RESEARCH, INSTRUCTIONAL ACTIVITIES AND CHEMICAL ANALYSIS

Section 80.35 - Unlicensed activity

RESEARCH, INSTRUCTIONAL ACTIVITIES AND CHEMICAL ANALYSIS

80.35 Unlicensed activity. (a) No person shall conduct research, instructional activities or chemical analysis of controlled substances in this State without first having obtained a license from the department.

(b) Licensees. Licensees shall register with the appropriate Federal agency or agencies in the comparable controlled substance schedule provided for under Federal regulations.
 

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Section 80.36 - Additional requirements, research, instructional activities and chemical analysis

80.36 Additional requirements, research, instructional activities and chemical analysis.

(a) Persons engaged in research of controlled substances in schedules II to V shall first obtain a Class 4 license from the department and thereafter a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(b) Persons engaged in industrial or commercial processes requiring the use of controlled, substances in schedules II to V shall first obtain a Class 4a license from the department and thereafter a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(c) Persons engaged in instructional activities requiring the use of controlled substances in schedules II to V shall first obtain a license from the department in Class 5 and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(d) Persons conducting research with controlled substances in schedule I shall apply to the department for such research license in Class 7 and file with the department three copies of a research protocol describing the research project.

(1) The research protocol shall contain all pertinent information including the objective, material, security, procedures (such as species and number of animals, daily dose regimen and route of administration) and investigators, if any.

(2) If the commissioner finds that the applicant is qualified and competent, and has furnished a satisfactory protocol, the department shall license such applicant unless he finds that the application should be denied by reason of false statements in the application, conviction of a felony relating to controlled substances suspension, revocation or denial of the applicant's Federal license or registration, failure to provide adequate safeguards against diversion of the controlled substances from legitimate medical or scientific use or other good and sufficient reason.

(e) A person licensed to conduct research with controlled substances listed in schedule I may conduct research with only such substances in schedule I for which he has filed and had approved a research protocol.

(f) All persons conducting research and instructional activities with controlled substances listed in schedule I shall first obtain a Class 7 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(g) All persons conducting analytical laboratories involving controlled substances shall first obtain a Class 8 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

Effective Date: 
Wednesday, November 26, 2008
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Section 80.37 - Records; researchers

80.37 Records; researchers.

(a) Researchers, licensed and authorized to possess and use controlled substances, shall keep a record of all such substances received and used by them.

(1) A record of all such controlled substances received shall include date of receipt, name and address of vendor, type and quantity of drug received. A duplicate invoice or separate itemized list furnished by the vendor will be sufficient to meet this record requirement providing it contains all the information required and is maintained in a separate file.

(2) A record of all controlled substances used shall include the name of the person authorized to control and use such drugs, the date, type and quantity of drug and signature of the user.

(b) In addition, such records shall contain the following information for each controlled substance:

(1) Name of substance.

(2) Each finished form (such as 10 mg. tablet, or 10 mg. concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container.

(3) The number of commercial containers of such finished form received from other persons, including the date of and number of containers in each receipt, and the name, address, and registration number of the person from whom the containers were received.

(4) The amount of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, and the written or typewritten name or initials of the individual who dispensed or administered the substance.

(5) The number of units or volume of the finished form and/or commercial containers disposed of in any other manner by the researcher, including the date and manner of disposal.
 

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Section 80.38 - Records; instructional activities

80.38 Records; instructional activities.

Persons authorized to possess and use controlled substances for instructional activities shall keep a record of all controlled substances received and used by them.

(a) The record shall include date of receipt, name and address of vendor, type and quantity of drug received. A duplicate invoice or separate itemized list furnished by the vendor for schedule III, IV and V controlled substances will be sufficient to meet this record requirement providing it contains all the information required and is maintained in a separate file. Duplicate copies of Federal order forms for schedule I and II substances shall also be maintained.

(b) A record of controlled substances used shall include the name of the person authorized to control and use such drugs, the date, type and quantity of drug and signature of the user.
 

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Section 80.39 - Records; analytical laboratories

80.39 Records; analytical laboratories.

Analytical laboratories authorized to possess and use controlled substances shall keep a record of all controlled substances received and used by them.

(a) The record of controlled substances received shall include date of receipt, name and address of vendor, type and quantity of drug received. A duplicate invoice or separate itemized list furnished by the vendor will be sufficient to meet this record requirement providing it contains all the information required and is maintained in a separate file. In addition, duplicate copies of Federal order forms for schedule II controlled substances shall be retained.

(b) A record of controlled substances used shall include the name of the person authorized to control and use such drugs, the date, type and quantity of drug used and signature of the user.
 

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