3 Colo. Code Regs. § 719-1-25.00.00
Current through Register Vol. 47, No. 20, October 25, 2024
Section 3 CCR 719-1-25.00.00 - SPECIALIZED PRESCRIPTION DRUG OUTLETS25.00.10 Definitions. a. "Automated device" or "AD" means a mechanical system that performs operations or activities relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains appropriate transaction information.b. "Hospice inpatient unit" means a facility as defined in section 15.5-4-103(8), C.R.S., that is licensed pursuant to section 25-1.5-103, C.R.S.c. "Long term care facility" or "LTCF" means a nursing facility as defined in section 25.5-4-103(14), C.R.S., that is licensed pursuant to section 25-1.5-103, C.R.S. An LTCF is a nursing home, skilled nursing facility or a nursing care facility that provides supportive, therapeutic, or compensating services with the availability of a licensed nurse for observation and treatment on a twenty-four hour basis.d. "Managing prescription drug outlet" means the prescription drug outlet located within the State of Colorado which is responsible for ownership and operation of a specialized prescription drug outlet located at an LTCF or hospice inpatient unit within Colorado. The managing prescription drug outlet is responsible for the application for the specialized prescription drug outlet on behalf of the LTCF or hospice inpatient unit. The managing prescription drug outlet shall own and operate the SPDO and maintain ownership of the drugs.e. "Specialized prescription drug outlet" or "SPDO" means an outlet located at an LTCF or hospice inpatient unit which is owned and operated by a managing prescription drug outlet located within the State of Colorado. The managing prescription drug outlet engages in the compounding, dispensing, and delivery of drugs and devices, or the provision of pharmaceutical care, residents of the LTCF or hospice inpatient unit. The managing prescription drug outlet may use automated devices in the SPDO to provide drugs, as well as other Board-approved nontraditional methods, to provide pharmaceutical care to the residents of the LTCF or hospice inpatient unit.f. "Stock drugs" mean non-patient specific prescription drugs or controlled substances that are distributed from a managing prescription drug outlet to a SPDO by means other than a patient-specific prescription order or LTCF or hospice inpatient unit chart order.25.00.12 Requirements for Registration. Eligibility requirements for an SPDO include the following: a. A current Board-issued registration of the managing prescription drug outlet that engages in the compounding, dispensing, and delivery of drugs, or provision of pharmaceutical care to residents of an LTCF or hospice inpatient unit;b. The submission of a separate application by the managing prescription drug outlet on behalf of the SPDO for a SPDO registration, on a form provided by the Division of Professions and Occupations. The managing prescription drug outlet shall submit an application for each individual SPDO to which the managing prescription drug outlet will provide stock drugs;c. A Drug Enforcement Administration registration specifically assigned to the SPDO if the managing prescription drug outlet provides stock controlled substances to the SPDO;d. A pharmacist manager who, in addition to being responsible for the operations of the managing prescription drug outlet in compliance with all state and federal laws and rules, is responsible for the operations of the SPDO in compliance with all provisions of Rule 25.00.00; ande. A secure AD that prevents the diversion of drugs and that limits the access to drugs within the AD only to those persons whom have been given permission to access the AD.25.00.14 Scope of Practice. a. An SPDO shall maintain and operate an AD for the purpose of storing drug stocks.b. The managing prescription drug outlet shall ensure that all medications stocked in the AD are either in unit dose form, single dose packages, or packaged as such or in customized medication packs prior to release from the AD for administration to a patient. All records of packaging shall be maintained at the managing prescription drug outlet.c. Medication that is packaged and labeled for a specific patient by an AD at the SPDO is the responsibility of the specific pharmacist that conducted the final verification of the prepackaged automated cassette pertaining to that specific drug at the PDO. The pharmacist that conducted the final verification of the prepackaged automated cassette pertaining to that specific drug at the PDO shall be deemed to be the pharmacist responsible for the final evaluation of all prescriptions dispensed from the automated cassette within the AD at the SPDO.d. An SPDO shall only utilize stock prescription drugs or controlled substances it receives from the managing prescription drug outlet for the purpose of drug administration, and not for the purpose of further dispensing.25.00.16 Records and Recordkeeping. a. The managing prescription drug outlet shall be exempt from any casual sale limitations specified in section 12-280-103(8), C.R.S., only to the extent of distributing drug stocks to an SPDO.b. Records of drug distribution from the managing prescription drug outlet to the SPDO shall be retained at the managing prescription drug outlet and shall be readily available for inspection by the Board or its inspectors for at least two years from the date of distribution. These records shall be maintained separately from all other records of distribution to Board-registered entities which are not SPDOs or individual practitioners authorized by law prescribe the drugs. The record of distribution shall include the following: 2. The strength of the drug;3. The dosage form if appropriate;4. The quantity of the drug;5. The name of the manufacturer or the NDC number of the drug if labeled only with its generic name;6. The date of distribution;7. The name and address of the distributing prescription drug outlet;8. The name and address of the receiving SPDO;9. If a controlled substance is distributed, the record shall also indicate the DEA registration number of the distributing prescription drug outlet and the receiving SPDO;10. A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form;11. The identity of the person in the prescription drug outlet who issued the drug; and12. The identity of the person who placed the drug into the SPDO's AD.c. A duplicate copy of the record of distribution outlined in Rule 25.00.16 shall be maintained at the SPDO in a readily retrievable manner for at least two years from the date of receipt. This record shall serve as the SPDO's record of receipt.d. Records of use from the AD shall be retained at the managing prescription drug outlet and shall be readily available for inspection by the Board or its inspectors for at least two years from the date of latest use transaction. The record of use shall include the following:1. The name of the patient;2. The name of the practitioner;4. The name, strength and dosage form of the drug removed;5. The quantity of the drug removed; and6. The identity of the person at the SPDO that removed the drug.e. A complete and exact inventory of all stocks of controlled substances shall be conducted at each SPDO at least once every month. The inventory shall be recorded on a uniform and readily retrievable record, and this record shall be signed by the pharmacist manager of the managing prescription drug outlet or another pharmacist as delegated by the pharmacist manager. The inventory shall include the date and time of day the inventory was conducted. A copy of this recorded inventory shall be maintained and readily available for inspection at both the managing prescription drug outlet and SPDO for at least two years from the date the inventory was conducted. This inventory record shall be maintained separately from all other recorded inventories of the managing prescription drug outlet.25.00.18 Policy and Procedure Manual.a. Each managing prescription drug outlet and corresponding SPDO shall maintain a policy and procedure manual which is approved by the Board or its designee prior to SPDO operation. This policy and procedure manual shall be reviewed, signed, and dated by both the pharmacist manager of the managing prescription drug outlet and the nursing home or hospice inpatient unit administrator or other accountable individual of the SPDO at least once annually. The pharmacist manager shall be responsible for assuring that the nursing home or hospice inpatient unit administrator or other accountable individual of the SPDO signs the policy and procedure manual.b. If a change in the pharmacist manager, or nursing home or hospice inpatient unit administrator or other accountable individual at the SPDO occurs, the new pharmacist manager and/or nursing home or hospice inpatient unit administrator or other accountable individual shall review, sign, and date the policy and procedure manual within thirty days of assuming the respective positions. The pharmacist manager shall be responsible for assuring that the new nursing home administrator or other accountable individual of the SPDO signs the policy and procedure manual.c. The policy and procedure manual shall, at minimum, address the accessibility to, the stocking of, the accountability and recordkeeping of, and the security of, the AD.25.00.21 Relocation. a. In the event of a relocation of a SPDO, the managing prescription drug outlet shall submit an application form provided by the Division of Professions and Occupations along with the prescribed fee at least 30 days prior to the effective date of relocation.25.00.22 Reinstatement of a SPDO Registration. If a registration of a SPDO has expired, the managing prescription drug outlet seeking to reinstate such SPDO registration shall submit an application on a form provided by the Division of Professions and Occupations along with the required fee.25.00.24 Closure. a. Upon the closure of the SPDO it shall be the responsibility of the managing prescription drug outlet's pharmacist manager to remove all drug stocks from the LTCF or hospice inpatient unit within seventy-two hours after closure.b. The pharmacist manager of the managing prescription drug outlet shall notify the Board of the closure of the SPDO location within seven business days of the closure.37 CR 18, September 25, 2014, effective 10/15/201438 CR 16, August 25, 2015, effective 9/14/201539 CR 04, February 25, 2016, effective 3/16/201639 CR 19, October 10, 2016, effective 11/14/201640 CR 04, February 25, 2017, effective 3/17/201740 CR 20, October 25, 2017, effective 11/14/201741 CR 16, August 25, 2018, effective 9/17/201842 CR 21, November 10, 2019, effective 11/30/201943 CR 10, May 25, 2020, effective 5/1/202043 CR 08, April 25, 2020, effective 5/15/202043 CR 15, August 10, 2020, effective 8/30/202043 CR 20, October 25, 2020, effective 11/14/202044 CR 04, February 25, 2021, effective 3/17/202144 CR 08, April 25, 2021, effective 5/15/202144 CR 21, November 10, 2021, effective 11/30/202145 CR 20, October 25, 2022, effective 9/29/202245 CR 21, November 10, 2022, effective 11/30/2022