COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, September 16, 2010
Proposed Changes with Statement of Basis, Purpose, and Authority
Basis and Purpose: The purpose of the amendment to Rule 5.00.55(b)(3) is to change the requirement for reinstatement of a non-resident prescription drug outlet to indicate that the report of inspection to be submitted should be the most recent inspection report completed within the past five years. Previously, the rule required an inspection report no older than two years. The rule extends that period to five years in light of the national trend of less frequent inspections by state agencies, usually for budgetary reasons.
Statement of Authority: The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, 12-22-130(1)(b) and 24-4-103.
5.00.55 Reinstatement of an In-State or Non-Resident Prescription Drug Outlet Registration.
a. In-state Prescription Drug Outlet. If a registration has expired, a facility seeking to reinstate such registration shall submit the following:
(1) The current reinstatement application with the required fee;
(2) If the owner of the in-state prescription drug outlet is a corporation, submit either a copy of the articles of incorporation as they were filed with the Colorado Secretary of State or a Certificate of Good Standing issued by the Colorado Secretary of State;
(3) A letter stating whether the corporation is public or private as follows:
(A) If the corporation is a public corporation, submit a list of all stockholders owning five percent or more of the stock; or
(B) If the corporation is a private corporation, submit a list of all stockholders;
(4) An accurate drawn-to-scale floor plan of the prescription drug outlet’s compounding / dispensing area detailing all counters, bays, sinks, refrigerators and, if applicable, sterile and non-sterile compounding hoods;
(5) A completed, dated and signed minimum equipment self-inspection form as provided with the reinstatement application; and
(6) A statement, signed by the pharmacist manager, stating whether or not greater than ten percent of the business is owned by a person or persons authorized by law to prescribe drugs.
b. Non-resident Prescription Drug Outlet. If a registration has expired, a facility seeking to reinstate such registration shall submit the following:
(1) The current reinstatement application with the required fee;
(2) A verification of the current pharmacy license or registration issued by the resident state board of pharmacy;
(3) If the registration has expired for more than two years, a copy of the most recent a report detailing an inspection of the non-resident prescription drug outlet by its resident state board of pharmacy dated within 5 years of submission of the reinstatement application.
Basis and Purpose: The proposed amendments to Rule 21.22.10 and 21.21.70 would afford prescription drug outlets flexibility to label a compounded prescription pursuant to a prescription order or LTCF chart order with a clear statement that the prescription was compounded by the pharmacy, rather than require the labeling of a compounded prescription with the exact statement “This product was compounded by the pharmacy,” for purposes of accommodating various label sizes.
Statement of Authority: The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, 12-22-120(2) and (3), and 24-4-103.
21.11.10 Labeling of Non-Sterile Compounded Preparations.
a. Labeling of non-sterile compounded products dispensed pursuant to a prescription order or LTCF chart order shall include at least the following:
(1) All requirements of CRS 12-22-123;
(2) Batch (lot) number, if appropriate;
(3) Beyond-use date;
(4) Storage directions when appropriate; and
(5) “A CLEAR STATEMENT THAT THIS This product was compounded by the pharmacy”.
21.21.70 Labeling of CSPs.
a. Labeling of CSPs dispensed pursuant to a prescription order or LTCF chart order shall include at least the following:
(1) All requirements of CRS 12-22-123;
(2) Batch (lot) number, if appropriate;
(3) Beyond-use date;
(4) If for parenteral administration, the following shall be included:
(a) Name of base solution; and
(b) name and amounts of drugs added.
(5) Storage directions; and
(6) A “This CLEAR STATEMENT THAT THIS product was compounded by the pharmacy.”