1.0 ADMINISTRATION

Effective January 30, 1993

1.1 Authority

Sections 12-22-321 (1), 12-22-322 and 18-18-301, Colorado Revised Statutes.

1.2 Basis and Purpose - The purpose of these Rules and Regulations is to:

1.2.1 Establish rules and regulations relating to the licensing and registration of researchers, including analytical laboratories, experimenting with, studying, or testing any controlled substance; and addiction programs compounding, administering or dispensing any controlled substance.

1.2.2 Establish rules and regulations for standards relating to the control of controlled substances, including records to be kept, reports to be made and security requirements.

2.0 DEFINITIONS

2.1 “Addict” means a person who has a physical or psychological dependence on a controlled substance, which dependence develops following the use of the controlled substance on a periodic or continuing basis and is demonstrated by appropriate observation and tests by a person licensed to practice medicine pursuant to Article 36 of Title 12, Colorado Revised Statutes.

2.2 “Addiction program” means a program licensed and registered by the Department pursuant to Section 12-22-304 thru 307 and 18-18-301 thru 303, Colorado Revised Statutes for the detoxification, withdrawal or maintenance treatment of addicts.

2.3 “Administer”, unless the context otherwise requires, means to apply a controlled substance, whether by injection, inhalation, ingestion, or any other means, directly to the body of a patient or research subject by:

(a) A practitioner (or, in the practitioner's/presence, by the practitioner's authorized agent); or (b) The patient or research subject at the direction and in the presence of the practitioner.

2.4 “Controlled Substance” means a drug, substance, or immediate precursor included in Schedules I through V or Article 18 of Title 12, Part 2, Colorado Revised Statutes including cocaine, marijuana, and marijuana concentrate.

2.5 “Department” means the Colorado Department of Health.

2.6 “Dispense” means to deliver a controlled substance to an ultimate user, patient, or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.

2.7 “Researcher” means any person licensed and registered by the Department pursuant to Sections 12- 22-301–307 and 18-18-301–303, Colorado Revised Statutes to experiment with, study or test any controlled substance within this state and includes analytical laboratories.

3.0 LICENSE REQUIRED

3.1 Every person, as defined by section 12-22-304 (1) (b), Colorado Revised Statutes conducting an addiction program by compounding, administering or dispensing any controlled substance, shall first obtain a license issued by the Department which shall be obtained annually.

3.2 Every person as defined by 12-22-304 (1) (a), Colorado Revised Statutes conducting research including analytical laboratory activities using controlled substances, shall first obtain a license issued by the Department which shall be obtained annually.

3.3 Every person who engages in activities designated in Sections 3.3.1, 3.3.2 and/or 3.3.3 at one location shall obtain a separate license for each group of activities:

3.3.1 Conducting research or instructional activities with controlled substances.

3.3.2 Conducting chemical analysis of controlled substances.

3.3.3 Conducting an addiction program using controlled substances.

3.4 A separate license is required for each principal place of business or independent activity at one general physical location where controlled substances are used for research, laboratory analysis or treatment of addicts.

3.5 At the time an initial license is issued, it will be assigned to one of 12 groups, corresponding to the months of the year. The expiration date of the licenses within any group will be the last day of the month designated for that group.

3.6 For each license or license renewal to engage in any group of independent activities using controlled substances, the license fee, which shall accompany the application, shall be $25.00 pursuant to Title 12, Article 22, Part 305, Colorado Revised Statutes.

3.7 Each application for a license or license renewal to conduct research shall be accompanied by a written statement describing the research, instructional activity, or chemical analysis being conducted.

3.8 Each application for a license or license renewal to conduct an addiction program shall be accompanied by the program's policies and procedures for treatment using controlled substances.

3.9 The Department may require an applicant to submit additional documents or written statements of fact relevant to the application as deemed necessary to determine whether a license should be issued.

3.10 The Department may suspend, revoke, limit, restrict or deny any license for the reasons listed in 12- 22-308, Colorado Revised Statutes. The license may be denied, even if all statutory and regulatory requirements have been met by the applicant, if the Department determines that issuance is against the public interest.

4.0 REGISTRATION REQUIRED

4.1 An applicant for licensure pursuant to Section 3 of these rules and regulation, shall also be considered an applicant for registration pursuant to 18-18-302, Colorado Revised Statutes.

4.2 Every person licensed by the Department pursuant to Section 3 of these rules and regulations shall also be registered with the Department.

4.3 The Department shall charge a registration fee as authorized by 18-18-301, Colorado Revised Statutes and this shall be an annual fee of two hundred dollars ($200.00), which shall accompany the application.

4.4 The Department will collect and analyze appropriate activity data during the period January 1, 1993 through July 1, 1993, for the purpose of establishing a licensing and registration fee schedule. Such data may include but not be limited to: (1) time necessary to inspect applicants and issue a license and registration; (2) number of reports and time necessary to process; and (3) time necessary for inspection and investigation of licensees and registrants regarding complaints or apparent non-compliance with statutes or regulations. A fee schedule will be recommended to the Board for adoption on or before June 30, 1993. It will be based on the cost of administering this licensing and registration program and shall be developed in consultation with the persons holding licenses and registrations.

4.5 The Department may suspend, revoke, limit, restrict or deny any registration for the reasons listed in 18-18-304, C.R.S. pursuant to Article 4 of Title 24, Colorado Revised Statutes. The registration may be denied, even if all statutory and regulatory requirements have been met by the applicant, if the Department determines that issuance is against the public interest.

5.0 SECURITY REQUIREMENTS

5.1 All licensed and registered researchers, analytical laboratories and addiction programs using controlled substances shall provide effective controls and procedures to prevent against theft and diversion of controlled substances.

5.2 Standards for the physical security controls and operating procedures necessary to prevent diversion required by the federal Drug Enforcement Administration by regulation (Title 21-Food and Drugs, Chapter II-Drug Enforcement Administration, Department of Justice, Code of Federal Regulations, Parts 1301.71 thru 1301.76) are acceptable and adopted as regulations.

6.0 RECORDS AND REPORTS TO BE KEPT

6.1 All licensed and registered researchers and addiction programs using controlled substances shall keep and maintain accurate and legible records and inventories for a period of two years.

6.2 Inventories, records and reports required by the federal Drug Enforcement Administration by regulation (Title 21-Food and Drugs, Chapter II-Drug Enforcement Administration, Department of Justice, Code of Federal Regulations, Part 1304) are acceptable and adopted as regulations.

6.3 All licensed and registered researchers, analytical laboratories and addiction programs shall report in writing to the Department any loss, disappearance or theft of a controlled substance within three (3) days after such discovery.

6.4 All licensed and registered researchers and analytical laboratories shall report at the time of submitting an application for licensure, the following information regarding drug precursors as defined by 12-22-303 (13.5).

1. All drug precursors which are manufactured, possessed and/or transported;

2. How the drug precursors are used;

3. Customers receiving drug precursors from the applicant;

4. Vendors distributing drug precursors to the applicant;

5. The approximate quantities of each drug precursor manufactured, possessed, and/or transported during the year preceding the year of application; and 6. Any other appropriate information.

7.0 INSPECTION

7.1 The Department may inspect the establishment, facilities, and all required records of a licensee and registrant or applicant for licensee and registration.

NOTE: A certified copy of the referenced material is available for public inspection during normal business hours at the Alcohol and Drug Abuse Division, 4300 Cherry Creek Drive South, Denver, Co. These rules do not include later amendments of the referenced material. Certified copies of the referenced material will be provided at cost upon request from the alcohol and Drug Abuse Division at the following mailing address: Director, Alcohol and Drug Abuse Division, ADAD-ADM-A-2, Colorado Department of Health, 4300 Cherry Creek Drive South, Denver, Colorado, 80222-1530.