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Wholesalers, Manufacturers, AB 128 Compliance and EPP

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Wholesalers and EPP Information
*Names without addresses are affiliated facilities

This page does NOT contain the application for licensure as a wholesaler. Click here if you are not currently registered. You MUST request a new application before needing the information on this page.
 

This page contains information specific to pharmaceutical wholesalers and Nevada's new Electronic Pedigree Program (EPP).  Any questions regarding Nevada's pharmaceutical wholesaling laws or the EPP can be directed to Carolyn Cramer, General Counsel at (775) 850-1440 or at ccramer@pharmacy.nv.gov.

NOTE:

The first EPP report is due on February 15, 2007

ELECTRONIC PEDIGREE PROGRAM
Electronic Pedigree Program Handbook (pdf)
Special Notice to Wholesalers Regarding Nevada's Electronic Pedigree Program (pdf)
  First Supplement to the Nevada Electornic Pedigree Program Handbook (pdf) (Version 12/28/06)
  
  The following is a blank Excel spreadsheet that can be used by a wholesaler who must manually input pedigree data or into which a wholesaler can place data it may already have so that the data can be transmitted to the EPP in the proper format.
Electronic Pedigree Program Excel Shell (excel)
 
   
NEVADA'S PHARMACEUTICAL WHOLESALER LAWS

Compliance by Manufacturers and Wholesalers with Reporting Requirements of AB 128

Office of Inspector General - phone (202) 619-1343
 
  Compliance Pack for Manufacturers and Wholesalers of Drugs, Medicines, Chemicals, Devices or Appliances (pdf)
  
AB128 Certification of Completion of Annual Audit Monitoring Compliance With Code of Conduct For Manufacturers and Wholesalers of Drugs, Medicines, Chemicals, Devices, or Appliances (pdf)  (Word)
   
AB128, Statutes of Nevada, Chapter 409 (effective October 1, 2007) requires that all wholesalers or manufacturers who employ a person to sell or market a drug, medicine, chemical, device, or appliance in Nevada comply with certain requirements regarding their marketing practices.

Under Nevada law, NRS 639.007, the definition of “drug” and “medicine” includes both prescription drugs and OTC medicines and therefore manufacturers and wholesalers of both prescription drugs and OTC medicines are required to comply with AB 128 if they sell or market a drug, medicine, chemical, device or appliance in Nevada.

Wholesalers or Manufacturers of food, aspirin and effervescent saline analgesics are exempt from the AB128. (NRS 639.007(3).

 
  2009-2010 AB 128 Code of Conduct Compliant Companies (pdf)
  2008-2009 AB 128 Code of Conduct Compliant Companies (pdf)
AB128 requires that each year a manufacturer or wholesaler certify that an annual audit to monitor compliance with the manufacturer or wholesaler’s marketing code of conduct has been done. The certification forms will be available on the Board’s website, and it is the manufacturer or wholesaler’s responsibility to download, complete, and mail in the form by June 1 of every year starting June 1, 2009.

If a wholesaler has submitted to the Board the information required pursuant to section 5 of this regulation at least once, the wholesaler may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to section 5 of this regulation.

If a medical products wholesaler has submitted to the Board the information required pursuant to section 8 of this regulation at least once, the medical products wholesaler may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to section 8 of this regulation.

If a manufacturer has submitted to the Board the information required pursuant to section 11 or 12 of this regulation at least once, the manufacturer may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to section 11 or 12 of this regulation, as applicable.

The annual submission of information to the Board may be made by:

(a) Mail or personal delivery of a printed copy of the information required;
(b) Electronic mail to the Board at the electronic mail address rseidlinger@pharmacy.nv.gov; or
(c) Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.

  • You should indicate on each document attached to the form the number of the item for which the document is being submitted.
  • Please clearly indicate on any document submitted with the form any claim that the document is confidential or proprietary business information subject to the disclosure protections of Section 1, subsection 4(d) of AB 128.
  • If you have any questions please e-mail Ray Seidlinger at rseidlinger@pharmacy.nv.gov and allow 10 business days for a response.
 


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