NAC639.594. Establishment of ongoing relationship.

     1. An ongoing relationship between a wholesaler and a manufacturer must be established by:

     (a) A written franchise, license or other agreement between a manufacturer and wholesaler to distribute prescription drugs;

     (b) The presence of the wholesaler on a list of distributors with which the manufacturer does business, created by the manufacturer and located on a publicly accessible website maintained by the manufacturer; or

     (c) The existence of the purchase by the wholesaler of at least 5,000 sales units of prescription drugs from the manufacturer within the 12 months immediately preceding the transaction for which the wholesaler claims to have an ongoing relationship and:

          (1) The Board or a purchasing wholesaler verifying the purchase with the manufacturer at its main corporate office in the United States; or

          (2) The wholesaler maintaining invoices showing that the purchase was made directly from the manufacturer which include an account number assigned by the manufacturer to the wholesaler’s address of record on file with the Board.

     2. The records establishing an ongoing relationship between a wholesaler and a manufacturer must be:

     (a) If the facility is located within this State, maintained at the facility of the wholesaler throughout the period that such a relationship exists;

     (b) Maintained for 3 years after the termination of any such relationship; and

     (c) Available for review and copying by the Board or by any authorized representative of a federal, state or local agency.

     3. An ongoing relationship between a wholesaler and a manufacturer may be attributed to an affiliated wholesaler if:

     (a) The affiliated wholesaler is licensed by the Board or the relevant authority of another state;

     (b) The wholesaler who has the ongoing relationship with the manufacturer and the affiliated wholesaler are wholly owned by a common owner; and

     (c) The common owner is a publicly traded corporation.

     4. As used in this section, “sales unit” means any standard container or unit of packaging used by the manufacturer for the prescription drug.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001; R049-04, 2-28-2005)