8.00.00  ADVERTISING.

8.00.10  Labels.  Only one address shall appear on a prescription label and that shall be the address of the prescription drug outlet from which the prescription was dispensed.  In the case of a central fill agreement or contract, the label shall contain the name and address of the originating pharmacy.

Rule 11.00.00

11.04.10  A hard copy of every prescription order shall be readily retrievable and available for inspection for a period of two years from the date of any transaction relating to such prescription order unless the prescription drug outlet has received written Board approval to not retain the original prescription order for non-controlled drugs AND SCHEDULE III, IV, and V CONTROLLED SUBSTANCES.  Prescription orders will be deemed to be readily retrievable and available if they are filed according to the numerical sequence of the serial numbers assigned pursuant to 2.01.10.  In addition to being filed in numerical sequence, three different prescription files shall be maintained:  one file shall consist only of schedule II controlled substance prescription orders; the second file shall consist only of schedule III, IV and V controlled substance prescription orders; and the third file shall consist of all non-controlled substance prescription orders.  Filing of prescription orders in any manner other than by numerical sequence will result in such prescription orders being deemed not readily retrievable and available.

A hard copy of every chart order shall be readily retrievable and available for inspection for a period of two years from the date of any transaction relating to such order.  The LTCF chart orders will be deemed to be readily retrievable and available if they are filed according to the date of dispensing.  Chart orders for schedule III, IV, and V controlled substances shall be readily identifiable from non-controlled chart orders.  Schedule II orders shall be retained separately from all other orders.

If a prescription drug outlet utilizes both prescription orders and chart orders, assigning serial numbers to both with the same computer system, the orders must be filed sequentially by serial number.

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.

20.00.20	Initial Interpretation means the review of an order accompanied by product selection and 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 (eg. 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.

20.00.40	Originating pharmacy or site means the pharmacy or hospital where the order is initially presented.

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 written contract/agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; 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 Colorado State Board of Pharmacy as either prescription drug outlets or non-resident prescription drug outlets, depending on the pharmacy’s location.  All pharmacies participating in the central fill agreement must be located within the United States.

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.	A pharmacy that outsources any portion of the dispensing process to another pharmacy shall:

1.	Prior to outsourcing their prescription:
(i)	Notify patients that their prescription may be outsourced to another pharmacy; 
(ii)	Give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may dispense 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.
(iii)	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 CRS 12-22-123.  In addition, the following shall be included on the label of any prescription dispensed via central processing: and
1.	The name and address of the originating pharmacy involved in the dispensing;
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 contracted 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 DEA registration of the pharmacy if a controlled substance order;
3.	Name of pharmacist transmitting the order; and
4.	The date of transmission.

b.	The originating pharmacy, when transmitting a non-controlled order to a contracted 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.	Upon receipt of the prescription 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 regulation 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 DEA 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; 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 regulation 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 regulation 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 shall be maintained  and complied with at all pharmacies involved in the dispensing of the prescriptions.  This policy and procedure manual shall be readily available for inspection.  Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy’s operations.  The manual shall:

1.	Outline the responsibilities of each involved pharmacy;
2.	Include a list of the name, address, telephone numbers, and all license/registration number (including DEA registrations) of involved pharmacies;
3.	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;
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 regulations;
vi.	A procedure 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 of the pharmacist manager.