1.0 ADMINISTRATION

Effective:

1.1 Authority - Sections 12-22-303 (13.5), 12-22-304 (2.5), 12-22-304 (5.6), and 12-22-318 (7) Colorado Revised Statutes.

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

1.2.1 Establish rules and regulations relating to the licensing and control of the manufacture, possession, transfer and transportation of drug precursors.

1.2.2 Establish rules and regulations implementing provisions relating to the control of drug precursors, including records to be kept and rules for common reporting forms for drug precursors.

2.0 DEFINITIONS

2.1 “Department” means the Colorado Department of Health.

2.2 “Drug precursor” means any substance, material, compound, mixture or preparation as listed in subsection 12-22-303 (13.5) CRS or any of their salts, isomers or salts of isomers. “Drug precursor” specifically excludes those substances, materials, compounds, mixtures or preparations which are prepared for dispensing pursuant to a prescription or over-the-counter distribution as a substance which is generally recognized as safe and effective within the meaning of the Federal Food, Drug and Cosmetic Act or have been manufacture, distributed or possessed in conformance with the provisions of an approved new drug application or an exemption for investigational use within the meaning of Section 505 of the Federal Food, Drug and Cosmetic Act;

2.3 “License” means a license issued by the Department to permit a person, not otherwise authorized, to manufacture, possess, transfer, transport or conduct a transaction involving a drug precursor.

2.4 “Manufacture” means the production, preparation, compounding, conversion or processing of a drug precursor by extraction from substances of natural origin, 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 a controlled substance by a practitioner:

(1) as an incident to his administering or dispensing of a controlled substance in the course of his professional practice; or (2) by his agent under his supervision, for the purpose of or an incident to research teaching or chemical analysis and not for sale.

2.5 “Transfer” means conveying or shifting from one person to another including selling, distributing, receiving, bartering, giving away or conducting any other type of transaction involving a drug precursor.

3.0 DRUG PRECURSOR LIST

3.1 Any substance, material, compound, mixture or preparation of the substances designated and listed in subsection 12-22-303 (13.5) CRS or any of their salts, isomers or salts of isomers are subject to these regulations and to the requirements of Title 12, Article 22 Part 3 relating to drug precursors.

3.2 The drug precursors designated and listed in subsection 12-22-303 (13.5) CRS are included by whatever official, common, usual, chemical, or trade name designated.

4.0 LICENSE REQUIRED

4.1 Every person who manufactures, possesses, transfers, or transports drug precursors or engages in such activities must first obtain a license issued by the Department, which shall be obtained annually.

4.2 Licenses shall be issued for the period July 1 through June 30 of each year. Licenses issued during the fiscal year shall expire June 30 that year and must be renewed prior to July 1.

4.3 Persons licensed by the Department to manufacture, possess, transfer, or transport drug precursors may do so only to the extent authorized by their licenses and in conformity with the other provisions of this Title 12, Article 22, Part 3.

4.4 Each site where drug precursors are manufactured, possessed, transferred or transported shall be licensed and the license shall be conspicuously displayed at each site.

4.5 Application for Licensure shall be made on forms prepared and furnished by the Department and shall include all information that the Department may require to assist the Department in determining the public interest by the consideration of the factors specified in 12-22-305 (1) and (1.5), CRS, and whether the applicant has met all statutory and regulatory requirements.

4.6 Each application for a license shall include information required by 12-22-318 (7) on all precursor recipients that meet the requirements under 12-22-318 (11) for whom the applicant desires to submit a comprehensive monthly report.

4.6.1 Recipients for comprehensive monthly reporting may be added to a license by requesting such action as a part of the initial transaction report required by 12-22-318 (7) (c).

4.6.2 The Department may approve, deny approval or revoke approval of regular precursor recipients.

4.7 The Department may suspend, revoke, limit, restrict or deny any license for the reasons listed in 12- 22-308, CRS pursuant to Article 4 of Title 24, CRS. 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.

4.8 The Department may charge a reasonable license fee as authorized be 12-22-304, section (2.5) (a). The schedule of fees shall be as follows:

4.8.1 All licenses issued during the first period, July 1, 1992 through June 30, 1993 will be charged a flat fee of five hundred dollars ($500.00).

4.8.2 The Department will collect and analyze appropriate activity data during the period July 1, 1992 through March 31 1993. Such data may include but not be limited to time necessary to investigate applicants for a license, number and time necessary to process transaction reports and investigate transactions that do not comply with statutes or regulations. This data will be used to recommend to the Board for adoption on or before June 30, 1993, a fee schedule based on the cost of administering this licensing program. Such recommendations shall be developed in consultation with the persons holding drug precursor licenses.

5.0 VERIFICATION OF TRANSACTIONS

5.1 Before selling, transferring, or otherwise conducting a transaction with another person in this state involving a drug precursor as defined in these regulations, a licensed person shall verify the identity of the recipient of the drug precursor and that he intends to use it in compliance with all federal and state licensing regulations.

6.0 REQUIRED REPORTS

6.1 The following is required for all drug precursor transactions:

6.1.1 Licensees may report regular lawful drug precursor transactions that meet the requirements of 12-22-318 (11) (a) in a comprehensive monthly report for regular recipients approved by the Department when the licensee's application was approved or when the recipient was approved as a regular recipient pursuant to an initial transaction report required by 12-22-318 (7) (b).

6.1.2 All other transactions must be reported as required by 12-22-318 (7) at least 21 calendar days before delivery of the drug precursor to the recipient.

6.1.3 The Department shall review all reports in a timely manner and contact the licensee if there is reason to believe that a transaction is not in the public interest. If a licensee has submitted a report required by 6.1.1 and the Department has not otherwise notified the licensee, delivery of the precursor can be made after 21 calendar days since the date of the report have lapsed.

6.2 Licensed persons shall indicate on each transaction required by 6.1.1 any suspicious drug precursor purchase and order attempts.

6.3 A suspicious order shall include, among others:

6.3.1 Any transaction involving an extraordinarily high quantity of drug precursor, an uncommon method of payment, an unusual method of delivery, or any other situation that causes the supplier to believe that the drug precursor might be used for other than a legitimate purpose.

6.3.2 Any proposed transaction with a person whose description or other identifying characteristics have been previously furnished by a law enforcement agency to the licensee.

6.3.3 Any unusual or excessive loss, disappearance or theft of a drug precursor in the possession of a licensee.

6.3.4 The Department shall provide to each licensee, at the time the license is issued, a detailed list of more specific ways to detect suspicious orders.

6.4 In no event shall the attempted transfer of a drug precursor be completed until after notice to the Department and the transfer has either been approved by the Department or twenty-one days has expired.

6.5 Any theft or loss of any drug precursor discovered by a licensee shall be reported to the Department within three days after such discovery by telephone followed up by a written report on forms furnished by the Department as per 12-22-318 (8) (a).

6.6 Any difference between the quantity of any drug precursor received and the quantity shipped (ordered) shall be reported to the department within three days after the receipt of actual knowledge of the discrepancy. Such report shall include the name, address and telephone number of any common carrier or person who transported the substance and the date of shipment of the substance (12-22-318 (9)(a)).

6.7 Any licensee who received from a source outside this state any drug precursor shall submit a monthly report of such transactions to the department on a form provided by the department. Each monthly report is due by the 10th of the month following the month in which the drug precursor(s) was received from the out-of-state source.

7.0 REQUIRED RECORDS

7.1 All licensees shall keep an accurate and legible record of all transactions involving drug precursors and shall maintain the records for a period of two (2) years from the year in which the transaction took place as required in 12-22-318, section (1) (b).

8.0 INSPECTIONS

8.1 The Department may inspect the establishment and all required records and reports relating to drug precursors of a licensee or applicant for license and/or waiver.