Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) The pharmacist-in-charge of each
automated drug delivery system as defined under section
4119.11,
4187.5 or section
4427.3
of the Business and Professions Code shall complete a self-assessment of the
pharmacy's compliance with federal and state pharmacy law. The assessment shall
be performed annually before July 1 of every year. The primary purpose of the
self-assessment is to promote compliance through self-examination and
education.
(b) In addition to the
self-assessment required in subdivision (a) of this section, the
pharmacist-in-charge shall complete a self-assessment within 30 days whenever:
(1) A new automated drug delivery system
license has been issued.
(2) There
is a change in the pharmacist-in-charge, and he or she becomes the new
pharmacist-in-charge of an automated drug delivery system.
(3) There is a change in the licensed
location of an automated drug delivery system to a new
address.
(c) A
pharmacist-in-charge of an automated drug delivery system shall assess the
system's compliance with current laws and regulations by using the components
of Form 17M-112 (Rev 12/18) entitled "Automated Drug Delivery System
Self-Assessment". Form 17M-112 shall be used for all automated drug delivery
systems and is hereby incorporated by reference.
(1) The pharmacist-in-charge shall provide
identifying information about the underlying operating pharmacy including:
(A) Name and any license number(s) of the
underlying pharmacy and their expiration date(s);
(B) Address, phone number, and website
address, if applicable, of the underlying pharmacy;
(C) DEA registration number, expiration date,
and date of most recent DEA inventory;
(D) Hours of operation of the pharmacy;
and
(E) ADDS license number,
address, and hours of operation.
(2) The pharmacist-in-charge shall respond
"yes", "no", or "not applicable" (N/A) about whether the automated drug
delivery system is, at the time of the self-assessment, in compliance with laws
and regulations that apply to that pharmacy setting.
(3) For each "no" response, the
pharmacist-in-charge shall provide a written corrective action or action plan
to come into compliance with the law.
(4) The pharmacist-in-charge shall initial
each page of the self-assessment with original handwritten initials in ink or
digitally signed in compliance with Civil Code Section
1633.2(h)
on the self-assessment form.
(5)
The pharmacist-in-charge shall certify on the last page of the self-assessment
that he or she has completed the self-assessment of the automated drug delivery
system of which he or she is the pharmacist-in-charge. The pharmacist-in-charge
shall also certify a timeframe within which any deficiency identified within
the self-assessment will be corrected and acknowledge that all responses are
subject to verification by the Board of Pharmacy. The certification shall be
made under penalty of perjury of the laws of the State of California that the
information provided in the self-assessment form is true and correct with an
original handwritten signature in ink or digitally signed in compliance with
Civil Code Section
1633.2(h)
on the self-assessment form.
(6)
The automated drug delivery system owner shall certify on the final page of the
self-assessment that he or she has read and reviewed the completed
self-assessment and acknowledges that failure to correct any deficiency
identified in the self-assessment could result in the revocation of the
automated dispensing system's license issued by the board. This certification
shall be made under penalty of perjury of the laws of the State of California
with an original handwritten signature in ink or digitally signed in compliance
Civil Code Section
1633.2(h)
on the self-assessment form.
(d) Each self-assessment shall be completed
in its entirety and kept on file in the underlying pharmacy for three years
after it is performed. The completed, initialed, and signed original must be
readily available for review during any inspection by the board.
(e) Any identified areas of noncompliance
shall be corrected as specified in the assessment.
1. New section
filed 5-19-2021; operative 7-1-2021 (Register 2021, No.
21).
Note: Authority cited: Sections
4119.11
and
4427.7,
Business and Professions Code. Reference: Sections
4001.1,
4008,
4017.3,
4021,
4022,
4036,
4037,
4038,
4040,
4050,
4051,
4052,
4059,
4070,
4076,
4081,
4101,
4105,
4107,
4113,
4119.11,
4125,
4126,
4180,
4186,
4305,
4330,
4332,
4333,
4400,
4427,
4427.1,
4427.2,
4427.3,
4427.4
and
4427.5,
Business and Professions Code; and Section
16.5,
Government Code.
