Conn. Agencies Regs. § 21a-408-1

Current through November 7, 2024

Section 21a-408-1 - Definitions

As used in sections 21a-408-1 to 21a-408-72, inclusive, of the Regulations of Connecticut State Agencies:

(1) "Abuse of drugs" means the use of controlled substances solely for their stimulant, depressant or hallucinogenic effect upon the higher functions of the central nervous system and not as a therapeutic agent prescribed in the course of medical treatment or in a program of research operated under the direction of a physician or pharmacologist;

(2) "Act" means chapter 420f of the Connecticut General Statutes;

(3) "Administer" means the direct application of marijuana to the body of a qualifying patient by inhalation, ingestion or any other means;

(4) "Adulterated" has the same meaning as described in section 21a-105 of the Connecticut General Statutes;

(5) "Advanced practice registered nurse" (APRN) has the same meaning as provided in chapter 378 of the Connecticut General Statutes;

(6) "Advertisement" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of marijuana by qualifying patients or primary caregivers;

(7) "Agent" means an authorized person who acts on behalf of or at the direction of another person. It does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman;

(8) "Approved safe" has the same meaning as described in section 21a-262-1 of the Regulations of Connecticut State Agencies;

(9) "Approved vault" has the same meaning as described in section 21a-262-1 of the Regulations of Connecticut State Agencies;

(10) "Batch" means a specific harvest of marijuana or marijuana products that are identifiable by a batch number, every portion or package of which is uniform within recognized tolerances for the factors that were subject to a laboratory test and that appear in the labeling;

(11) "Board" means the Board of Physicians appointed under the provisions of section 21a-408l of the Connecticut General Statutes;

(12) "Bona fide healthcare professional-patient relationship" means a relationship in which the physician or APRN has ongoing responsibility for the assessment, care and treatment of a patient's debilitating medical condition, or a symptom of the patient's debilitating medical condition, for which the physician or APRN has certified to the department that the patient would benefit from the palliative use of marijuana;

(13) "Commissioner" means the Commissioner of Consumer Protection or the commissioner's designee;

(14) "Compounding" means to combine, mix or put together two or more ingredients and includes the preparation of a marijuana product in anticipation of a qualifying patient, primary caregiver or physician request;

(15) "Controlled substance" means a drug, substance, or immediate precursor listed in sections 21a-243-7 through 21a-243-11, inclusive, of the Regulations of Connecticut State Agencies;

(16) "Cultivation" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(17) "Debilitating" means a chronic medical condition that causes weakness or impairs the strength or ability of an individual and has progressed to such an extent that it substantially limits one or more major life activities of such individual. An assessment of whether a major life activity has been substantially limited shall be guided by interpretations of the term "disability" as set forth in 42 USC 12102(1)(A);

(18) "Debilitating medical condition" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(19) "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another of marijuana, whether or not there is an agency relationship;

(20) "Department" means the Department of Consumer Protection;

(21) "Dietary supplement" has the same meaning as provided in 21 U.S.C. 321;

(22) "Dispensary" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(23) "Dilute" or "dilution" means to make thinner or weaker by adding water or another solvent to the product;

(24) "Dispensary department" means that area within a dispensary facility where marijuana is stored, dispensed and sold. If a dispensary facility does not offer any products or services other than marijuana and paraphernalia, the entire dispensary facility is a dispensary department for purposes of sections 21a-408-1 to 21a-408-70, inclusive, of the Regulations of Connecticut State Agencies;

(25) "Dispensary facility" means a place of business where marijuana may be dispensed, sold or distributed in accordance with Section 21a-408-35 of the Regulations of Connecticut State Agencies to qualifying patients and primary caregivers and for which the department has issued a dispensary facility license to an applicant under the Act and section 21a-408-14 of the Regulations of Connecticut State Agencies;

(26) "Dispensary facility backer" means, except in cases where the dispensary is the sole proprietor of a dispensary facility, any person with a direct or indirect financial interest in a dispensary facility, except "dispensary facility backer" does not include a person with an investment interest in a dispensary facility provided the interest held by such person and such person's coworkers, employees, spouse, parent or child, in the aggregate, do not exceed five per cent of the total ownership or interest rights in such dispensary facility and such person does not participate directly or indirectly in the control, management or operation of the dispensary facility;

(27) "Dispensary facility manager" means the dispensary who has complete control and management over the dispensary facility;

(28) "Dispensary facility employee" means a dispensary, dispensary technician, dispensary facility staff, a person who does not have a personal ownership interest in a dispensary facility, but sits on a board of a company with such an ownership interest, and all other persons employed by a dispensary facility or who otherwise have access to the dispensary facility including independent contractors who are routinely on the facility premises;

(29) "Dispensary technician" means an individual who has had an active pharmacy technician registration in Connecticut within the past five years, is affiliated with a licensed dispensary and is registered with the department in accordance with sections 21a-408-24 and 21a-408-25 of the Regulations of Connecticut State Agencies;

(30) "Dispense" or "dispensing" means those acts of processing marijuana for delivery or for administration for a qualifying patient pursuant to a written certification consisting of:

(A) Comparing the directions on the label with the instructions on the written certification, if any, to determine accuracy;

(B) the selection of the appropriate marijuana product from stock;

(C) the affixing of a label to the container; and

(D) the provision of any instructions regarding the use of the marijuana;

(31) "Dispensing error" means an act or omission relating to the dispensing of marijuana that results in, or may reasonably be expected to result in, injury to or death of a qualifying patient or results in any detrimental change to the medical treatment for the patient;

(32) "Disqualifying conviction" means a conviction for the violation of any statute or regulation pertaining to the illegal manufacture, sale or distribution of a controlled substance or controlled substance analog unless the violation resulting in the conviction occurred when the person held a valid license or registration certificate from the department and the violation was of a federal statute or regulation related to the possession, purchase or sale of marijuana that is authorized under the Act and sections 21a-408-1 to 21a-408-72, inclusive, of the Regulations of Connecticut State Agencies;

(33) "Drug Control Division" means the division within the department responsible for overseeing the medical marijuana program;

(34) "Drug" has the same meaning as provided in section 20-571 of Connecticut General Statutes;

(35) "Electronic data intermediary" means an entity that provides the infrastructure that connects the computer systems or other electronic devices utilized by dispensaries with those used by physicians or the department in order to facilitate the secure transmission of qualifying patient or primary caregiver information;

(36) "Financial interest" means any actual, or a future right to, ownership, investment or compensation arrangement with another person, either directly or indirectly, through business, investment or family. "Financial interest" does not include ownership of investment securities in a publicly-held corporation that is traded on a national exchange or over-the-counter market, provided the investment securities held by such person and such person's co-workers, employees, spouse, parent or child, in the aggregate, do not exceed one-half of one per cent of the total number of shares issued by the corporation;

(37) "Forms" means applications, registrations, written certifications or other documents prescribed by the commissioner in either hardcopy or electronic format;

(38) "Good standing" means a person has a license or registration with the department that is not on probation or subject to any other restriction or oversight by the department beyond others in the same class;

(39) "Label" means a display of written, printed or graphic matter upon the immediate container of any product containing marijuana;

(40) "Laboratory" means a laboratory located in Connecticut that is licensed by the department to provide analysis of controlled substances pursuant to section 21a-246 of the Connecticut General Statutes;

(41) "Legend drug" has the same meaning as provided in section 20-571 of the Connecticut General Statutes;

(42) "Manufacture" or "manufacturing" means any process by which marijuana is converted to a marijuana product and that involves heating, mixing marijuana with any other ingredient or otherwise altering the raw material;

(43) "Marijuana" has the same meaning as provided in section 21a-240 of the Connecticut General Statutes;

(44) "Marijuana product" means any product containing marijuana, including raw materials, that requires no further processing and that is packaged for sale or for research purposes;

(45) "Minor" means a person who is under 18 years of age and is not an emancipated minor;

(46) "One-month supply" means the amount of marijuana reasonably necessary to ensure an uninterrupted availability of supply for a thirty-day period for qualifying patients, which amounts shall be determined by the commissioner on the basis of available research and recommendations from the Board of Physicians;

(47) "Palliative use" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(48) "Paraphernalia" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(49) "Person" includes any corporation, limited liability company, association or partnership, or one or more individuals, government or governmental subdivisions or agency, estate, trust, or any other legal entity;

(50) "Pesticide chemical" has the same meaning as provided in section 21a-92 of the Connecticut General Statutes;

(51) "Petition" means a written request submitted pursuant to the Act and section 21a-408-12 of the Regulations of Connecticut State Agencies that recommends adding a medical condition, medical treatment or disease to the list of debilitating medical conditions that qualify for the palliative use of marijuana;

(52) "Pharmaceutical grade marijuana" means marijuana or marijuana products that are not adulterated and are:

(A) processed, packaged and labeled according to the Food and Drug Administration's "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," 21 CFR 111;

(B) labeled with the results of an active ingredient analysis, a microbiological contaminants analysis, a mycotoxin analysis, a heavy metal analysis and a pesticide chemical residue analysis which have been completed on a batch basis by a laboratory; and

(C) where each step of the production, cultivating, trimming, curing, manufacturing, processing and packaging method has been documented by using established standard operation procedures approved by the commissioner;

(53) "Pharmacist" has the same meaning as provided in section 20-571 of the Connecticut General Statutes;

(54) "Pharmacy technician" has the same meaning as provided in section 20-571 of the Connecticut General Statutes;

(55) "Physician" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(56) "Prescription monitoring program" means the electronic prescription drug monitoring program established by section 21a-254(j) of the Connecticut General Statutes;

(57) "Primary caregiver" or "caregiver" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes for "primary caregiver";

(58) "Producer" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(59) "Producer backer" means any person with a direct or indirect financial interest in an entity licensed as a producer, except it shall not include a person with an investment interest in a producer, provided the interest held by such person and such person's co-workers, employees, spouse, parent or child, in the aggregate, does not exceed five per cent of the total ownership or interest rights in such producer and such person does not participate directly or indirectly in the control, management or operation of the production facility;

(60) "Production" or "produce" means the manufacture, planting, preparation, cultivation, growing, harvesting, propagation, compounding, conversion or processing of marijuana, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container, except that this term does not include the preparation or compounding of marijuana by a patient, dispensary or caregiver for the patient's use;

(61) "Production facility" means a secure, indoor facility where the production of marijuana occurs and that is operated by a person to whom the department has issued a producer license under the Act and sections 21a-408-20 of the Regulations of Connecticut State Agencies;

(62) "Production facility employee" means any person employed by a producer, any person who does not have a personal ownership interest in a producer, but sits on a board of a company with such an ownership interest, or any person who otherwise has access to the production facility, including independent contractors who are routinely on the production facility premises;

(63) "Qualifying patient" or "patient" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes;

(64) "Registration certificate" means an identification card or other document issued by the department that identifies a person as a registered qualifying patient or primary caregiver;

(65) "Sale" is any form of delivery, which includes barter, exchange or gift, or offer therefor, and each such transaction made by any person whether as principal, proprietor, agent, servant or employee; and

(66) "Usable marijuana" has the same meaning as provided in section 21a-408 of the Connecticut General Statutes; and

(67) "Written certification" means a written or electronically submitted statement issued by a physician or an APRN to the department certifying a patient for the palliative use of marijuana, which shall be submitted on a form and in a manner prescribed by the commissioner.

Conn. Agencies Regs. § 21a-408-1

Effective September 6, 2013; amended 8/28/2018