Duties of Board; requirements concerning use, form and contents of statement.

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1. The Board shall ensure the safe and efficient operation of wholesalers and the integrity and propriety of transactions involving the purchase and sale of prescription drugs by wholesalers, including, without limitation, ensuring:

(a) The circumstances and conditions under which a wholesaler must prepare, deliver, acquire and maintain a statement of prior sales regarding a transaction involving the purchase or sale of a prescription drug;

(b) The form and contents of a statement of prior sales; and

(c) The process and procedures for verifying and certifying that the information contained in a statement of prior sales is complete and accurate.

2. In ensuring the circumstances and conditions under which a wholesaler must prepare, deliver, acquire and maintain a statement of prior sales regarding a transaction involving the purchase or sale of a prescription drug, the Board shall consider:

(a) The need for verification to ensure that the transaction is a bona fide transaction pursuant to NRS 639.595; and

(b) The level of risk the transaction poses to public health and safety, including, without limitation, the potential that the transaction may involve the sale or purchase of a prescription drug that is:

(1) Counterfeit;

(2) Deemed to be adulterated or misbranded in accordance with the provisions of chapter 585 of NRS;

(3) Mislabeled;

(4) Damaged or compromised by improper handling, storage or temperature control;

(5) From a foreign or unlawful source; or

(6) Manufactured, packaged, labeled or shipped in violation of any state or federal law relating to prescription drugs.

3. If a statement of prior sales is required for a transaction involving the purchase or sale of a prescription drug by a wholesaler, the statement:

(a) Must include the signature of the wholesaler or the wholesaler’s designated representative certifying that the information contained in the statement is complete and accurate; and

(b) Except as otherwise provided in subsection 4, must be:

(1) In written or electronic form, if the transaction occurs before January 1, 2007; and

(2) In electronic form, if the transaction occurs on or after January 1, 2007.

4. The Board may extend the date for compliance with the requirement that the statement of prior sales must be in electronic form if the Board determines that the technology to provide such a statement in electronic form is not reasonably available or that the licensed wholesalers in this State otherwise require additional time to carry out the requirements of an electronic form. If the Board extends the deadline pursuant to this subsection, the Board shall ensure that all licensed wholesalers in this State are provided adequate notice of the extension.

(Added to NRS by 2005, 1611)


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