STATE OF COLORADO

State PHARMACY Board	Department of Regulatory Agencies
Wendy L. Anderson, Program Director	D. Rico Munn
	Executive Director
1560 Broadway, Suite 1300	
Denver, Colorado 80202-5146					Division of Registrations
Phone (303) 894-7800		Rosemary McCool
Fax (303) 894-7764		Director
TTY:Dial 711 for Relay Colorado			
www.dora.state.co.us/pharmacy	
	Bill Ritter, Jr.
	Governor

NOTICE OF RULE MAKING HEARING

Pursuant to Colorado Revised Statutes, Title 12, Article 22 and Title 24, Article 4, CRS (2006), you are hereby advised that the Colorado State Pharmacy Board will hold a public rule making hearing on Thursday, May 17, 2007, at 9:30 a.m., at the Denver Post Building, 1560 Broadway, Suite 1380 Conference Room, Denver, Colorado 80202, for consideration of the following:

Hearing Regarding Modification, Amendment, Revision or Adoption of:
Rules 2.01.10, 2.01.30, 3.00.50, 6.00.20, 6.00.30, 6.00.40, 8.00.10, 11.04.20, 14.03.10, and 20.00.00  (3 CCR, 719-1)

The proposed rules under consideration are attached to this notice and fully incorporated herein.

The Board encourages interested parties to submit written comments to the letterhead address regarding any of the above-listed rulemaking matters no later than April 26, 2007.  In addition, at the time and place designated in this notice, the Board of Pharmacy will afford interested parties an opportunity to submit written information, data, views or arguments.  The Board also will afford interested parties an opportunity to make brief oral presentations unless the Board in its discretion determines that such oral presentations are unnecessary.  All submissions will be considered.  The rules under consideration may be changed or modified after public comment and hearing.

BY ORDER OF THE COLORADO STATE BOARD OF PHARMACY

_______________________________________
Wendy Anderson, Program Director

Dated this ___________ day of __________________, 2007

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 17, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		Rule 2.01.10, 2.01.30, 11.04.20 and 14.03.10 are being amended to accommodate the proposed changes to Rule 3.00.50, initial interpretation and final evaluation.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

2.00.00  ORDERS.

2.01.10  Information to Appear on Each Order.  The following information must appear on each written or oral order except as provided for chart orders for hospitalized patients (hospital chart orders):

a.  The name, initials, or license number, OR SECURE ELECTRONIC IDENTIFIER of the pharmacist making the final evaluation INITIAL INTERPRETATION as required by regulation 3.00.50;

b.  The date the order was compounded and dispensed; and

c.  In the case of a prescription or chart order for a resident of a long term care facility (LTCF chart order), the assigned serial number.

d.  The quantity dispensed if differs from the quantity ordered.

e.  In the case of a controlled substance order, the patient address, prescriber address, and prescriber’s DEA registration.

2.01.30  Responsibility of a Pharmacist in Recording Refills.  When a prescription order is refilled, the following information must be recorded on the back of the prescription order, or on the daily computer printout as specified in Regulation 11.00.00, and may be entered by an unlicensed assistant if no interpretation is required:  Date refilled and quantity, if different from the quantity shown on the face of the prescription order.  If authority to refill is obtained, the name of the individual conveying such authority must be recorded.  The entry shall also bear the name, initials, or license number, OR SECURE ELECTRONIC IDENTIFIER of the pharmacist making the final evaluation.  This information shall be maintained and available for inspection for a period of two years from the date of any transaction relating to the order unless otherwise required by statute.

11.00.00	RECORDKEEPING

11.04.20  Computer Use With Prescription Order or LTCF Chart Order Transactions.

A prescription drug outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding prescription and LTCF chart order transactions.  The following requirements shall be met:

a.  All new and refill prescription and LTCF chart order transactions shall be entered into the system at the time of the transaction, except as provided in regulation 11.04.20(i).

b.  Every 24 hours, except as provided in regulation 11.04.30, the system must produce a hard-copy document which, for the purposes of these regulations, shall be known as the “daily printout”.  It shall consist of a single, uniform, complete document, except as otherwise permitted in this regulation.  The daily printout shall list, separately, each prescription or LTCF chart order transaction for the previous 24 hours and shall contain all information required by this regulation.  Daily printouts shall be retained in a chronological manner.  If the printouts are bound, the sheets shall be separated into individual pages which are then placed in the same order as printed and bound uniformly.  If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable and available.

c.  The daily printout shall contain all of the following information for each prescription or LTCF chart order transaction and shall differentiate between new and refill transactions.  As an alternative, new and refill transactions may be separated into two separate uniform and complete documents which contain the following:

(1)  The serial number;

(2)  The name of the patient;

(3)  The name of the practitioner:

(4)  For each controlled substance dispenses, the practitioner’s Drug Enforcement Administration registration number;

(5)  The date of issue by the practitioner, the date dispensed shall be presumed to be the date of issue.

(6)  The total number of refills authorized;

(7)  Date dispensed;

(8)  The initials, LICENSE NUMBER, OR NAME of the pharmacist making the final evaluation;

(9)  The name and strength of the drug dispensed;

(10)  The quantity of the drug dispensed;

(11)  In the case of a refill, the total number of refills dispensed to date.

14.00.00  OTHER OUTLETS

14.03.10  Computer use for dispensing transactions.  An other outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding dispensing transactions.  The following requirements shall be met:

a.  All new and refill transactions shall be entered into the system at the time of the transaction, except as provided in regulation 14.03.10(i).

b.  Every 24 hours, except as provided in regulation 14.03.20, the system must produce a hard-copy document which, for the purposes of these regulations, shall be known as the "daily printout".  It shall consist of a single, uniform, complete document, except as otherwise permitted by this regulation.  The daily printout shall list, separately, each prescription order transaction for the previous 24 hours and shall contain all information required by this regulation.  Daily printouts shall be retained in a chronological manner.  If the printouts are bound, the sheets shall be separated into individual pages which are then placed in the same order as printed and bound uniformly.  If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable and available.

c.  The daily printout shall contain all of the following information for each dispensing transaction and shall differentiate between new and refill transactions.  As an alternative, new and refill transactions may be separated into two separate uniform and complete documents which contain the following:

(1)  The serial number;

(2)  The name of the patient;

(3)  The name of the practitioner;

(4)  For each controlled substance dispensed, the practitioner's Drug Enforcement Administration registration number;

(5)  The date of issue by the practitioner.  If the date is omitted by the practitioner, the date dispensed shall be presumed to be the date of issue;

(6)  The total number of refills authorized;

(7)  The date dispensed;

(8)  The initials OR NAME of the individual making the final evaluation;

(9)  The name and strength of the drug dispensed;

(10)  The quantity of the drug dispensed;

(11)  In the case of a refill, the total number of refills dispensed to date.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 17, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being amended to define initial interpretation, final evaluation drug regimen and to review, delineate the recordkeeping requirements for initial and final evaluation.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

3.00.50  Final Evaluation. Each time a prescription drug or device is dispensed in a prescription drug outlet, a pharmacist shall make the final evaluation of the transaction.  At the time of such final evaluation, the pharmacist shall take whatever action is necessary to ensure that the initial interpretation, container, label, and prescription drug or device dispensed, as well as all records relating to the transaction are complete, accurate, and appropriate.

a.  The record or records of each dispensing transaction shall bear the identity of the pharmacist making the final evaluation, and this pharmacist shall be held responsible and accountable for each dispensing transaction which bears this pharmacist’s identity.

b.  In the event that the pharmacist making the final evaluation did not make the initial interpretation and does not have access to the order, then the pharmacist making the initial interpretation must be identified in the transaction record as responsible for that initial interpretation.

3.00.50  Final Evaluation AND INITIAL INTERPRETATION. 

A.	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 DRUG REGIMEN REVIEW.

B.	FINAL EVALUATION MEANS THE REVIEW OF THE FINAL PRESCRIPTION TO ENSURE THAT THE ORDERED MEDICATION IS PROPERLY PREPARED AND PLACED IN A SUITABLE CONTAINER WITH APPROPRIATE LABELING.

C. 	DRUG REGIMEN REVIEW INCLUDES BUT IS NOT LIMITED TO THE EVALUATION OF ORDER(S) AND PATIENT RECORDS(S) FOR:

1)	KNOWN ALLERGIES;
2)	RATIONAL THERAPY AND CONTRAINDICATIONS
3)	REASONABLE DOSE, DURATION OF USE, AND ROUTE OF ADMINISTRATION CONSIDERING AGE, GENDER, AND OTHER PATIENT FACTORS;
4)	REASONABLE DIRECTIONS FOR USE;
5)	POTENTIAL OR ACTUAL ADVERSE DRUG REACTIONS;
	6)	DRUG-DRUG INTERACTIONS;
	7)	DRUG-FOOD INTERACTIONS;
	8)	DRUG-DISEASE CONTRAINDICATIONS;
	9)	THERAPEUTIC DUPLICATION;
10)	PROPER UTILIZATION (INCLUDING OVER- OR UNDER-UTILIZATION) AND OPTIMUM THERAPEUTIC OUTCOMES; AND
	11)	ABUSE/MISUSE

D.	A PHARMACIST SHALL CONDUCT AN INITIAL INTERPRETATION OF EACH NEW ORDER AND A PHARMACIST SHALL CONDUCT THE FINAL EVALUATION OF EACH ORDER DISPENSED.  WHEN REFILLS ARE DISPENSED, THE PHARMACIST MAKING THE FINAL EVALUATION SHALL BE HELD ACCOUNTABLE FOR THE APPROPRIATE DISPENSING OF REFILLS.   THE PHARMACIST MANAGER SHALL BE HELD ACCOUNTABLE FOR THE MAINTENANCE OF ALL APPROPRIATE RECORDS.   

E..	THE ORIGINAL PRESCRIPTION OR LTCF ORDER SHALL BEAR THE IDENTITY OF THE PHARMACIST MAKING THE INITIAL INTERPRETATION, BY EITHER LICENSE NUMBER, INITIALS, NAME OR SECURE ELECTRONIC IDENTIFIER. THE PHARMACIST MAKING THE INITIAL INTERPRETATION ON A HOSPITAL CHART ORDER SHALL BE IDENTIFIED AS REQUIRED BY REGULATION 2.01.20(C).	  THE PHARMACIST MAKING THE FINAL EVALUATION SHALL BE IDENTIFIED BY EITHER LICENSE NUMBER, INITIALS, NAME, OR SECURE ELECTRONIC IDENTIFIER ON A UNIFORMLY MAINTAINED, READILY RETRIEVABLE DOCUMENT.  THE ORDER OR A UNIFORMLY MAINTAINED, READILY RETRIEVABLE DOCUMENT SHALL BEAR THE LICENSE NUMBER, INITIALS, NAME, OR SECURE ELECTRONIC IDENTIFIER OF ANY ADDITIONAL PHARMACISTS INVOLVED IN THE DISPENSING OF THE ORDER.  THE PHARMACIST CONDUCTING THE INITIAL INTERPRETATION AND FINAL EVALUATION MAY BE THE SAME PERSON.

F.	IN THE CASE WHERE THE COMPUTER SOFTWARE UTILIZED IS NOT PASSWORD PROTECTED, THE INITIAL INTERPRETATION AND FINAL EVALUATION SHALL BE MAINTAINED IN A HANDWRITTEN FORMAT BEARING THE LICENSE NUMBER, INITIALS, OR NAME OF THE RESPONSIBLE PHARMACIST.  IN ADDITION, THE IDENTIFICATION OF ANY OTHER PHARMACISTS INVOLVED IN THE DISPENSING SHALL BE MAINTAINED IN THE SAME HANDWRITTEN FORMAT.

G.	IN THE EVENT THE BOARD OR ITS INSPECTORS, CANNOT IDENTIFY THE IDENTITY OF THE PHARMACIST CONDUCTING EITHER THE INITIAL INTERPRETATION OR FINAL EVALUATION, THE PHARMACIST MANAGER OF THE PRESCRIPTION DRUG OUTLET WHERE THE FINAL EVALUATION OCCURRED SHALL BE THE PHARMACIST RESPONSIBLE.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 17, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		These rules are being amended to clarify how patient authorization for drug therapy management may be given in inpatient or group model integrated closed HMO settings, to amend the requirements for pharmacists to practice drug therapy management and to clarify how drug therapy management is conducted in inpatient and group model integrated closed HMO settings.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

6.00.00  PHARMACEUTICAL CARE, DRUG THERAPY MANAGEMENT AND PRACTICE BY PROTOCOL.

6.00.20  Drug therapy management requirements for all practice settings.

a.  Drug therapy management may only be conducted by a pharmacist upon the presentation of a valid order for a specific, individual patient from that patient’s physician.  The order must specify the protocol to be used, and the protocol must either accompany the order, or otherwise be provided to the pharmacist in advance of starting drug therapy management.

b.  The pharmacist must ensure that the physician with whom the pharmacist is working is licensed in Colorado, in good standing, and the protocols used are within the scope of the physician’s current practice.

c.  Prior to initiation of drug therapy management in any setting, the pharmacist or institution must inform the patient that he/she may refuse to participate in drug therapy management.  INPATIENT OR GROUP MODEL INTEGRATED CLOSED HMO SETTINGS MAY USE THE PATIENT’S SIGNATURE ON THE INSTITUTION’S GENERAL CONSENT TO TREAT AS THE PATIENT’S INDICATION TO PARTICIPATE IN DRUG THERAPY MANAGEMENT.

d.  At a minimum the written agreement for carrying out drug therapy management between physicians and pharmacists shall be reviewed annually, and revised, if necessary.

e.  Pharmacists may perform by protocol all aspects of drug therapy management referenced in 6.00.10 b and c, provided the protocol complies with 6.00.10 d, and the pharmacists performing these functions are qualified as set forth in section 6.00.30 and are working pursuant to a written agreement with an appropriately qualified physician.

f.  Filing requirements.

1.  Any pharmacist wishing to engage in or engaging in drug therapy management must file a copy of the written agreement between the physician and the pharmacist with the Board.  Pharmacists conducting such therapy in inpatient settings or group model integrated closed HMO’s must also notify the Board, on a form developed by the Board, that they are practicing drug therapy management, and provide a copy of their general authorization plan as required by 6.00.40.

2.  Pharmacists practicing drug therapy management must also provide the Board documentation of their successful completion of all qualification requirements as set forth below in 6.00.30 upon request.  Copies of pharmacy degrees are not required.  Copies of completion of residency or other educational programs or certifications must be on file in the location of practice.  Attestations from the supervising pharmacist or physician for clinical practice must be on file.

3.  Pharmacists practicing drug therapy management must have a copy of the pertinent protocols at the location at which they are practicing.  Upon request by Board inspectors, pharmacists must produce the scientific literature upon which their protocols are derived.

6.00.30  Pharmacist Qualifications.

Any pharmacist engaged in drug therapy management shall meet the following qualifications:

a.  Have and maintain an unrestricted license in good standing to practice pharmacy in Colorado; and

b.  Meet one of the following qualifications:

1.  Proof of completion of a pharmacy practice residency accredited by the American Society of Health Systems Pharmacists or the American Pharmaceutical Association; or

2.  A bachelor of pharmacy degree and completion of a certificate program accredited by the Accreditation Council for Pharmacy Education in each area of practice, and 40 hours of on site supervised clinical practice and training in each area in which the pharmacist is choosing to practice; or

3.  A Doctor of Pharmacy degree and completion of at least 40 hours of ACPE approved continuing education regarding clinical practice and 40 hours of on site supervised clinical practice and training in the area in which the pharmacist is choosing to practice; or

4.  Current Board specialty certification in Pharmacotherapy from the Board of Pharmaceutical Specialties, or current certification from the National Institute for Standards in Pharmacist Credentialing, OR CURRENT CERTIFICATION FROM THE COMMISSION FOR CERTIFICATION IN GERIATRIC PHARMACY.   Such credentials must be in the area of pharmacy practice undertaken in the drug therapy management.

5.	IN AN INPATIENT OR GROUP MODEL INTEGRATED CLOSED HMO SETTING, ALL OF THE FOLLOWING CRITERIA SHALL BE MET IN ORDER TO PRACTICE DRUG THERAPY MANAGEMENT:

	A.	FORTY (40) HOURS OF ONSITE SUPERVISED CLINICAL PRACTICE AND TRAINING THE AREA(S) IN WHICH THE PHARMACIST IS CHOOSING TO PRACTICE;

	B.	PROTOCOLS MUST BE APPROVED BY THE HEALTH-SYSTEM’S MEDICAL COMMITTEE, OR PHARMACY AND THERAPEUTICS COMMITTEE; AND

	C.	DOCUMENTED COMPETENCY OF EACH AREA OF PRACTICE IN WHICH THE PHARMACIST IS CHOOSING TO PRACTICE SHALL BE MAINTAINED ON SITE.

5. 6. Licensed Colorado pharmacists practicing drug therapy management prior to August 1, 2005, must attest and certify that they were provided clinical training, experience, and oversight practicing in the disease state(s) that they work in, and the physician with whom they are currently practicing must attest that they are practicing to the standard of care required for management of the specific disease.  Such attestations must be on file at the site of practice.  Copies of their written agreement must be submitted to the Board.  Documentation of their employment dates must be on file as proof of practice prior to August 2, 2005.

6.00.40  Drug Therapy Management in inpatient and group model integrated closed HMO settings.

a.  Pharmacists engaging in drug therapy management in inpatient and group model integrated closed HMO settings must conduct activities pursuant to a valid order and must follow the protocols set forth by the hospital medical committee, or pharmacy and therapeutics committee.  They must record all of the items required in subsection c. below for each patient, or the hospital may create a general authorization plan, identifying where such information will be located, and how it will be accessed throughout the facility by participating pharmacists and physicians.  The general authorization plan serves as the pharmacist/physician agreement in these settings.  The general authorization plan must identify which physicians and pharmacists are authorized and have agreed to participate in the facility to engage in drug therapy management.  A pharmacist engaging in drug therapy management must read, sign and date the plan and the pertinent protocols that he/she agrees to use in the cases undertaken.

a.  Pharmacists engaging in drug therapy management in inpatient and group model integrated closed HMO settings must conduct activities pursuant to a valid order and must follow the protocols set forth by the hospital medical committee, or pharmacy and therapeutics committee.  They must record all of the items required in subsection c. below for each patient, or the hospital may create a general authorization plan, identifying where such information will be located, and how it will be accessed throughout the facility by participating pharmacists and physicians.  The general authorization plan serves as the pharmacist/physician agreement in these settings.  The general authorization plan must identify which physicians and pharmacists are authorized and have agreed to participate in the facility to engage in drug therapy management. The hospital medical committee or Pharmacy & Therapeutics committee serves as the authorizing agent for the organization’s medical staff, identifying which physician groups are authorized to participate, and may restrict authorization for certain protocols to specific physician groups or specialties. A pharmacist engaging in drug therapy management must read, sign and date the plan and the pertinent protocols that he/she agrees to use in the cases undertaken.

 COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 17, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being amended to clarify the labeling of prescriptions when dispensed through central prescription processing.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

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.

 COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 17, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being added to delineate and define the processes involved in central prescription processing.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

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.