Section 175-8-004 - INSPECTIONS For the purpose of assuring compliance, each licensee must prepare an annual Pharmacy Quality Assurance Report (PQAR).
004.01PHARMACY QUALITY ASSURANCE REPORT (PQAR). The Pharmacy Quality Assurance Report (PQAR) is due 1 year from the date of the initial on-site inspection and annually thereafter. All licensees must ensure that the pharmacist in charge or the practitioner annually submits a completed Pharmacy Quality Assurance Report (PQAR) on a form provided by the Department, electronically or upon request. A Pharmacy Quality Assurance Report (PQAR) self-inspection may be completed no more than 30 days before the due date of the report. 004.01(A)REPORTED INFORMATION. At a minimum, the Pharmacy Quality Assurance Report (PQAR) must provide information on the following: (i) Standards for the Operations of a Pharmacy (1) Staffing requirements;(2) Storage requirements;(3) Record keeping requirements;(4) Dispensing requirements;(5) Controlled substance dispensing requirement for emergency situations; and(6) Disaster preparedness management;(ii) Physical Plant Standards (1) Equipment, facilities, and utilities;(2) Shelving, counters, floor, inventory, fixtures, equipment, and utensils; and(iii) Sterile Compounding Requirements, if applicable for the facility(iv) Non-sterile compounding requirements, if applicable for the facility004.01(B)VERIFICATION OF THE REPORT. The Pharmacy Quality Assurance Report (PQAR) must be accompanied by a signed statement from the pharmacist in charge or the practitioner verifying that all information in the Pharmacy Quality Assurance Report (PQAR) is accurate, complete, and correct.004.02ANNUAL INSPECTION. All licensees are required to complete and submit the Department Pharmacy Quality Assurance Report (PQAR) form for an annual self-inspection, and may be subject to an on-site inspection to verify the pharmacy fully complies with all requirements. 004.02(A)SELF-INSPECTION. The Pharmacy Quality Assurance Report (PQAR) will fulfill the annual inspection requirement when the Department determines that the report indicates that the licensee is in full compliance with the Health Care Facility Licensure Act, the Controlled Substances Act, the Prescription Drug Safety Act, and this chapter. However, the report will not fulfill the annual inspection requirement when: (i) The Department has determined, based on the review of the Pharmacy Quality Assurance Report (PQAR), that the pharmacy is not in compliance with the Health Care Facility Licensure Act, or this chapter;(ii) The pharmacy failed to be in full compliance with the Health Care Facility Licensure Act, or this chapter at the time of its last inspection;(iii) The licensee failed to submit a Pharmacy Quality Assurance Report (PQAR);(iv) The pharmacy is randomly selected as part of the 25% of licensed pharmacies chosen annually for inspection; (v) Any other event that raises concerns about the maintenance, operation, or management of the pharmacy.004.02(B)COMPLIANCE INSPECTION. An unannounced inspection may be conducted of the facility or service anytime the Department deems necessary, including, the passage of five years without an inspection.175 Neb. Admin. Code, ch. 8, § 004
Amended effective 11/3/2020