3 Colo. Code Regs. § 719-1-5.00.00

Current through Register Vol. 48, No. 1, January 10, 2025

Section 3 CCR 719-1-5.00.00 - OUTLETS

5.00.01 Definitions. The following words and terms shall have the following meanings, unless the context clearly indicates otherwise.

a. Compounding / Dispensing Area: means any area in a prescription drug outlet where "compounding / dispensing" is performed.

b. In-State Prescription Drug Outlet: means any prescription drug outlet located within Colorado that is registered pursuant to Title 12, Article 280, C.R.S., where prescriptions are compounded and dispensed.

c. Non-Resident 503 Outsourcing Facility: means a facility that is registered by the Federal Food and Drug Administration, that is located outside the state, and that distributes compounded drugs into the state without a prescription order.

d. Non-Resident Prescription Drug Outlet: means any pharmacy outlet located outside this state that is registered pursuant to Title 12, Article 280, C.R.S., which ships, mails, or delivers, in any manner, drugs or devices into this state pursuant to a prescription order.

e. Risk-Base Assessment: means, pursuant to section 12-280-108(1)(a)(II), C.R.S., to inspect a non-resident prescription drug outlet, a non-resident 503B outsourcing facility, or an out-of-state prescription drug wholesaler when the Board determines, based on a complaint, that there may be an imminent threat to the health, safety and welfare of Colorado consumers and that such an inspection is imperatively necessary to preserve health, safety and welfare of Colorado consumers.

f. Third-Party Logistics Provider: means a person that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer but does not take title to a prescription drug or have general responsibility to direct the prescription drug's sale or distribution.

g. "Automated Pharmacy Dispensing System" or "System" means a mechanical system that dispenses prescription drugs to a person interacting with a remote pharmacist and maintains related transaction information.

(1) An "Automated Pharmacy Dispensing System" may only be operated under a Pharmacy Drug Outlet license type.

(2) Automated pharmacy dispensing systems may be stocked or loaded by a pharmacist, or a pharmacy technician (provisional and non-provisional) or intern under the supervision of a pharmacist.

5.00.10 Registration. The applicant for registration shall obtain the appropriate form as approved by the Board to register an outlet. In the case of an application for a new in-state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, for a transfer of ownership of an in-state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, or for the relocation of an in-state or nonresident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, the applicant shall submit such additional documentation as the Board may require.

5.00.15 Registration for nonresident prescription drug outlets. An applicant for a new nonresident prescription drug outlet registration shall submit the following:

a. The current application with required fee;

b. A verification of the current pharmacy license or registration issued by the applicant's resident state board of pharmacy;

c. A copy of the most recent report detailing an inspection of the nonresident prescription drug outlet by either its resident state board of pharmacy or the National Association of Boards of Pharmacy's Verified Pharmacy Program dated within the previous two years of submission of the application; and

d. An affidavit attesting that the nonresident prescription drug outlet shall not ship compounded or other prescription drugs into the State of Colorado without a prescription order for a specific patient, except as provided pursuant to Rule 21.00.20.

5.00.17 Non-Resident 503B Outsourcing Facility. A nonresident 503B outsourcing facility shall submit the following to the Board with the application:

a. Proof that the facility is actively registered with the Federal Food and Drug Administration as a 503B outsourcing facility and is actively licensed, permitted, or registered in the state in which it is a resident;

b. The location, names, and titles of all principle entity officers and the name of the pharmacist in charge of the operations of the facility;

c. Verification that the facility complies with all lawful directions and requests for information from the Federal Food and Drug Administration and from the regulatory or licensing agency of the state in which it is licensed, permitted, or registered, as well as all requests for information made by the Board pursuant to this section; and

d. A copy of the most recent inspection report resulting from an inspection by the Federal Food and Drug Administration.

5.00.19 Third-Party Logistics Provider. A third-party logistics provider shall submit the following to the Board with the application:

a. Proof, if available, that the facility is actively registered with the Federal Food and Drug Administration as third-party logistics provider;

b. The location, names, and titles of all principle entity officers; and

c. Verification that the facility complies with all lawful directions and requests for information from the Federal Food and Drug Administration as well as all requests for information made by the Board pursuant to this section.

5.00.20 Applications. The Board, or its agent, may require any applicant or pharmacist manager of an outlet to meet with the Board, or its agent, before the Board takes action on any registration.

5.00.21 Automated Pharmacy Dispensing System. Requirements for Registration. Eligibility requirements for an Automated Pharmacy Dispensing System application include the following:

a. Automated Pharmacy Dispensing Systems do not include those that do not involve direct patient interaction and are for internal operations use only.

b. 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 patients receiving prescriptions from the Automated Pharmacy Dispensing System;

c. The submission of a separate application by the managing prescription drug outlet on behalf of the Automated Pharmacy Dispensing System for an Automated Pharmacy Dispensing System registration, on a form provided by the Division of Professions and Occupations. The managing prescription drug outlet shall submit an application for each individual Automated Pharmacy Dispensing System to which the managing prescription drug outlet will provide stock drugs;

d. A Drug Enforcement Administration registration specifically assigned to the Automated Pharmacy Dispensing System if the managing prescription drug outlet provides stock controlled substances to the Automated Pharmacy Dispensing System;

e. 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 Automated Pharmacy Dispensing System; and

f. A secure Automated Pharmacy Dispensing System that prevents the diversion of drugs and that limits the access to drugs within the Automated Pharmacy Dispensing System only to those persons whom have been given permission to access the Automated Pharmacy Dispensing System;

g. The necessary fee;

h. The APDS shall be located in the state of Colorado and a pharmacist providing any clinical services, including initial and final interpretation, must be licensed in the state of Colorado.

i. Automated pharmacy dispensing systems may be stocked or loaded by a pharmacist or a pharmacy technician (provisional and non-provisional) or intern under the supervision of a pharmacist.

5.00.30 No two registered in-state or non-resident prescription drug 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.

5.00.40 Transfer of Ownership. Application to transfer registration of an in-state or non-resident prescription drug outlet or a non-resident 503B outsourcing facility or third-party logistics provider shall be submitted to the Board within thirty (30) days of the transfer of ownership. A transfer of ownership shall be deemed to have occurred:

a. In the event the in-state or non-resident prescription drug outlet or a non-resident 503B outsourcing facility or third-party logistics provider 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 in-state or non-resident prescription drug outlet or a non-resident 503B outsourcing facility or third-party logistics provider is owned by a partnership, upon sale or transfer of twenty percent or more of any ownership interest.

c. In the event the in-state or non-resident prescription drug outlet or a non-resident 503B outsourcing facility or third-party logistics provider 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 in-state or non-resident prescription drug outlet or nonresident 503B outsourcing facility or third-party logistics provider.

5.00.50 Relocation.

a. In the event of a relocation of an in-state or non-resident prescription drug outlet or nonresident 503B outsourcing facility or third-party logistics provider, the outlet 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.

b. The registration of a non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider shall become void and shall be cancelled if the non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider relocates to a state other than that which appears on its registration. In the event the non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider wishes to continue conducting business in Colorado, it must apply for and receive a new Colorado registration prior to conducting business in Colorado.

5.00.55 Reinstatement of an In-State or Non-Resident Prescription Drug Outlet Registration.

a. In-state Prescription Drug Outlet. If a registration has expired, a facility seeking to reinstate such registration shall submit the following:

(1) The current reinstatement application with the required fee;

(2) If the owner of the in-state prescription drug outlet 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 prescription drug outlet'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.

b. Non-resident Prescription Drug Outlet or non-resident 503B outsourcing facility or third-party logistics provider. If a registration has expired, a facility seeking to reinstate such registration shall submit the following:

(1) The current reinstatement application with the required fee;

(2) A verification of the current pharmacy license, registration, or permit issued by the resident state board of pharmacy for the non-resident pharmacy or 503B outsourcing facility, and a verification of the current license or registration issued by the Federal Food and Drug Administration for a non-resident 503B outsourcing facility or third-party logistics provider;

(3) If the registration has expired for a non-resident pharmacy for more than two years, a copy of the most recent report detailing an inspection of the non-resident prescription drug outlet by its resident state board of pharmacy dated within five years of submission of the reinstatement application.

5.00.60 Closure.

a. Closure shall mean the permanent cessation of the practice of pharmacy in any in state or non-resident prescription drug outlet or the permanent cessation of conducting business in Colorado for a non-resident 503B outsourcing facility or third-party logistics provider. For in-state prescription drug outlets, closure shall also be deemed to have occurred if the compounding/dispensing area is not open for business the minimum hours specified in Rule 5.01.40(a).

b. Upon the closure of any in-state or non-resident prescription drug outlet, it shall be the responsibility of the last pharmacist manager of record to remove the prescriptions and/or chart orders to another 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 prescription drug outlet or nonresident prescription drug outlet 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 prescription drug outlet of the location of the records. A non-resident 503B outsourcing facility or third-party logistics provider shall inform the Board, in writing, within seventy-two hours after closure.

c. The Board on request shall provide the owner of any prescription drug outlet an instruction sheet applicable to the transaction prior to closure, or conducting bankruptcy proceedings, or transferring or selling the prescription drug inventory.

d. The preceding subsections under 5.00.60 shall not apply if a public health order is in effect and consequently and temporarily impacts operating hours.

5.00.70 Change in Pharmacist manager.

a. An in-state and non-resident prescription drug outlet shall be under the direct charge of a pharmacist manager. A proprietor who is not a pharmacist shall comply with this requirement and shall provide a manager who is a pharmacist.

b. The registration of any in-state and non-resident prescription drug outlet shall become void if the pharmacist manager in whose name the registration was issued ceases to be engaged as the manager, and the owner shall close the outlet unless such owner has employed a pharmacist manager and, within thirty days after termination of the former manager's employment, has made application to transfer the registration to the new pharmacist manager and has paid the transfer fee therefor.

5.00.80 Disclosure. Any Board registered non-resident prescription drug outlet shall disclose to the Board, in writing, the location, names, and titles of all principal entity officers and all pharmacists who are dispensing drugs to residents of this state on an annual basis and within thirty days after any change of office, officer or pharmacist.

5.01.00 Prescription Drug Outlets (In-State).

5.01.10 Controlled Substance Inventory.

a. Upon the change of pharmacist manager of a prescription drug outlet, an inventory of all controlled substances shall be taken within seventy-two hours, by the new pharmacist manager or the new pharmacist manager's designee. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record.

b. Upon the transfer of ownership of a prescription drug outlet, an inventory of all controlled substances shall be taken by the pharmacist manager or the pharmacist manager's designee. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record.

5.01.20 Compounding/Dispensing Area (In-State)

5.01.21 In the event a transfer of ownership of a prescription drug outlet occurs, and the principal compounding/dispensing area or any satellite compounding/dispensing area does not meet the physical requirements of this Rule, the transfer of the registration may be approved, provided that compliance with such requirements shall be accomplished within six months of the approval of the transfer of the registration or by the next prescription drug outlet registration renewal date, whichever time is greater.

5.01.31 Within every prescription drug outlet as defined in section 12-280-103(43), C.R.S., there shall be one area designated as the principal compounding/dispensing area. In addition to the principal compounding/dispensing area there may be satellite compounding/dispensing areas and drug storage areas ("satellites") which are located at the same location as the principal compounding/dispensing area. The principal compounding/dispensing area and any satellite shall comply with the following conditions:

a. The principal compounding/dispensing area shall not be less than 225 continuous square feet, except that prescription drug outlets registered by the Board prior to the effective date of this regulation that do not meet this space requirement are hereby exempted from such requirement. However, any new prescription drug outlet shall comply with this requirement prior to the granting of the initial registration. Any existing prescription drug outlet which is being remodeled or is being moved from one location to another, whether or not there is a change of address, shall submit documentation required by the Board prior to remodeling or relocation.

b. All compounding/dispensing satellites and any drug storage satellites in excess of the two permitted in subsection c below that are at the same location as the principal compounding/dispensing area must not be less than 100 continuous square feet and must be approved by the Board prior to use for compounding/dispensing.

c. In addition to the satellite areas permitted in the previous paragraph, up to two satellites at the same location may be used solely for storage of prescription drugs and controlled substances. Such drug storage satellites must possess square footage commensurate for the safe storage and removal of drugs within the affected satellites and approved by the Board prior to use.

d. 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 prescription drug outlet 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.

e. All compounding/dispensing areas and satellites 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.

f. In every prescription drug outlet and in every satellite 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 as defined. 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.

g. In every satellite used for the sole purpose of storing prescription drugs or controlled substances, there shall be:

(1) At least twenty-four inches of free floor space between shelving rows; and

(2) At least thirty inches of free floor space behind any counters, if counters are available.

h. 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. Each satellite area shall also be so equipped if appropriate to the compounding/dispensing activities which are or will be performed therein.

i. The prescription drug outlet shall have all the technical equipment necessary for the appropriate compounding and dispensing it conducts.

j. If refrigerated drugs are stored in the principal compounding/dispensing area or in any satellite, 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.

k. If frozen drugs are stored in the principal compounding/dispensing area or in any satellite, 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.

l. There shall be a professional reference library available in the prescription drug outlet. If an electronic library is provided, workstations must be provided in a compounding/dispensing area and must be readily available for use by staff, interns and Board personnel. This library shall contain current copies of the following:

(1) A Title 12, Article 280, C.R.S.; the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act;

(2) Title 18, Article 18, C.R.S., the Uniform Controlled Substances Act of 1992;

(3) Board Rules;

(4)21 Code of Federal Regulations ("CFR") Part 1300 to End containing Drug Enforcement Administration rules relating to controlled substances;

(5) If compounding sterile products, Guide to Parenteral Admixtures or Handbook on Injectable Drugs or other comparable references as determined by the pharmacist manager;

(6) If compounding hazardous products, Technical Manual Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs or ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs; and

(7) Any other references that the pharmacist manager of the prescription drug outlet may deem necessary.

m. If telephone prescription orders are accepted, a voice recording device shall be provided to receive them, and they shall be played back and transcribed to writing by the pharmacist or intern.

n. Written prescription orders and refill requests for prescription orders may be delivered to the prescription drug outlet while the compounding/dispensing areas are closed, provided a slot or drop box is provided for the prescription order or prescription order refill requests.

o. All prescription drug outlets shall maintain an adequate inventory of prescription drugs and shall offer adequate pharmaceutical service to the public they normally serve.

p. Every prescription drug outlet 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 prescription drug outlet.

q. No person other than a pharmacist or intern employed by the prescription drug outlet shall be permitted in the compounding/dispensing area without the consent of the pharmacist in charge of the compounding/dispensing area.

r. If a computer terminal or other device is used by pharmacy personnel outside the compounding/dispensing area, but within the same location (building) as the prescription drug outlet, when a Colorado-licensed pharmacist is in the building, for the purpose of processing, gathering or storing prescription information, the pharmacist manager of the prescription drug outlet shall determine procedures for the storage and security of, the access to, and the confidentiality of patient information within the computer terminal or other device and shall be subject to Rule 1.00.16, and the federal Health Insurance Portability and Accountability Act of 1996.

5.01.33 The use of any tobacco product in any compounding/dispensing area is hereby prohibited. However, this Rule shall not apply to the compounding, dispensing or use of a drug which has been derived from a tobacco product and which is being used as an adjunct to a smoking cessation program.

5.01.34 Delivery and Temporary Storage of Prescriptions. Upon the request of a patient or an agent of the patient and with the approval of the pharmacist on duty a prescription may be delivered or temporarily stored outside the confines of a compounding/dispensing area. The pharmacist manager of the prescription drug outlet shall determine or approve procedures for the storage and security of, the access to, the confidentiality of, and the counseling regarding, prescriptions, including record keeping.

5.01.40 Minimum Hours of Operation.

a. The principal compounding/dispensing area of a prescription drug outlet shall be open for normal business a minimum of two designated days per week (Monday through Sunday) and at least four continuous hours on each such designated day. These minimum requirements shall not apply within the first 120 calendar days after the prescription drug outlet has been registered by the Board if the outlet has not obtained prescription drug or controlled substance stocks.

b. In the event that the principal compounding/dispensing area is open less than thirty-two hours per week on an updated permanent basis (beyond a 2 week temporary basis), the pharmacist manager shall submit to the Board a written statement of the designated days and hours when the principal compounding/dispensing area will be open for business, and this statement shall be submitted at least thirty days prior to the date on which the hours of operation will be less than thirty-two hours per week.

c. In the event a pharmacy is not able to remain open during the posted hours of operation on a temporary basis, then it must notify the public by posting a sign in front of the closed pharmacy notifying the public of the temporary closure and contact information of the nearest closest pharmacy, their address, and phone number in an effort to provide continuity of care. Additionally, closure must be noted on each telephone greeting and pharmacy operated internet application as soon as possible, with information on hours, prescription pick-ups, and alternative options for the public to get their medication.

5.01.50 Security. In every prescription drug outlet, 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 must be physically present within the same building of the prescription drug outlet. This Rule shall not apply if the prescription drug outlet does not possess prescription drug or controlled substance stocks or patient information within the first 120 calendar days after the prescription drug outlet has been registered by the Board.

b. In the event a pharmacist is within the building but absent from a compounding/dispensing area, it is the responsibility of the pharmacist to ensure the proper safeguard of all drugs.

c. If a compounding/dispensing area is continually attended by a pharmacist 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 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 5.01.50(a).

d. If more than one prescription drug outlet is located within the same building, a pharmacist shall not operate more than one outlet at the same time. If a pharmacist 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 shall be enclosed by a barrier as specified in paragraph e below and a non-pharmacist shall not remain inside the enclosed outlet during that time unless the prescription drug outlet qualifies for the exemption provided under Rule 5.01.50(a).

e. A prescription drug outlet 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 leaves the building except as provided in Rule 5,01.50(a). No one other than a pharmacist 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 left unsecured from unauthorized entry when the pharmacist 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.

g. While the compounding/dispensing area is closed and the rest of the establishment is open, a person on duty in the establishment shall be able to contact a pharmacist in case of emergency.

h. The hours of business of the compounding/dispensing area shall be submitted to the Board in writing.

i. No prescription drug outlet shall avail itself of the privileges of this Rule until the barrier system and other requirements have been acknowledged, subject to final approval by the Board.

j. This paragraph applies only to the compounding/dispensing areas of a hospital which operates a prescription drug outlet pursuant to a certificate of compliance; or which operates a registered prescription drug outlet on the premises of the hospital for the primary purpose of providing pharmaceutical services to the hospital's in-patients; or permits a registered prescription drug outlet to be operated on the premises of the hospital by another business entity for the primary purpose of providing pharmaceutical service to the hospital's in-patients.

(1) In an emergency situation and when a pharmacist is not on the premises of the hospital and administration of a drug to, or use of a device by or on, an in-patient is necessary pursuant to a chart order, and such drug or device is only available from a locked compounding/dispensing area, an authorized registered nurse may enter a locked compounding/dispensing area to obtain the drug or device. In the case of a drug, only pre-labeled packages, such as unit dose or unit-of-use packages, or a pre-labeled container, may be removed from the compounding/dispensing area.

(2) The following information regarding the removal of such drug or device shall be consistently recorded and maintained in a retrievable document: date; time; name, strength and dosage form of drug, and/or name, and size, if applicable, of device; total quantity of drug or device removed; name and location of patient for whose use the drug or device is necessary; name of the practitioner ordering the drug or device; and the initials or signature of the nursing obtaining the drug or device. This document shall be available for inspection by the Board for a period of two years. Additionally, the original, duplicate or electronic or mechanical facsimile of the chart order shall be left with the above document by the nurse at the time of obtaining the drug or device.

(3) Any unused portion of a drug or device so removed shall be returned to the compounding/dispensing area when a pharmacist is again on the premises. Additional quantities of the drug or device shall be supplied by a pharmacist and properly recorded as required by sections 12-280-120(4) and 12-280-123(1), C.R.S., and Rule 11.05.20.

3 CCR 719-1-5.00.00

37 CR 18, September 25, 2014, effective 10/15/2014

38 CR 16, August 25, 2015, effective 9/14/2015

39 CR 04, February 25, 2016, effective 3/16/2016

39 CR 19, October 10, 2016, effective 11/14/2016

40 CR 04, February 25, 2017, effective 3/17/2017

40 CR 20, October 25, 2017, effective 11/14/2017

41 CR 16, August 25, 2018, effective 9/17/2018

42 CR 21, November 10, 2019, effective 11/30/2019

43 CR 10, May 25, 2020, effective 5/1/2020

43 CR 08, April 25, 2020, effective 5/15/2020

43 CR 15, August 10, 2020, effective 8/30/2020

43 CR 20, October 25, 2020, effective 11/14/2020

44 CR 04, February 25, 2021, effective 3/17/2021

44 CR 08, April 25, 2021, effective 5/15/2021

44 CR 21, November 10, 2021, effective 11/30/2021

45 CR 20, October 25, 2022, effective 9/29/2022

45 CR 21, November 10, 2022, effective 11/30/2022

46 CR 16, August 25, 2023, effective 9/14/2023

46 CR 16, August 25, 2023, effective 7/20/2023 (EMERGENCY)

46 CR 21, November 10, 2023, effective 11/30/2023