N.M. Admin. Code § 7.34.4.30

Current through Register Vol. 35, No. 20, October 22, 2024

Section 7.34.4.30 - MONITORING AND CORRECTIVE ACTIONS

A.Monitoring:

(1) The department or its designee may perform on-site assessments of a licensed producer or producer-applicant, an approved manufacturer or manufacturer-applicant, an approved laboratory or a laboratory-applicant, and an approved courier or courier-applicant, to determine compliance with these rules or submissions made pursuant to this rule. The department may enter the premises of a licensed producer, approved manufacturer, approved laboratory, or approved courier at any time to assess or monitor.

(2) 24 hours' notice shall be provided to personal production license holders prior to an on-site assessment, except when the department has reasonable suspicion to believe that providing notice will result in the destruction of evidence, or that providing such notice will impede the department's ability to enforce these regulations.

(3) The department may review any and all records of a licensed non-profit producer, a qualified patient or primary caregiver, an approved manufacturer, approved laboratory, and approved courier, and may require and conduct interviews with such persons or entities and persons affiliated with such entities, for the purpose of determining compliance with department rules and applicable laws.

(4) All licensed producers, approved manufacturers, approved laboratories, and approved couriers shall provide the department or the department's designee immediate access to any material and information necessary for determining compliance with this rule.

(5) Failure by a licensed producer, approved manufacturer, approved laboratory, or approved courier to provide the department access to the premises or materials may result in disciplinary action(s), in accordance with this rule.

(6) Any failure to adhere to these rules that is documented by the department during monitoring may result in disciplinary action, in accordance with this rule.

(7) The department shall refer complaints alleging criminal activity that are made against a licensed producer, approved manufacturer, approved laboratory, or approved courier to appropriate New Mexico state or local law enforcement authorities.

B.Financial records: A licensed non-profit producer and a manufacturer shall maintain detailed sales records in a manner and format approved by the department, and shall inform the department of the location where such records are kept, and promptly update that information if the records are removed.

(1)Access: The department and its agents shall have reasonable access to the financial records of a licensed non-profit producer manufacturer, laboratory, or courier, including but not limited to sales records and data from point of sale systems, and shall be granted immediate access to inspect or copy those records upon request. A patient shall be granted reasonable access to a licensed non-profit producer's or manufacturer's sales records for that patient upon request.

(2)Audit: A licensed non-profit producer shall submit the results of an annual audit to the department no later than 90 days after the end of each fiscal year of the licensed non-profit. For the purposes of this section, the fiscal year of a non-profit producer shall be the 12 month cycle identified by the producer in its filings with the New Mexico taxation and revenue department. The annual audit shall be conducted by an independent certified public accountant; the costs of any such audit shall be borne by the private entity. Results of the annual audit shall be forwarded to the medical cannabis program director or designee. The department may also periodically require, within its discretion, the audit of a non-profit producer's financial records by the department.

(3)Quarterly reports: A non-profit producer shall submit reports on at least a quarterly basis, or as otherwise requested, and in the format specified by the department. The quarterly report shall include at a minimum:

(a) number of qualified patients and primary caregivers who purchased usable cannabis;

(b) total number of retail transactions;

(c) average amount (in units) purchased per retail transaction;

(d) number of units provided without charge;

(e) number of cannabis plants in production, including mature plants and seedlings;

(f) number of cannabis plants harvested;

(g) total yield of usable cannabis harvested from cannabis plants (in grams);

(h) average yield per plant (in grams);

(i) amount of cannabis (in grams) sold by wholesale;

(j) amount of cannabis (in grams) purchased by wholesale;

(k) number of live cannabis plants (including clones) and cannabis seeds sold;

(l) amount of dried cannabis leaves and flowers in stock;

(m) average price per gram of dried cannabis leaves and flowers;

(n) total amount of dried cannabis leaves and flowers sold (in units);

(o) total sales of dried cannabis leaves and flowers (in dollars and units);

(p) amount of cannabis derived products in stock (in units);

(q) total amount of cannabis derived products sold (in units);

(r) total sales of cannabis derived products (in dollars and units);

(s) amount of gross receipts tax paid to the New Mexico department of taxation and revenue;

(t) all quality testing reports, to be included as attachments; and

(u) such additional information as the department may request.

C.Corrective action:

(1) If violations of requirements of this rule are cited on the basis of a violation that is directly observed in the course of a monitoring visit at an approved location, or on the basis of a review of financial records, the licensed producer, manufacturer, laboratory, or courier shall be provided with an official written report of the findings within seven business days following the monitoring visit or the review of financial records.

(2) Unless otherwise specified by the department, the licensed producer, manufacturer, laboratory, or courier shall correct the violation within five calendar days of receipt of the official written report citing the violation(s).

(3) The violation shall not be deemed corrected until the department verifies in writing within seven calendar days of receiving notice of the corrective action that the corrective action is satisfactory.

(4) If the violation has not been corrected, the department may issue a notice of contemplated action to suspend, revoke, or take other disciplinary action against the license of the producer, manufacturer, laboratory, or courier, in accordance with the provisions of this rule.

D.Suspension of license without prior hearing: If immediate action is required to protect the health and safety of the general public, a qualified patient, or a primary caregiver, the program director or designee may suspend the license of a non-profit producer or personal production license holder without notice, and may immediately withdraw approval for a laboratory, manufacturer, or courier without notice.

(1) A licensee or approved entity whose license has been summarily suspended or whose approval has been withdrawn may request a record review in accordance with this part.

(2) The record review requested subsequent to a summary suspension shall be conducted by the administrative review committee.

(3) The administrative review committee shall conduct the record review on the summary suspension or withdrawal of approval by reviewing all documents submitted by both licensee and the department.

(4) The sole issue at a record review on a summary suspension or withdrawal of approval is whether the license shall remain suspended or whether the approval shall remain withdrawn pending a final adjudicatory hearing and subsequent ruling by the secretary.

(5) A licensee or approved entity given notice of summary suspension or summary withdrawal by the program may submit a written request for a record review. To be effective, the written request shall:

(a) be made within 30 calendar days, from the date of the notice issued by the department, as determined by the postmark;

(b) be properly addressed to the medical cannabis program;

(c) state the applicant's name, address, and telephone numbers;

(d) provide a brief narrative rebutting the circumstances of the suspension or withdrawal, and

(e) include attachments of any additional documentation that the individual or entity wishes to be considered in the record review.

N.M. Admin. Code § 7.34.4.30

Adopted by New Mexico Register, Volume XXXI, Issue 04, February 25, 2020, eff. 2/25/2020, Adopted by New Mexico Register, Volume XXXI, Issue 12, June 23, 2020, eff. 6/23/2020