Section 639.603 - Prescription drugs: Requirements regarding statements of prior sales1. Except as otherwise provided in paragraph (a) of subsection 6 of NAC 639.5975 and NAC 639.6035, each wholesaler shall provide a statement of prior sales identifying each sale of a prescription drug before the prescription drug is sold to another wholesaler or to a pharmacy when supplying prescription drugs if the wholesaler: (a) Has not established an ongoing relationship with the manufacturer from whom the prescription drug was purchased; or(b) Purchased the prescription drug from another wholesaler.2. The statement of prior sales must: (a) Be in writing and bear the title "Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act";(b) Include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer or wholesaler;(c) Accompany all prescription drugs purchased from a wholesaler, even if they are resold to another distributor;(d) Include the business name and address of the person from whom the prescription drug was purchased;(e) Include the date of the sale; and(f) Include the: (1) Name of the prescription drug;(2) Strength of the prescription drug;(3) Size of the container;(4) Number of containers;(5) Lot number of the prescription drug; and(6) Name of the manufacturer of the finished dosage form.3. Each statement of prior sales must be: (a) Maintained by the buyer and the wholesaler for 3 years;(b) Except as otherwise provided in subsection 4, available for copying or inspection upon a request by an authorized representative of any federal, state or local agency, a manufacturer of prescription drugs or a pharmacist or practitioner who purchases prescription drugs from the wholesaler; and(c) Maintained by the wholesaler at its facility.4. If a wholesaler cannot provide a statement of prior sales upon request made pursuant to paragraph (b) of subsection 3 because the wholesaler purchased a prescription drug with a particular lot number from more than one source, the wholesaler must provide:(a) Copies of all of the "Statements Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act," as described in subsection 2, that relate to the prescription drug with the particular lot number; or(b) A statement certifying how much of a prescription drug the wholesaler purchased directly from the drug's manufacturer and how much of the prescription drug the wholesaler purchased from other wholesalers, which must accurately account for the wholesaler's purchases of a prescription drug for the 12 months immediately preceding the request and may be made in the form of a percentage, ratio or per unit accounting. The wholesaler must provide, upon request, all "Statements Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act" that were the basis for the statement made pursuant to this paragraph.5. A wholesaler shall make a record of any statement of prior sale readily retrievable for inspection by the Board .Nev. Admin. Code § 639.603
Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A 10-1-93; R049-04, 2-28-2005; R218-05, 5-4-2006; A by R040-20A, eff. 8/26/2020