documented by written certification from the registrar or
training director of the educational institution or program from
which the licensee graduated stating that the training is included
within the institution’s curriculum required for graduation at the
time the pharmacist graduated, or within the coursework that was
completed by the pharmacist. Documentation maintained pursuant
494
to this subdivision must be made available upon request of the
board.
Note: Authority cited: Sections 4005, 4052.02, and 4052.03,
Business and Professions Code. Reference: Sections 4052, 4052.02,
and 4052.03, Business and Professions Code; Section 120972,
Health and Safety Code.
Article 6. Fees
1749. Fee Schedule.
The application, renewal, penalties, and other fees, unless
otherwise specified, are hereby fixed as follows:
(a) The fee for the issuance of any pharmacy license, including a
remote dispensing site pharmacy license, is five hundred seventy
dollars ($570). The fee for the annual renewal of any pharmacy
license, including a remote dispensing site pharmacy license, is
nine hundred and thirty dollars ($930). The penalty for failure to
renew is one hundred fifty dollars ($150).
(b) The fee for the issuance of any temporary pharmacy license
is three hundred twenty-five dollars ($325).
(c) The fee for the issuance of a pharmacy technician license is
one hundred ninety-five dollars ($195). The fee for the biennial
renewal of a pharmacy technician license is one hundred ninety-
five dollars ($195). The penalty for failure to renew is ninety-
seven dollars and fifty cents ($97.50).
(d) The application fee for examination as a pharmacist is two
hundred eighty-five dollars ($285).
(e) The fee for regrading an examination is one hundred fifteen
dollars ($115).
(f)(1) The fee for the issuance of an original pharmacist license is
two hundred and fifteen dollars ($215).
(2) The application fee for an advanced practice pharmacist
license is three hundred dollars ($300). If granted, there is no fee
for the initial license issued, which will expire at the same time
the pharmacist license expires.
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(g)(1) The fee for the biennial renewal of a pharmacist's license
is five hundred five dollars ($505). The penalty fee for failure to
renew is one hundred fifty dollars ($150).
(2) The fee for the biennial renewal of an advanced practice
pharmacist license is three hundred dollars ($300). The penalty
fee for failure to renew is one hundred fifty dollars ($150). The
fees in this paragraph are in addition to the fees required to
renew the pharmacist’s license as specified in paragraph 1.
(h) The fee for the issuance of a wholesaler or third-party
logistics provider license is eight hundred twenty dollars ($820).
The fee for the annual renewal of a wholesaler or third-party
logistics provide license is eight hundred twenty dollars ($820).
The penalty for failure to renew is one hundred fifty dollars
($150). The fee for a temporary wholesaler or third-party logistics
provider license is seven hundred fifteen dollars ($715).
(i) The fee for the issuance of a hypodermic license is two
hundred forty dollars ($240). The fee for the annual renewal of a
hypodermic needle license is two hundred eighty dollars ($280).
The penalty for failure to renew is one hundred forty dollars
($140).
(j) The fee for the issuance of a designated representative
license pursuant to Section 4053 of the Business and Professions
Code, a designated representative-3PL license pursuant to
Section 4053.1 of the Business and Professions Code, or a
designated representative-reverse distributor license pursuant to
Section 4053.2 of the Business and Professions Code, is two
hundred ten dollars ($210). The fee for the annual renewal of a
license as a designated representative, designated
representative-3PL, or a designated representative-reverse
distributor is three hundred dollars ($300). The penalty for failure
to renew is one hundred fifty dollars ($150).
(k) The application fee for the application or renewal of a license
as a nonresident wholesaler or nonresident third-party logistics
provider is eight hundred twenty dollars ($820). The fee for the
annual renewal of a nonresident wholesaler or nonresident third-
496
party logistics provider is eight hundred twenty dollars ($820).
The penalty for failure to renew is one hundred fifty dollars
($150). The fee for a nonresident wholesaler or nonresident
third-party logistics provider temporary license is seven hundred
fifteen dollars ($715).
(l) The fee for an intern pharmacist license is two hundred thirty
dollars ($230). The fee for transfer of intern hours or verification
of licensure to another state is thirty dollars ($30).
(m) The fee for the reissuance of any license, or renewal
thereof, which must be reissued because of change in the
information, other than name change, is one hundred thirty
dollars ($130).
(n) The fee for the reissuance of any license that has been lost
or destroyed or reissued due to a name change is forty-five
dollars ($45).
(o) The fee for evaluation of continuing education courses for
accreditation is forty dollars ($40) for each hour of accreditation
requested.
(p) The fee for the issuance of a clinic license is five hundred
seventy dollars ($570). The fee for the annual renewal of a clinic
license is three hundred sixty dollars ($360). The penalty for
failure to renew is one hundred fifty dollars ($150).
(q) The fee for the issuance of a nongovernmental license to
compound sterile drug preparations or a hospital satellite
compounding pharmacy license is two thousand three hundred
five dollars ($2,305). The fee for the annual renewal of a
nongovernmental license to compound sterile drug preparations
or a hospital satellite compounding pharmacy license is one
thousand eight hundred fifty-five dollars ($1,855). The penalty
for failure to renew a nongovernmental license to compound
sterile drug preparations or a hospital satellite compounding
pharmacy license is one hundred fifty dollars ($150). The fee for
a nongovernmental temporary license to compound sterile drug
preparations or a hospital satellite compounding pharmacy
license temporary license is seven hundred fifteen dollars ($715).
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(r) The fee for the issuance of a nonresident sterile
compounding pharmacy is three thousand three hundred thirty-
five dollars ($3,335). The fee for the annual renewal of
nonresident sterile compounding pharmacy license is three
thousand one hundred eighty dollars ($3,180). The penalty for
failure to renew is one hundred fifty dollars ($150). The fee for a
temporary non-resident sterile compounding pharmacy license is
seven hundred fifteen dollars ($715).
(s) The fee for the issuance of a license as a designated
representative for a veterinary food-animal drug retailer is two
hundred ten dollars ($210). The fee for the annual renewal of a
license as a designated representative for a veterinary food-
animal drug retailer is three hundred dollars ($300). The penalty
for failure to renew is one hundred fifty dollars ($150).
(t)The fee for a veterinary food-animal drug retailer license is six
hundred ten dollars ($610). The application fee for the annual
renewal for a veterinary food-animal drug retailer is four
hundred sixty dollars ($460). The fee for a veterinary food-animal
drug retailer temporary license is two hundred and fifty dollars
($250). The penalty for failure to renew is one hundred fifty
dollars ($150).
(u) The fee for the issuance of a retired pharmacist license shall
be forty-five dollars ($45).
(v) The fee for the issuance of a centralized hospital packaging
pharmacy license is one thousand one hundred fifty dollars
($1,150). The fee for the annual renewal of a centralized hospital
packaging pharmacy license is one thousand one hundred twenty
five dollars ($1,125). The penalty for failure to renew is one
hundred fifty dollars ($150).
(w) The fee for the issuance of an outsourcing facility license is
three thousand one hundred eighty dollars ($3,180). The fee for
the annual renewal of an outsourcing facility is one thousand
eight hundred fifty-five dollars ($1,855). The penalty for failure
to renew is one hundred fifty dollars ($150). The fee for an
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outsourcing facility temporary license is seven hundred fifteen
dollars ($715).
(x) The fee for the issuance of a nonresident outsourcing facility
license is three thousand three hundred thirty-five dollars
($3,335). The fee for the annual renewal of a nonresident
outsourcing facility is three thousand one hundred eighty dollars
($3,180). The penalty for failure to renew is one hundred fifty
dollars ($150). The fee for a nonresident outsourcing facility
temporary license is seven hundred fifteen dollars ($715).
(y) The fee for the issuance of a correctional clinic license that is
not owned by the state is five hundred seventy dollars ($570).
The annual renewal application fee for a corrections clinic license
is three hundred sixty dollars ($360). The penalty for failure to
renew is one hundred fifty dollars ($150).
(z) The application and initial license fee for the operation of an
EMSADDS is one hundred dollars ($100). The application fee for
the annual renewal of an EMSADDS is one hundred dollars
($100). The penalty for failure to renew is thirty-five dollars ($35).
(aa) The application fee of a co-location clinic license is seven
hundred fifty dollars ($750).
(ab) The application and initial license fee for a designated
paramedic license is one hundred and forty dollars ($140). The
application fee for the biennial renewal of a designated
paramedic license is one hundred forty dollars ($140). The
penalty for failure to renew a designated paramedic license is
sixty-five dollars ($65).
Note: Authority cited: Sections 4005 and 4400, Business and
Professions Code. Reference: Sections 163.5, 4005, 4044.3, 4053,
4053.1, 4110, 4112, 4119.01, 4120, 4127.1, 4127.2, 4127.15,
4128.2, 4129.1, 4129.2, 4129.8, 4130, 4160, 4161, 4180, 4180.5,
4187, 4190, 4196, 4200, 4202, 4202.5, 4203, 4208, 4210, 4304,
4400, 4401 and 4403, Business and Professions Code.
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Article 7. Sterile Compounding
1751. Sterile Compounding; Compounding Area; Self-
Assessment
(a) Any pharmacy engaged in compounding sterile drug
preparations shall conform to the parameters and requirements
stated by Article 4.5 (Section 1735 et seq.), applicable to all
compounding, and shall also conform to the parameters and
requirements stated by this Article 7 (Section 1751 et seq.),
applicable solely to sterile compounding.
(b) Any pharmacy compounding sterile drug preparations shall
have a compounding area designated for the preparation of
sterile drug preparations that is in a restricted location where
traffic has no impact on the performance of the PEC(s). The
cleanroom, including the walls, ceilings, and floors, shall be
constructed in accordance with Section 1250.4 of Title 24, Part 2,
Chapter 12, of the California Code of Regulations. The pharmacy
shall be ventilated in a manner in accordance with Section 505.5
of Title 24, Part 4, Chapter 5 of the California Code of
Regulations. The environments within the pharmacy shall meet
the following standards:
(1) Each ISO environment shall be certified at least every six
months by a qualified technician in accordance with Section
1751.4. Certification records must be retained in the pharmacy.
(2) Items related to the compounding of sterile drug
preparations within the compounding area shall be stored in such
a way as to maintain the integrity of an aseptic environment.
(3) A sink shall be included in accordance with Section 1250.4 of
Title 24, Part 2, Chapter 12, of the California Code of Regulations.
Sinks and drains shall not be present in any ISO Class 7 or better
cleanroom, nor in a segregated sterile compounding area within
three feet of an ISO Class 5 or better PEC, with the exception of
emergency eye-rinsing stations. A sink may be located in an ante-
area. When the PEC in the segregated sterile compounding area
is a CAI or CACI and the documentation provided by the
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manufacturer shows it meets the requirements listed in
1751.4(f)(1)-(3) the sterile compounding area is exempt from the
room requirement listed in 1751(b)(3).
(4) There shall be a refrigerator and, where appropriate, a
freezer, of sufficient capacity to meet the storage requirements
for all material requiring refrigeration or freezing, and a backup
plan to ensure continuity of available compounded drug
preparations in the event of a power outage.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code; and Section
18944, Health and Safety Code.
1751.1. Sterile Compounding Recordkeeping Requirements.
(a) In addition to the records required by section 1735.3, any
pharmacy engaged in any compounding of sterile drug
preparations shall maintain the following records, which must be
readily retrievable, within the pharmacy:
(1) Documents evidencing training and competency evaluations
of employees in sterile drug preparation policies and procedures.
(2) Results of hand hygiene and garbing assessments with
integrated gloved fingertip testing.
(3) Results of assessments of personnel for aseptic techniques
including results of media-fill tests and gloved fingertip testing
performed in association with media-fill tests.
(4) Results of viable air and surface sampling.
(5) Biannual video of smoke studies in all ISO Class 5 certified
spaces.
(6) Documents indicating daily documentation of room,
refrigerator, and freezer temperatures appropriate for sterile
compounded drug preparations consistent with the
temperatures listed in section 1735.1 for:
(A) Controlled room temperature.
(B) Controlled cold temperature.
(C) Controlled freezer temperature.
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(7) Certification(s) of the sterile compounding environment(s).
(8) Documents indicating daily documentation of air pressure
differentials or air velocity measurements between all adjoining
ISO rooms or areas, including those associated with
compounding aseptic (containment) isolators, and air pressure
differentials or air velocity measurements between all rooms or
spaces with an immediate entry or opening to ISO rooms or
areas.
(9) Other facility quality control records specific to the
pharmacy’s policies and procedures (e.g., cleaning logs for
facilities and equipment).
(10) Logs or other documentation of inspections for expired or
recalled chemicals, bulk drug substances, drug products, or other
ingredients.
(11) Preparation records including the master formula
document, the preparation compounding log, and records of
end-product evaluation testing and results.
(b) Pharmacies compounding sterile drug preparations for
future use pursuant to section 1735.2 shall, in addition to those
records required by section 1735.3, make and keep records
indicating the name, lot number, and amount of any drug
preparation compounded for future use, the date on which any
preparation was provided to a prescriber, and the name, address,
license type and number of the prescriber.
(c) 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 created. 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 and 4127, Business and
Professions Code. Reference: Sections 4005, 4029, 4036, 4037,
4051, 4052, and 4127, Business and Professions Code.
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1751.2. Sterile Compounding Labeling Requirements.
In addition to the labeling information required under Business
and Professions Code section 4076 and California Code of
Regulations, title 16, sections 1707.5 and 1735.4, a pharmacy
that compounds sterile drug preparations shall include the
following information on the labels for each such preparation:
(a) The telephone number of the pharmacy. The telephone
number is not required on the label for sterile drug preparations
administered to inpatients within the hospital.
(b) Instructions for storage, handling, and administration.
(c) 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.
1751.3. Sterile Compounding Policies and Procedures.
(a) Any pharmacy engaged in compounding sterile drug
preparations shall maintain written policies and procedures for
compounding. Any material failure to follow the pharmacy’s
written policies and procedures shall constitute a basis for
disciplinary action. In addition to the elements required by
section 1735.5, there shall be written policies and procedures
regarding the following:
(1) Action levels for colony-forming units (CFUs) detected during
viable surface sampling, glove fingertip, and viable air sampling
and actions to be taken when the levels are exceeded.
(2) Airflow considerations and pressure differential monitoring.
(3) An environmental sampling plan and procedures specific to
viable air, surface and gloved fingertip sampling as well as
nonviable particle sampling.
(4) Cleaning and maintenance of ISO environments and
segregated compounding areas.
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(5) Compounded sterile drug preparation stability and beyond
use dating.
(6) Compounding, filling, and labeling of sterile drug
preparations.
(7) Daily and monthly cleaning and disinfection schedule for the
controlled areas and any equipment in the controlled area as
specified in section 1751.4.
(8) Depyrogenation of glassware (if applicable)
(9) Facility management including certification and maintenance
of controlled environments and related equipment.
(10) For compounding aseptic isolators and compounding
aseptic containment isolators, documentation of the
manufacturer’s recommended purge time.
(11) Hand hygiene and garbing.
(12) Labeling of the sterile compounded drug preparations
based on the intended route of administration and
recommended rate of administration.
(13) Methods by which the supervising pharmacist will fulfill his
or her responsibility to ensure the quality of compounded drug
preparations.
(14) Orientation, training, and competency evaluation of staff in
all aspects of the preparation of sterile drug preparations
including didactic training and knowledge/competency
assessments that include at minimum: hand hygiene and garbing;
decontamination (where applicable); cleaning and disinfection of
controlled compounding areas; and proper aseptic technique,
demonstrated through the use of a media-fill test performed by
applicable personnel; and aseptic area practices.
(15) Preparing sterile compounded drug preparations from non-
sterile components (if applicable). This shall include sterilization
method suitability testing for each master formula document.
(16) Procedures for handling, compounding and disposal of
hazardous agents. The written policies and procedures shall
describe the pharmacy protocols for cleanups and spills in
conformity with local health jurisdiction standards.
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(17) Procedures for handling, compounding and disposal of
infectious materials. The written policies and procedures shall
describe the pharmacy protocols for cleanups and spills in
conformity with local health jurisdiction standards.
(18) Proper use of equipment and supplies.
(19) Quality assurance program compliant with sections 1711,
1735.8 and 1751.7.
(20) Record keeping requirements.
(21) Temperature monitoring in compounding and controlled
storage areas.
(22) The determination and approval by a pharmacist of
ingredients and the compounding process for each preparation
before compounding begins.
(23) Use of automated compounding devices (if applicable).
(24) Visual inspection and other final quality checks of sterile
drug preparations.
(b) For lot compounding, the pharmacy shall maintain written
policies and procedures that includes, in addition to the elements
required by section 1735.5 and 1751.3(a), written policies and
procedures regarding the following:
(1) Use of master formula documents and compounding logs.
(2) Appropriate documentation.
(3) Appropriate sterility and potency testing.
(c) For non-sterile-to-sterile batch compounding, the pharmacy
shall maintain written policies and procedures for compounding
that includes, in addition to the elements required by section
1735.5, 1751.3(a), and 1751.7(e), written policies and procedures
regarding the following:
(1) Process validation for chosen sterilization methods.
(2) End-product evaluation, quantitative, and qualitative testing.
(d) Policies and procedures shall be immediately available to all
personnel involved in compounding activities and to board
inspectors.
(e) All personnel involved must read the policies and procedures
before compounding sterile drug preparations. All personnel
505
involved must read all additions, revisions, and deletions to the
written policies and procedures. Each review must be
documented by a signature and date.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code
1751.4. Facility and Equipment Standards for Sterile
Compounding
(a) No sterile drug preparation shall be compounded if it is
known, or reasonably should be known, that the compounding
environment fails to meet criteria specified in the pharmacy’s
written policies and procedures for the safe compounding of
sterile drug preparations.
(b) During the compounding of sterile drug preparations,
access to the areas designated for compounding must be
limited to those individuals who are properly attired.
(c) All equipment used in the areas designated for
compounding must be made of a material that can be easily
cleaned and disinfected.
(d) Cleaning shall be done using a germicidal detergent and
sterile water. The use of a sporicidal agent is required to be
used at least monthly.
(1) All ISO Class 5 surfaces, work table surfaces, carts,
counters, and the cleanroom floor shall be cleaned at least
daily. After each cleaning, disinfection using a suitable sterile
agent shall occur on all ISO Class 5 surfaces, work table
surfaces, carts, and counters.
(2) Walls, ceilings, storage shelving, tables, stools, and all
other items in the ISO Class 7 or ISO Class 8 environment shall
be cleaned at least monthly.
(3) Cleaning shall also occur after any unanticipated event
that could increase the risk of contamination.
(4) All cleaning materials, such as wipers, sponges, and mops,
shall be non-shedding and dedicated to use in the cleanroom,
506
or ante-area, and segregated sterile compounding areas and
shall not be removed from these areas except for disposal.
(e) Disinfection, using a suitable sterile agent, shall also occur
on all surfaces in the ISO Class 5 PEC frequently, including:
(1) At the beginning of each shift;
(2) At least every 30 minutes when compounding involving
human staff is occurring or before each lot;
(3) After each spill; and
(4) When surface contamination is known or suspected.
(f) Pharmacies preparing sterile compounded preparations
require the use of a PEC that provides ISO Class 5 air or better
air quality. Certification and testing of primary and secondary
engineering controls shall be performed no less than every six
months and whenever the device or area designated for
compounding is relocated, altered or a service to the facility is
performed that would impact the device or area. Certification
must be completed by a qualified technician who is familiar
with certification methods and procedures in accordance with
CETA Certification Guide for Sterile Compounding Facilities
(CAG-003-2006-13, Revised May 20, 2015), which is hereby
incorporated by reference. Certification records must be
retained for at least 3 years. Unidirectional compounding
aseptic isolators or compounding aseptic containment
isolators may be used outside of an ISO Class 7 cleanroom if
the isolator is certified to meet the following criteria:
(1) Particle counts sampled approximately 6-12 inches
upstream of the critical exposure site shall maintain ISO Class 5
levels during compounding operations.
(2) Not more than 3520 particles (0.5 um and larger) per
cubic meter shall be counted during material transfer, with the
particle counter probe located as near to the transfer door as
possible without obstructing transfer.
(3) Recovery time to achieve ISO Class 5 air quality shall be
documented and internal procedures developed to ensure
that adequate recovery time is allowed after material transfer
507
before and during compounding operations. Compounding
aseptic isolators that do not meet the requirements as
outlined in this subdivision or are not located within an ISO
Class 7 cleanroom may only be used to compound
preparations that meet the criteria specified in accordance
with subdivision (d) of Section 1751.8 of Title 16, Division 17,
of the California Code of Regulations.
(g) Pharmacies preparing sterile hazardous agents shall do so
in accordance with Section 505.5.1 of Title 24, Chapter 5, of
the California Code of Regulations, requiring a negative
pressure PEC. Additionally, each PEC used to compound
hazardous agents shall be externally vented. The negative
pressure PEC must be certified every six months by a qualified
technician who is familiar with CETA Certification Guide for
Sterile Compounding Facilities (CAG-003-2006-13, Revised
May 20, 2015), which is hereby incorporated by reference. Any
drug preparation that is compounded in a PEC where
hazardous drugs are prepared must be labeled as hazardous,
regardless of whether the drug ingredients are considered
hazardous.
(1) During the hazardous drug compounding that is
performed in a compounding aseptic containment isolator, full
hand hygiene and garbing must occur. Garbing shall include
hair cover, facemask, beard cover (if applicable),
polypropylene or low shedding gown that closes in the back,
shoe covers, and two pairs of sterile ASTM D6978-05 standard
gloves.
(h) If a compounding aseptic isolator is certified by the
manufacturer to maintain ISO Class 5 air quality during
dynamic operation conditions during compounding as well as
during the transfer of ingredients into and out of the
compounding aseptic isolator, then it may be placed into a
non-ISO classified room. Individuals that use compounding
aseptic isolators in this manner must ensure appropriate
garbing, which consists of donning sterile gloves over the
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isolator gloves immediately before non-hazardous
compounding. These sterile gloves must be changed by each
individual whenever continuous compounding is ceased and
before compounding starts again.
(i) Compounding aseptic isolator and compounding aseptic
containment isolator used in the compounding of sterile drug
preparations shall use non-turbulent unidirectional air flow
patterns. A smoke patterned test shall be used to determine
air flow patterns.
(j) Viable surface sampling shall be done at least every six
months for all sterile-to-sterile compounding and quarterly for
all non-sterile-to-sterile compounding. Viable air sampling
shall be done by volumetric air sampling procedures which test
a sufficient volume of air (400 to 1,000 liters) at each location
and shall be done at least once every six months. Viable
surface and viable air sampling shall be performed by a
qualified individual who is familiar with the methods and
procedures for surface testing and air sampling. Viable air
sampling is to be performed under dynamic conditions that
simulate actual production. Viable surface sampling is to be
performed under dynamic conditions of actual compounding.
When the environmental monitoring action levels are
exceeded, the pharmacy shall identify the CFUs at least to the
genus level in addition to conducting an investigation pursuant
to its policies and procedures. Remediation shall include, at
minimum, an immediate investigation of cleaning and
compounding operations and facility management.
(k) The sterile compounding area in the pharmacy shall have
a comfortable and well-lighted working environment, which
typically includes a room temperature of 20 degrees Celsius
(68 degrees Fahrenheit) or cooler to maintain comfortable
conditions for compounding personnel when attired in the
required compounding garb.
(l) A licensee may request a waiver of these provisions as
provided in section 1735.6(f).
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Authority Cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4029, 4036, 4037,
4051, 4052 and 4127, Business and Professions Code; and
Section 18944, Health and Safety Code.
1751.5. Sterile Compounding Attire.
(a) When compounding sterile drug preparations the following
standards must be met:
(1) Personal protective equipment consisting of a non-shedding
gown, head cover, face mask, facial hair covers (if applicable),
and shoe covers must be worn inside the designated area at all
times. For hazardous compounding double shoe covers are
required.
(2) Personal protective equipment must be donned and
removed in an ante-area or immediately outside the segregated
compounding area.
(3) Personnel shall don personal protective equipment in an
order that proceeds from those activities considered the dirtiest
to those considered the cleanest. The following order is to be
followed unless the pharmacy has a procedure in place that
documents a method equivalent to or superior to the method
described here: The donning of shoe covers or dedicated shoes,
head and facial hair covers and face masks shall be followed by
the washing of hands and forearms up to the elbows for 30
seconds with soap and water, drying hands, and then the
donning of a non-shedding gown.
(4) Compounding personnel shall not wear any wrist, hand,
finger, or other visible jewelry, piercing, headphones, earbuds, or
personal electronic device.
(5) Sterile gloves that have been tested for compatibility with
disinfection with isopropyl alcohol are required. Hand cleansing
with a persistently active alcohol-based product followed by the
donning of sterile gloves may occur within the ante or
cleanroom. Gloves are to be routinely disinfected with sterile 70
percent isopropyl alcohol before entering or re-entering the PEC
510
and after contact with non-sterile objects. Gloves shall also be
routinely inspected for holes, punctures, or tears and replaced
immediately if such are detected.
(6) Individuals experiencing exposed rashes, sunburn, weeping
sores, conjunctivitis, active respiratory infections or other
communicable disease, or those wearing cosmetics, nail polish,
or artificial nails shall be excluded from the ISO Class 5 and ISO
Class 7 compounding areas until their conditions are remedied.
(b) When preparing hazardous agents, appropriate gowns and
personal protective equipment shall be worn regardless of the
PECs used (e.g., biological safety cabinet and compounding
aseptic containment isolator).
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code.
1751.6. Sterile Compounding Consultation; Training of Sterile
Compounding Staff
(a) Consultation shall be available to the patient and/or primary
caregiver concerning proper use, storage, handling, and disposal
of sterile drug preparations and related supplies furnished by the
pharmacy.
(b) The pharmacist-in-charge shall ensure that all pharmacy
personnel engaging in compounding sterile drug preparations
have training and demonstrated competence in the safe handling
and compounding of sterile drug preparations, including
hazardous agents if the pharmacy compounds products with
hazardous agents.
(c) Records of training and demonstrated competence shall be
available for each individual and shall be retained for three years
beyond the period of employment.
(d) The pharmacist-in-charge shall be responsible to ensure the
continuing competence of pharmacy personnel engaged in
compounding sterile drug preparations.
511
(e) Pharmacies that compound sterile drug preparations must
comply with the following training requirements:
(1) The pharmacy must establish and follow a written program
of training and performance evaluation designed to ensure that
each person working in the designated area has the knowledge
and skills necessary to perform their assigned tasks properly. This
program of training and performance evaluation must address at
least the following:
(A) Aseptic technique.
(B) Pharmaceutical calculations and terminology.
(C) Sterile preparation compounding documentation.
(D) Quality assurance procedures.
(E) Aseptic preparation procedures.
(F) Proper hand hygiene, gowning and gloving technique.
(G) General conduct in the controlled area (aseptic area
practices).
(H) Cleaning, sanitizing, and maintaining of the equipment and
the controlled area
(I) Sterilization techniques for compounding sterile drug
preparations from one or more non-sterile ingredients.
(J) Container, equipment, and closure system selection.
(2) Each person engaged in sterile compounding must
successfully complete practical skills training in aseptic technique
and aseptic area practices using models that are comparable to
the most complex manipulations to be performed by the
individual. Each pharmacist responsible for, or directly
supervising and controlling, aseptic techniques or practices, must
demonstrate the skills needed to ensure the sterility of
compounded drug preparations. Evaluation must include written
testing and a written protocol of periodic routine performance
checks involving adherence to aseptic area policies and
procedures. Each person’s proficiency and continuing training
needs must be reassessed at least every 12 months. Results of
these assessments must be documented and retained in the
pharmacy for three years.
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Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code.
1751.7. Sterile Compounding Quality Assurance and Process
Validation.
(a) Any pharmacy engaged in compounding sterile drug
preparations shall maintain, as part of its written policies and
procedures, a written quality assurance plan including, in
addition to the elements required by section 1735.8, a
documented, ongoing quality assurance program that monitors
personnel performance, equipment, and facilities. The end
product shall be examined on a periodic sampling basis as
determined by the pharmacist-in-charge to assure that it meets
required specifications. The quality assurance program shall
include at least the following:
(1) Procedures for cleaning and sanitization of the sterile
preparation area.
(2) Actions to be taken in the event of a drug recall.
(3) Documentation justifying the chosen beyond use dates for
compounded sterile drug preparations.
(b)(1) The pharmacy and each individual involved in the
compounding of sterile drug preparations must successfully
demonstrate competency on aseptic technique and aseptic area
practices before being allowed to prepare sterile drug
preparations. The validation process shall be carried out in the
same manner as normal production, except that an appropriate
microbiological growth medium is used in place of the actual
product used during sterile preparation. The validation process
shall be representative of the types of manipulations, products
and batch sizes the individual is expected to prepare and include
a media-fill test. The validation process shall be as complicated as
the most complex manipulations performed by staff and contain
the same amount or greater amount of volume transferred
during the compounding process. The same personnel,
513
procedures, equipment, and materials must be used in the
testing. Media used must have demonstrated the ability to
support and promote growth. Completed medium samples must
be incubated in a manner consistent with the manufacturer’s
recommendations. If microbial growth is detected, then each
individual’s sterile preparation process must be evaluated,
corrective action taken and documented, and the validation
process repeated.
(2) Each individual’s competency must be revalidated at least
every twelve months for sterile to sterile compounding and at
least every six months for individuals compounding sterile
preparations from non-sterile ingredients.
(3) The pharmacy’s validation process on aseptic technique and
aseptic area practices must be revalidated whenever:
(A) the quality assurance program yields an unacceptable result,
(B) there is any change in the compounding process, the Primary
Engineering Control (PEC), or the compounding environment. For
purposes of this subsection, a change includes, but is not limited
to, when the PEC is moved, repaired or replaced, when the
facility is modified in a manner that affects airflow or traffic
patterns, or when improper aseptic techniques are observed.
(4) The pharmacy must document the validation and
revalidation process.
(c) All sterile compounding personnel must successfully
complete an initial competency evaluation. In addition,
immediately following the initial hand hygiene and garbing
procedure, each individual who may be required to do so in
practice must successfully complete a gloved fingertip (all fingers
on both hands) sampling procedure (zero colony forming units
for both hands) at least three times before initially being allowed
to compound sterile drug preparations.
(d) Re-evaluation of garbing and gloving competency shall occur
at least every 12 months for personnel compounding products
made from sterile ingredients and at least every six months for
personnel compounding products from non-sterile ingredients.
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(e)(1) Batch-produced sterile drug preparations compounded
from one or more non-sterile ingredients, except as provided in
paragraph (2), shall be subject to documented end product
testing for sterility and pyrogens and shall be quarantined until
the end product testing confirms sterility and acceptable levels of
pyrogens. Sterility testing shall be USP chapter 71 compliant and
pyrogens testing shall confirm acceptable levels of pyrogens per
USP chapter 85 limits, before dispensing. This requirement of end
product testing confirming sterility and acceptable levels of
pyrogens prior to dispensing shall apply regardless of any sterility
or pyrogen testing that may have been conducted on any
ingredient or combination of ingredients that were previously
non-sterile. Exempt from pyrogen testing are topical ophthalmic
and inhalation preparations.
(2) The following non-sterile-to-sterile batch drug preparations
do not require end product testing for sterility and pyrogens:
(A) Preparations for self-administered ophthalmic drops in a
quantity sufficient for administration to a single patient for 30
days or less pursuant to a prescription.
(B) Preparations for self-administered inhalation in a quantity
sufficient for administration to a single patient for 5 days or less
pursuant to a prescription.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code.
1751.8. Beyond Use Dating for Sterile Compounded Drug
Preparations
In conformity with and in addition to the requirements and
limitations of section 1735.2, subdivision (h), every sterile
compounded drug preparation shall be given and labeled with a
beyond use date that does not exceed the shortest expiration
date or beyond use date of any ingredient in sterile compounded
drug preparation, nor the chemical stability of any one ingredient
in the sterile compounded drug preparation, nor the chemical
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stability of the combination of all ingredients in the sterile
compounded drug preparation, and that, in the absence of
passing a sterility test in accordance with standards for sterility
testing 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, that would justify an extended beyond use date,
conforms to the following limitations:
(a) The beyond use date shall specify that storage and exposure
periods cannot exceed 48 hours at controlled room temperature,
14 days at controlled cold temperature, and 45 days in solid
frozen state, where the sterile compounded drug preparation is
compounded solely with aseptic manipulations and all of the
following apply:
(1) The preparation is compounded entirely within an ISO Class
5 PEC located in an ISO Class 7 cleanroom with an ante-area or
compounded entirely within a CAI which meets the requirements
in 1751.4(f)(1)-(3), using only sterile ingredients, products,
components, and devices; and
(2) The compounding process involves transferring, measuring,
and mixing manipulations using not more than three
commercially manufactured packages of sterile preparations and
not more than two entries into any one sterile container or
package of sterile preparations or administration
containers/devices to prepare the drug preparation; and
(3) Compounding manipulations are limited to aseptically
opening ampules, penetrating disinfected stoppers on vials with
sterile needles and syringes or spiked transfer devices, and
transferring sterile liquids in sterile syringes to sterile
administration devices, package containers of other sterile
preparations, and containers for storage dispensing.
(b) The beyond use date shall specify that storage and exposure
periods cannot exceed 30 hours at controlled room temperature,
9 days at controlled cold temperature, and 45 days in solid frozen
state, where the sterile compounded drug preparation is
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compounded solely with aseptic manipulations and all of the
following apply:
(1) The preparation is compounded entirely within an ISO Class
5 PEC located in an ISO Class 7 cleanroom with an ante-area or
compounded entirely within a CAI which meets the requirements
in 1751.4(f)(1)-(3), using multiple individual or small doses of
sterile preparations combined or pooled to prepare a
compounded sterile preparation that will be administered either
to multiple patients or to one patient on multiple occasions; and
(2) The compounding process involves complex aseptic
manipulations other than the single-volume transfer; and
(3) The compounding process requires unusually long duration
such as that required to complete dissolution or homogenous
mixing.
(c) The beyond use date shall specify that storage and exposure
periods cannot exceed 24 hours at controlled room temperature,
3 days at controlled cold temperature, and 45 days in solid frozen
state, where the sterile compounded drug preparation is
compounded solely with aseptic manipulations using non-sterile
ingredients, regardless of intervening sterilization of that
ingredient and the following applies:
(1) The preparation is compounded entirely within an ISO Class
5 PEC located in an ISO Class 7 cleanroom with an ante-area or
compounded entirely within a CAI which meets the requirements
in 1751.4(f)(1)-(3).
(d) The beyond use date shall specify that storage and exposure
periods cannot exceed 12 hours where the sterile compounded
drug preparation is compounded solely with aseptic
manipulations and all of the following apply:
(1) The preparation was compounded entirely within an ISO
Class 5 PEC that is located in a segregated sterile compounding
area and restricted to sterile compounding activities, using only
sterile ingredients, components, and devices, by personnel
properly cleansed and garbed; and
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(2) The compounding process involves simple transfer of not
more than three commercially manufactured packages of sterile
nonhazardous preparations or diagnostic radiopharmaceutical
preparations from the manufacturer’s original containers; and
(3) The compounding process involves not more than two
entries into any one container or package (e.g., bag, vial) of
sterile infusion solution or administration container/device.
(e) Where any sterile compounded drug preparation was
compounded either outside of an ISO class 5 PEC or under
conditions that do not meet all of the requirements for any of
subdivisions (a) through (d), the sterile compounded drug
preparation shall be labeled “for immediate use only” and
administration shall begin no later than one hour following the
start of the compounding process. Unless the “immediate use”
preparation is immediately and completely administered by the
person who prepared it or immediate and complete
administration is witnessed by the preparer, the preparation shall
bear a label listing patient identification information, the names
and amounts of all ingredients, the name or initials of the person
who prepared the compounded sterile preparation, and the
exact one-hour beyond use date and time. If administration has
not begun within one hour following the start of the
compounding process, the compounded sterile preparation shall
be promptly, properly, entirely, and safely discarded. This
provision does not preclude the use of a PEC to compound an
“immediate use” preparation. A PEC used solely to compound
‘immediate use’ preparations need not be placed within an ISO
Class 7 cleanroom, with an ante-area. Such “immediate use”
preparations shall be compounded only in those limited
situations where there is a need for immediate administration of
a sterile preparation compounded outside of an ISO class 5
environment and where failure to administer could result in loss
of life or intense suffering. Any such compounding shall be only
in such quantity as is necessary to meet the immediate need and
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the circumstance causing the immediate need shall be
documented in accordance with policies and procedures.
(f) The beyond use date for any compounded allergen extracts
shall be the earliest manufacturer expiration date of the
individual allergen extracts.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code.
1751.9. Single-Dose and Multi-Dose Containers; Limitations on
Use
(a) Single-dose ampules are for immediate use only, and once
opened shall not be stored for any time period.
(b) Unless otherwise specified by the manufacturer, any single-
dose container of a compounded sterile drug preparation other
than an ampule, such as a bag, bottle, syringe or vial, shall be
used in its entirety or its remaining contents shall be labeled with
a beyond use date and discarded within the following time limit,
depending on the environment:
(1) When needle-punctured in an environment with air quality
worse than ISO Class 5, within one (1) hour;
(2) When needle-punctured in an environment with ISO Class 5
or better air quality, within six (6) hours. A container must remain
within the ISO Class 5 or better air quality to be used for the full
six hours, unless otherwise specified by the manufacturer.
(3) If the puncture time is not noted on the container, the
container must immediately be discarded.
(c) Unless otherwise specified by the manufacturer, a multi-dose
container stored according to the manufacturer’s specifications
shall be used in its entirety or its remaining contents shall be
labeled with a beyond use date and discarded within twenty
eight (28) days from initial opening or puncture. Any multi-dose
container not stored according to the manufacturer’s
specifications shall be discarded immediately upon identification
of such storage circumstance. If any open container is not labeled
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