RXUSA Creates Program With NAIPW And AIPWA To Protect Nations Drug Supply

(EMAILWIRE.COM, January 10, 2007 ) Port Washington, NY -- RxUSA, in cooperation with the NAIPW (National Association of Independent Pharmaceutical Wholesalers, www.naipw.org) ) and the AIPWA (Association of Independent Pharmaceutical Wholesalers of America, www.apiwa.com ) have released a new 24 point program aimed at improving and protecting the nations drug supply from counterfeit drugs.RxUSA and a group of 10 other Pharmaceutical Wholesaler’s were granted an injunction by Federal Judge Johanna Seybert, effective 12/1/2006 blocking the FDA from implementing regulations that would have caused the virtual destruction of the secondary pharmaceutical distributor industry in the United States, and collaterally eliminating the transmission of Drug Pedigrees in the USA.In response to the vacuum created by the Court’s injunction, the Major Pharmaceutical Authorized Distributors may have to provide complete pedigree information, as Congress intended, with all transactions and not be exempt from the same laws and regulations as all other members of the Pharmaceutical supply chain.The full contents of the NAIPW /AIPWA /RXUSA 24 POINT PROGRAM TO PROTECT THE NATIONS DRUG SUPPLY can be viewed in its entirety at www.naipw.org/pedigree.html or www.aipwa.com/pedigree.html .No one is or should be above the law. No one should be exempt from the law by virtue of their monopolistic of monopsonistic power. Big Pharma should be in the forefront of making the nation’s drug supply safe. NAIPW and AIPWA invite membership in their organizations to completely protect the nation’s drug supply. We invite Big Pharma to join us in fairly extending this complete protection of the nation’s drug supply to everyone manufacturing, wholesaling, distributing or being involved in the nation’s drug supply.NAIPW/AIPWA NATIONAL PEDIGREE GUIDLELINE RECOMMENDATIONS1. - 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 the DEA, upon license renewal. 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 rules to allow for the waivers of pedigree papers during public emergencies. 17.-Promulgate rule to require wholesale licensees to report all instances of fraud, to a centralized FDA website. 18.-Require pedigree papers from all vendors tracing the pharmaceuticals to the manufacturer whether or not required by law. 19.-Perform due diligence by authenticating all pedigree papers whether or not required by law. 20.-Refuse to do business with any wholesaler that does not provide a pedigree paper. 21.-Report all suspected fraud to special FDA website or phone number or national law enforcement. 22.-Improve anti-counterfeiting measures for labels and packaging. 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.Contact:ROBERT DRUCKERTel: (516) 467-2500 x201

RxUSA
ROBERT DRUCKER

RDRUCKER@RXUSA.COM