Tracking #2007-00849
(former emergency #2007-00895)
Final (permanent) adoption of emergency 9/7/07, eff. 9/7/07

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(6 CCR 1008-2)

[Instructions:  Replace lines 843718 through 843771 in entirety under the Department of Human Services).]]
Rules concerning the Licensing and Registration of Researchers, Analytical Laboratories, and Addiction Programs Using Controlled Substances (6 CCR 1008-2) were adopted on 7/28/71, effective 10/1/71 by the Department of Health. Revisions to pp. 1-10 were adopted 3/26/83, effective 4/30/83. Revisions to pp. 1-6 were adopted 12/16/92, effective 1/30/93. Contact the Colorado Department of Public Health and Environment for these materials. 
Re-write of Section 6 CCR 1008-2 (22.000 through 22.800) was adopted as emergency at the 8/3/2007 State Board of Human Services meeting, with an effective date of 9/1/2007 (Rule-Making# 07-3-22-1). Statement of Basis and Purpose and specific statutory authority for these revisions were incorporated by reference into the rule. These materials are available for review by the public during normal working hours at the Colorado Department of Human Services, State Board Administration.
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22.000 LICENSING OF ADDICTION PROGRAMS USING CONTROLLED SUBSTANCES
[Technical note:  Publisher, please note the change in the rule/section title]
22.100  ADMINISTRATION [Rev. eff. 9/7/07]
The Colorado Department of Human Services, Alcohol and Drug Abuse Division (ADAD) is authorized to establish rules by which it licenses and monitors the administration and provision of services of approved treatment facilities that dispense controlled substances to treat addiction or that use controlled substances to treat the withdrawal symptoms of an addiction.
22.200  DEFINITIONS [Rev. eff. 9/7/07]
"Addicted" or "addiction" means dependence upon a drug in the following manner: 
A.  Psychological dependence upon a drug so that the user lacks the ability to abstain from taking or using the drug or experiences a compulsive need to continue its use; and,
B.  A tolerance to the effects of the drug which leads the user to require larger and more potent doses; and,
C.  Such physical dependence upon the drug that the user suffers withdrawal symptoms if the user is deprived of its dosage.
“Administer “ means the direct application of a controlled substance, whether by injection, inhalation, ingestion or any other means to the body of a patient.
“Approved private treatment facility” means a private agency meeting the standards prescribed in Section 25-1-1102(1) and approved under Section 25-1-1102, Colorado Revised Statutes and shall be referred to as “approved treatment facility.”
“Approved public treatment facility” means a treatment agency operating under the direction and control of or approved by the Alcohol and Drug Abuse Division  and meeting standards prescribed in Section 25-1-1102(1) and approved under Section 25-1-1102, Colorado Revised Statutes and shall be referred to as “approved treatment facility.”
“Compound” means to produce or create by combining two or more substances.
“Controlled substance” means a drug whose general availability is restricted or any substance that is strictly regulated or outlawed because of its potential for abuse or dependence. Controlled substances include narcotics, stimulants, depressants, hallucinogens, and cannabis.
“Corrective action” means a time limited remedial measure applied to treatment agencies that are out of compliance during a three year licensing period.
“Critical incident” means a significant event or condition, which may be of public concern, which jeopardizes the health, safety, and/or welfare of staff and/or clients including client deaths on or off treatment agency premises and theft or loss of controlled substances prescribed for clients and dispensed, administered, and/or monitored by licensed treatment agencies.
“Department” means the Colorado Department of Human Services.
"Dispense" means to interpret, evaluate, and implement a prescription drug order or chart order, including the preparation of a drug for a patient in a suitable container appropriately labeled for subsequent administration to or use by a patient.
"Dispenser" means a practitioner who dispenses.
“Diversion” means the transfer of any controlled substance from a licit to an illicit channel of distribution or use.
“Division” means the Division of Alcohol and Drug Abuse within the Colorado Department of Human Services.
“Maintenance treatment” means the dispensing of a controlled substance, such as methadone or buprenorphine, at stable dosage levels for a period in excess of twenty-one (21) days in the supervised treatment of an individual for opioid addiction.
“Medication assisted treatment" means any treatment for an addiction that includes giving a controlled substance for medical addiction detoxification or maintenance treatment, which may be combined with other treatment services including medical, and shall be combined in all circumstances with psychosocial services.
“Medical detoxification” means the process through which a person who is physically dependent on alcohol, illicit drugs, prescription medications, or a combination of these substances is over a period of time withdrawn from the substances of dependence and the process may include the use of controlled substances to alleviate the symptoms of withdrawal under the supervision of a licensed practitioner.
“Patient” means any individual who receives a controlled substance for the purpose of addiction treatment or to treat withdrawal symptoms of an addiction
"Physical dependence" means a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
“Practitioner” means: 
A.  A physician or other person licensed, registered or otherwise permitted to distribute, dispense, or to administer a controlled substance in the course of professional practice.
B.  A pharmacy, hospital or other institution licensed, registered, or otherwise permitted to distribute, dispense, or to administer a controlled substance in the course of its professional practice in this state.
“Ultimate user” means an individual who lawfully possesses a controlled substance for the individual’s own use or for the use of a member of the individual’s household.
22.300  CONTROLLED SUBSTANCE LICENSE REQUIREMENTS [Rev. eff. 9/7/07]
Approved treatment facilities shall obtain a controlled substance license if they dispense, compound, or administer (Section 12-22-304, C.R.S.) a controlled substance in order to treat an addiction or to treat the withdrawal symptoms of an addiction. All applicants for an ADAD controlled substance license shall demonstrate compliance with these rules and all applicable state and federal statutes and regulations including, but not limited to those pertaining to controlled substances.
22.310  (None)
22.320  LICENSING PROCEDURES [Rev. eff. 9/7/07]
The Division shall issue a controlled substance license to each approved treatment facility meeting all the requirements of Colorado Revised Statutes 12-22-Part 3, 25-1-1102, 18-18-Part 3, the requirements of the controlled substance license rules, and all applicable state and federal statutes and regulations including those that apply to controlled substances.
A.  A controlled substance license issued by the Division shall be obtained annually for each approved treatment facility that dispenses, compounds, or administers a controlled substance to treat addiction or the withdrawal symptoms of an addiction.
B.  A separate controlled substance license is required for each approved treatment facility site where controlled substances are dispensed, compounded, or administered, in order to treat addiction or the withdrawal symptoms of an addiction.
C.  Any approved treatment facility that receives a controlled substance license may dispense, compound, or administer controlled substances only to the extent authorized by their license and in conformity with Colorado Revised Statutes 12-22, Part 3 and with Article 18 of Title 18, C.R.S.
D.  Routine monitoring: controlled substance licensing visits shall be scheduled and conducted by ADAD during the approved treatment facilities normal business hours to the extent possible.
E.  ADAD shall conduct unscheduled site visits for specific monitoring purposes and investigation of complaints or critical incidents involving approved treatment facilities that have an ADAD controlled substance license. These unscheduled visits shall be in accordance with the: 
1.  Controlled substance license rules;
2.  ADAD policies and procedures; 
3.  ADAD substance use disorder treatment rules;
4.  Any statutes and regulations that protect the confidentiality of client identifying information.
F.  ADAD shall have access to all individuals, agencies, client, and staff records and any other relevant documentation required to determine compliance with these rules and to coordinate client placement and care.
G.  No controlled substance license shall be granted to any practitioner who has been convicted within the last two (2) years of a willful violation of Title 12, Article 22, Part 3 of the Colorado Revised Statutes or any other state or federal law regulating controlled substances.
22.330  INITIAL LICENSE [Rev. eff. 9/7/07]
Applicants for an initial controlled substance license to dispense, compound, or administer controlled substances to treat an addiction or to treat the withdrawal symptoms of an addiction shall submit an ADAD controlled substance license application that has been affirmed and signed by a physician, a copy of current policies and procedures addressing the use of controlled substances to treat addiction or withdrawal symptoms of an addiction, and the application fee of $275. 
A.  No approved treatment facility that is required to be licensed shall engage in any activity for which a controlled substance license is required until the facility’s application is granted and a license is issued to the facility by the Division.
B.  Initial controlled substance license applications received by ADAD that are not completed according to instructions, do not include the application fee, or do not include the required policies and procedures shall be returned to the applicant by certified mail with the submitted application fee and a written explanation as to why their application is being returned.
C.  ADAD shall review complete initial applications that have the required fee and appropriate policies and procedures and ADAD shall conduct an on site inspection to determine that the applicant is in compliance with these controlled substance license rules, treatment rules, and all state and federal statutes and regulations.
D.  Initial applicants that are in full compliance shall be granted a controlled substance license that shall remain in effect for one (1) year from the date the license is issued. 
E.  An applicant for licensure pursuant to these rules and regulations, shall also be considered an applicant for registration pursuant to Section 18-18-302, Colorado Revised Statutes.
F.  Initial applicants that are found not to be in full compliance shall have their license applications returned by certified mail with a written explanation as to why their application is being returned and notification that their controlled substance license application has been denied. Application fees shall not be refunded. Applicants may re-apply for initial licenses in accordance with these standards.
22.340  LICENSE RENEWAL [Rev. eff. 9/7/07]
A controlled substance license shall expire one year from the date the license is granted. 
A.  Treatment facilities wishing to continue their controlled substance license shall submit a license renewal application affirmed and signed by a physician to ADAD 30 days prior to the expiration date of their current controlled substance license along with the required fee of $275. A copy of the licensee’s current controlled substance policies and procedures shall also be submitted with each annual renewal application.
B.  Any treatment facility that currently has a controlled substance license issued by ADAD may not apply for renewal more than sixty days before the expiration date of the current controlled substance license.
C.  A controlled substance license renewal application that is received by ADAD after the expiration date of the current license shall be returned to applicant by certified mail with submitted application fee and written notification that the licensee’s controlled substance license is no longer in effect as of the date the certified mail is received. An applicant may re-apply for an initial license in accordance with the controlled substance license rules.
D.  A controlled substance license renewal application that is received by ADAD on or before the current licenses’ expiration date shall be reviewed and on site inspections may be conducted to determine that the licensee is in compliance with all controlled substance license rules.
E. A licensee that is in full compliance shall be granted renewal of their annual controlled substance license that shall be effective for one year from the prior expiration date.
F.  Licensees not in full compliance shall have their applications for renewal of their controlled substance license denied. The licensee shall receive by certified mail written notification as to why the license was denied and notification that their current controlled substance license is no longer in effect as of the date the certified mail is received. Application fees shall not be refunded. Applicants may re-apply for an initial controlled substance license in accordance with these rules.
22.400  LICENSE DENIAL, REVOCATION, OR SUSPENSION [Rev. eff. 9/7/07]
A controlled substance license may be denied, suspended, or revoked upon finding that the licensee: 
A.  Is not in compliance with the controlled substance license rules;
B.  Has violated any provision of Title 12, Article 22, Part 3, and Title 18, Article 18 of the Colorado Revised Statutes or the Department’s rules;
C.  Is not in compliance with applicable state and federal statutes and regulations;
D.  Is not in compliance with the Departments substance use disorder treatment rules; 
E.  Has failed to implement ADAD imposed corrective actions;
F.  Has been negligent resulting in risk to client and/or staff health or safety;
G.  Has failed to provide for adequate supervision of treatment staff as outlined in addiction counselor certification and licensure standards (6 CCR 1008-3);
H.  Has furnished false or fraudulent information in an application;
I.  Has, as a practitioner, been convicted of, or has had accepted by a court a plea of guilty or nolo contendere to a felony under any state or federal law relating to a controlled substance;
J. Has had their federal registration to manufacture, conduct research on, distribute, or dispense a controlled substance suspended or revoked.
22.410 [Rev. eff. 9/7/07]
The Department may limit revocation or suspension of a controlled substance license to the particular controlled substance, which was the basis for revocation or suspension.
22.420 [Rev. eff. 9/7/07]
If the Department denies, suspends or revokes a controlled substance license, all controlled substances owned or possessed by the licensee at the time of the denial or suspension or on the effective date of the revocation order may be placed under seal. No disposition may be made of substances under seal until the time for making an appeal has elapsed or until all appeals have concluded unless a court orders otherwise or orders the sale of any perishable controlled substances and the deposit of the proceeds with the court. Upon a revocation order’s becoming final, all controlled substances may be forfeited to the state.
22.430 [Rev. eff. 9/7/07]
The Department shall promptly notify the Drug Enforcement Administration and the appropriate professional licensing agencies, if any, of all charges and the final disposition thereof and of all forfeitures of a controlled substance.
22.500  NOTIFICATION [Rev. eff. 9/7/07]
Written notification of actions to deny, revoke, or suspend a controlled substance license shall be sent by ADAD via certified mail to last known address of licensee at least ten working days prior to date such actions go into effect. Written notification shall include: 
A.  Reasons for actions, citing applicable controlled substance license rules, applicable substance use disorder treatment rules and/or state and federal statutes and regulations; and,
B.  Rights of appeal in accordance with the State Administrative Procedure Act, Section 24-4-104, C.R.S.
22.600  GENERAL PROVISIONS [Rev. eff. 9/7/07]
Medication assisted treatment using a controlled substance shall be provided to persons who are physically dependent on alcohol, illicit drugs, prescription medications, or a combination of these substances to alleviate the person’s physical withdrawal symptoms and cravings, to help stabilize behavior, to increase productivity, and to reduce the risk of contracting and transmitting infectious diseases.
22.610  MEDICATION ASSISTED TREATMENT [Rev. eff. 9/7/07]
A.  Approved treatment facilities shall only dispense, compound, or administer, controlled substances by or on the order of a physician who currently possesses and maintains a license to practice medicine in the State of Colorado as provided by Article 36, Title 12, C.R.S. The physician’s medical order shall be documented in the patient’s treatment record.
B.  Approved treatment facilities that dispense, compound, or administer, controlled substances must also have a current registration from the Drug Enforcement Administration.
C.  All controlled substances shall be dispensed, compounded, or administered, according to applicable state and federal statutes, regulations, and rules, controlled substance license rules, and ADAD policies and procedures.
D.  Controlled substances shall be dispensed, compounded, or administered, in accordance with the manufacturer’s specifications found on product labels and/or in printed instructions accompanying the product.
E.  Licensees shall maintain an individual dispensing record on each patient that receives controlled substances at their facility. The dispensing record shall include: 
1.  Complete name of person receiving the controlled substance: 
2.  Name of the controlled substance, strength, and dosage form; 
3.  Amount consumed; 
4.  Amount dispensed; 
5.  Date dispensed; 
6.  Amount and dosage form taken home by person (if applicable); 
7.  First initial and last name and the credentials of the person who dispensed the controlled substance medication. 
F.  Licensees shall ensure that all personnel are working within their scope of practice and shall only allow licensed medical personnel to dispense, compound, or administer, controlled substances.
G.  Each approved treatment facility shall provide formal training and testing on an annual basis to all employees on the Department’s rules, the pharmacology of the substances dispensed, and state and federal requirements especially around confidentiality.
22.700  FACILITY POLICIES AND PROCEDURES [Rev. eff. 9/7/07]
Licensees shall develop and implement policies and procedures, as defined in this section, that address the use of controlled substances in the treatment of addiction or the withdrawal symptoms of an addiction. These policies shall include, but are not limited to, how clients are assessed to be appropriate to receive a controlled substance to treat their addiction or the withdrawal symptoms of an addiction. These policies shall meet the requirements of all federal, state, and local laws pertaining to controlled substances.  
22.710  MEDICAL EVALUATIONS [Rev. eff. 9/7/07]
Patients who wish to receive medication assisted treatment shall have medical evaluations conducted by a physician, physician’s assistant, or nurse practitioner to determine physical dependence and to determine that such patients are appropriate for treatment with a controlled substance. Evaluations shall include, but are not limited to: 
A.  A medical history that includes a detailed and comprehensive account of substance use history that includes all substances of abuse;
B.  Evidence of current physiological dependence; and,
C.  A pregnancy screen for females of childbearing age.
22.720  INFORMED CONSENT [Rev. eff. 9/7/07]
All patients receiving medication assisted treatment shall sign informed consent that they are voluntarily agreeing to treatment with a controlled substance. The patient shall be informed of what controlled substance they are receiving and the expected benefits and risks of medication assisted treatment. All patients receiving controlled substances must also be informed of the risks of using other substances in combination with a controlled substance.
22.730  SECURITY CONTROLS AND OPERATING PROCEDURES [Rev. eff. 9/7/07]
All licensees must follow the standards of physical security controls and operating procedures required by the federal Drug Enforcement Administration necessary to prevent diversion as outlined in Title 21, Food and Drugs, Chapter ii, Code of Federal Regulations, Sections 1301.71 through 1301.76; no later editions are incorporated. These regulations are available from the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control, 2401 Jefferson Davis Highway, Alexandria, VA 22301; or, the Colorado Department of Human Services, Alcohol and Drug Abuse Division, 4055 S. Lowell Blvd., Bldg. KA, Denver, Colorado 80236; or at any state publications depository library.
22.740  RECORD KEEPING [Rev. eff. 9/7/07]
Licensees shall follow the record keeping requirements of the federal Drug Enforcement Administration, Code of Federal Regulations (Title 21, Food and Drugs, Part 1304) to ensure compliance with the requirements in Title 12, Article 22, Part 3, Colorado Revised Statutes; no later editions are incorporated. These regulations are available from the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control, 2401 Jefferson Davis Highway, Alexandria, VA 22301; or the Colorado Department of Human Services, Alcohol and Drug Abuse Division, 4055 S. Lowell Blvd., Bldg. KA, Denver, Colorado 80236; or at any state publications depository library.
Licensees shall also keep inventories, records, and reports that are required by any other state or federal law or standard regulating controlled substances.
22.750  CRITICAL INCIDENT REPORTING [Rev. eff. 9/7/07]
A critical incident is any significant event or condition that may jeopardize the health, safety, and/or welfare of patients or staff. Theft, loss, or diversion of a controlled substance shall also be considered a critical incident and the ADAD critical incident reporting policy shall be followed. ADAD must be notified verbally within twenty-four (24) hours of the critical incident and a written report must be submitted to ADAD within thirty (30) days. 
22.760  HANDLING AND STORAGE [Rev. eff. 9/7/07]
All licensees shall have adequate and proper facilities for the handling and storage of controlled substances. All licensees must maintain proper control over such controlled substances to ensure against their being illegally dispensed or distributed. Access to the storage area shall be restricted to persons specifically authorized to handle controlled substances. This includes restricting the number and accessibility of keys or passwords.
Licensees shall also develop and implement policies on how controlled substances will be obtained, stored, and accounted for. These policies shall include, but are not limited to: 
A.  What controlled substance the licensee will be using for the addiction they are treating and how these controlled substances will be dispensed, compounded, or administered, as well who will be responsible for ordering the controlled substances;
B.  Where the controlled substances will be stored;
C.  How the controlled substances will be accounted for; and, 
D.  Who will have access to the controlled substances.
22.800  TOXICOLOGY SCREENING REQUIREMENTS [Rev. eff. 9/7/07]
Licensees shall develop and implement toxicology screen policies and procedures that specifies a random sample collection protocol and these policies shall include, but not be limited to: 
A.  How appropriate and approved samples for drug testing shall be collected and analyzed in accordance with applicable state and federal statutes and regulations.
B.  How toxicology screens shall be used to detect the presence of the approved controlled substance, that is being dispensed, and its metabolite, for which laboratory analyses are available.
C.  How all patients entering medication assisted treatment shall provide a toxicology screen at time of admission and then at least one random toxicology screen per month which test for the presence of all substances of abuse, including alcohol and marijuana.
D.  How a licensee shall address a patient having illicit substances in a toxicology screen, including unauthorized prescription medications.
E.  How the licensee will have the ability to observe sample collection by appropriate personnel to help minimize falsification.