STATEMENT OF BASIS AND PURPOSE 
and spECIFIC STATUTORY AUTHORITY FOR
Rules for The Colorado Cancer Drug Repository Program 
6 CCR 1015-10
Adopted by the State Board of Health on
May 17, 2006
Basis and Purpose. These rules implement the Colorado Cancer Drug Repository Program, that was created by Senate Bill 05-165 which was signed by the Governor on April 14, 2005.  The law provides for the donation of unused cancer drugs and devices to health care facilities, medical clinics, and prescription drug outlets to be redistributed or redispensed for use by uninsured and underinsured cancer patients. 
Specific Statutory Authority.  These rules are promulgated pursuant to C.R.S. 25-35-101 et seq., 
Major Factual and Policy Issues Encountered. 
The Department’s priority in establishing these rules is to maintain patient safety while establishing a framework for donation and distribution of unused cancer drugs and devices for use by uninsured and underinsured cancer patients.  .  
In accordance with legislative directives, the Department consulted with the state Board of Pharmacy at their board meeting on March 16, 2006.    The Board of Pharmacy asked that a stipulation be placed so that drugs requiring specific registration with the manufacturer for dispensing not be accepted for the program.  The Board of Pharmacy felt this stipulation was necessary for manufacturers of registered drugs to maintain records of location and usage, and to ensure usage within limited manufacturers’ guidelines.  The Board of Pharmacy was in agreement with the content of the remainder of the proposed rules.  
There are multiple other reasons that certain drugs may not be appropriate for redispensing or redistribution.  For instance, federal law prohibits the return of controlled substances, eliminating many drugs that are used to treat painful conditions associated with cancer.  
The Department chose to define “family member” to include authorized agents.  As a result, the regulation accommodates cancer patients who do not have next of kin able to make a donation by allowing such patient’s authorized agents to make donations. .  
The statute specifically requires a list of cancer drugs, arranged by category or individual cancer drug, which will and will not be acceptable to the program.  The Department could not realistically develop an itemized list of individual cancer drugs, given the frequent additions of new cancer drugs to the oncology formulary, and frequent revisions in prescribing recommendations.   For that reason, the Department has identified general guidelines that allow continuous change in the formulary of oncology drugs without requiring constant revision to the regulations.  
Finally, the legislature granted the Department the ability to determine the amount of the dispensing fee, if any.  After analysis, the Department determined that the distribution or dispensing fee should be set  at the Medicaid reimbursement level, to be consistent with the intent to assist uninsured and underinsured patients.  At the current time, the Medicaid reimbursement amount for prescriptions is $4.00.
Alternative Rules Considered and Why Rejected.
The Department evaluated the possibility of expanding the definition of medical device to be consistent with the FDA definition of medical device.  This would allow supplies not requiring a prescription to be donated.  After careful consideration, the Department determined that the considered expanded definition exceeded the statutory authority given in Colorado Cancer Drug Repository Act and, therefore, is not included in the proposed rules.