639.585 - On-site inspections; agreements with other wholesalers.
639.585 On-site inspections; agreements with other wholesalers.
1. A person who is licensed to engage in wholesale distribution pursuant to this chapter shall, within 30 days after beginning a business relationship with another wholesaler, conduct an on-site inspection of each facility of the wholesaler to verify that the wholesaler complies with federal requirements for the storage of prescription drugs and the operation of the facilities where prescription drugs are stored.
2. After the date of the inspection pursuant to subsection 1, the licensee shall conduct an on-site inspection biannually.
3. Each on-site inspection conducted pursuant to this section must include:
(a) An assessment of the authority, training and experience of persons who are responsible for receiving, inspecting, storing, handling and shipping prescription drugs at the facility;
(b) An assessment of the operational conditions of each facility of the wholesaler, including, without limitation, security, climate control and cleanliness;
(c) An assessment of compliance with:
(1) The Federal Prescription Drug Marketing Act;
(2) Appropriate recordkeeping measures;
(3) The Drug Enforcement Administration recordkeeping requirements if the wholesaler maintains a federal controlled substance registration; and
(4) Temperature monitoring and documentation requirements; and
(d) An assessment of the procedures of the wholesaler for detecting adulterated, misbranded or counterfeit prescription drugs.
4. For each inspection pursuant to this section, the licensee shall obtain and maintain the signature of the appropriate representative of the wholesaler verifying the accuracy of the inspection.
5. Each licensee shall enter into an agreement with each wholesaler with whom the licensee enters into a business relationship providing that the wholesaler will comply with all applicable federal and state laws and regulations relating to the purchase and sale of prescription drugs and requiring the wholesaler to notify the licensee of any material change regarding the integrity or legal status of prescription drugs received by the licensee or any other material change regarding the legal status of the wholesaler.
(Added to NRS by 2005, 1614)