Nevada Administrative Code (Last Updated: January 6, 2015) |
Chapter639 Pharmacists and Pharmacy |
WHOLESALERS |
NAC639.599. Prescription drugs: Examination of shipments; actions upon determination of certain conditions.
-
1. Each wholesaler shall, upon receiving a prescription drug, examine each outside shipping container of the drug and any accompanying document, including, without limitation, the invoice, the shipping record and the “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” described in NAC 639.603, to determine its identity and to prevent the acceptance of a prescription drug that is:
(a) Counterfeit;
(b) Deemed to be adulterated or misbranded in accordance with the provisions of chapter 585 of NRS;
(c) Mislabeled;
(d) Damaged or compromised by improper handling, storage or temperature control;
(e) From a foreign or unlawful source; or
(f) Manufactured, packaged, labeled or shipped in violation of any state or federal law relating to prescription drugs.
Ê The examination must be sufficient to detect any damage to the container which would indicate contamination or other damage to the contents of the container.
2. Each wholesaler shall examine each outgoing shipment of prescription drugs to identify the prescription drugs contained in the shipment and to ensure that the prescription drugs contained in the shipment are not damaged and have been stored under proper conditions.
3. If a wholesaler determines that a prescription drug has one or more of the conditions set forth in paragraphs (a) to (f), inclusive, of subsection 1, the wholesaler:
(a) If the prescription drug is not subject to a recall or withdrawn from the market, shall:
(1) Separate the prescription drug from other prescription drugs; and
(2) Provide to the Board, not later than 10 business days after the inspection, a written notice that includes:
(I) The name and address of the supplier of the prescription drug;
(II) The name of the prescription drug;
(III) The lot number and expiration date of the prescription drug;
(IV) The quantity of the prescription drug;
(V) Whether the wholesaler returned the prescription drug to the supplier or decided to destroy the prescription drug;
(VI) The reason for the action taken by the wholesaler; and
(VII) If the prescription drug was returned to the supplier, the date on which the prescription drug was returned to the supplier.
(b) If the prescription drug is not subject to a recall or withdrawn from the market, may return the prescription drug to the supplier or destroy the prescription drug.
4. Within 48 hours after receipt by the Board of a notice required pursuant to subsection 3, a member of the staff of the Board shall inspect the prescription drug at the facility of the wholesaler and may impound or remove the prescription drug. If the member of the staff of the Board does not impound or remove the prescription drug, the wholesaler may return the prescription drug to the supplier or destroy the drug.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005)