Cal. Code Regs. Tit. 16, § 1784 - Self-Assessment of a Wholesaler/Third-Party Logistics Provider by the Designated Representative-in-Charge or Responsible Manager

(a) Each wholesaler and third-party logistics provider, as defined under section 4160 of the Business and Professions Code, shall complete a self-assessment of its compliance with federal and state pharmacy law. The assessment shall be performed by the designated representative-in-charge of the wholesaler, or by the responsible manager of the third-party logistics provider, before July 1 of every odd-numbered 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 designated representative-in-charge or responsible manager shall complete a self-assessment within 30 days whenever:

(1) A new license is issued.

(2) There is a change in the designated representative-in-charge or responsible manager. The new designated representative-in-charge of a wholesaler or responsible manager of a third-party logistics provider is responsible for compliance with this subdivision.

(3) There is a change in the licensed location of a wholesaler or third-party logistics provider to a new address.

(c) . Each wholesaler and third-party logistics provider conducting business in California, through its designated representative-in-charge or responsible manager, shall complete the "Wholesaler/Third Party Logistics Provider Self-Assessment," Form 17M-26 (Rev. 12/21) which is hereby incorporated by reference. The form shall include the information required by this section.

(1) The designated representative-in-charge or responsible manager shall provide identifying information about the wholesaler or third-party logistics provider including:

(A) Name, license number of the premises, and the license expiration date;

(B) Address, phone number, website address, if applicable, and type of ownership;

(C) Federal Drug Enforcement Administration (DEA) registration number and expiration date and date of most recent DEA inventory;

(D) Verified-Accredited Wholesale Distributor accreditation number and expiration date, if applicable; and

(E) Hours of operation of the licensee.

(2) The designated representative-in-charge or responsible manager shall list the name of each Board-licensed staff person currently employed by the licensee in the facility at the time the self-assessment is completed, the person's license type and number, and the expiration date for each license.

(3) The designated representative-in-charge or responsible manager shall respond "yes", "no" or "not applicable" (N/A) about whether the licensed premises is, at the time of the self-assessment, in compliance with each of the requirements.

(4) For each "no" response, the designated representative-in-charge or responsible manager shall provide a corrective action or action plan to come into compliance with the law.

(5) The designated representative-in-charge or responsible manager shall initial each page of the self-assessment form.

(6) The designated representative-in-charge or responsible manager shall certify, under penalty of perjury, on the final page of the self-assessment that:

(A) They have completed the self-assessment of the licensed premises for which they are responsible;

(B) Any deficiency identified within the self-assessment will be corrected and the timeframe for correction;

(C) They understand that all responses are subject to verification by the Board of Pharmacy; and

(D) The information provided in the self-assessment form is true and correct.

(7) The licensed premises owner, partner or corporate officer shall certify on the final page of the self-assessment that they have read and reviewed the completed self-assessment and understand that failure to correct any deficiency identified in the self-assessment could result in the revocation of the license issued by the board. This certification shall be made under penalty of perjury of the laws of the State of California.

(d) Each self-assessment shall be completed in its entirety and kept on file in the licensed premises for three years after it is completed. The completed, initialed, and signed original must be readily available for review during any inspection by the board.

(e) The wholesaler or third-party logistics provider is jointly responsible with the designated representative-in-charge or responsible manager, respectively, for compliance with this section.

(f) Any identified areas of noncompliance shall be corrected as specified in the certification.

Notes

Cal. Code Regs. Tit. 16, § 1784

1. New section filed 3-26-2007; operative 4-25-2007 (Register 2007, No. 13). For prior history, see Register 84, No. 10.
2. Change without regulatory effect amending subsection (c) filed 3-11-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 11).
3. Amendment of subsection (c) filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).
4. Amendment of subsection (c) filed 4-20-2016; operative 4-20-2016 pursuant to Government Code section 11343.4(b)(3) (Register 2016, No. 17).
5. Amendment of section heading, section and NOTE filed 8-24-2022; operative 10-1-2022 (Register 2022, No. 34).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4022.5, 4022.7, 4043, 4044.5, 4045, 4053, 4053.1, 4059, 4120, 4160, 4161, 4201, 4301 and 4305.5, Business and Professions Code.

1. New section filed 3-26-2007; operative 4-25-2007 (Register 2007, No. 13). For prior history, see Register 84, No. 10.
2. Change without regulatory effect amending subsection (c) filed 3-11-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 11).
3. Amendment of subsection (c) filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).
4. Amendment of subsection (c) filed 4-20-2016; operative 4/20/2016 pursuant to Government Code section 11343.4(b)(3) (Register 2016, No. 17).
5. Amendment of section heading, section and Note filed 8-24-2022; operative 10/1/2022 (Register 2022, No. 34).