Home Table of Contents

§ 1715.1. Self-Assessment of an Automated Drug Delivery System by the Pharmacist-in-Charge.

16 CA ADC § 1715.1BARCLAYS OFFICIAL CALIFORNIA CODE OF REGULATIONS

Barclays Official California Code of Regulations Currentness
Title 16. Professional and Vocational Regulations
Division 17. California State Board of Pharmacy
Article 2. Pharmacies (Refs & Annos)
16 CCR § 1715.1
§ 1715.1. Self-Assessment of an Automated Drug Delivery System by the Pharmacist-in-Charge.
(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.
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.
HISTORY
1. New section filed 5-19-2021; operative 7-1-2021 (Register 2021, No. 21).
This database is current through 5/6/22 Register 2022, No. 18
16 CCR § 1715.1, 16 CA ADC § 1715.1
End of Document