Volume 43 - Issue 18 - May 2, 2024
State of Kansas
Board of Pharmacy
Notice of Hearing on Proposed Administrative Regulations
A public hearing will be conducted at 8:30 a.m. and 1:00 p.m. Thursday, July 11, 2024, at the Board of Healing Arts Conference Room, Lower Level, 800 SW Jackson, Topeka, Kansas, to review and consider the adoption of the proposed permanent regulations of the Kansas State Board of Pharmacy.
This 60-day notice of the public hearing shall constitute a public comment period for the purpose of receiving written public comments on the proposed regulations. All interested parties may submit written comments prior to the public hearing to Alexandra Blasi, Executive Secretary, 800 SW Jackson, Suite 1414, Topeka, KS 66612-1244, or by email to pharmacy@ks.gov. All interested parties will be given a reasonable opportunity to present their views orally regarding the adoption of the proposed regulations during the public hearing. In order to provide all parties an opportunity to present their views, it may be necessary to request that each participant limit any oral presentation to five minutes.
Any individual with a disability may request an accommodation in order to participate in the public hearing and may request the regulations and economic impact statements in an accessible format. Requests for accommodation to participate in the public hearing should be made at least 10 business days in advance of the hearing by contacting Alexandra Blasi, Executive Secretary, 800 SW Jackson, Suite 1414, Topeka, KS 66612-1244 or by phone at 785-296-4056. Handicapped parking is located at the north entrance to the building. Curbs at the north entrance are accessible to individuals with disabilities.
Summaries of the proposed regulations and their economic impact follow. Copies of the regulations and economic impact statements may be viewed at https://pharmacy.ks.gov/statutes-regs/proposed-changes. (Note: Statements indicating that “The Board anticipates that the proposed new regulation/revocation will have minor to no economic impact” are intended to indicate that no economic impact on the Board, other state agencies, state employees, or the general public have been identified.)
8:30 a.m. Meeting
K.A.R. 68-2-5. Revoked. The Board proposes revoking K.A.R. 68-2-5. K.A.R. 68-2-5 was merged into K.A.R. 68-1-9; as such, the regulation is duplicative and redundant. The Board anticipates that the proposed revocation will have no economic impact.
K.A.R. 68-2-25. Minimum requirements of a prescription for a non-controlled substance. The proposed new regulation is the non-controlled substance counterpart to K.A.R. 68-20-18. The regulation establishes minimum requirements for non-controlled substance prescriptions, including the information required on the prescription, the pharmacy personnel who received the prescription, and any changes made to the prescription. The Board anticipates that the proposed new regulation will have minor to no economic impact.
K.A.R. 68-7-14. Prescription labels. The proposed amendments to the regulation establish what information a prescription label must include and who shall be permitted to label or relabel drugs or devices originally dispensed from their registered location. The Board anticipates that the proposed amendments will have minor to no economic impact.
K.A.R. 68-7-18. Health departments, private not-for-profit family planning clinics, federally qualified health centers, and indigent healthcare clinics. The proposed amendments to this regulation add federally qualified health centers and indigent healthcare clinics to the regulation, allowing it to more closely mirror its authorizing statute. Proposed amendments clarify that only federally qualified health centers may store and supply controlled substances, require pharmacists-in-charge to ensure that facilities maintain and implement policies and procedures for drugs, and require facilities to maintain records and searchable databases. The Board anticipates that the proposed amendments will have minor to no economic impact.
K.A.R. 68-19-1. Minimum program requirements. The proposed amendments to the regulation set out the new continuous quality improvement (CQI) program requirements for each Kansas pharmacy. The amendment details the new incident report review process, root cause analysis, corrective action plan, and null report pharmacies must follow. The amendment also provides an exception to certain requirements if a pharmacy actively reports to a patient safety organization. The regulation will enhance patient safety, prevent dispensing errors, and ensure that policies and procedures reflect current standards of pharmacy practice and support pharmacy personnel. The Board anticipates that the proposed amendment will have minor to no economic impact.
1:00 p.m. Meeting
The proposed new Article 23 regulations provide requirements for the new practice of telepharmacy as required by the Kansas Pharmacy Act.
K.A.R. 68-23-1. Definitions. This proposed new regulation provides definitions for the new practice of telepharmacy as required by the Kansas Pharmacy Act. The Board anticipates that the proposed new regulation will have minor to no economic impact.
K.A.R. 68-23-2. Telepharmacy outlet application; facility; managing pharmacy. This regulation sets forth the requirements for pharmacy owners who wish to establish a telepharmacy outlet, including where it can be established, how many prescriptions can be dispensed from the outlet, how the outlet is to be supervised, the opportunity for the outlet to receive a waiver, and the compliance of the outlet.
The Board is unable to quantify an economic impact. While the proposed new regulation creates new requirements for pharmacies that wish to utilize telepharmacy, the proposed new regulation does not require pharmacies to utilize telepharmacy. Pharmacies wishing to open a telepharmacy may incur costs ranging from $5,000 to $25,000 for initial setup and ongoing maintenance approximating $1,500 to $5,000 per month.
K.A.R. 68-23-3. Personnel, staffing, training, and supervision. This regulation sets forth the requirements for the personnel who would staff the telepharmacy outlet, internal inspection, storage of drugs and devices, emergency procedures, and what constitutes direct supervision.
The Board is unable to quantify an economic impact. While the proposed language does create new requirements for these practices, pharmacies already have the capacity to comply as they are closely aligned with routine prescription dispensing practices.
K.A.R. 68-23-4. Practice of pharmacy. This regulation sets forth the requirements for when a prescription may be dispensed, what tasks may be performed by pharmacist interns and pharmacy technicians, and the outlet’s compliance.
The Board is unable to quantify an economic impact. While the proposed language does create new requirements for these practices, pharmacies already have the capacity to comply as they are closely aligned with routine prescription dispensing practices.
K.A.R. 68-23-5. Operation of telepharmacy outlet. This regulation sets forth the requirements for when the telepharmacy outlet can be operated, what prescription application must be utilized, where the outlet receives prescriptions and devices, what notices and licenses must be displayed, how often a pharmacist must be on site, storage of drugs and devices, recordkeeping, emergencies, and closure of the outlet.
The Board is unable to quantify an economic impact. While the proposed language does create new requirements for these practices, pharmacies already have the capacity to comply as they are closely aligned with routine prescription dispensing practices.
K.A.R. 68-23-6. Structural, security, technology, and equipment requirements; restrictions. This regulation sets forth the requirements for the security system employed by the telepharmacy outlet, plumbing and electricity, sanitation, lighting and climate, recordkeeping, and automated dispensing.
Vendors and other state boards of pharmacy estimate the costs of continuous video surveillance of the telepharmacy outlet at $20,000, and costs of ongoing maintenance and storage to range from $300–$1,650 per month. The cost of a monitored alarm system is estimated under $1,000 per year. This is also referenced in K.A.R. 68-23-2. Pharmacies already have the capacity to comply with routine pharmacy operation costs as they are closely aligned with routine prescription dispensing practices.
Alexandra Blasi
Executive Secretary
Board of Pharmacy
Doc. No. 052099
