3 Colo. Code Regs. § 719-1-31.00.00
Current through Register Vol. 47, No. 20, October 25, 2024
Section 3 CCR 719-1-31.00.00 - TELEPHARMACIES31.00.05 Definitions. a. "Area of need" means any health facility licensed or certified by the Department of Public Health and Environment pursuant to section 25-1.5-103(1), C.R.S., or any area where a demonstration of need is approved by the Board.b. "Central pharmacy" means a registered prescription drug outlet located in Colorado which is responsible for overseeing the operation of no more than two (2) telepharmcies.c. "Telepharmacy" has the same meaning as set forth in section 12-280-103(50), C.R.S.31.00.10. Application Requirements.31.00.11 Registration. The applicant for registration shall obtain the appropriate form as approved by the Board to register a telepharmacy. In the case of an application for a new telepharmacy, for a transfer of ownership of a telepharmacy, or for the relocation of a telepharmacy, the applicant shall submit such additional documentation as the Board may require.31.00.15 Applications. The Board, or its agent, may require any applicant or pharmacist manager of a telepharmacy to meet with the Board, or its agent, before the Board takes action on any registration.31.00.20 No two registered outlets may occupy the same physical space. If there are two (or more) registrants co-located within the same building or at the same address, each must have its own area, separated by floor to ceiling walls, and separate entrances.31.00.30 Transfer of Ownership. Application to transfer registration of a telepharmacy shall be submitted to the Board as provided in section 12-280-118, C.R.S., within thirty (30) days of the transfer of ownership. A transfer of ownership shall be deemed to have occurred: a. In the event the telepharmacy is owned by a corporation, upon sale or transfer of twenty percent or more of the shares of said corporation to a single individual or entity.b. In the event the telepharmacy is owned by a partnership, upon sale or transfer of twenty percent or more of any ownership interest.c. In the event the telepharmacy is owned by a limited liability company (LLC), upon sale or transfer of twenty percent or more of the membership interests.d. Upon incorporation of an existing telepharmacy.31.00.40 Relocation. In the event of a relocation of a telepharmacy shall submit an application provided by the board along with the prescribed fee no more than thirty (30) days prior to the effective date of relocation.31.00.50 Reinstatement of a Telepharmacy Registration. a. If a registration has expired, a telepharmacy seeking to reinstate such registration shall submit the following: (1) The current reinstatement application with the required fee;(2) If the owner of the telepharmacy is a corporation, submit either a copy of the articles of incorporation as they were filed with the Colorado Secretary of State or a Certificate of Good Standing issued by the Colorado Secretary of State;(3) A letter stating whether the corporation is public or private as follows:(A) If the corporation is a public corporation, submit a list of all stockholders owning five percent or more of the stock; or(B) If the corporation is a private corporation, submit a list of all stockholders;(4) An accurate drawn-to-scale floor plan of the telepharmcy's compounding / dispensing area detailing all counters, bays, sinks, refrigerators and, if applicable, sterile and non-sterile compounding hoods; and(5) A completed, dated and signed minimum equipment self-inspection form as provided with the reinstatement application.31.00.60 Closure. a. Closure shall mean the permanent cessation of the practice of pharmacy in any telepharmcy.b. Upon the closure of any telepharmacy, it shall be the responsibility of the last pharmacist manager of record to remove the orders, if applicable, to another telephamacy or prescription drug outlet where patrons and/or practitioners are afforded reasonable access to a pharmacist's interpretation of such orders. Such relocation of records shall be made within seventy-two hours after closure. The pharmacist manager shall submit a notice, on a form and manner approved by the Board, detailing the closure of the telepharmacy within seventy-two hours after closure. If the last pharmacist manager of record fails to relocate the records as required herein, the Board may direct the removal of the records to a suitable location. The last pharmacist manager of record shall make a reasonable effort to inform patrons of the telepharmacy of the location of the records.c. The Board on request shall provide the owner of any telepharmacy an instruction sheet applicable to the transaction prior to closure, or conducting bankruptcy proceedings, or transferring or selling the prescription drug inventory.31.01.00 Structural Requirements.31.01.10 Within every telepharmacy there shall be one area designated as the principal compounding/dispensing area. The principal compounding/dispensing area shall comply with the following conditions: a. The principal compounding/dispensing area shall not be less than 150 continuous square feet.b. Any room included within or adjacent to the principal compounding / dispensing area that is separated from the principal compounding / dispensing area by a door must meet the following: (1) The telepharmacy shall submit documentation required by the board to remodel the principal compounding / dispensing area prior to the utilizing the room or rooms for the purposes of compounding and dispensing or for the storage of prescription drugs and controlled substance stocks;(2) The door must have a conspicuously displayed sign attached to it, and facing the principal compounding / dispensing area, that states "This room is part of the Board-approved designated principal compounding / dispensing area";(3) If a locked or otherwise secured door is used to separate parts of the compounding / dispensing area, it shall be unlocked immediately upon the request of the Board or of its inspectors and be available for inspection.c. All compounding/dispensing areas shall be well-lighted and well-ventilated with clean and sanitary surroundings devoted primarily to compounding/dispensing or drug storage. These areas shall provide necessary protection for drugs, chemicals and devices from deterioration due to light, heat or evaporation and shall be arranged to protect all prescription drugs and devices from pilferage or other unauthorized removal. No areas shall be subject to any condition likely to lead to errors.d. In every telepharmacy where compounding or dispensing is physically occurring, there shall be a minimum of twelve continuous square feet of free and clear counter space, and a minimum of six continuous square feet of free and clear counter space for each person engaged in compounding/dispensing. These counters and surfaces shall be kept free and clear at all times for the purpose of compounding/dispensing. Any computer workstation or other equipment for the preparation of prescription labels and/or storage and retrieval of records shall be in addition to the minimum free compounding/dispensing area.(1) The free floor space behind all compounding/dispensing counters or work surfaces shall be not less than thirty inches in width;(2) The free floor space between shelving rows shall be not less than twenty-four inches; and(3) There shall be sufficient shelf, drawer and/or cabinet space for proper storage of prescription drugs and devices.e. In the principal compounding/dispensing area there shall be a sink, equipped with running hot and cold water, which is attached to an approved drain, waste and vent system, or to a portable enclosed tank which is emptied as frequently as necessary.f. The telepharmacy shall have all the technical equipment necessary for the appropriate compounding and dispensing it conducts and as required pursuant to section 12-280-103(50), C.R.S.g. If refrigerated drugs are stored in the principal compounding/dispensing area, there shall be a refrigerator, dedicated to storing only drugs, meeting the compendia requirements and with an accurate thermometer in the refrigerator. The temperature of which shall be maintained between two and eight degrees Celsius (2 and 8 degrees C.) or thirty-six and forty-six degrees Fahrenheit (36 and 46 degrees F.) or in accordance with the corresponding drug manufacturer's directions. The temperature shall be electronically monitored each calendar day. Records detailing instances in which temperatures fall outside the aforementioned range requirement, for any period of time, shall be maintained at the prescription drug outlet and shall be made readily available for inspection upon request by the Board or its representatives for a period of at least two years preceding the request. Such records shall include the duration of time the temperature fell outside the aforementioned range requirement, based on the best available data, and measures taken by the outlet as a result of the temperature falling outside the aforementioned range requirement.h. If frozen drugs are stored in the principal compounding/dispensing area, there shall be a freezer, dedicated to storing only drugs, meeting the compendia requirements and with an accurate thermometer in the freezer. The temperature of which shall be maintained between twenty-five degrees below zero and ten degrees below zero Celsius (- 25 and - 10 degrees C.) or thirteen degrees below zero and fourteen degrees Fahrenheit (- 13 and 14 degrees F.) or in accordance with the corresponding drug manufacturer's directions. The temperature shall be electronically monitored each calendar day. Records detailing instances in which temperatures fall outside the aforementioned range requirement, for any period of time, shall be maintained at the prescription drug outlet and shall be made readily available for inspection upon request by the Board or its representatives for a period of at least two years preceding the request. Such records shall include the duration of time the temperature fell outside the aforementioned range requirement, based on the best available data, and measures taken by the outlet as a result of the temperature falling outside the aforementioned range requirement.i. Every telepharmacy shall display in the principal compounding/dispensing area the report of the most recent inspection conducted by the Board or a photocopy of the most recent self-inspection performed by the pharmacist manager using the form provided by the Board, whichever is more recent, and have readily available documents sent or provided by the Board to clarify or assist in the legal operation of the telepharmacy.31.02.00 Staffing and Training Requirements. Only a Colorado licensed pharmacist, Colorado-licensed pharmacy intern, or Colorado-certified pharmacy technician may engage in the practice of pharmacy. All personnel engaged in the practice of pharmacy shall be adequately trained to, as applicable to the practice setting, dispense and compound prescriptions and administer vaccines.31.03.00 Pharmacist Manager or Licensed Pharmacist Delegate Visitation Requirements. The pharmacist manager or licensed pharmacist delegate shall visit the telepharmacy at least once monthly. Documentation of these visits shall be readily available and retrievable for inspection at the telepharmacy upon the request of the Board or its representatives for at least two years preceding the request.31.04.00 Security in every telepharmacy, all compounding/dispensing areas shall comply with this regulation. a. When any compounding/dispensing area of a prescription drug outlet is occupied by any employee, a pharmacist or Board-certified pharmacy technician must be physically present within the same building of the telepharmacy. This Rule shall not apply if the telepharmacy does not possess prescription drug or controlled substance stocks or patient information within the first 120 calendar days after the telepharmacy has been registered by the Board.b. In the event a pharmacist or Board-certified pharmacy technician is within the building but absent from a compounding/dispensing area, it is the responsibility of the pharmacist or Board-certified pharmacy technician to ensure the proper safeguard of all drugs.c. If a compounding/dispensing area is continually attended by a pharmacist or Board-certified pharmacy technician when other people are in the building, the compounding/dispensing area need not be enclosed. However, if other people are in the building when there is not a pharmacist or Board-certified pharmacy technician present, every compounding/dispensing area must be enclosed by a barrier as specified in paragraph e below unless the prescription drug outlet qualifies for the exemption provided under Rule 31.04.00(a).d. If more than one telepharmacy is located within the same building, a pharmacist or Board-certified pharmacy technician shall not operate more than one telepharmacy at the same time. If a pharmacist or Board-certified pharmacy technician physically leaves one outlet for the purpose of entering into another outlet within the same building, any outlet not being physically attended to by a pharmacist or Board-certified pharmacy technician shall be enclosed by a barrier as specified in paragraph e below and a non-pharmacist or non-Board-certified pharmacy technician shall not remain inside the enclosed outlet during that time unless the telepharmacy qualifies for the exemption provided under Rule 5.01.50.e. A telepharmacy constituting part of a large establishment may be closed while the balance of the establishment is open for business, provided every compounding/dispensing area is enclosed with a secure floor-to-ceiling physical barrier, which shall be a divider or secure total enclosure, in which any openings shall not be large enough to permit removal of items from the compounding/dispensing area. The barrier must be of weight and strength sufficient to prevent it from being readily lifted, removed, penetrated or bent.f. All entrances to every compounding/dispensing area shall be secured from unauthorized entry when the pharmacist or Board-certified pharmacy technician leaves the building except as provided in Rule 5.01.50(a). No one other than a Board-certified pharmacy technician shall be permitted to enter any compounding/dispensing area containing drugs, devices or patient information except in extreme emergencies, which shall be defined as a threat to property, public disaster or other catastrophe whereby the public is better served by overlooking the security restrictions of drugs and devices. If any compounding/dispensing area containing drugs, devices or patient information is opened in the absence of a pharmacist or Board-certified pharmacy technician or left unsecured from unauthorized entry when the pharmacist or Board-certified pharmacy technician leaves the building, the pharmacist manager shall notify the Board in writing within ten days of the discovery of the occurrence. This written notice shall state: (1) The name of the person authorizing the opening of the compounding/dispensing area if known, or the name of the pharmacist responsible for securing the compounding/dispensing area from unauthorized entry;(2) The name of the person opening the compounding/dispensing area if known; and(3) A description of the situation requiring opening of the compounding/dispensing area including the date and time of the opening.31.05.00 Unless as otherwise specified in this Board Rule 31.00.00, telepharmacies shall, as applicable, operate and maintain such records as required by the Board for prescription drug outlets relating to, but not limited to, the receipt, storage, dispensing, administration, prepackaging, compounding and other disposition of prescription drugs and controlled substances.31.06.00 The pharmacist manager shall be responsible for the operations of a telepharmacy in compliance with all applicable state and federal rules and laws pertaining to drugs.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 11/30/202246 CR 21, November 10, 2023, effective 11/30/2023