Volume 42 - Issue 5 - February 2, 2023
State of Kansas
Board of Pharmacy
Notice of Hearing on Proposed Administrative Regulations
A public hearing will be conducted at 9:00 a.m. Thursday, April 27, 2023, at the Office of Administrative Hearings, 1020 S. Kansas Ave., Topeka, Kansas, to review and consider the adoption of 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 statement may be viewed at https://pharmacy.ks.gov/statutes-regs/proposed-changes. (Note: Statements indicating that “The Board anticipates that the proposed amendment/new regulation 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.)
K.A.R. 68-1-1b. Continuing education for pharmacists. The proposed amendment to this regulation modifies the continuing education requirement for pharmacists licensed by the Board. The amendment would require pharmacists to obtain a topical one hour of continuing education provided by the Board; this hour would be counted towards the 30 clock-hour requirement. The Board would make the one-hour course available to pharmacists free of charge and anticipates the proposed amendment will have minor to no economic impact.
K.A.R. 68-1-2a. Pharmacist-in-charge; acknowledgment; notice of designation. The proposed amendments to this regulation clarify the process for becoming a pharmacist-in-charge (PIC), including an acknowledgment of PIC responsibilities. The amendment also updates and clarifies Board notification requirements for PICs beginning and ceasing to serve as PIC, and allows pharmacies to request a 30-day waiver for additional time to designate a new PIC. The Board anticipates that the proposed amendment will have minor to no economic impact.
K.A.R. 68-1-9. Pharmacist-in-charge; responsibilities. The proposed new regulation is designed to provide greater consistency and clarity of pharmacy PIC requirements and highlight practice setting variance. The proposed regulation captures general PIC responsibilities, including supervision, availability, record-keeping, resources, managing drug recalls, changing PIC, drug inventory, newsletter review, and development of pharmacy policies and procedures. The Board anticipates the proposed regulation will have minor to no economic impact.
K.A.R. 68-2-20. Pharmacist’s function in filling a prescription. The proposed amendments to this regulation provide consistency with updates to the Pharmacy Act, including the ability for pharmacists to fill prescriptions based on a prescriber’s telephonic consultation with a patient, which judgmental functions a pharmacist may delegate to a pharmacist intern or pharmacy technician, and which nonjudgmental functions may be delegated within certain limitations. Finally, the proposed amendments authorize an exception to the verbal patient counseling requirement in limited circumstances. The Board anticipates the proposed amendments will have minor to no economic impact.
K.A.R. 68-7-8. Records. The proposed amendments to this regulation are designed to allow pharmacies the ability to digitize prescription records to reduce costs associated with paper storage. Language sets forth basic requirements for ensuring accurate copies and retrievable electronic records. This amendment does not require any pharmacy to participate in digital recordkeeping. Amendments do not require record digitization and are designed to be business-friendly and allow autonomy in recordkeeping processes, while providing minimum safeguards to ensure public protection. While pharmacies that elect to engage in digitization of records may incur costs associated with electronic storage systems, this is not required and estimated expenses are unknown to the Board. Additionally, many pharmacies may already have electronic storage systems capable of storing additional electronic records without additional expense. Pharmacies electing to participate in electronic scanning and shredding of paper records could experience decreased costs associated with physical record storage in the long-run. Since the regulation does not mandate pharmacies engage in electronic storage, no economic impact is anticipated.
K.A.R. 68-7-11. Medical care facility pharmacy. The proposed amendments to this regulation are designed to clarify the responsibilities of the PIC, which have been moved into new K.A.R. 68-1-9. New language outlines the requirements for pharmacies registered as medical care facilities in Kansas, including updating emergency supply labeling requirements, allowing a physician’s assistant to enter the pharmacy as directed, and requiring a pharmacist to review medication orders within three days. Any economic impact will likely stem from shortening the medication order review timeline, but the Board anticipates this will be de minimus.
K.A.R. 68-7-12. Responsibility of pharmacist-in-charge in other than a medical care facility pharmacy. The proposed amendments to this regulation are designed to clarify the responsibilities of the PIC, which have been moved into new K.A.R. 68-1-9. The Board anticipates the proposed amendments will have minor to no economic impact.
K.A.R. 68-7-15. Packaging of drugs or devices in advance of immediate need. The proposed amendments to this regulation require prepackaged drugs to be packaged in a suitable container consistent with the Pharmacy Act and the State and Federal Uniform Controlled Substances Acts. The proposed amendments also require a pharmacist to verify all prepackaged drugs or devices prior to release, consistent with requirements for prescription dispensing. The Board anticipates the proposed amendment will have minor to no economic impact.
K.A.R. 68-7-16. Labels for drugs or devices packaged in advance of immediate need. While proposed amendments to this regulation appear vast, they are actually very minor. Language changes represent technical updates since the last revision in 1978. Substantive amendments include updating and streamlining the labeling requirement for drugs or devices packaged in advance of immediate need. This change is consistent with updates to the Pharmacy Act and the State and Federal Uniform Controlled Substances Acts. The Board anticipates that the proposed amendment will have minor to no economic impact.
K.A.R. 68-7-19. Transfer of a refillable prescription between pharmacies. The proposed amendments to this regulation respond to recent changes in the Pharmacy Act, which authorizes the pharmacy to transfer certain prescriptions at the patient’s request and allows additional pharmacy personnel to receive and transfer such prescriptions. Amendments also update current standards and clarify the process for completing such transfers. Amendments are consistent with federal requirements and those for controlled substances, additionally updating requirements for electronic prescriptions. The Board anticipates that the proposed amendment will have minor to no economic impact but will provide substantial benefit to Kansas patients.
K.A.R. 68-7-20a. Delivery of prescriptions dispensed to an alternate site for administration. The proposed new regulation addresses the practices known as “white bagging” and “brown bagging” in the pharmacy setting. The Board identified several areas for public protection, including requirements for specific communication between the pharmacies, delivery to a pharmacy versus a practitioner’s office, policies and procedures, recordkeeping, prescription tracking, patient consent, patient counseling, prescription storage in accordance with manufacturer requirements, and return of any prescription not administered to the patient. The regulation also eliminates the practice of “brown bagging” or delivering a prescription to a patient’s residence required to be administered by a healthcare provider, except in limited circumstances, and restricts prescriptions for controlled substances.
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 implement compliance as the proposed regulation is closely aligned with routine prescription dispensing practices.
K.A.R. 68-20-1. Definitions. The proposed amendments to this regulation clarify and modify the definitions specific to the Kansas Uniform Controlled Substances Act. Amendments align with current federal requirements. The Board anticipates that the proposed amendment will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-20-16. Records and inventories of registrants. The proposed amendments to this regulation clarify and modify recordkeeping and inventory requirements for controlled substances in Kansas pharmacies. Specifically, the proposed amendments update federal regulatory sections, including drugs of concern, limit to non-liquid dosage forms, and clarify documentation requirements. Amendments align with current federal requirements. The Board anticipates that the proposed amendment will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-20-18. Information concerning prescriptions. The proposed amendments to this regulation update requirements for controlled substance medications including identifying and verifying a valid prescription, contents of a valid prescription, electronic prescriptions, transmission, and dispensing. Amendments align with current federal requirements. The Board anticipates that the proposed amendment will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-20-18a. Information concerning prescriptions; recordkeeping; pharmacy prescription application. The proposed new regulation includes requirements for controlled substance medications including supplying, dispensing, and administering these medications, and sets forth procedures and requirements for partial fills and refills, and outlines recordkeeping requirements. Language aligns with current federal requirements. The Board anticipates that the regulation will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-20-19. Controlled substances listed in schedule II. The proposed amendments to this regulation update requirements specific to Schedule II controlled substance medications, including specific dispensing requirements, patient records, and annotations. Amendments align with current federal requirements. The Board anticipates that the proposed amendment will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-20-20. Controlled substances listed in schedules III, IV, and V. The proposed amendments to this regulation update requirements specific to Schedule III, IV, and V controlled substance medications, including specific dispensing requirements, patient records, and annotations. Amendments align with current federal requirements. The Board anticipates that the proposed amendment will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-20-21. Revoked. The proposed revocation is due to the content of the regulation being consolidated into K.A.R. 68-20-20. No economic impact.
K.A.R. 68-20-22. Selling without a prescription. The proposed amendments to this regulation update requirements for sales of prescription-only drugs without a prescription (i.e., methamphetamine precursors). Amendments align with current federal requirements. The Board anticipates that the proposed amendment will have minor to no economic impact since pharmacies are already required to comply with federal law.
K.A.R. 68-21-1. Definitions. The proposed amendments update and clarify several definitions within the Prescription Drug Monitoring Program (K-TRACS) to match current pharmacy recordkeeping practices. The Prescription Monitoring Program Act was amended in 2022 and changes are reflected in this amendment. The Board anticipates that the proposed amendment will have minor to no economic impact.
K.A.R. 68-21-2. Electronic reports. The proposed amendment updates and clarifies when a dispenser shall file controlled substance prescriptions reports in K-TRACS, shortens the timeframe for filing, and updates requirements for requesting exemption. The Prescription Monitoring Program Act was amended in 2022 and changes are reflected in this amendment. The Board anticipates any economic impact will relate to dispensers no longer qualifying for the exemption, pharmacies changing or updating software vendor agreements, and software vendors changing how controlled substance prescriptions are reported to K-TRACS on the pharmacies’ behalf. However, as vendors are likely to be multi-state vendors, they are likely already compliant with the amendment in Kansas.
K.A.R. 68-21-3. Revoked. This regulation is revoked as moot and in conflict with recent updates to Prescription Monitoring Program Act. No economic impact.
K.A.R. 68-21-4. Notice of requests for information. The proposed amendments to this regulation provide technical clarification since the regulation has not been updated since 2010. The Board anticipates no economic impact.
K.A.R. 68-21-5. Access to program information. The proposed amendments to this regulation clarify existing requirements for requesting data from K-TRACS. The Prescription Monitoring Program Act was amended in 2022 and changes are reflected in this amendment. The Board anticipates that the proposed amendment will have minor to no economic impact.
K.A.R. 68-23-1. Definitions. The proposed new regulation provides requirements for the new practice of telepharmacy as required by the Pharmacy Act. The Board anticipates no economic impact from definitions.
K.A.R. 68-23-2. Telepharmacy outlet application; facility; managing pharmacy. The proposed new regulation provides requirements for the new practice of telepharmacy as required by the Pharmacy Act. 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 from the Board in certain circumstances to operate a telepharmacy, and outlet compliance.
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. The proposed new regulation provides requirements for the new practice of telepharmacy as required by the Pharmacy Act. 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. Additional travel and coverage by a pharmacist-in-charge or supervising pharmacist that would be above and beyond routine in-person pharmacy supervision. While no additional pharmacist hours are required to operate a telepharmacy outlet, there may be a shift in the location for hours worked or those dedicated to particular tasks/functions which may have an economic impact. The Board anticipates no additional economic impact.
K.A.R. 68-23-4. Practice of pharmacy. The proposed new regulation provides requirements for the new practice of telepharmacy as required by the Pharmacy Act. 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 outlet compliance.
K.A.R. 68-23-5. Operation of telepharmacy outlet. The proposed new regulation provides requirements for the new practice of telepharmacy as required by the Pharmacy Act. This regulation sets forth the requirements for when the telepharmacy outlet can be operated, what electronic prescription application may 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.
K.A.R. 68-23-6. Structural, security, technology, and equipment requirements; restrictions. The proposed new regulation provides requirements for the new practice of telepharmacy as required by the Pharmacy Act. 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. No additional economic impact is anticipated aside and apart from routine pharmacy operation costs.
Alexandra Blasi
Executive Secretary
Board of Pharmacy
Doc. No. 050848
