Statutes, codes, and regulations
Colorado Administrative Code
Department 700 - Department of Regulatory AgenciesDivision 719 - Division of Professions and Occupations - State Board of Pharmacy
Rule 3 CCR 719-1 - STATE BOARD OF PHARMACY RULES AND REGULATIONS
Section 3 CCR 719-1-20.00.00 - CENTRAL PRESCRIPTION PROCESSING

3 Colo. Code Regs. § 719-1-20.00.00

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Current through Register Vol. 47, No. 23, December 10, 2024
Section 3 CCR 719-1-20.00.00 - CENTRAL PRESCRIPTION PROCESSING
20.00.10 "Central prescription processing" means the dispensing of an order when more than one registered prescription drug outlet (pharmacy) is involved in the transaction. It is the processing by one pharmacy of a request from another pharmacy to fill or refill an order or to perform one or more dispensing functions, such as preparation, mixing, labeling, initial interpretation, and refill authorizations.
20.00.11 "Central prescription processing contract" means a written contract which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy that is a party to the central prescription processing contract in compliance with federal and state laws and rules.
20.00.12 "Contract pharmacy" means a pharmacy that is a party to the same central prescription processing contract as another pharmacy performing a portion of the fulfillment of a given prescription in a shared pharmacy services arrangement.
20.00.20 "Initial interpretation" means the review of an order accompanied by order entry. The pharmacist(s) conducting the initial interpretation shall be held accountable for the accuracy of the electronic order entry/ manual transcription and for appropriateness of therapy (e.g. known allergies, reasonable dose, duration of use, and route of administration, considering age, gender, and other patient factors; reasonable directions for use; potential or actual adverse drug reactions; drug-drug interactions; drug-food interactions; drug-disease contraindications; therapeutic duplication; proper utilization (including over- or under-utilization) and optimum therapeutic outcomes; and abuse/misuse.)
20.00.30 "Fulfillment" means the preparation, mixing, and placement of the ordered medication in a suitable container with appropriate labeling.
20.00.31 "Fulfillment pharmacy" means the pharmacy where fulfillment occurs.
20.00.40 "Originating pharmacy" means the pharmacy or hospital where the order is initially presented.
20.00.41 "Network pharmacies" means pharmacies that are under common ownership, or are parties to a central prescription processing contract, which pharmacies may perform one or more parts of the fulfillment of a given prescription.
20.00.43 "Shared pharmacy services" means a system that allows a common ownership or contract pharmacy to request another common ownership or contract pharmacy to conduct the initial interpretation of a prescription order or chart order. Pharmacies participating in shared pharmacy services shall comply with all provision of this Rule 20.00.00 unless otherwise specifically stated in the Rule.
20.00.50 The dispensing, delivery, and return of prescriptions by one pharmacy for another pursuant to this section shall not be construed as the filling of a transferred prescription or as a wholesale distribution.
20.00.60 Operational Standards.
a. A pharmacy may outsource one or more portions of the dispensing of an order to other pharmacies provided the pharmacies:
1. Have the same owner or have entered into a central prescription processing contract; and
2. Share a common electronic file or have appropriate technology/interface to allow access to information required to process the order; and
3. Are registered with the Board as either prescription drug outlets or non-resident prescription drug outlets, depending on the pharmacy's location, except that a nonresident pharmacy that does not physically ship, mail or deliver dispensed prescriptions directly into this state from the nonresident pharmacy location shall be exempt from the requirement of obtaining a nonresident prescription drug outlet registration pursuant to section 12-280-133(2), C.R.S. All pharmacies participating in the central prescription processing contract, or who are engaged in shared pharmacy services, must be located within the United States regardless of the requirement of a Colorado registration.
b. The pharmacist manager of the fulfillment pharmacy shall assure that:
1. The pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process; and
2. The filled prescriptions are shipped in containers, which are sealed in a manner as to show evidence of opening or tampering.
20.00.70 Notification to Patients.
a. Prior to the outsourcing of any portion of the dispensing process to another pharmacy that is a contract pharmacy or pharmacy under common ownership, the pharmacy shall:
1. Notify the patient that their prescription may be outsourced to the other pharmacy; and
2. Give the name of the contract pharmacy or common ownership pharmacy. If the pharmacy is part of a network of pharmacies that may participate in dispensing the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.
b. Prescription drug outlets in hospitals are exempt from this requirement.
20.00.80 Prescription Labeling.
a. Prescriptions shall be labeled with all information required by section 12-280-124, C.R.S. In addition, the following shall be included on the label of any prescription dispensed via central processing:
1. The name and address of the originating and/or fulfillment pharmacy involved in the dispensing; and
2. The telephone number of the pharmacy that the patient or caregiver should contact regarding refills or questions about the prescription.
20.00.90 Responsibilities of Originating Pharmacy.
a. The originating pharmacy, when transmitting a controlled substance order to a contract or common ownership pharmacy, shall write "Central Fill" on the face of the original order and record the following:
1. The name, and address of the pharmacy to whom the order is transmitted;
2. The Drug Enforcement Administration registration of the pharmacy if a controlled substance order;
3. Name of pharmacist transmitting the order; and
4. The date of transmission.
5. Dispensing transactions in the shared pharmacy services process are exempt from the requirement of writing "Central Fill" on the face of the original prescription
b. The originating pharmacy, when transmitting a non-controlled substance order to a contract or common ownership pharmacy, shall maintain records of the following:
1. The name, and address of the pharmacy to whom the order is transmitted;
2. Name of pharmacist transmitting the order; and
3. The date of transmission.
c. If the prescription is received from the fulfillment pharmacy and not delivered directly to the patient from the fulfillment pharmacy, the originating pharmacy shall record the following:
1. Date of receipt;
2. Method of delivery (private, common, or contract carrier); and
3. Name of pharmacy employee accepting delivery.
d. The above records shall be retained for a period not less than two years.
e. The originating pharmacy is responsible for the maintenance of the original order in accordance with Rule 11.00.00.
20.01.00 Responsibilities of Fulfillment Pharmacy.
a. The fulfillment pharmacy shall:
1. Retain an electronic record of all information transmitted by the originating pharmacy, including the name, address, and Drug Enforcement Administration registration (for controlled substances only) of originating pharmacy.
2. Retain a record detailing the following:
i) Date the transmitted order was received;
ii) Identity of the pharmacist responsible for the final evaluation;
iii) Date the order was fulfilled;
iv) Date prescription delivered to the originating pharmacy or delivered directly to the patient; and
v) The method of delivery.
20.01.10 Records.
a. Each pharmacy shall comply with all the laws and rules relating to the maintenance of records as required by Rule 11.00.00 and be able to produce an audit trail showing all prescriptions dispensed by the pharmacy.
b. The originating pharmacy is responsible for retaining the order in the manner specified in Rule 11.00.00.
c. All involved pharmacies shall maintain appropriate records which identify the identity, date, and location of each individual performing any processing function for an order.
20.01.20 Policies and Procedures.
a. A policy and procedure manual as it relates to central prescription processing or shared pharmacy services shall be maintained and complied with by all pharmacies involved in the dispensing of the prescriptions. This policy and procedure manual shall be readily available for inspection. The manual shall:
1. Outline the responsibilities of each involved pharmacy;
2. Include a list of the names, addresses, telephone numbers, and all license/registration numbers (including Drug Enforcement Administration registrations) of involved pharmacies;
3. Delineate which pharmacy name and address appears on the prescription label.
4. Include policies and procedures for:
i) Notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription processing and the name of that pharmacy or pharmacies;
ii) Protecting the confidentiality and integrity of patient information;
iii) Dispensing prescriptions when the filled prescription has not been received from the fulfillment pharmacy;
iv) Maintaining appropriate records to identify the location and pharmacist responsible for all aspects of dispensing of any order;
v) Complying with federal and state laws and rules;
vi) Identifying the pharmacist responsible for each aspect of prescription preparation including, but not limited to, the drug regimen review, the initial electronic entry, any changes or modifications of the prescription record or patient profile, and the final evaluation of the completed prescription;
vii) Reviewing the policy and procedure at least annually. Such review shall be done by the pharmacist manager and documented as to the date of the review accompanied by the signature or electronic approval if version and approval histories are available of the pharmacist manager.

3 CCR 719-1-20.00.00

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