Ohio Health Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Serving Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Parma, Youngstown, Canton, and Lorain OH

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Last week, the National Association of Independent Pharmaceutical Wholesalers (NAIPW) and the Association of Independent Pharmaceutical Wholesalers of America (AIWPA) issued recommendations for national pedigrees.  The NAIPW and the AIWPA were both founded by Robert C. Drucker, President and CEO of RX USA Wholesale, Inc. and Mark S. Scovotti. 

As reported on the web site for the NAIPW and the AIWPA, the proposed standards are as follows:

1.- Mandate the creation of a standardized Federal form for pedigree papers to be used in all transactions.

2. -Require that pedigree papers, at a minimum, contain amounts, dosage form, strength, and lot numbers of all drugs; name and address of each owner of the drug;    shipping information; a signature and license number of person certifying delivery or receipt of drugs; date of each transaction; phone number or e-mail contact of each wholesaler; signature certifying that the pedigree paper was verified.

3.- Require that pedigree papers be provided in sales transactions all the way from the manufacturer to the dispenser, at no cost. 

4.- Classify repackagers as wholesalers and require original manufacturer’s lot number to be retained on new packaging.

5.- Require that wholesalers, repackagers and dispensers perform due diligence by verifying contents of pedigree papers.

6.- Increase the civil or criminal penalty for failure to provide pedigree papers.

7.- Increase the civil or criminal penalty for forging pedigree papers.

8.- Increase the civil or criminal penalty for knowingly purchasing from or selling to an unlicensed person or entity.

9.- Increase the criminal penalty for forging a prescription label.

10.-Require one $100,000 National performance bond to be posted by wholesalers with DEA.

11.-Require wholesalers to carry $2,000,000 in liability insurance.

12.-Require licensees to secure and retain receipts for all cash transactions of pharmaceuticals.

13.-Clarify the definition and responsibility of an authorized distributor of record. Track the proposed federal rule by requiring pedigree papers to be provided all the way to dispensers.

14.-Require all licensed wholesalers to have on-line access for verification of pedigree papers back to the manufacturer, without charge to any licensed wholesalers, distributor, or other licensed health care provider..

15.-Post names and business addresses of all current pharmaceutical wholesale licensees on the appropriate FDA website.

16.-Promulgate rule to require wholesale licensees to report all instances of fraud, to a centralized FDA website.

17.-Require pedigree papers from all vendors tracing the pharmaceuticals to the manufacturer whether or not required by law.

18.-Perform due diligence by authenticating all pedigree papers whether or not required by law.

19.-Refuse to do business with any wholesaler that does not provide a pedigree paper.

20.-Report all suspected fraud to special FDA website or phone number or national law enforcement.

21.-Improve anti-counterfeiting measures for labels and packaging.

22.-Provide complete access at no cost to all wholesalers and dispensers attempting to authenticate pedigree papers or products. 

23.-Provide complete access at no cost to all wholesalers and dispensers attempting to authenticate pedigree papers or products.

 24.-Make mandatory regulations, with no exceptions, that no Imported drugs, or Re-imported prescription drugs be allowed to be resold in the USA, unless the resale to any user, end-user, wholesaler, Chain warehouse, or ADR, includes full pedigree trails back to an original US FDA Approved Manufacturer, at a US FDA approved plant which complies with all United States Federal and State laws and regulations.