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4120. Nonresident Pharmacy: Registration Required
(a) A nonresident pharmacy shall not sell or distribute
dangerous drugs or dangerous devices in this state through any
person or media other than a wholesaler or third-party logistics
provider who has obtained a license pursuant to this chapter or
through a selling or distribution outlet that is licensed as a
wholesaler or third-party logistics provider pursuant to this
chapter without registering as a nonresident pharmacy.
(b) Applications for a nonresident pharmacy registration shall be
made on a form furnished by the board. The board may require
any information as the board deems reasonably necessary to
carry out the purposes of this section.
(c) The Legislature, by enacting this section, does not intend a
license issued to any nonresident pharmacy pursuant to this
section to change or affect the tax liability imposed by Chapter 3
(commencing with Section 23501) of Part 11 of Division 2 of the
Revenue and Taxation Code on any nonresident pharmacy.
(d) The Legislature, by enacting this section, does not intend a
license issued to any nonresident pharmacy pursuant to this
section to serve as any evidence that the nonresident pharmacy
is doing business within this state.
4121. Advertisement for Prescription Drug: Requirements;
Restrictions
(a) Notwithstanding Section 651, an advertisement of the retail
price for a drug that requires a prescription shall be limited to
quantities of the drug that are consistent with good medical
practice and shall include the strength, dosage form, and the
exact dates during which the advertised price will be in effect.
(b) This section shall not apply to a pharmacy that is located in a
licensed hospital and that is accessible only to hospital medical
staff and personnel.
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4122. Required Notice of Availability of Prescription Price
Information, General Product Availability, Pharmacy Services;
Providing Price Information; Limitations on Price Information
Requests
(a) In every pharmacy there shall be prominently posted in a
place conspicuous to, and readable by, prescription drug
consumers a notice provided by the board concerning the
availability of prescription price information, the possibility of
generic drug product selection, the type of services provided by
pharmacies, and a statement describing patients' rights relative
to the requirements imposed on pharmacists pursuant to Section
733. The format and wording of the notice shall be adopted by
the board by regulation. A written receipt that contains the
required information on the notice may be provided to
consumers as an alternative to posting the notice in the
pharmacy.
(b) A pharmacist, or a pharmacist's employee, shall give the
current retail price for any drug sold at the pharmacy upon
request from a consumer, however that request is
communicated to the pharmacist or employee.
(c) If a requester requests price information on more than five
prescription drugs and does not have valid prescriptions for all of
the drugs for which price information is requested, a pharmacist
may require the requester to meet any or all of the following
requirements:
(1) The request shall be in writing.
(2) The pharmacist shall respond to the written request within a
reasonable period of time. A reasonable period of time is
deemed to be 10 days, or the time period stated in the written
request, whichever is later.
(3) A pharmacy may charge a reasonable fee for each price
quotation, as long as the requester is informed that there will be
a fee charged.
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(4) No pharmacy shall be required to respond to more than
three requests as described in this subdivision from any one
person or entity in a six-month period.
(d) This section shall not apply to a pharmacy that is located in a
licensed hospital and that is accessible only to hospital medical
staff and personnel.
(e) Notwithstanding any other provision of this section, no
pharmacy shall be required to do any of the following:
(1) Provide the price of any controlled substance in response to
a telephone request.
(2) Respond to a request from a competitor.
(3) Respond to a request from an out-of-state requester.
4123. Compounding Drug for Other Pharmacy for Parenteral
Therapy; Notice to Board
Any pharmacy that contracts to compound a drug for parenteral
therapy, pursuant to a prescription, for delivery to another
pharmacy shall report that contractual arrangement to the
board. That information shall be reported by the pharmacy
performing the compounding services within 30 days of
commencing that compounding.
4124. Dispensing Replacement Contact Lenses: Requirements;
Patient Warnings; Registration with Medical Board; Application
of Section to Nonresident Pharmacies
(a) Notwithstanding Section 2543, a pharmacist may dispense
replacement contact lenses pursuant to a valid prescription of a
physician or optometrist. Nothing in this section authorizes a
pharmacist to conduct an examination of the eyes or to fit or
adjust contact lenses. For purposes of this section, "replacement
contact lenses" means soft contact lenses that require no fitting
or adjustment, and that are dispensed as packaged and sealed by
the manufacturer.
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(b) No replacement contact lenses may be sold or dispensed
except pursuant to a prescription that meets all of the following
requirements:
(1) Conforms to state and federal statutes and regulations
governing those prescriptions and includes the name, address,
and state license number of the prescribing practitioner.
(2) Explicitly states an expiration date of not more than one year
from the date of the last prescribing examination.
(3) Explicitly states that the prescription is for contact lenses and
includes the lens brand name, type, and tint, including all
specifications necessary for the ordering of lenses.
(c) The contact lenses that are dispensed shall be the exact
contact lenses that have been prescribed, and no substitutions
shall be made.
(d) Any pharmacist and pharmacy that dispenses replacement
contact lenses shall direct the patient to confer with his or her
eyecare practitioner in the event of any eye problem or reaction
to the lenses.
(e) Any pharmacist and pharmacy that sells replacement contact
lenses shall provide the following or substantially equivalent
written notification to the patient whenever contact lenses are
supplied:
WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE
DISCOMFORT, WATERING, VISION CHANGE, OR REDNESS,
REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE
CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN.
(f) Any pharmacy and pharmacist dispensing replacement
contact lenses shall be subject to all statutes, regulations, and
ordinances governing the advertisement of contact lenses. In
addition, any advertisement by a pharmacy or pharmacist that
mentions replacement contact lenses shall include within the
advertisement all fees, charges, and costs associated with the
purchase of the lenses from that pharmacy and pharmacist.
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(g) Any pharmacy dispensing replacement contact lenses shall
register with the Medical Board of California at the time of initial
application for a license or at the time of annual renewal of that
license.
(h) All nonresident pharmacies shall maintain records of
replacement contact lenses shipped, mailed, or delivered to
persons in California for a period of at least three years. The
records shall be available for inspection upon request by the
board or the Division of Licensing of the Medical Board of
California.
(i) The requirements of this section are applicable to
nonresident pharmacies as defined in subdivision (a) of Section
4112. A nonresident pharmacy may dispense contact lenses only
as provided in this section.
4125. Pharmacy Quality Assurance Program Required; Records
Considered Peer Review Documents
(a) Every pharmacy shall establish a quality assurance program
that shall, at a minimum, document medication errors
attributable, in whole or in part, to the pharmacy or its
personnel. The purpose of the quality assurance program shall be
to assess errors that occur in the pharmacy in dispensing or
furnishing prescription medications so that the pharmacy may
take appropriate action to prevent a recurrence.
(b) Records generated for and maintained as a component of a
pharmacy's ongoing quality assurance program shall be
considered peer review documents and not subject to discovery
in any arbitration, civil, or other proceeding, except as provided
hereafter. That privilege shall not prevent review of a
pharmacy's quality assurance program and records maintained as
part of that system by the board as necessary to protect the
public health and safety or if fraud is alleged by a government
agency with jurisdiction over the pharmacy. Nothing in this
section shall be construed to prohibit a patient from accessing his
or her own prescription records. Nothing in this section shall
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affect the discoverability of any records not solely generated for
and maintained as a component of a pharmacy's ongoing quality
assurance program.
(c) This section shall become operative on January 1, 2002.
4126. Covered Entity May Contract With Pharmacy to Provide
Pharmacy Services; Segregation of Drug Stock; Return of Drugs
Not Dispensed; Wholesale License Not Permitted or Required
(a) Notwithstanding any other provision of law, a covered entity
may contract with a pharmacy to provide pharmacy services to
patients of the covered entity, as defined in Section 256b of Title
42 of the United States Code, including dispensing preferentially
priced drugs obtained pursuant to Section 256b of Title 42 of the
United States Code. Contracts between those covered entities
and pharmacies shall comply with guidelines published by the
Health Resources and Services Administration and shall be
available for inspection by board staff during normal business
hours.
(b) Drugs purchased pursuant to Section 256b of Title 42 of the
United States Code and received by a pharmacy shall be
segregated from the pharmacy's other drug stock by either
physical or electronic means. All records of acquisition and
disposition of these drugs shall be readily retrievable in a form
separate from the pharmacy's other records.
(c) Drugs obtained by a pharmacy to be dispensed to patients of
a covered entity pursuant to Section 256b of Title 42 of the
United States Code that cannot be distributed because of a
change in circumstances for the covered entity or the pharmacy
shall be returned to the distributor from which they were
obtained. For the purposes of this section, a change in
circumstances includes, but is not limited to, the termination or
expiration of the contract between the pharmacy and the
covered entity, the closure of a pharmacy, disciplinary action
against the pharmacy, or closure of the covered entity.
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(d) A licensee that participates in a contract to dispense
preferentially priced drugs pursuant to this section shall not have
both a pharmacy and a wholesaler license.
(e) Neither a covered entity nor a pharmacy shall be required to
obtain a license as a wholesaler based on acts reasonably
necessary to fully participate in the drug purchase program
established by Section 256b of Title 42 of the United States Code.
4126.5. Furnishing Dangerous Drugs by Pharmacy
(a) A pharmacy may furnish dangerous drugs only to the
following:
(1) A wholesaler owned or under common control by the
wholesaler from whom the dangerous drug was acquired.
(2) The pharmaceutical manufacturer from whom the
dangerous drug was acquired.
(3) A licensed wholesaler acting as a reverse distributor.
(4) Another pharmacy or wholesaler to alleviate a temporary
shortage of a dangerous drug that could result in the denial of
health care. A pharmacy furnishing dangerous drugs pursuant to
this paragraph may only furnish a quantity sufficient to alleviate
the temporary shortage.
(5) A patient or to another pharmacy pursuant to a prescription
or as otherwise authorized by law.
(6) A health care provider that is not a pharmacy but that is
authorized to purchase dangerous drugs.
(7) To another pharmacy under common control. During a
proclaimed state of emergency, “another pharmacy” as used in
this paragraph shall include a mobile pharmacy, as described in
subdivision (c) of Section 4062.
(b) Notwithstanding subdivision (a), or any other law, a clinic
licensed under Section 4180 may furnish dangerous drugs to any
of the following during a proclaimed state of emergency:
(1) Another clinic or wholesaler to alleviate a temporary
shortage of a dangerous drug that could result in the denial of
health care. A clinic furnishing dangerous drugs pursuant to this
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paragraph may only furnish a quantity sufficient to alleviate the
temporary shortage.
(2) A patient pursuant to a prescription or as otherwise
authorized by law.
(3) A health care provider that is not a clinic but that is
authorized to purchase dangerous drugs.
(4) To another clinic under common control, including a mobile
clinic, as described in subdivision (c) of Section 4062.
(c) Notwithstanding any other law, a violation of this section
may subject the person or persons who committed the violation
to a fine not to exceed the amount specified in Section 125.9 for
each occurrence pursuant to a citation issued by the board.
(d) Amounts due from any person under this section on or after
January 1, 2005, shall be offset as provided under Section
12419.5 of the Government Code. Amounts received by the
board under this section shall be deposited into the Pharmacy
Board Contingent Fund.
(e) For purposes of this section, "common control" means the
power to direct or cause the direction of the management and
policies of another person whether by ownership, by voting
rights, by contract, or by other means.
4126.8 Compounding Consistent with United States
Pharmacopeia - National Formulary
The compounding of drug preparations by a pharmacy for
furnishing, distribution, or use in this state shall be consistent
with standards established in the pharmacy compounding
chapters of the current version of the United States
Pharmacopeia-National Formulary, including relevant testing and
quality assurance. The board may adopt regulations to impose
additional standards for compounding drug preparations.
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4126.9. Recall of Nonsterile Compounded Drug Products -
Requirements
(a) A pharmacy that issues a recall notice regarding a nonsterile
compounded drug product shall, in addition to any other duties,
contact the recipient pharmacy, prescriber, or patient of the
recalled drug and the board within 12 hours of the recall notice if
both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
(1) If the recalled drug was dispensed directly to the patient, the
notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber, who shall ensure the
patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy,
the notice shall be made to the pharmacy, which shall notify the
prescriber or patient, as appropriate. If the pharmacy notifies the
prescriber, the prescriber shall ensure the patient is notified.
(c) A pharmacy that has been advised that a patient has been
harmed by using a nonsterile compounded product potentially
attributable to the pharmacy shall report the event to MedWatch
within 72 hours of the pharmacy being advised.
4126.10. Reporting Requirements for Interstate Distribution of
Compounded Human Drug Preparations
(a) A pharmacy located in California may distribute compounded
human drug preparations interstate only if all of the following
conditions are met:
(1) Between January 1 and March 31 of each year, the pharmacy
reports all required data for the previous calendar year into the
Information Sharing Network established by the National
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Association of Boards of Pharmacy in conjunction with the United
States Food and Drug Administration (FDA) to implement the
Memorandum of Understanding Addressing Certain Distributions
of Compounded Human Drug Products.
(2) On an annual basis, in connection with and as a condition of
renewal of the pharmacy’s license, the pharmacist-in-charge of
the pharmacy certifies that the reporting requirements of
paragraph (1) have been satisfied.
(3) The pharmacy reports any adverse drug experience and
product quality issue for any compounded product to the board
within 12 hours after the pharmacy receives notice of the
adverse drug experience or product quality issue.
(b) Information reported by the board to the FDA directly or
through the Information Sharing Network established by the
National Association of Boards of Pharmacy in conjunction with
the FDA to implement the Memorandum of Understanding
Addressing Certain Distributions of Compounded Human Drug
Products shall not be subject to public disclosure under the
California Public Records Act (Chapter 3.5 (commencing with
Section 6250) of Division 7 of Title 1 of the Government Code).
Article 7.5 Compounded Sterile Drug Products
4127. License to Compound Sterile Drug Products Required
(a) A pharmacy that compounds sterile drug products shall
possess a sterile compounding pharmacy license as provided in
this article.
(b) The board shall adopt regulations in accordance with the
Administrative Procedure Act (Chapter 3.5 (commencing with
Section 11340) of Part 1 of Division 3 of Title 2 of the
Government Code) to establish policies, guidelines, and
procedures to implement this article.
(c) The board shall review any formal revision to General
Chapter 797 of the United States Pharmacopeia and The National
Formulary (USP-NF), relating to the compounding of sterile
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preparations, not later than 90 days after the revision becomes
official, to determine whether amendments are necessary for the
regulations adopted by the board pursuant to subdivision (b).
4127.1. License for Compounding Sterile Drug Products;
Requirements; Exceptions
(a) A pharmacy shall not compound sterile drug products unless
the pharmacy has obtained a sterile compounding pharmacy
license from the board pursuant to this section. The license shall
be renewed annually and is not transferable.
(b) A license to compound sterile drug products shall be issued
only to a location that is licensed as a pharmacy and shall be
issued only to the owner of the pharmacy licensed at that
location.
(c) A license to compound sterile drug products shall not be
issued or renewed until the location is inspected by the board
and found in compliance with this article and regulations
adopted by the board.
(d) A license to compound sterile drug products shall not be
issued or renewed until the board does all of the following:
(1) Reviews a current copy of the pharmacy’s policies and
procedures for sterile compounding.
(2) Reviews the pharmacy’s completed self-assessment form
required by Section 1735.2 of Title 16 of the California Code of
Regulations.
(3) Is provided with copies of all inspection reports conducted of
the pharmacy’s premises, and any reports from a private
accrediting agency, conducted in the prior 12 months
documenting the pharmacy’s operations.
(4) Receives a list of all sterile medications compounded by the
pharmacy since the last license renewal.
(e) A pharmacy licensed pursuant to this section shall do all of
the following:
(1) Provide to the board a copy of any disciplinary or other
action taken by another state within 10 days of the action.
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(2) Notify the board within 10 days of the suspension of any
accreditation held by the pharmacy.
(3) Provide to the board, within 12 hours, any recall notice
issued by the pharmacy for sterile drug products it has
compounded.
(f) Adverse effects reported or potentially attributable to a
pharmacy’s sterile drug product shall be reported to the board
within 12 hours and immediately reported to the MedWatch
program of the federal Food and Drug Administration.
(g) The reconstitution of a sterile powder shall not require a
license pursuant to this section if both of the following
requirements are met:
(1) The sterile powder was obtained from a manufacturer.
(2) The drug is reconstituted for administration to patients by a
health care professional licensed to administer drugs by injection
pursuant to this division.
(h) This section shall become operative on July 1, 2014.
4127.2. Nonresident Pharmacy License for Compounding and
Shipping Sterile Drug Products into California; Requirements;
Adverse Effects Reporting
(a) A nonresident pharmacy shall not compound sterile drug
products for shipment into this state without a sterile
compounding pharmacy license issued by the board pursuant to
this section. The license shall be renewed annually and shall not
be transferable.
(b) A license to compound sterile drug products shall be issued
only to a location that is licensed as a nonresident pharmacy and
shall be issued only to the owner of the nonresident pharmacy
licensed at that location.
(c) A license to compound sterile drug products shall not be
issued or renewed until the location is inspected by the board
and found in compliance with this article and any regulations
adopted by the board. The nonresident pharmacy shall
reimburse the board for all actual and necessary costs incurred
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by the board in conducting an inspection of the pharmacy at least
once annually pursuant to subdivision (v) of Section 4400.
(d) A license to compound sterile drug products shall not be
issued or renewed until the board does all of the following:
(1) Reviews a current copy of the nonresident pharmacy’s
policies and procedures for sterile compounding.
(2) Reviews the pharmacy’s completed self-assessment form
required by Section 1735.2 of Title 16 of the California Code of
Regulations.
(3) Is provided with copies of all inspection reports conducted of
the nonresident pharmacy’s premises, and any reports from a
private accrediting agency, conducted in the prior 12 months
documenting the nonresident pharmacy’s operations.
(4) Receives a list of all sterile drug products compounded by
the pharmacy within the prior 12 months.
(e) A pharmacy licensed pursuant to this section shall do all of
the following:
(1) Provide to the board a copy of any disciplinary or other
action taken by its state of residence or another state within 10
days of the action.
(2) Notify the board within 10 days of the suspension of any
accreditation held by the pharmacy.
(3) Provide to the board, within 12 hours, any recall notice
issued by the pharmacy for sterile drug products it has
compounded that have been shipped into, or dispensed in,
California.
(4) Advise the board of any complaint it receives from a
provider, pharmacy, or patient in California.
(f) Adverse effects reported or potentially attributable to a
nonresident pharmacy’s sterile compounded drug product shall
be reported to the board within 12 hours and immediately
reported to the MedWatch program of the federal Food and
Drug Administration.
(g) On or before January 1, 2018, the board shall provide a
report to the Legislature regarding the regulation of nonresident
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pharmacies. The report shall be submitted to the Legislature in
the manner required pursuant to Section 9795 of the
Government Code. At a minimum, the report shall address all of
the following:
(1) A detailed description of board activities related to the
inspection and licensure of nonresident pharmacies.
(2) Whether fee revenue collected pursuant to subdivision (v) of
Section 4400 and travel cost reimbursements collected pursuant
to subdivision (c) of this section provide revenue in an amount
sufficient to support the board’s activities related to the
inspection and licensure of nonresident pharmacies.
(3) The status of proposed changes to federal law that are under
serious consideration and that would govern compounding
pharmacies, including legislation pending before the United
States Congress, administrative rules, regulations, or orders
under consideration by the federal Food and Drug Administration
or other appropriate federal agency, and cases pending before
the courts.
(4) If applicable, recommended modifications to the board’s
statutory duties related to nonresident pharmacies as a result of
changes to federal law or any additional modifications necessary
to protect the health and safety of the public.
(h) The requirement for submitting a report imposed under
subdivision (g) is inoperative on January 1, 2022, pursuant to
Section 10231.5 of the Government Code.
(i) This section shall become operative on July 1, 2014.
4127.3. Cease and Desist Order; Hearing
(a) Whenever the board has a reasonable belief, based on
information obtained during an inspection or investigation by the
board, that a pharmacy compounding sterile drug products poses
an immediate threat to the public health or safety, the executive
officer of the board may issue an order to the pharmacy to
immediately cease and desist from compounding sterile drug
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products. The cease and desist order shall remain in effect for no
more than 30 days or the date of a hearing seeking an interim
suspension order, whichever is earlier.
(b) Whenever the board issues a cease and desist order pursuant
to subdivision (a), the board shall immediately issue the owner a
notice setting forth the acts or omissions with which the owner is
charged, specifying the pertinent code section or sections.
(c) The order shall provide that the owner, within 15 days of
receipt of the notice, may request a hearing before the president
of the board to contest the cease and desist order. Consideration
of the owner’s contest of the cease and desist order shall comply
with Section 11425.10 of the Government Code. The hearing
shall be held no later than five business days from the date the
request of the owner is received by the board. The president
shall render a written decision within five business days of the
hearing. In the absence of the president of the board, the vice
president of the board may conduct the hearing permitted by
this subdivision. The owner or person in possession or control of
the pharmacy may seek review of the decision of the president of
the board pursuant to Section 1094.5 of the Code of Civil
Procedure.
(d) Failure to comply with a cease and desist order issued
pursuant to this section shall be unprofessional conduct.
4127.4. Fine for Violation
Notwithstanding any other provision of law, a violation of this
article, or regulations adopted pursuant thereto, may subject the
person or entity that committed the violation to a fine of up to
two thousand five hundred dollars ($2,500) per occurrence
pursuant to a citation issued by the board.
4127.6. Article Operative Upon Allocation of Positions
This article shall become operative upon the allocation of
positions to the board for the implementation of the provisions
of this article in the annual Budget Act.
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4127.7. Temporary License to Compound Injectables
The board may, at its discretion, issue a temporary license to
compound sterile drug products upon the conditions and for any
periods of time as the board determines to be in the public
interest. A temporary license fee shall be required in an amount
established by the board as specified in subdivision (u) of Section
4400. When needed to protect public safety, a temporary license
may be issued for a period not to exceed 180 days, and may be
issued subject to terms and conditions the board deems
necessary. If the board determines a temporary license was
issued by mistake or denies the application for a permanent
license, the temporary license shall terminate upon either
personal service of the notice of termination upon the
licenseholder or service by certified mail, return receipt
requested at the licenseholder's address of record with the
board, whichever comes first. Neither for purposes of retaining a
temporary license nor for purposes of any disciplinary or license
denial proceeding before the board shall the temporary
licenseholder be deemed to have a vested property right or
interest in the license.
4127.8. Pharmacies That Compound Sterile Drug Products;
Recalls; Requirements
(a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2
that issues a recall notice regarding a sterile compounded drug
shall, in addition to any other duties, contact the recipient
pharmacy, prescriber, or patient of the recalled drug and the
board as soon as possible within 12 hours of the recall notice if
both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
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(1) If the recalled drug was dispensed directly to the patient, the
notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber, who shall ensure the
patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy,
the notice shall be made to the pharmacy, who shall notify the
prescriber or patient, as appropriate. If the pharmacy notifies the
prescriber, the prescriber shall ensure the patient is notified.
4127.15. Hospital Satellite Compounding Pharmacy
Subject to the requirements of this section, the board may issue
a license to a hospital satellite compounding pharmacy. The
license fee and annual renewal fee shall be in an amount
established by the board in subdivision (u) of Section 4400. The
license shall not be transferable.
(a) A hospital satellite compounding pharmacy license shall not
be issued or renewed until the location is inspected by the board
and found to be in compliance with this article and regulations
adopted by the board.
(1) A hospital satellite compounding pharmacy shall compound
sterile drug products for administration only to registered
hospital patients who are on the premises of the same physical
plant in which the hospital satellite compounding pharmacy is
located.
(2) The services provided shall be directly related to the services
or treatment plan administered in the physical plant.
(b) A hospital satellite compounding pharmacy license shall not
be issued or renewed until the board does all of the following:
(1) Reviews a current copy of the hospital satellite compounding
pharmacy’s policies and procedures for sterile compounding.
(2) Reviews the hospital satellite compounding pharmacy’s
completed self-assessment form as described in Section 1735.2
of Title 16 of the California Code of Regulations.
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(3) Receives a list of all products compounded by the hospital
satellite compounding pharmacy since the last license renewal.
(c) A hospital satellite compounding pharmacy shall do all of the
following:
(1) Purchase, procure, or otherwise obtain all components
through the license of the hospital pharmacy as defined in
subdivision (a) of Section 4029.
(2) Satisfy the ratio of not less than one pharmacist on duty for a
total of two pharmacy technicians on duty.
(3) Ensure immediate supervision, as defined in Section 70065
of Title 22 of the California Code of Regulations, by a pharmacist
of licensed ancillary staff involved in sterile compounding.
(4) Provide to the board, within 12 hours, any recall notice
issued by the hospital satellite compounding pharmacy for sterile
drug products it has compounded.
(5) Report to the board, within 12 hours, adverse effects
reported or potentially attributable to the sterile drug products
compounded by the hospital satellite compounding pharmacy.
Unexpected adverse effects shall also be, within 12 hours,
reported to the MedWatch program of the federal Food and
Drug Administration.
Article 7.6.
Centralized Hospital Packaging Pharmacies
4128. Centralized Hospital Packaging
(a) Notwithstanding Section 4029, a centralized hospital
packaging pharmacy may prepare medications, by performing
the following specialized functions, for administration only to
inpatients within its own general acute care hospital and one or
more general acute care hospitals if the hospitals are under
common ownership and located within a 75-mile radius of each
other:
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(1) Preparing unit dose packages for single administration to
inpatients from bulk containers, if each unit dose package is
barcoded pursuant to Section 4128.4.
(2) Preparing sterile compounded unit dose drugs for
administration to inpatients, if each compounded unit dose drug
is barcoded pursuant to Section 4128.4.
(3) Preparing compounded unit dose drugs for administration to
inpatients, if each unit dose package is barcoded pursuant to
Section 4128.4.
(b) For purposes of this article, “common ownership” means
that the ownership information on file with the board pursuant
to Section 4201 for the licensed pharmacy is consistent with the
ownership information on file with the board for the other
licensed pharmacy or pharmacies for purposes of preparing
medications pursuant to this section.
4128.2. Specialty License Required; Application; Fees
(a) In addition to the pharmacy license requirement described in
Section 4110, a centralized hospital packaging pharmacy shall
obtain a specialty license from the board prior to engaging in the
functions described in Section 4128.
(b) An applicant seeking a specialty license pursuant to this
article shall apply to the board on forms established by the
board.
(c) Before issuing the specialty license, the board shall inspect
the pharmacy and ensure that the pharmacy is in compliance
with this article and regulations established by the board.
(d) A license to perform the functions described in Section 4128
may only be issued to a pharmacy that is licensed by the board as
a hospital pharmacy.
(e) A license issued pursuant to this article shall be renewed
annually and is not transferrable.
(f) An applicant seeking renewal of a specialty license shall apply
to the board on forms established by the board.
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(g) A license to perform the functions described in Section 4128
shall not be renewed until the pharmacy has been inspected by
the board and found to be in compliance with this article and
regulations established by the board.
(h) Until July 1, 2017, the fee for issuance or annual renewal of a
centralized hospital packaging pharmacy license shall be six
hundred dollars ($600) and may be increased by the board to
eight hundred dollars ($800).
(Amended by Stats. 2016, Ch. 799, Sec. 24. Effective January 1,
2017.)
4128.3. Preparing and Storing Limited Quantity of Unit Dose
Drugs in Advance of a Patient-Specific Prescription
A centralized hospital packaging pharmacy may prepare and
store a limited quantity of the unit dose drugs authorized by
Section 4128 in advance of receipt of a patient-specific
prescription in a quantity as is necessary to ensure continuity of
care for an identified population of inpatients of the general
acute care hospital based on a documented history of
prescriptions for that patient population.
4128.4. Barcode Required; Information Retrievable Upon
Reading Barcode (Effective September 2, 2015)
(a) Any unit dose medication produced by a centralized hospital
packaging pharmacy shall be barcoded to be machine readable at
the inpatient’s bedside using barcode medication administration
software.
(b) The barcode medication administration software shall
permit health care practitioners to ensure that, before a
medication is administered to an inpatient, it is the right
medication, for the right inpatient, in the right dose, and via the
right route of administration. The software shall verify that the
medication satisfies these criteria by reading the barcode on the
medication and comparing the information retrieved to the
electronic medical record of the inpatient.
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(c) For purposes of this section, “barcode medication
administration software” means a computerized system designed
to prevent medication errors in health care settings.
4128.5. Labeling for Unit Dose Medications
(a) Any label for each unit dose medication produced by a
centralized hospital packaging pharmacy shall display a human-
readable label that contains all of the following:
(1) The date that the medication was prepared.
(2) The beyond-use date.
(3) The established name of the drug.
(4) The quantity of each active ingredient.
(5) Special storage or handling requirements.
(6) The lot number or control number assigned by the
centralized hospital packaging pharmacy.
(7) The name of the centralized hospital packaging pharmacy.
(b) For quality control and investigative purposes, a pharmacist
shall be able to retrieve all of the following information using the
lot number or control number described in subdivision (a):
(1) The components used in the drug product.
(2) The expiration date of each of the drug’s components.
(3) The National Drug Code Directory number.
(Amended by Stats. 2015, Ch. 241, Sec. 3. Effective September 2,
2015.)
4128.6. Compounding
All compounding and packaging functions specified in Section
4128 shall be performed only in the licensed centralized hospital
packaging pharmacy and that pharmacy shall comply with all
applicable federal and state statutes and regulations, including,
but not limited to, regulations regarding compounding and, when
appropriate, sterile compounding.
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4128.7. Integrity, Potency, Quality and Labeled Strength of Unit
Dose Drug Products
A centralized hospital packaging pharmacy and the pharmacists
working in the pharmacy shall be responsible for the integrity,
potency, quality, and labeled strength of any unit dose drug
product prepared by the centralized hospital packaging
pharmacy.
Article 7.7. Outsourcing Facilities
4129. Outsourcing Facility - License Required
(a) A facility registered as an outsourcing facility with the federal
Food and Drug Administration (FDA) shall be concurrently
licensed with the board as an outsourcing facility if it compounds
sterile medication or nonsterile medication for nonpatient-
specific distribution within or into California.
(b) A facility premises licensed with the board as a sterile
compounding pharmacy shall not be concurrently licensed with
the board as an outsourcing facility at the same location.
(c) The board may adopt regulations in accordance with the
Administrative Procedure Act (Chapter 3.5 (commencing with
Section 11340) of Part 1 of Division 3 of Title 2 of the
Government Code) to establish policies, guidelines, and
procedures to implement this article.
(d) The board shall review any formal requirements or guidance
documents developed by the FDA regarding outsourcing facilities
within 90 days after their release in order to determine whether
revisions are necessary for any regulations promulgated by the
board.
(e) An outsourcing facility licensed by the board dispensing
patient-specific compounded preparations pursuant to a
prescription for an individual patient shall not be required to be
licensed as a pharmacy, but shall otherwise comply with the
same requirements of a pharmacy.
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4129.1. Licensing Requirements
(a) An outsourcing facility that is licensed with the federal Food
and Drug Administration (FDA) and with an address in this state
shall also be licensed by the board as an outsourcing facility
before doing business within this state. The license shall be
renewed annually and is not transferable.
(b) An outsourcing facility shall compound all sterile products
and nonsterile products in compliance with regulations issued by
the board and with federal current good manufacturing practices
applicable to outsourcing facilities.
(c) An outsourcing facility license shall not be issued or renewed
until the location is inspected by the board and found in
compliance with this article and regulations adopted by the
board.
(d) An outsourcing facility license shall not be issued or renewed
until the board does all of the following:
(1) Prior to inspection, reviews a current copy of the outsourcing
facility’s policies and procedures for sterile compounding and
nonsterile compounding.
(2) Is provided with copies of all federal and state regulatory
agency inspection reports, as well as accreditation reports, and
certification reports of facilities or equipment of the outsourcing
facility’s premises conducted in the prior 12 months.
(3) Prior to inspection, receives a list of all sterile drugs and
nonsterile drugs compounded by the outsourcing facility as
reported to the FDA in the last 12 months.
(e) An outsourcing facility licensed pursuant to this section shall
provide the board with all of the following:
(1) A copy of any disciplinary or other action taken by another
state or the FDA within 10 days of the action.
(2) Notice within 24 hours of any recall notice issued by the
outsourcing facility.
(3) A copy of any clinically related complaint it receives involving
an outsourcing facility’s compounded products from or involving
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any provider, pharmacy, or patient in California within 72 hours
of receipt.
(4) Notice within 24 hours after learning of adverse effects
reported or potentially attributable to the outsourcing facility’s
products.
4129.2. Nonresident Outsourcing Facility - License Required
(a) An outsourcing facility that is licensed with the federal Food
and Drug Administration (FDA) as an outsourcing facility and has
an address outside of this state but in the United States of
America is a nonresident outsourcing facility. A nonresident
outsourcing facility shall not compound sterile drug products or
nonsterile drug products for distribution or use into this state
without an outsourcing license issued by the board pursuant to
this section. The license shall be renewed annually and shall not
be transferable.
(b) A nonresident outsourcing facility shall compound all sterile
products and nonsterile products to be distributed or used in this
state in compliance with regulations of the board and with
federal current good manufacturing practices applicable to
outsourcing facilities.
(c) A license for a nonresident outsourcing facility shall not be
issued or renewed until the location is inspected by the board
and found in compliance with this article and any regulations
adopted by the board. The nonresident outsourcing facility shall
reimburse the board for all actual and necessary costs incurred
by the board in conducting an inspection of the nonresident
outsourcing facility at least once annually pursuant to subdivision
(x) of Section 4400.
(d) A license for a nonresident outsourcing facility shall not be
issued or renewed until the board:
(1) Prior to inspection, reviews a current copy of the
nonresident outsourcing facility’s policies and procedures for
sterile compounding and nonsterile compounding.
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(2)
(A) Is provided with copies of all federal and state regulatory
agency inspection reports, as well as accreditation reports, and
certification reports of facilities or equipment of the nonresident
outsourcing facility’s premises conducted in the prior 12 months.
(B) For purposes of this paragraph, “state” refers to the state in
which the nonresident outsourcing facility resides.
(3) Prior to inspection, receives a list of all sterile drug products
and nonsterile drug products compounded by the pharmacy as
reported to the FDA within the prior 12 months.
(e) A nonresident outsourcing facility licensed pursuant to this
section shall provide the board with all of the following:
(1) A copy of any disciplinary or other action taken by another
state or the FDA within 10 days of the action.
(2) Notice within 24 hours of any recall notice issued by the
nonresident outsourcing facility.
(3) A copy of any complaint it receives involving an outsourcing
facility’s compounded products from or involving any provider,
pharmacy, or patient in California within 72 hours of receipt.
(4) Notice within 24 hours after learning of adverse effects
reported or potentially attributable to a nonresident outsourcing
facility’s products.
4129.3. Board Report to Legislature
(a) On or before January 1, 2018, the board shall provide a
report to the Legislature regarding the regulation of nonresident
outsourcing facilities. The report shall be submitted to the
Legislature in the manner required pursuant to Section 9795 of
the Government Code. At a minimum, the report shall address all
of the following:
(1) A detailed description of board activities related to the
inspection and licensure of nonresident outsourcing facilities.
(2) Whether fee revenue collected pursuant to subdivision (x) of
Section 4400 and travel cost reimbursements collected pursuant
to subdivision (c) of Section 4129.2 provide revenue in an
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amount sufficient to support the board’s activities related to the
inspection and licensure of nonresident outsourcing facilities.
(3) The status of proposed changes to federal law that are under
serious consideration and that would govern outsourcing
facilities and compounding pharmacies, including, but not limited
to, legislation pending before Congress, administrative rules,
regulations or orders under consideration by the FDA or other
appropriate federal agency, and cases pending before the courts.
(4) If applicable, recommended modifications to the board’s
statutory duties related to nonresident outsourcing facilities as a
result of changes to federal law or any additional modifications
necessary to protect the health and safety of the public.
(b) The requirement for submitting a report imposed under
subdivision (a) is inoperative on January 1, 2022, pursuant to
Section 10231.5 of the Government Code.
4129.4. Cease and Desist Order
(a) Whenever the board has a reasonable belief, based on
information obtained during an inspection or investigation by the
board, that an outsourcing facility compounding sterile drug
products or nonsterile drug products poses an immediate threat
to the public health or safety, the executive officer of the board
may issue an order to the outsourcing facility to immediately
cease and desist compounding sterile drug products or nonsterile
drug products. The cease and desist order shall remain in effect
for no more than 30 days or the date of a hearing seeking an
interim suspension order, whichever is earlier.
(b) Whenever the board issues a cease and desist order pursuant
to subdivision (a), the board shall immediately issue a notice to
the owner setting forth the acts or omissions with which the
owner is charged, specifying the pertinent code section or
sections and any regulations.
(c) The cease and desist order shall state that the owner, within
15 days of receipt of the notice, may request a hearing before
the president of the board to contest the cease and desist order.
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Consideration of the owner’s contest of the cease and desist
order shall comply with Section 11425.10 of the Government
Code. The hearing shall be held no later than five business days
after the date the request of the owner is received by the board.
The president shall render a written decision within five business
days after the hearing. In the absence of the president of the
board, the vice president of the board may conduct the hearing
permitted by this subdivision. The owner or person in possession
or control of the outsourcing facility may seek review of the
decision pursuant to Section 1094.5 of the Code of Civil
Procedure.
(d) Failure to comply with a cease and desist order issued
pursuant to this section shall be unprofessional conduct.
4129.5. Violation Fine
Notwithstanding any other law, a violation of this article, or
regulation adopted pursuant thereto, may subject the person or
entity that committed the violation to a fine of up to five
thousand dollars ($5,000) per occurrence pursuant to a citation
issued by the board.
4129.8. Temporary License
The board, at its discretion, may issue a temporary license to an
outsourcing facility upon the conditions and for any periods of
time as the board determines to be in the public interest. A
temporary license fee shall be required as specified in subdivision
(w) of Section 4400. When needed to protect public safety, a
temporary license may be issued for a period not to exceed 180
days, and may be issued subject to terms and conditions the
board deems necessary. If the board determines a temporary
license was issued by mistake or denies the application for a
permanent license, the temporary license shall terminate upon
the earlier of personal service of the notice of termination upon
the licenseholder or service by certified mail with return receipt
requested at the licenseholder’s address of record with the
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board. The temporary licenseholder shall not be deemed to have
a vested property right or interest in the license for purposes of
retaining a temporary license or for purposes of any disciplinary
or license denial proceeding before the board.
4129.9. Recall - Notice Required
(a) An outsourcing facility licensed pursuant to Section 4129.1 or
4129.2 that issues a recall notice for a sterile drug or nonsterile
drug compounded by the outsourcing facility, in addition to any
other duties, shall contact the recipient pharmacy, prescriber, or
patient of the recalled drug and the board as soon as possible
within 24 hours of the recall notice if both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
(1) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber and the prescriber
shall ensure the patient is notified.
(2) If the recalled drug was dispensed directly to a pharmacy,
the notice shall be made to the pharmacy and that pharmacy
shall notify the prescriber or patient, as appropriate. If the
pharmacy notifies the prescriber, the prescriber shall ensure the
patient is notified.
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Article 8. Telepharmacy Systems and Remote
Dispensing Site Pharmacies
4130. Remote Dispensing Site Pharmacy - Use of Telepharmacy
System; Medically Underserved Areas; Staffing; Transition to
Full-Service Pharmacy
(a) A telepharmacy system shall be used for the dispensing of
prescription drugs and providing related drug regimen review
and patient counseling services at a remote dispensing site
pharmacy.
(b) If all of the requirements of this article and other relevant
provisions of this chapter are met, the board shall issue a remote
dispensing site pharmacy license for the purpose of increasing
access to dispensing or pharmaceutical care services in the
geographic area in which the remote dispensing site pharmacy is
to be located.
(c) (1) A remote dispensing site pharmacy shall only be located
in a medically underserved area unless otherwise approved by
the board. For purposes of this section, a “medically underserved
area” means a location that does not have a pharmacy that
serves the general public within 10 road miles of the remote
dispensing site.
(2) Notwithstanding paragraph (1), if a pharmacy serving the
general public is later established within 10 road miles of a
remote dispensing site pharmacy, the remote dispensing site
pharmacy may continue to operate.
(d) A remote dispensing site pharmacy shall only be staffed by
pharmacists or pharmacy technicians, or both, and shall not
employ any unlicensed personnel.
(e) A remote dispensing site pharmacy license shall be issued
only to the supervising pharmacy. A supervising pharmacy shall
not obtain more than one remote dispensing site pharmacy
license.
(f) A remote dispensing site pharmacy shall not be operated by
the state and shall not be located in any state facility, including,
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but not limited to, correctional facilities, state hospitals, or
developmental centers. This section shall not be construed to
preclude a pharmacist who is otherwise eligible to operate a
remote dispensing site pharmacy pursuant to this section from
leasing space in property owned by the state, provided it is not
for the purpose of serving individuals otherwise served by
pharmacists and pharmacy technicians employed by the state.
(g) A remote dispensing site pharmacy shall not be located or
operated for the purpose of displacing state employees.
(h) If a remote dispensing site pharmacy dispenses more than
225 prescriptions per day, calculated each calendar year, it shall
cease to be a remote dispensing site pharmacy and may become
a full-service pharmacy licensed under Section 4110 with a
pharmacist onsite if it meets all the requirements for licensure
for a pharmacy.
4131. Remote Dispensing Site Pharmacy - Distance from
Supervising Pharmacy; Common Ownership; Staffing by
Pharmacy Technician; Pharmacist-in-Charge
(a) A supervising pharmacy shall provide telepharmacy services
for only one remote dispensing site pharmacy.
(b) A supervising pharmacy shall not be located greater than 150
road miles from a remote dispensing site pharmacy, unless
otherwise approved by the board.
(c) A supervising pharmacy and remote dispensing site pharmacy
shall be under common ownership.
(d) Unless staffed by a pharmacist, a remote dispensing site
pharmacy shall be staffed by at least one registered pharmacy
technician meeting the qualifications of Section 4132. A
technician shall remain under the direct supervision and control
of a pharmacist at the supervising pharmacy at all times that the
remote dispensing site pharmacy is operational. For the purposes
of this article, direct supervision and control does not require the
pharmacist to be physically present at the remote dispensing site
pharmacy, but the pharmacist shall use a telepharmacy system to
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supervise operations through audio and visual technology from
the supervising pharmacy.
(e) Notwithstanding any other law, a pharmacist may serve as the
pharmacist-in-charge for a pharmacy in addition to serving as
pharmacist-in-charge of a supervising pharmacy. The designated
pharmacist-in-charge of the supervising pharmacy shall also
serve as the designated pharmacist-in-charge at the remote
dispensing site pharmacy.
(f) Notwithstanding any other law, the pharmacist-in-charge of
the remote dispensing site pharmacy and the pharmacist-on-duty
at the supervising pharmacy shall be responsible for ensuring
that both the supervising pharmacy and remote dispensing site
pharmacy are sufficiently staffed to allow for appropriate
supervision, which is supervision that would not be reasonably
expected to result in an unreasonable risk of harm to public
health, safety, or welfare.
4132. Remote Dispensing Site Pharmacy - Pharmacy
Technician: Permitted Duties; Prohibited Duties; Pharmacist-to-
Pharmacy Technician Ratio
(a) In addition to the requirements of Section 4202, a pharmacy
technician shall satisfy each of the following requirements before
working at a remote dispensing site pharmacy.
(1) Possess a pharmacy technician license that is in good
standing.
(2) Possess and maintain a certification issued by a board-
approved pharmacy technician certification program.
(3) Possess one of the following:
(A) A minimum of an associate degree in pharmacy technology.
(B) A minimum of a bachelor’s degree in any subject.
(C) A certificate of completion from a course of training
specified by regulations adopted by the board pursuant to
Section 4202.
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(4) Complete a minimum of 2,000 hours of experience working
as a pharmacy technician within the two years preceding first
commencing work in the remote dispensing site pharmacy.
(b) Notwithstanding Section 4115, a registered pharmacy
technician may perform order entry, packaging, manipulative,
repetitive, and other nondiscretionary tasks at a remote
dispensing site pharmacy under the supervision of a pharmacist
at a supervising pharmacy using a telepharmacy system.
(c) A pharmacy technician at a remote dispensing site pharmacy
shall not do any of the following:
(1) Receive a new prescription order orally from a prescriber or
other person authorized to prescribe by law.
(2) Consult with a patient or his or her agent regarding a
prescription, either prior to or after dispensing, or regarding any
medical information contained in a patient medication record
system or patient chart.
(3) Identify, evaluate, or interpret a prescription.
(4) Interpret the clinical data in a patient medication record
system or patient chart.
(5) Consult with any prescriber, nurse, or other health care
professional or authorized agent thereof.
(6) Supervise the packaging of drugs and check the packaging
procedure and product upon completion.
(7) Perform any function that requires the professional
judgment of a licensed pharmacist.
(8) Compound drug preparations.
(d) Notwithstanding Section 4115, a pharmacist at a supervising
pharmacy may supervise up to two pharmacy technicians at each
remote dispensing site pharmacy. This subdivision shall not be
construed to alter a pharmacist’s ability to also supervise
pharmacy technicians at the supervising pharmacy.
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4133. Telepharmacy System - Audio-Visual System; Use in
Patient Counseling; System Capabilities; Recordkeeping
(a) A telepharmacy system shall maintain a video and audio
communication system that provides for effective
communication between the supervising pharmacy and the
remote dispensing site pharmacy’s personnel and patients.
(b) A telepharmacy system shall facilitate adequate pharmacist
supervision and allow the appropriate exchange of visual, verbal,
and written communications for patient counseling and other
matters involved in the lawful dispensing of drugs.
(c) Patient counseling shall be provided using audio-visual
communication prior to all prescriptions being dispensed from a
remote dispensing site pharmacy.
(d) A telepharmacy system shall be able to do all of the
following:
(1) Identify and record the pharmacy technician preparing each
prescription and the supervising pharmacist who reviewed and
authorized the dispensing of the prescription.
(2) Require a pharmacist to review and compare the electronic
image of any new prescription presented at the remote
dispensing site pharmacy with the data entry record of the
prescription.
(3) Require the pharmacy technician to use barcode technology
to verify the accuracy of the drug to be dispensed.
(4) Require remote visual confirmation by a pharmacist at the
supervising pharmacy of the drug stock bottle and the drug to be
dispensed prior to dispensing.
(5) Ensure that a prescription is not sold or delivered to a
patient prior to a pharmacist performing final verification of the
accuracy of the prescription and releasing the prescription for
sale and delivery.
(e) The video and audio communication system used to counsel
and interact with each patient or patient’s caregiver shall be
secure and compliant with the federal Health Insurance
Portability and Accountability Act (Public Law 104-191).
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(f) All records of prescriptions dispensed including the records of
the actions performed through the telepharmacy system shall be
maintained at the remote dispensing site pharmacy and shall be
maintained for three years after the filling of the prescription.
4134. Remote Dispensing Site Pharmacy - Pharmacist
Inspection; Perpetual Inventory; Securing Controlled
Substances; Inventory and Reconciliation; Controlled
Substances Inventory; Requirement to Report Losses
(a) A pharmacist from the supervising pharmacy shall complete
a monthly in-person, self-inspection of each remote dispensing
site pharmacy using a form designated by the board and shall
retain all inspection reports.
(b) A perpetual inventory shall be kept for all controlled
substances stored at a remote dispensing site pharmacy.
(c) All controlled substances at a remote dispensing site
pharmacy shall be stored in a secure cabinet or safe that is
locked.
(d) A pharmacist from the supervising pharmacy shall perform
inventory and inventory reconciliation functions at a remote
dispensing site pharmacy to detect and prevent the loss of any
controlled substance.
(e) The pharmacist-in-charge of a remote dispensing site
pharmacy shall review all inventory and inventory reconciliation
reports taken and shall establish and maintain secure methods to
prevent losses of any controlled substance. The board shall
develop written policies and procedures for performing the
inventory reconciliation reports required by this section.
(f) A pharmacist from the supervising pharmacy shall compile an
inventory reconciliation report of all Schedule II controlled
substances at a remote dispensing site pharmacy at least once
every three months. This compilation shall require all of the
following:
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(1) A physical count, not an estimate, of all quantities of
Schedule II controlled substances at the remote dispensing site
pharmacy. The biennial inventory of controlled substances as
required under federal law may serve as one of the mandated
inventories under this section in the year that the federal biennial
inventory is performed, provided that the biennial inventory was
taken no more than three months from the last inventory
required by this section.
(2) A review of all acquisitions and dispositions of Schedule II
controlled substances since the last inventory reconciliation
report.
(3) A comparison of paragraphs (1) and (2) in order to determine
if there are any variances.
(4) All records used to compile each inventory reconciliation
report shall be maintained in the remote dispensing site
pharmacy for at least three years in a readily retrievable form.
(g) A remote dispensing site pharmacy shall report to the board,
in writing, any identified losses of controlled substances and
possible causes of the loss within 30 days of discovering the loss
unless the cause of loss is theft, diversion, or self-use in which
case the report shall be made within 14 days of discovering the
loss. If the remote dispensing site pharmacy is unable to identify
the cause of the loss, the remote dispensing site pharmacy shall
undertake further investigation to identify the cause of the loss
and security improvements necessary to prevent any additional
losses of controlled substances. The pharmacist-in-charge shall
be responsible for submitting the report to the board.
(h) Possible causes of overages shall be identified in writing and
incorporated into the inventory reconciliation report.
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(i) The inventory reconciliation report shall be dated and signed
by the individual or individuals performing the inventory and
countersigned by the pharmacist-in-charge of the remote
dispensing site pharmacy. A countersignature shall not be
required if the pharmacist-in-charge personally completed the
inventory reconciliation report. The inventory reconciliation
report shall be maintained in the remote dispensing site
pharmacy for at least three years in a readily retrievable form.
4135. Remote Dispensing Site Pharmacy - Alarm Required;
Closed When Supervising Pharmacy Is Closed; Maintaining
Surveillance Recording
(a) While closed, a remote dispensing site pharmacy shall utilize
an alarm or other comparable monitoring system to protect its
equipment, records, and supply of drugs, devices, and other
restricted sale items from unauthorized access, acquisition, or
use.
(b) Unless a pharmacist is present at the remote dispensing site
pharmacy, a remote dispensing site pharmacy shall not be open
or its employees allowed access to it during times the supervising
pharmacy is closed. The security system shall allow for tracking of
entries into the remote dispensing site pharmacy and the
pharmacist-in-charge shall periodically review the record of
entries. Pharmacy services shall not be provided at a remote
dispensing site pharmacy if the telepharmacy system is
unavailable.
(c) The remote dispensing site pharmacy shall retain a recording
of facility surveillance, excluding patient communications, for a
minimum of 120 days.
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Article 9. Hypodermic Needles and Syringes
4141. Furnishing without License
No person shall furnish hypodermic needles or syringes, by sale
or otherwise, without a license issued by the board, except as
otherwise provided by this article.
4143. Exemption: Sale to Other Entity, Physician, etc.
This article shall not apply to the sale of hypodermic syringes
and needles at wholesale by pharmacies, drug wholesalers, drug
manufacturers or manufacturers and dealers in surgical
instruments to pharmacies, physicians, dentists, podiatrists,
veterinarians, or persons to whom a license has been issued
under this article.
4144.5. Industrial Use; Exception
A person may sell or obtain hypodermic needles and
hypodermic syringes without a prescription or permit, for uses
that the board determines are industrial, and that person shall
not be required to comply with Section 4145.5 or 4146.
4145.5. Conditions for Furnishing Hypodermic and Syringes for
Human Use and Specified Animal Use without a Prescription
(a) Notwithstanding any other provision of law, a pharmacist or
physician may, without a prescription or a permit, furnish
hypodermic needles and syringes for human use, and a person
may, without a prescription or license, obtain hypodermic
needles and syringes from a pharmacist or physician for human
use, if the furnisher has previously been provided a prescription
or other proof of a legitimate medical need requiring a
hypodermic needle or syringe to administer a medicine or
treatment.
(b) Notwithstanding any other provision of law, and until January
1, 2026, as a public health measure intended to prevent the
transmission of HIV, viral hepatitis, and other bloodborne
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diseases among persons who use syringes and hypodermic
needles, and to prevent subsequent infection of sexual partners,
newborn children, or other persons, a physician or pharmacist
may, without a prescription or a permit, furnish hypodermic
needles and syringes for human use to a person 18 years of age
or older, and a person 18 years of age or older may, without a
prescription or license, obtain hypodermic needles and syringes
solely for personal use from a physician or pharmacist.
(c) Notwithstanding any other provision of law, a pharmacist,
veterinarian, or person licensed pursuant to Section 4141 may,
without a prescription or license, furnish hypodermic needles
and syringes for use on animals, and a person may, without a
prescription or license, obtain hypodermic needles and syringes
from a pharmacist, veterinarian, or person licensed pursuant to
Section 4141 for use on animals.
(d) A pharmacy that furnishes nonprescription hypodermic
needles and syringes shall store hypodermic needles and syringes
in a manner that ensures that they are available only to
authorized personnel, and are not accessible to other persons.
(e) In order to provide for the safe disposal of hypodermic
needles and syringes, a pharmacy or hypodermic needle and
syringe exchange program that furnishes nonprescription
hypodermic needles and syringes shall counsel consumers on
safe disposal and provide consumers with one or more of the
following disposal options:
(1) It shall establish an onsite, safe, hypodermic needle and
syringe collection and disposal program that meets applicable
state and federal standards for collection and disposal of medical
sharps waste.
(2) It shall furnish, or make available, mail-back sharps
containers authorized by the United States Postal Service that
meet applicable state and federal requirements for the transport
of medical sharps waste, and shall provide tracking forms to
verify destruction at a certified disposal facility.
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(3) It shall furnish, or make available, a sharps container that
meets applicable state and federal standards for collection and
disposal of medical sharps waste.
(f) Until January 1, 2026, a pharmacy that furnishes
nonprescription syringes shall provide written information or
verbal counseling to consumers at the time of furnishing or sale
of nonprescription hypodermic needles or syringes on how to do
the following:
(1) Access drug treatment.
(2) Access testing and treatment for HIV and hepatitis C.
(3) Safely dispose of sharps waste.
4146. Needle/Syringe Return in Sharps Container
A pharmacy may accept the return of needles and syringes from
the public if contained in a sharps container, as defined in Section
117750 of the Health and Safety Code.
4147. Disposal of Needle or Syringe
(a) For the purposes of this section, "playground" means any
park or outdoor recreational area specifically designed to be used
by children that has play equipment installed or any similar
facility located on public or private school grounds or county
parks.
(b) Any hypodermic needle or syringe that is to be disposed of,
shall be contained, treated, and disposed of, pursuant to Part 14
(commencing with Section 117600) of Division 104 of the Health
and Safety Code.
(c) It is unlawful to discard or dispose of a hypodermic needle or
syringe upon the grounds of a playground, beach, park, or any
public or private elementary, vocational, junior high, or high
school.
(d) A person who knowingly violates subdivision (c) is guilty of a
misdemeanor, and upon conviction shall be punished by a fine of
not less than two hundred dollars ($200) and not more than two
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thousand dollars ($2,000), or by imprisonment in a county jail for
up to six months, or by both that fine and imprisonment.
(e) Subdivision (c) does not apply to the containment,
treatment, and disposal of medical sharps waste from medical
care or first aid services rendered on school grounds, nor to the
containment, treatment, and disposal of hypodermic needles or
syringes used for instructional or educational purposes on school
grounds.
4148.5. Confiscation if Found Outside Licensed Premises
All stocks of hypodermic needles or syringes shall be confiscated
if found outside the licensed premises of any person holding a
permit under Section 4141 and found not in the possession or
under the control of a person entitled to an exemption under
Section 4143, 4144.5, or 4145.5, or under Section 11364, 121349,
or 121349.1 of the Health and Safety Code.
4149. License Required for Nonresident Distributor of Needles
or Syringes
(a) A nonresident distributor shall not sell or distribute
hypodermic needles or syringes in this state without obtaining a
license from the board pursuant to Section 4141.
(b) Notwithstanding subdivision (a), a license is not required if
the nonresident distributor sells or distributes solely through a
person who is licensed as a wholesaler or third-party logistics
provider pursuant to Section 4160.
(c) The Legislature, by enacting this section, does not intend a
license issued to any nonresident distributor pursuant to this
article to serve as evidence that the entity is doing business
within this state.
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