Part 3. Regulation of Manufacture, Distribution, and Dispensing of Controlled Substances

The board or the department may adopt rules and charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances within this state.

(1) Every person who manufactures, distributes, or dispenses any controlled substance within this state, or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance within this state, shall obtain annually or biannually, if applicable, a registration, issued by the respective licensing board or the department in accordance with rules adopted by such board or by the department. For purposes of this section and this article 18, “registration” or “registered” means the registering of manufacturers, pharmacists, pharmacies, and humane societies located in this state, and distributors located in or doing business in this state, by the state board of pharmacy, as set forth in article 280 of title 12, the licensing of physicians by the Colorado medical board, as set forth in article 240 of title 12, the licensing of podiatrists by the Colorado podiatry board, as set forth in article 290 of title 12, the licensing of dentists by the Colorado dental board, as set forth in article 220 of title 12, the licensing of optometrists by the state board of optometry, as set forth in article 275 of title 12, the licensing of veterinarians by the state board of veterinary medicine, as set forth in article 315 of title 12, and the licensing of researchers and addiction programs by the department of human services, as set forth in part 2 of article 80 of title 27.
(2) A person registered by the board or the department under this part 3 to manufacture, distribute, dispense, or conduct research with controlled substances may possess, manufacture, distribute, dispense, or conduct research with those substances to the extent authorized by the registration and in conformity with this article 18 and with article 280 of title 12.
(3) The following persons need not register and may lawfully possess controlled substances under this article:
(a) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if the agent or employee is acting in the usual course of business or employment;
(b) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance is in the usual course of business or employment;
(c) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner.
(4) The board or department may waive by rule the requirement for registration of certain manufacturers, distributors, or dispensers upon finding it consistent with the public health and safety.
(5) The board or department may inspect the establishment of a registrant or applicant for registration of those persons they are authorized to register under this part 3 in accordance with rules adopted by the board or department.

(1) The board or department shall register an applicant to manufacture or distribute substances included in schedules I through V unless the board or department determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the board or department shall consider the following factors:
(a) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, research, or industrial channels;
(b) Compliance with applicable state and local law;
(c) Promotion of technical advances in the art of manufacturing controlled substances and the development of new substances;
(d) Any convictions of the applicant under any laws of another country or federal or state laws relating to any controlled substance;
(e) Past experience of the applicant in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion of controlled substances into other than legitimate medical, scientific, research, or industrial channels;
(f) Furnishing by the applicant of false or fraudulent material in any application filed under this article;
(g) Suspension or revocation of the applicant’s federal registration or the applicant’s registration of another state to manufacture, distribute, or dispense controlled substances as authorized by federal law; and
(h) Any other factors relevant to and consistent with the public health and safety.
(2) Registration under subsection (1) of this section entitles a registrant to manufacture or distribute a substance included in schedule I or II only if it is specified in the registration.
(3) A practitioner must be registered with the board or department before dispensing a controlled substance or conducting research with respect to a controlled substance included in schedules II through V. The department need not require separate registration under this article for practitioners engaging in research with nonnarcotic substances included in schedules II through V where the registrant is already registered under this article in another capacity. Practitioners registered under federal law to conduct research with substances included in schedule I may conduct research with substances included in schedule I within this state upon furnishing the department evidence of that federal registration.
(4) A manufacturer or distributor registered under the federal “Controlled Substances Act”, 21 U.S.C. sec. 801 et seq., may submit a copy of the federal application as an application for registration as a manufacturer or distributor under this section. The board may require a manufacturer or distributor to submit information in addition to the application for registration under the federal act.
(5) Persons licensed or registered under article 280 of title 12 or article 220, 240, 275, 290, or 315 of title 12 need not be licensed separately to distribute or dispense controlled substances to the extent provided under law if they are registered or are exempt from registration by the federal drug enforcement administration, provided that such persons indicate on any initial application or renewal application the schedules of controlled substances that the persons are authorized to use under Public Law 91-513, known as the federal “Comprehensive Drug Abuse Prevention and Control Act of 1970”.

(1) The board or department may suspend or revoke a registration under section 18-18-303 to manufacture, distribute, or dispense a controlled substance upon finding that the registrant has:
(a) Furnished false or fraudulent material information in any application filed under this part 3;
(b) Been convicted of a felony under any state or federal law relating to any controlled substance;
(c) Had the registrant’s federal registration suspended or revoked and is no longer authorized by federal law to manufacture, distribute, or dispense controlled substances; or
(d) Committed acts that would render registration under section 18-18-303 inconsistent with the public interest as determined under that section.
(2) The board or department may deny, suspend, revoke, or take other authorized disciplinary action to limit the authority of any registrant to prescribe, distribute, dispense, or administer controlled substances, or any classification thereof, within this state if grounds for denial, suspension, or revocation exist. These proceedings shall be conducted in accordance with the provisions of article 4 of title 24, C.R.S.
(3) If a registration is suspended or revoked, the board or department may place under seal all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. When a revocation order becomes final, the court may order the controlled substances forfeited to the state.
(4) The board or department may seize or place under seal any controlled substance owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by the registration. The controlled substance must be held for the benefit of the registrant or the registrant’s successor in interest. The board or department shall notify a registrant, or the registrant’s successor in interest, whose controlled substance is seized or placed under seal, of the procedures to be followed to secure the return of the controlled substance and the conditions under which it will be returned. The board or department may not dispose of any controlled substance seized or placed under seal under this subsection (4) until the expiration of one hundred eighty days after the controlled substance was seized or placed under seal. The costs incurred by the board or department in seizing, placing under seal, maintaining custody, and disposing of any controlled substance under this subsection (4) may be recovered from the registrant, any proceeds obtained from the disposition of the controlled substance, or from both. Any balance remaining after the costs have been recovered from the proceeds of any disposition must be delivered to the registrant or the registrant’s successor in interest.
(5) The board or department shall promptly notify the drug enforcement administration of all orders restricting, suspending, or revoking registration and all forfeitures of controlled substances.

(1) Before denying, suspending, or revoking a registration, or refusing a renewal of registration, the board or department shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended, or the renewal refused. The order must state its grounds and direct the applicant or registrant to appear before the board or department at a specified time and place not less than thirty days after the date of service of the order. In case of a refusal to renew a registration, the order must be served not later than thirty days before the expiration of the registration. These proceedings must be conducted in accordance with section 24-4-105, C.R.S. The proceedings do not preclude any criminal prosecution or other proceeding. A proceeding to refuse to renew a registration does not affect the existing registration, which remains in effect until completion of the proceeding.
(2) The board or department may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings under section 18-18-304, or where renewal of registration is refused, upon finding that there is an imminent danger to the public health or safety which warrants this action. The suspension continues in effect until the conclusion of the proceedings, including judicial review thereof, unless sooner withdrawn by the board or department or dissolved by a court of competent jurisdiction.

Persons registered to manufacture, distribute, or dispense controlled substances under this part 3 shall keep records and maintain inventories in conformance with the record keeping and inventory requirements of federal law and with any additional rules adopted by the board or department.

A substance included in schedule I or II may be distributed by a registrant to another registrant only pursuant to an order form. Compliance with the provisions of federal law respecting order forms constitutes compliance with this section.

(1) As used in this section, “medical treatment” includes dispensing or administering a narcotic drug for pain, including intractable pain.
(2) Except as provided in section 18-18-414, a person may dispense a controlled substance only as provided in this section.
(3)
(a) Except as provided in paragraph (b) of this subsection (3), a person shall not dispense a substance included in schedule II to an ultimate user of the substance without:
(I) The written prescription of a practitioner; or
(II) An electronic prescription drug order for a schedule II substance that is created and transmitted in accordance with 21 CFR 1311.
(b) A practitioner, other than a pharmacy, may dispense a schedule II substance directly to the ultimate user without a written prescription.
(4)
(a) Except as provided in paragraph (b) of this subsection (4), a person shall not dispense a substance included in schedule III, IV, or V to an ultimate user of the substance without:
(I) A written or oral prescription order of a practitioner; or
(II) An electronic prescription drug order for a schedule III, IV, or V substance that is created and transmitted in accordance with 21 CFR 1311.
(b) A practitioner, other than a pharmacy, may dispense a schedule III, IV, or V substance directly to the ultimate user without a written prescription.
(c) A prescription order for a schedule III, IV, or V substance must not be filled or refilled more than six months after the date of the order or be refilled more than five times.
(5) A practitioner may dispense or deliver a controlled substance to or for an individual or animal only for medical treatment or authorized research in the ordinary course of that practitioner’s profession.
(6) No civil or criminal liability or administrative sanction may be imposed on a pharmacist for action taken in reliance on a reasonable belief that an order purporting to be a prescription was issued by a practitioner in the usual course of professional treatment or in authorized research.

(1) As used in this section, “diversion” means the transfer of any controlled substance from a licit to an illicit channel of distribution or use.
(2) The department shall regularly prepare and make available to other state regulatory, licensing, and law enforcement agencies a report on the patterns and trends of actual distribution, diversion, and abuse of controlled substances.
(3) The department shall enter into written agreements with local, state, and federal agencies for the purpose of improving identification of sources of diversion and to improve enforcement of and compliance with this article and other laws and regulations pertaining to unlawful conduct involving controlled substances. An agreement must specify the roles and responsibilities of each agency that has information or authority to identify, prevent, and control drug diversion and drug abuse. The department shall convene periodic meetings to coordinate a state diversion prevention and control program. The department shall arrange for cooperation and exchange of information among agencies and with neighboring states and the federal government.
(4) Repealed.