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NAIPW/AIPWA
NATIONAL PEDIGREE GUIDELINE RECOMMENDATIONS
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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.
