HB12-1311 - Sunset Continue Pharmacy Board

Passed/Signed into Law
Concerning Continuation Of The State Board Of Pharmacy, And, In Connection Therewith, Implementing The Recommendations Contained In The Sunset Review And Report Regarding The Board And Recodifying The Laws Regulating Pharmacists, The Practice Of Pharmacy, And The Manufacture, Distribution, And Dispensing Of Prescription Drugs And Controlled Substances.

Sunset Process - House Health and Environment Committee. The bill implements the recommendations of the sunset review and report on the Colorado state board of pharmacy as follows:

Recommendation 1 - Contained in C.R.S. section 12-42.5-103 (3)(b) and Section 3 of the bill

  • The bill continues the state board of pharmacy (board) and its functions and the regulation of the practice of pharmacy through September 1, 2021.

Recommendation 2 - Contained in C.R.S. sections 12-42.5-106 (1)(j) and 12-42.5-202 (1.5) and Section 2 of the bill

  • The bill repeals the rehabilitation evaluation committee, which is tasked with reviewing applications to participate in the pharmacy peer health assistance program and making recommendations to the board. The functions of the rehabilitation evaluation committee are transferred to the board.

Recommendation 3 - Contained in C.R.S. section 12-42.5-203 (2)(a)

  • The pharmacy peer health assistance program is funded from license and renewal fees, the amount of which are set in statute. The bill permits the board annually to increase license and renewal fees, based on increases in the consumer price index, to cover the costs of the pharmacy peer health assistance program.

Recommendation 4 - Contained in C.R.S. section 12-42.5-102 (25)(b)

  • The definition of an "other outlet" that registers with the board is expanded to include ambulatory surgical centers, medical clinics operated by hospitals, and long-term care facilities for seniors.

Recommendation 5 - Contained in C.R.S. sections 12-42.5-102 (16) and 12-42.5-118 (10)

  • Currently, hospitals, which are registered as prescription drug outlets (PDOs), are allowed to operate "satellite" pharmacies that are located in an area outside the PDO but at the same location as the PDO. If a satellite has an address that differs from the PDO, the satellite must obtain a separate registration from the federal drug enforcement agency (DEA), which requires, as a prerequisite, a state registration; however, current law does not permit a separate registration for a satellite that has a different address than the PDO. The bill establishes a new hospital satellite pharmacy registration to require a satellite that is located in a building that is under the same ownership and control as a registered PDO but that has a different address to obtain a separate registration from the board, thereby allowing the hospital satellite pharmacy to obtain its own registration from the DEA.

Recommendation 6 - Contained in C.R.S. section 12-42.5-302 (2)

  • Current law permits the board to exempt wholesalers who exclusively distribute veterinary prescription drugs from the requirements that otherwise apply to prescription drug wholesalers, including the requirement to maintain records of the pedigree of each wholesale distribution of a prescription drug that occurs outside the normal distribution channel. The bill allows the board to exempt wholesalers that distribute veterinary prescription drugs from the pedigree requirement, regardless of whether the wholesaler exclusively distributes veterinary prescription drugs.

Recommendation 7 - Contained in C.R.S. section 12-42.5-119 (3)(b) and 12-64-111 (1)(hh)

  • A licensed veterinarian is permitted to issue an oral prescription order to a wholesaler, in which case the veterinarian must provide a written prescription to the wholesaler within 72 hours after issuing the oral order. A licensed veterinarian is subject to discipline by the state board of veterinary medicine if he or she fails to provide a written prescription within 72 hours as required by section 12 of the bill.

Recommendation 8 - Contained in C.R.S. section 12-42.5-125 (6)

  • Under current law, the board may issue a letter of admonition to a licensee as a form of discipline, but the board is not authorized to issue letters of admonition to registrants. The bill permits the board to issue letters of admonition to registrants as a disciplinary tool.

Recommendation 9 - Contained in C.R.S. section 12-42.5-125 (7)

  • When the board issues a confidential letter of concern to a licensee or registrant, current law requires the board to send the letter via certified mail. The bill deletes the certified mail requirement, thereby allowing the board to determine the manner in which to transmit the letter to the licensee or registrant.

Recommendation 10 - Contained in C.R.S. section 12-42.5-117 (1)(b)

  • PDOs are required to employ a pharmacist manager to ensure the PDO operates in accordance with applicable laws. If the pharmacist manager's employment is terminated, either voluntarily or involuntarily, the PDO must replace the former pharmacist manager and, within 14 days after termination of the former pharmacist manager, apply to transfer the registration of the former pharmacist manager to a new pharmacist manager, and pay a transfer fee. The bill extends the deadline for applying for the registration transfer and payment of the fee to 30 days after termination of the former pharmacist manager.

Recommendation 11 - Contained in C.R.S. section 12-42.5-204 (1) and (2)(a)

  • Current law requires a pharmacist or pharmacy intern to actually experience impaired practice before he or she is allowed to apply to the board for participation in a pharmacy peer health assistance program. The requirement to experience impaired practice is repealed, and a pharmacist or pharmacy intern who recognizes a potential for the existence of a problem that may impair his or her practice is allowed to apply for the program.

Recommendation 12 - Contained in C.R.S. section 12-42.5-123 (2)

  • When a practitioner determines that an equivalent drug should not be substituted for the prescribed drug, the practitioner must indicate that order by writing "dispense as written" on the prescription order or by initialing in his or her own handwriting a preprinted box labeled "dispense as written". The bill allows the practitioner, when issuing an electronically generated prescription order, to indicate the "dispense as written" by electronic means, including use of an electronic signature.

Recommendation 13 - Contained in C.R.S. sections 12-42.5-124 (1)(d) and (1)(r) and 12-42.5-125

  • Under current law, a pharmacist or pharmacy intern is subject to discipline if he or she is unfit to practice by reason of a physical or mental illness. The bill removes as grounds for discipline the mere existence of a physical or mental illness and instead authorizes discipline only if the pharmacist or pharmacy intern fails to notify the board of a physical or mental illness or condition that affects his or her ability to safely practice pharmacy; fails to act within the limitations of the illness or condition; or fails to comply with the limitations agreed to under a confidential agreement with the board. Additionally, the bill authorizes the board to enter into a confidential agreement to limit the practice of a pharmacist or pharmacy intern who has a physical or mental illness or condition that impedes his or her ability to practice with reasonable skill and safety.

The bill, in C.R.S. section 12-42.5-119 (13), permits interns to practice pharmacy under the direct and immediate supervision of a registered manufacturer or regulated health care-related professional, as determined pursuant to board rule.

Section 1 of the bill also recodifies and relocates the laws regulating pharmacists and the practice of pharmacy by the board from article 22 in title 12, C.R.S., to a new article 42.5 in title 12, C.R.S. Section 5 relocates laws pertaining to the licensing of addiction programs and researchers by the department of human services to a new part 2 in article 80 of title 27, C.R.S.

Sections 6 through 91 contain conforming amendments related to the recodification and relocations.

The bill takes effect July 1, 2012.

Latest update: June 8, 2012
06/08/2012 Governor Action - Signed
05/25/2012 Sent to the Governor
05/25/2012 Signed by the President of the Senate
05/24/2012 Signed by the Speaker of the House
05/09/2012 Senate Third Reading Passed
05/09/2012 House Considered Senate Amendments - Result was to Concur - Repass
05/08/2012 Senate Second Reading Special Orders - Passed with Amendments
05/04/2012 Senate Committee on Appropriations Refer Unamended to Senate Committee of the Whole
05/03/2012 Senate Committee on Finance Refer Amended to Appropriations
04/27/2012 Senate Committee on Health and Human Services Refer Amended to Finance
04/18/2012 Introduced In Senate - Assigned to Health and Human Services
04/18/2012 House Third Reading Passed
04/17/2012 House Second Reading Passed with Amendments
04/12/2012 House Second Reading Laid Over Daily
04/10/2012 House Committee on Appropriations Refer Amended to House Committee of the Whole
03/21/2012 House Committee on Finance Refer Amended to Appropriations
03/08/2012 House Committee on Health and Environment Refer Amended to Finance
02/20/2012 Introduced In House - Assigned to Health and Environment