STATE OF COLORADO

Department of Regulatory Agencies
D. Rico Munn, Executive Director

Division of Registrations
Rosemary McCool, Director

STATE BOARD OF PHARMACY
Wendy L. Anderson, Program Director
1560 Broadway, Suite 1300
Denver, Colorado  80202
Phone (303) 894-7800
Fax (303) 894-7692
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 (2007), you are hereby advised that the Colorado State Pharmacy Board will hold a public rule making hearing on Thursday, May 15, 2008, at 9:30 a.m., at the Denver Post Building, 1560 Broadway, Conference Room 1380, Denver, Colorado 80202, for consideration of the following:

Hearing Regarding Modification, Amendment, Revision or Adoption of:
Rule 3.00.50(e) (3 CCR, 719-1)
Rule 4.02.00(c) (3 CCR, 719-1)
Rule 23.00.00 (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 24, 2008.  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 __________________, 2008

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 15, 2008

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendment to Rule 4.02.00 is to clarify that examination scores are only considered valid for 24 months from the date of examination.

Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, and 24-4-103.
4.02.00  Licensure by Examination.  The examinations for licensure as a pharmacist shall consist of an     academic examination and a jurisprudence examination, each approved by the Board.   Eff  05/30/2006
a.    	For licensure by examination the academic examination shall be fairly designed to test the applicant’s knowledge of pharmacy and other related subjects.  The passing point shall be set at 75 to reflect minimum competence.   Eff  05/30/2006
b.    	The candidate for licensure by examination must pass a Board approved jurisprudence examination, which, for the purpose of this regulation, shall be the practical examination.  The passing point shall be set at 75 to reflect minimum competence.   Eff  05/30/2006
c.    	If an applicant for licensure by examination passes only one of the required examinations, the applicant shall be required to repeat the failed examination.  If, after 24 months, the applicant has not passed both required examinations, he shall be required to also repeat the previously passed examination.   Eff  05/30/2006  EXAMINATION SCORES ARE VALID FOR 24 MONTHS FROM THE DATE OF EXAMINATION.
d.    	Score Transfer applicants must complete their licensure within one year from the date the score transfers are received by the Colorado State Board of Pharmacy.   Eff  05/30/2006
e.   	If a candidate for licensure fails to appear for a scheduled examination, the fee shall be forfeited.  If the candidate later desires to take the examination, he/she shall reapply and pay the current fee.   Eff  05/30/2006
f.    	Practice in lieu of internship.  One year of practice of pharmacy as a licensed pharmacist in another state may be accepted by the Board in lieu of a Colorado internship, if the candidate is seeking licensure by examination and has completed this year of practice prior to taking the examination.   Eff  05/30/2006
g.    	Examination results.  Results of the examination for licensure by examination shall be released whether the candidate is eligible for licensure or not.  The Board's staff may release licenses to all candidates when all requirements have been met, and the Board shall act on such released licenses at the next scheduled meeting.   Eff  05/30/2006
h.   	Intern hours obtained over five years past graduation from a school or college of pharmacy shall not be valid for the purposes of obtaining a license by examination or score transfer.   Eff  05/30/2006

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, May 15, 2008

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		Rule 23.00.00 is being adopted to implement the Electronic Prescription Drug Monitoring Program created by statute under Part 7 of the Pharmaceuticals and Pharmacists Act.

Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108,  12-22-110, 12-22-701 et seq.,  specifically 12-22-705(2), and 24-4-103.

23.00.00	ELECTRONIC PRESCRIPTION DRUG MONITORING PROGRAM
23.00.10	Definitions:
	a.	“Prescription Drug Outlet” means any resident or nonresident pharmacy registered with the Colorado State Board of Pharmacy.
	b.	“PDMP” means the Electronic Prescription Drug Monitoring Program.
23.00.20	Submission Requirement.
All prescription drug outlets shall submit their controlled substance dispensing transactions for Schedule II, III, IV, and V Controlled Substances to the PDMP with the exception of the following:
	a.	Hospitals licensed or certified pursuant to CRS 25-1.5-103 that dispense no more than a 24-hour supply of a controlled substance to an outpatient; or
	b.	Hospitals licensed or certified pursuant to CRS 25-1.5-103 which dispense controlled substances only pursuant to chart orders; or
	c.	A prescription drug outlet which has applied to the Board and received a waiver from the Prescription Controlled Substance Abuse Monitoring Advisory Committee.  Waivers will only be considered if the pharmacy has no electronic automation.
23.00.30	Data Submission Timeline.
Every prescription drug outlet must ensure controlled substance dispensing transactions are reported to the PDMP twice each month on the following schedule: 
	a.	For dispensing transactions from the first through the 15th day of each month, data shall be transmitted to the PDMP between the 16th and 25th day of that month.
	b.	For dispensing transactions from the 16th through the last day of the month, data shall be transmitted to the PDMP between the 1st through the 10th day of the subsequent month.
	c.	If the prescription drug outlet does not dispense any controlled substances for the reporting period, it must enter a “zero” entry or will be considered non-compliant.
23.00.40	Data Submission Format.
Prescription drug outlets shall submit to the PDMP the following data requirements:
a.	Identifier (Transmission type identifier);
b	Bin (Bank Identification Number);
c	Version Number (a number to identify the format of the transaction sent or received);
d.	Transaction Code;
e.	NABP or DEA number assigned to pharmacy;
f.	Customer ID (number to identify the patient receiving the RX);
g.	Zip Code (3 digit US Postal Code identifying the State Code); 
h.	Customer’s Birth Date;
i.	Sex Code;
j.	Date Filled;
k.	Prescription Number;
l.	New/Refill Number;
m.	Metric Quantity;
n.	Days Supply;
o.	Compound Code;
p.	NDC Number of the drug dispensed;
q.	Prescriber ID Number;
r.	DEA suffix;
s.	Date RX Written;
t.	Number of Refills Authorized;
u.	RX Origin Code;
v.	Customer Location;
w.	Diagnosis Code, if available;
x.	Alternate Prescriber #;
y.	Patient Last Name;
z.	Patient First Name;
aa.	Patient Street Address;
bb.	State;
cc.	Zip Code;
dd.	Triplicate Serial Number, if appropriate; and
ee.	Filler Field to be populated with Payment Type

23.00.50	Data Correction.
	a.	Any errors identified by the PDMP shall be corrected and resubmitted by the prescription drug outlet on the following schedule:
	1.	For dispensing transactions from the 1st through the 15th day of each month, errors shall be corrected no later than the first day of the following month.
	2.	For dispensing transactions from the 16th through the 31st of each month, errors shall be corrected no later than the 16th day of the following month.
	b.	If errors cannot be corrected, the pharmacy must retain a record in written format detailing the following information for each uncorrected error:
	1.	Detail of Error Notification highlighting uncorrected error(s); and
	2.	Detailed reason of why error cannot be corrected.
23.00.60  Subpoenas from other jurisdictions accepted – limitations.  
For the limited purpose of effectuating the requirements set forth in sections 12-22-705(3)(e) and 12-22-705(6), C.R.S., the PDMP shall release information recorded in the program to law enforcement officials upon presentation of an official court order or subpoena issued by a court in a jurisdiction other than the State of Colorado, if the following conditions are satisfied:
a.	the official court order or subpoena is issued pursuant to a bona fide investigation occurring in the jurisdiction of the issuing court; and
b.	the information requested in the official court order or subpoena is specific to an individual who is the subject to the bona fide investigation; and 
c.	the party seeking information enters a written confidentiality agreement stating that the information to be released shall be kept confidential in conformity with the requirements of 12-22-701, et seq., C.R.S. and 28 CFR §§22.21 through 22.28; and
d.	the party seeking the information enters a into written agreement with the Board stating that:
	1.	the release of information shall not constitute an acceptance of jurisdiction over the Board by the issuing court for any purpose beyond the release of the information recorded in the program that is specifically requested in the official court order or subpoena, and
	2.	the party in the other jurisdiction shall not attempt to subpoena or otherwise require the appearance or attendance by a Board official, employee or contractor in any proceeding in the jurisdiction which is the origin of the subpoena.