Section 61-02-08-03 - Operations1. A remote site shall comply with North Dakota Century Code section 43-15-35 governing requirements for a permit to operate a pharmacy. The remote site is considered to be under the personal charge of the pharmacist at the central pharmacy. 2. A remote site shall be connected to its central pharmacy via computer link, videolink, and audiolink. 3. A remote site shall use its central pharmacy's central processing unit. a. Consecutive prescription numbers and all prescription records must be maintained at the central pharmacy. b. Prescriptions filled at the remote site must be distinguishable on records from those filled at the central pharmacy. c. Daily reports must be separated for the central pharmacy and the remote site but must be maintained at the central pharmacy. d. Pharmacies must be able to generate labels from the central pharmacy or at the remote site. e. All prescriptions distributed at the remote site must have a label that meets requirements set forth in chapter 61-04-06 attached to the final drug container before the pharmacist verifies the dispensing process. 4. A pharmacist at the central pharmacy must approve each prescription before it leaves the remote site. a. Dispensing is considered to be done at the central pharmacy. b. Both the pharmacist's and the technician's initials must appear on the fill screen, patient profile, and label. c. A pharmacist shall compare via videolink the stock bottle, drug dispensed, and strength. The entire label must be checked for accuracy on the videolink. 5. Counseling must be done by a pharmacist via videolink and audiolink. The pharmacist must counsel the patient or the patient's agent on all new prescriptions and refills. 6. A pharmacist must complete monthly inspections of the remote site. Inspection criteria must be included in the policies and procedures for the site. The inspection reports must be maintained until the next state board of pharmacy inspection. 7. The remote site may have a prescription inventory. Controlled substances shall be kept at the remote site in accordance with North Dakota Century Code chapter 19-03.1, the Uniform Controlled Substances Act. a. If controlled substances are kept, the remote site must be registered with the drug enforcement administration and obtain its own drug enforcement administration number. b. All records must be stored at the central pharmacy, except those required by the drug enforcement administration to be at the drug enforcement administration-registered site. 8. There must be policies and procedures in place to ensure the safe and effective distribution of pharmaceutical products and delivery of required pharmaceutical care. There must be an ongoing review of incident reports and outcomes, with appropriate corrective action taken when necessary, to ensure there is no abnormal frequency of errors in dispensing drugs or devices. 9. The telepharmacy location must be in compliance with 61-02-02, building standards for pharmacies; 61-02-03, security standards for pharmacies; and 61-02-04, sanitary standards for pharmacies; except as otherwise provided in this chapter. 10. Dispensing and consultation may be done when the registered pharmacy technician is not present, under the following circumstances: a. The prescription has been prepared by the registered pharmacy technician and checked by the licensed pharmacist. b. The prescription area is locked. c. A separate locked drawer or cabinet is maintained for prescriptions ready for dispensing. d. A log is maintained by the registered pharmacy technician of prescriptions placed in the locked drawer or cabinet. e. A record must be made by the pharmacist as to the date and time at which dispensing and counseling occurs. f. Supportive personnel, trained in the use of the audiolink and videolink, to the licensed pharmacist, are on hand, to assist the patients. g. The patients receive their prescriptions as they are being counseled by the licensed pharmacist. 11. The permitholder or the pharmacist in charge of the central pharmacy must apply for a permit for the remote site. A class K permit is established under section 61-02-01-01 for the purpose of conducting a telepharmacy. These permits are issued to a remote site connected to a central pharmacy via computer link, videolink, and audiolink. N.D. Admin Code 61-02-08-03
Effective October 1, 2001; amended effective December 1, 2003.General Authority: NDCC 43-15-10(7)(9)(11)(12)(14)(19)
Law Implemented: NDCC 43-15-10, 43-15-32, 43-15-34, 43-15-35