Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) A pharmacy may offer a program to
automatically refill prescriptions provided the pharmacy complies with this
section.
(1) The pharmacy shall have written
policies and procedures describing the program, which shall set forth, at a
minimum, how the pharmacy will comply with this section.
(2) Before a patient enrolls, the pharmacy
shall provide a written or electronic notice summarizing the program to the
patient or patient's agent. Such notice shall include, at a minimum,
instructions about how to withdraw a prescription medication from refill
through the program or to disenroll entirely from the program. The patient or
patient's agent shall enroll by written, online, or electronic informed consent
to participate in the program for each new prescription wherein there is a
change in the prescription medication, strength, dosage form, or directions for
use.
(3) For each prescription to
be refilled through the program, the pharmacy shall obtain annual renewal of
each prescription from the patient or patient's agent no later than 12 months
after the prescription was enrolled in the program.
(4) The pharmacy shall keep a copy of the
written or electronic informed consent to enroll on file for one year from date
of dispensing.
(5) The pharmacy
shall complete a drug regimen review for each prescription refilled through the
program at the time of refill.
(6)
Each time a prescription is refilled through the program, the pharmacy shall
provide a written or electronic notification to the patient or patient's agent
confirming that the prescription medication is being refilled through the
program.
(7) The patient or
patient's agent shall at any time be able to withdraw a prescription medication
from automatic refill or to disenroll entirely from the program. The pharmacy
shall document and maintain such withdrawal or disenrollment for one year from
the date of withdrawal or disenrollment and shall provide confirmation to the
patient or patient's agent.
(8) The
pharmacy shall provide a full refund to the patient, patient's agent, or payer
for any prescription medication refilled through the program if the pharmacy
was notified that the patient did not want the refill, regardless of the
reason, or the pharmacy had been notified of withdrawal or disenrollment from
the program prior to dispensing the prescription medication.
(9) A pharmacy shall make available any
written or electronic notification required by this section in alternate
languages as required by state or federal law.
(b) A licensed health facility, as defined in
Health and Safety Code section
1250,
that automatically refills prescriptions for its patients need not comply with
the provisions of this section.
(c)
Pharmacies automatically refilling prescriptions for inmates of an adult
correctional facility or a juvenile detention facility need not comply with the
provisions of this section if the facility has written policies and procedures
describing how a patient may request that a medication be automatically
refilled and how a patient may refuse the medication.
1. New section
filed 6-22-2021; operative 7-1-2022 pursuant to Government Code section
11343.4(b)(3)
(Register 2021, No. 26). Filing deadline specified in Government Code section
11349.3(a)
extended 60 calendar days pursuant to Executive Order
N-40-20.
Note: Authority cited: Section
4005,
Business and Professions Code. Reference: Sections
4001.1,
4005,
4063
and
4076.6,
Business and Professions Code; and Section
1250,
Health and Safety Code.