3 Colo. Code Regs. § 719-1-27.00.00

Current through Register Vol. 47, No. 20, October 25, 2024

Section 3 CCR 719-1-27.00.00 - HOSPITAL SATELLITE PHARMACY

27.00.10 Definitions.

a. "Hospital satellite pharmacy (HSP)" is a pharmacy located in a facility under the same management or control as the building or site where the hospital's Primary pharmacy is located, has a different address than the primary pharmacy, and is housed in a building with a main entrance that is no more than one mile from the main entrance to the building which houses the primary pharmacy. Hospital satellite pharmacies may stock drugs at areas of the building where the hospital pharmacy is located, provided the areas are under the same management or control as the building or site where the hospital's primary pharmacy is located. The one mile requirement shall not apply if a public health order is in effect and consequently requires a greater distance temporarily.

b. "Primary pharmacy" is a registered prescription drug outlet in the hospital where the principal compounding/dispensing area is located.

27.00.20 Registration requirements.

a. Hospitals which own or operate a pharmacy shall register all HSPs.

b. The primary pharmacy shall submit an application on a form provided by the Division of Professions and Occupations on behalf of the HSP and for any drug storage satellites at the same location as the HSP.

c. HSPs and any drug storage satellites placed at the same location as the HSP must pass a pre-registration inspection by the Board or its inspectors prior to registration.

d. Any existing HSP or drug storage satellite at the same location as the HSP which is being remodeled or is being moved from one area of the location of the HSP to another shall submit documentation required by the Board prior to remodeling or moving.

e. The compounding/dispensing area of an HSP shall not be less than 100 continuous square feet and must be approved by the Board prior to use for the practice of pharmacy.

f. Any room included within or adjacent to the compounding/dispensing area that is separated from the compounding/dispensing area by a door must meet the following:

1. The HSP shall submit documentation required by the Board to remodel the compounding/dispensing area prior to the utilizing the room 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 compounding/dispensing area, that states "This room is part of the approved designated compounding/dispensing area";

3. Unless the door is used to secure a room dedicated to storing controlled substances, it shall not have the ability to be locked or otherwise secured. The Board or its representatives shall have readily available and unimpeded access to this room at all times during normal business hours; and

4. If a locked or otherwise secured door is used to secure a room dedicated to storing controlled substances, it shall be unlocked immediately upon the request of the Board or its representatives.

g. Up to two satellites at the same location as the HSP 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.

h. All HSPs and all 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.

i. If the HSP engages in compounding/dispensing, there shall be a minimum of twelve continuous square feet of compounding/dispensing area, and a minimum of six continuous square feet of compounding/dispensing area 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.

j. The free floor space behind any compounding/dispensing counters or work surfaces shall be not less than thirty inches in width;

k. The free floor space between rows of shelving shall be not less than twenty-four inches;

l. If the HSP engages in compounding/dispensing, there shall be sufficient shelf, drawer and/or cabinet space for proper storage of prescription drugs and devices.

m. If the HSP engages in compounding/dispensing, 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.

n. Any other professional and technical equipment appropriate and adequate for the type of practices the HSP engages in shall at all times be located within the compounding/dispensing area.

o. If refrigerated drugs are stored at the HSP or drug storage 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 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.). 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 HSP 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.

p. If frozen drugs are stored at the HSP or drug storage 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 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.). 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 HSP 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.

q. There shall be a professional reference library available in the HSP. If an electronic library is provided, workstations must be provided in the 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. Title 12, Article 280, C.R.S.; the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act.

2. CRS Title 18, Article 18, the Uniform Controlled Substances Act of 1992;

3. Board of Pharmacy 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, the Guide to Parenteral Admixtures or Handbook on Injectable Drugs or other comparable references as determined by the pharmacist manager;

6. If compounding cytotoxic 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 primary pharmacy may deem necessary.

r. The preceding subsections under 27.00.20(c), (e), (f), (i), (m), and (q) shall not apply if a public health order is in effect and consequently and temporarily impacts timely compliance with such requirements. The Pharmacy and staff will make attempts to the best of their ability to ensure compliance is achieved in as timely a manner as possible, and document such efforts.

27.00.30 Requirements for operation of an HSP

a. The pharmacist manager of the primary pharmacy shall have responsibility for the operation and control of the HSP;

b. For the purpose of recordkeeping, drug stocks of the HSP shall be included in the inventory of the primary pharmacy;

c. All records from the HSP shall be maintained at the primary pharmacy in accordance with Rule 11.00.00;

d. Pharmacist staffing at the HSP cannot be considered in the computation of the pharmacists to pharmacy technician ratio in the primary pharmacy;

e. Pharmacist staffing at the primary pharmacy cannot be considered in the computation of the pharmacists to pharmacy technician ratio in the HSP;

f. The primary pharmacy may distribute drugs to the HSP in the same manner it would to other units of the hospital, and records shall be maintained in accordance with Rule 11.07.10;

g. Every HSP shall display in the HSP 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

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

27.00.40 Minimum Hours of Operation

a. The principal compounding/dispensing area of an HSP 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. This requirement shall not apply if a public health order is in effect and consequently and temporarily impacts operating hours.

b. In the event that the principal compounding/dispensing area is open less than thirty-two hours per week, 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.

27.00.50 Security. All HSPs and additional satellites shall comply with this Rule.

a. When any compounding/dispensing area of an HSP is occupied by any employee, a pharmacist must be physically present within the same building of the HSP.

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.

d. If more than one HSP 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.

e. An HSP 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 where the HSP is located. No one other than a pharmacist shall be permitted to enter any compounding /dispensing area 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 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 building where the HSP is located is open, a person on duty in the building shall be able to contact a pharmacist in case of emergency.

h. No HSP 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.

i. Procedures to follow in an emergency situation when a pharmacist is not in the building where the HSP is located are as follows:

1. In an emergency situation and when a pharmacist is not in the building where the HSP is and administration of a drug to, or use of a device by or on, a 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 containers, 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 nurse 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 returns to the building. Additional quantities of the drug or device shall be supplied by a pharmacist and properly recorded as required by law and rule.

27.00.70 Relocation. In the event of a relocation of an HSP, the primary pharmacy shall submit an application on a form provided by the Division of Professions and Occupations along with the required fee at least thirty days prior to the effective date of relocation.

27.00.80 Reinstatement of an HSP registration. If a registration of an HSP has expired, the primary pharmacy shall submit a reinstatement application on a form provided by the Division of Professions and Occupations along with the required fee.

27.00.90 Closure.

a. Closure shall mean the permanent cessation of the practice of pharmacy in any HSP. Closure shall also be deemed to have occurred if the compounding/dispensing area is not open for business the minimum hours specified in Rule 27.00.40.

b. Upon the closure of the HSP, it shall be the responsibility of the pharmacist manager of the primary pharmacy to relocate the chart orders and drugs to the primary pharmacy. Such relocation of records shall be made within seventy-two hours after closure of the HSP. The pharmacist manager shall notify the Board on a form provided by the Board, detailing the closure of the HSP within seventy-two hours after closure. If the pharmacist manager fails to relocate the drugs and records as required herein, the Board may direct the removal of the drugs and records to a suitable location.

3 CCR 719-1-27.00.00

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