STATE OF COLORADO
Bill Ritter, Jr.Governor
COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 15, 2009
Proposed Changes with Statement of Basis, Purpose, and Authority
Basis and Purpose: The purpose of the amendment to Rule 6.00.30 is to clarify the requirements for pharmacists to conduct pharmaceutical care, drug therapy management, and practice by protocol.
Statement of Authority: The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, and 24-4-103.
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 IN THE SPECIALTY BEING PRACTICED; or
2. A bachelor of pharmacy degree and cCompletion 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 cCompletion 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 from the Board of Pharmaceutical Specialties, 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 in 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.
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.
COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 15, 2009
Proposed Changes with Statement of Basis, Purpose, and Authority
Basis and Purpose: The purpose of the amendments to Rule 11.06.00 is to detail the requirements to electronically maintain receipts of non-controlled prescription drugs.
Statement of Authority: The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, and 24-4-103.
11.06.00 Receipts
11.06.05 ALL PRESCRIPTION DRUGS AND CONTROLLED SUBSTANCES RECEIVED BY A PRESCRIPTION DRUG OUTLET SHALL ONLY BE PROCURED FROM ANOTHER ENTITY OR PERSON REGISTERED BY THE COLORADO STATE BOARD OF PHARMACY.
11.06.10 Records of receipts of prescription drugs and controlled substances shall contain the following information for each such substance received:
a. Name of the drug;
b. Strength of the drug;
c. Dosage form if appropriate;
d. Quantity received;
e. Date received if a controlled substance;
f. Name of the labeler of the drug AND/OR NDC NUMBER OF THE DRUG if it is labeled only with its generic name;
g. Name AND ADDRESS of the distributor;
H. NAME AND ADDRESS OF THE RECEIVING OUTLET;
Ih. DEA number of distributor AND RECEIVER if a controlled substance; AND
Ji. IF A SCHEDULE II CONTROLLED SUBSTANCE, The DEA form 222 or a copy of the DEA form 222 and the corresponding invoice shall be attached to each other IF A SCHEDULE II CONTROLLED SUBSTANCE.
11.06.20 All records of receipt (including credit invoices) of prescription drugs and controlled substances shall be maintained for a period of time not less than two years from the date the drugs were received. HARD COPY rRecords of receipt (including credit invoices) of non-controlled prescription drugs need not be maintained on the premises provided that they shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors.
11.06.30 All records of receipt of schedule II controlled substances shall be maintained separately from all other records AND SHALL AT ALL TIMES BE MAINTAINED AND BE READILY AVAILABLE FOR INSPECTION IN HARD COPY FORM AT THE OUTLET FOR A PERIOD OF TIME NOT LESS THAN TWO YEARS FROM THE DATE THE DRUGS WERE RECEIVED.
11.06.40 ALL rRecords of receipt of schedule III, IV, and V controlled substances SHALLmay be maintained SEPARATELY FROM ALLwith other records AND SHALL AT ALL TIMES BE MAINTAINED AND READILY AVAILABLE FOR INSPECTION IN HARD COPY FORM AT THE OUTLET FOR A PERIOD OF TIME NOT LESS THAN TWO YEARS FROM THE DATE THE DRUGS WERE RECEIVED. of receipt.
11.06.50 RECORDS DETAILING THE RECEIPT OF PRESCRIPTION DRUGS, AS REQUIRED BY REGULATION 11.06.10(A) THROUGH (H), MAY BE MAINTAINED ELECTRONICALLY IF THE FOLLOWING REQUIREMENTS ARE MET:
A. THE PRESCRIPTION DRUG OUTLET MUST ENSURE A DAILY (I.E., EVERY TWENTY- FOUR HOURS) BACK UP IS PERFORMED FOR USE IN RESTORING REQUIRED INFORMATION IN CASE OF A SYSTEM FAILURE.
B. HAVE AND MAINTAIN A COMPLETE ON-LINE RECEIPT FILE THAT IS PRINTABLE ON THE INSPECTOR’S REQUEST.
C. HAVE A “LOCK-OUT” FEATURE THAT PREVENTS EDITING OF RECEIPT INFORMATION.
D. THE BOARD OR ITS INSPECTORS MUST BE ABLE TO INSPECT AND REVIEW ALL OF THE PRESCRIPTION DRUG RECEIPT TRANSACTIONS OF THE OUTLET FOR THE PRECEEDING TWO YEARS. THEREFORE, IMMEDIATELY UPON THE ORAL OR WRITTEN REQUEST OF THE BOARD OR ITS INSPECTORS, THE OUTLET SHALL EITHER:
(1) PRINT A REPORT OF ALL PRESCRIPTION DRUG RECEIPT TRANSACTIONS FOR A PERIOD OF TIME AS THE BOARD OR ITS INSPECTOR(S) MAY SPECIFY. THE SYSTEM MUST BE CAPABLE OF RETRIEVING AND PRINTING SUCH A REPORT WITHIN A LIMITED TIME NOT TO EXCEED TWO HOURS.
OR
(2) PROVIDE A COMPUTER TERMINAL AND MONITOR FOR THE SOLE USE OF THE BOARD OR ITS INSPECTOR(S) TO INSPECT AND REVIEW PRESCRIPTION DRUG RECEIPT TRANSACTIONS, AND IF NECESSARY, PROVIDE A PERSON TO ASSIST THE BOARD OR ITS INSPECTOR(S) FOR A PERIOD OF TIME NOT TO EXCEED TWO HOURS IN OPERATING THE SYSTEM. IF THE OUTLET ELECTS TO COMPLY WITH THIS SUBPARAGRAPH (2), THE SYSTEM MUST ALSO BE CAPABLE OF PRINTING THE SAME REPORTS DESCRIBED IN SUBPARAGRAPH (1).
(3) IT IS THE RESPONSIBILITY OF THE PHARMACIST MANAGER OF THE OUTLET TO ENSURE THAT ALL OUTLET STAFF ARE AWARE OF THE REQUIREMENTNS OF SUBPARAGRAPHS (1) AND (2). ANY FAILURE OR REFUSAL BY THE PHARMACIST MANAGER AND/OR A STAFF PHARMACIST TO COMPLY WITH A REQUEST BY THE BOARD OR ITS INSPECTOR(S) WILL BE DEEMED TO BE A WILLFUL VIOLATION OF THESE REGULATIONS.
E. IF THE OUTLET CHOOSES TO MAINTAIN RECORDS DETAILING THE RECEIPT OF PRESCRIPTION DRUGS ELECTRONICALLY, ANY REPORTS PRINTED UPON THE REQUEST SHALL CONTAIN, AT A MINIMUM, THE FOLLOWING INFORMATION FOR EACH RECEIPT TRANSACTION:
(1) NAME OF THE DRUG;
(2) STRENGTH OF THE DRUG;
(3) DOSAGE FORM IF APPROPRIATE;
(4) QUANTITY OF THE DRUG RECEIVED;
(5) DATE RECEIVED;
(6) NAME OF THE LABELER OF THE DRUG AND/OR NDC NUMBER OF THE DRUG IF IT IS LABELED ONLY WITH ITS GENERIC NAME;
(7) NAME AND ADDRESS OF THE DISTRIBUTOR; AND
(8) NAME AND ADDRESS OF THE RECEIVING OUTLET.
COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 15, 2009
Proposed Changes with Statement of Basis, Purpose, and Authority
Basis and Purpose: The purpose of the amendments to Rule 22.00.00 is to clarify the procedures involved with the handling of Initial Decisions.
Statement of Authority: The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, and 24-4-103.
22.00.00 INITIAL DECISIONS
22.00.10 Written form, service, TIME, and filing requirements.
a. All designations of record, requests, MOTIONS, exceptions, and ANY RESPONSES THERETO (HERINAFTER “PLEADING” OR PLEADINGS”)responsive pleadings (“pleadings”) must be in written form, mailed with a certificate of mailing to the board and the opposing party.
B. IN THE EVENT THAT AN ELECTRONIC FILING SYSTEM IS IMPLEMENTED IN THE DIVISION OF REGISTRATIONS FOR THE RECEIPT OF PLEADINGS, THE ITEMS LISTED IN THIS PARAGRAPH MAY BE SUBMITTED IN ELECTRONIC FORM WITH A CERTIFICATE OF FILING TO THE BOARD AND THE OPPOSING PARTY.
bC. All pleadings must be RECEIVED filedBY with the board by 5:00 pm on the date the filing is due. These rules do not provide for any additional time service by mail.
c. Any pleadings must be served on the opposing party by mail or by hand delivery on the date on which the pleading is filed with the Board.
dD. All pleadings must be filed with the board and not with the Office of Administrative Courts. Any pleading FILED IN ERROR WITH THE OFFICE OF ADMINISTRATIVE COURTS WILL NOT BE CONSIDERED.s filed with the Office of Administrative courts will not be considered.
22.00.20 Authority to review.
a. The board hereby preserves the Board’s option to initiateS a review of an ALL initial decisionS on its own motion pursuant to §24-4-105(14)(a)(ii) and (b)(iii), C.R.S. beyond thirty days after service of the initial decision upon the parties without requiring a vote for each case.
b. This option to review shall apply regardless of whether a party files exceptions to the initial decision.
22.00.30 Designation of record and transcripts.
a. Any party seeking to reverse or modify the initial decision of the administrative law judge shall file with the Board a designation of the relevant parts of the record for review (“Ddesignation of rRecord”). Designations of record ARE DUE AND MUST BE RECEIVED BY THE BOARD must be filed with the Board within twenty days of the date on which the Board mails the initial decision to the parties’ address of record with the Board.
b. IN THE ABSENCE OF A DESIGNATION OF RECORD, Even if no party files a designation of record, the recordTHE RECORD FOR THE PURPOSES OF THE BOARD’S REVIEW OF THE INITIAL DECISION AS SET FORTH IN SECION 24-4-105(14)(A) SHALL IN ALL CASES INCLUDE THE FOLLOWING: shall include the following:
(1) All pleadings FILED WITH THE OFFICE OF ADMINISTRATIVE COURTS OR APPLICABLE HEARING TRIBUNAL;
(2) All applications presented or considered during the hearing;
(3) All documentary or other exhibits admitted into evidence AT THE HEARING;
(4) All documentary or other exhibits presented or considered during the hearing;
(5) All matters officially noticed DURING THE HEARING; AND
(6) Any findings of fact and conclusions of law proposed by any party AT THE HEARING. ; and
(7) Any written brief filed.
c. Transcripts: Transcripts will SHALL not be deemed as part of a designation of record unless specifically identified, and ordered, AND TIMELY FILED. TO DESIGNATE Should a party wish to designate a transcript or portion thereof, the following procedures will apply:
(1) The designation of record must identify with specificity the transcript or portion thereof to be transcribed. For example, a party may designate the entire transcript, TESTIMONY OF PARTICULAR or may identify witness(es) whose testimony is to be transcribed, the A legal ruling or argument to be transcribed,, or other information necessary to identify a THE portion of the transcript TO BE TRANSCRIBED..
(2) Any party who includes a transcript or a portion thereof as part of the designation of record must order the transcript or relevant portions by the date on which the designation of record IS DUE. AS NOTED ABOVE, A DESIGNATION OF RECORD IS DUE must be filed (within twenty days of THE date on which the Board mails the initial decision to the parties).
(3) When ordering the transcript, the ORDERING party shall request the court reporter to prepare COMPLETE AND PROVIDE THE BOARD the transcript AND ONE COPY OF THE TRANSCRIPT within thirty days AND SHALL TIMELY PAY ALL FEES ASSOCIATED WITH SUCH A REQUEST.
. The party shall timely pay the necessary fees to obtain and file with the board an original transcription and one copy within thirty days.
(4) The ordering party shall direct the court reporter to complete and file with the board the transcript and one copy of the transcript within thirty days.
(54) If a party designates a portion of the transcript, the opposing party may also file a supplemental Ddesignation of Rrecord IDENTIFYING, in which the opposing party may designate additional portions of the transcript. This supplemental designation of record IS DUE AND must be filed RECEIVEDwith BY the board within ten days after the date on which the original designation of record was due AND RECEIVED BY THE BOARD.
(65) An opposing party filing a supplemental designation of record SHALL REQUEST THE COURT REPORTER TO COMPLETE AND PROVIDE THE BOARD THE SUPPLEMENTAL TRANSCRIPT AND ONE COPY OF THE SUPPLEMENTAL TRANSCRIPT WITHIN THIRTY DAYS OF THE SUPPLEMENTAL DESIGNATION OF RECORD AND SHALL TIMELY PAY ALL FEES ASSOCIATED WITH SUCH A REQUEST.
must order and pay for such transcripts or portions thereof within the deadlines set forth above. An opposing party must also cause the court reporter to complete and file with the board the transcript and one copy of the transcript within thirty days.
(76) Transcripts that are ordered by either party and not filed with PROVIDED TO the Board in a timely manner by the COURT reporter due to non-payment, insufficient payment or failure to direct REQUEST as set forth above will not be considered by the Board.
22.00.40 Filing of exceptions and responsive pleadings
a. Any party wishing to file exceptions shall adhere to the following timelines:
(1) If no transcripts are ordered, exceptions are due within thirty days from the date on which the Board mails the initial decision to the parties. Both parties’ exceptions are due on the same date.