Q. What is an Automated Data Processing System?
A. An Automated Data Processing System in a pharmacy is the computer software and hardware that the pharmacy uses for the purpose of prescription processing and record keeping.
201 KAR 2:171 Computerized Record Keeping
201 KAR 2:171 Section 1 (9) An auxiliary recordkeeping system shall be established for the documentation of refills if the automated data processing system is inoperative for any reason. The auxiliary system shall ensure that all refills are authorized by the original prescription order and that the maximum number of refills is not exceeded. If the automated data processing system is restored to operation, the information regarding prescriptions filled and refilled during the inoperative period shall be entered into the automated data processing system within seventy-two (72) hours.
_____________________________________________________________________________________________________________
Q. Are only respiratory therapists allowed to do CPAP or BiPAP setups?
Q. Who may act as pharmacist-in-charge (PIC) of a Medical Gas Permit?
A. Any pharmacist licensed by the Kentucky Board of Pharmacy may act as PIC of a Medical Gas Permit. The PIC of a Medical Gas Permit may act as PIC of multiple locations.
Q. What is required of the pharmacist-in-charge (PIC) of a Medical Gas Permit?
A. The PIC of a Medical Gas Permit is required to perform quarterly inspections of the permitted facility. The inspection shall include a review of the permit’s records, sanitation, and security and control. 201 KAR 2:225
Q. The business is moving, what steps need to be taken to notify the Board of Pharmacy?
A. If a home medical equipment or medical gas permit holder wants to change location a change of address form needs to be submitted to the Board office. Once the application is processed the permit holder will need to contact the inspector for the area. The new location will be inspected and approved prior to authorizing the change in address. Disciplinary action may result in relocation without proper notification and authorization.
Q. What is considered manufacturing? And who is required to obtain a manufacturer’s permit?
A. "Manufacturer" means any person, except a pharmacist compounding in the normal course of professional practice, within the Commonwealth engaged in the commercial production, preparation, propagation, compounding, conversion, or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container. Any business engaged in these activities within the Commonwealth is required to be permitted by the Kentucky Board of Pharmacy. KRS 315.010
Q. Who may act as pharmacist-in-charge (PIC) of a Manufacturer’s Permit?
A. Any pharmacist licensed by the Kentucky Board of Pharmacy may act as PIC of a Manufacturer Permit. The PIC of a Manufacturer Permit may act as PIC of multiple locations.
Q. What is required of the pharmacist-in-charge (PIC) of a Manufacturer Permit?
A. The PIC of a Manufacturer Permit is required to perform quarterly inspections of the permitted facility. The inspection shall include a review of the permit’s records, and security and control. 201 KAR 2:320
Q. Is an out-of-state manufacturer required to obtain a manufacturer permit in Kentucky?
A. No, only in-state manufacturers are required to obtain a manufacturer permit. An out-of-state manufacturer shipping drugs into Kentucky may be required to obtain a wholesale distributor permit.