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Download PDMA 2007 and Beyond FDA Counterfeit Drug Task Force Public Workshop
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PDMA 2007 and Beyond FDA Counterfeit Drug Task Force Public Workshop Bethesda, MD February 9, 2006 Eleni Z. Anagnostiadis, R.Ph. National Association of Boards of Pharmacy Overview The presentation will highlight: NABP and FDA collaborative efforts to address counterfeit drug issue State legislative and regulatory activity Federal Regulation of Wholesale Distributors Prescription Drug Marketing Act (PDMA) of 1987, Prescription Drug Amendments (PDA) of 1992 Banned the Sale of Drug Samples and Drug Coupons Banned Reimportation (limited exceptions) Set Requirements for Sample Distribution and Storage Required State Licensing of Wholesale Distributors Required Identity Statements for Sales (pedigrees) by Unauthorized Distributors of Record – stayed until December 1, 2006 NABP Commission to Combat Counterfeiting FDA Counterfeit Drug Task Force (July 2003) NABP Task Force on Counterfeit Drugs and Wholesale Distributors (October 2003) NABP Model Rules for the Licensure of Wholesale Distributors (February 2004; Revised in March 2005) NABP Task Force on Counterfeit Drugs and Wholesale Distributors Input from Industry Stakeholders, State and Federal Governmental Agencies Concerted Effort over the Course of Four Months Ultimate Goal: Obtaining Uniformity Among States New Concepts in the Model Rules Pedigree: A document (written or electronic) that records each distribution of the drug from the sale of manufacturer through the acquisition and sale by any wholesale distributor or repackager Components: Drug Info, Seller Info, Due Diligence Indicator, Certification by the Designated Representative Authorized Distributor of Records vs. Unauthorized Distributor of Record NABP Task Force to Develop Recommendations on Electronic Pedigrees Primary Objective: Gain consensus from state boards of pharmacy and other applicable state regulatory agencies regarding the necessary components for electronic pedigrees NABP Task Force to Develop Recommendations on Electronic Pedigrees Recommendations: Electronic pedigree records all transactions and distributions of a product beginning with manufacturer until final sale and distribution to the pharmacy Implementation of electronic pedigrees by December 2007 Specified data elements of electronic pedigrees: Drug name, amount of drug, dosage form, dosage strength, lot/control numbers, NDC (optional), name of manufacturer Dates of transactions, sales invoice numbers Name, address, telephone, number, e-mail address, VAWD #, state license number of each entity involved in the chain of custody Certification that each recipient has authenticated the pedigree and information included within the pedigree is true Name and address of each person certifying delivery or receipt of the drug Pedigree Legislation in States Arizona California Florida Indiana Iowa Nevada New Jersey New Mexico Oklahoma Texas Virginia State Licensing of Wholesale Distributors State Boards of Pharmacy Renewal Schedule: One to Two years Out-of-State Wholesale Distributors Regulatory Challenges Limited Board of Pharmacy/State Agency Resources Lack of Uniformity of States’ Regulation Lack of Communication Between Regulators NABP Verified-Accredited Wholesale Distributors™ (VAWD™) Program Primary Objective Based upon NABP Model Rules, State and Federal Laws Launched February 2005 Pathway to Accreditation Voluntary Third party requirements State Regulation VAWD Accreditation Process Application Policy and Procedure Evaluation Facility Inspection Verification of licensure (Facility and Personnel) Clearinghouse screening (Facility and Personnel) Tour, staff interviews, documentation review Periodic reviews and inspections Award Accreditation State Legislation - VAWD Indiana and Oklahoma specifically mention VAWD in their wholesale distributor legislation. Idaho - Although not explicitly stated in their legislation or regulations, Idaho endorses VAWD and requires nonresident wholesales who are not able to obtain an inspection from their state to be VAWD accredited. State Legislation - VAWD Nebraska has included language in their proposed legislation to allow for an inspection to be performed "by the department or a nationally recognized accreditation program approved by the board". Several other states that are working on wholesale distributor legislation that have expressed an interest in endorsing VAWD in their upcoming regulations and legislation. Conclusion Counterfeit drugs – patient safety issue Progress in states Federal and state legislation must be complimentary Set target date for electronic pedigree implementation Uniformity among states Eleni Anagnostiadis, RPh Professional Affairs Director, NABP [email protected] Visit the NABP website at www.nabp.net VAWD Accreditation Program and Criteria NABP Model Rules for the Licensure of Wholesale Distributors
