I am a new wholesaler and my warehouse is not yet accredited. Can I work partly via a vawd accredited 3PL while my warehouse is ready for vawd research? If the 3PL is Vawd and it never physically affect my business it is as a VAWD. Can I call my vawd basically accredited? Or another terminology that says I`m Vawd so that pharmacies don`t risk losing money during an optum audit. Non-state virtual manufacturers who want to continue doing business in Maryland must scratch their heads. Here`s why. Maryland is now a distributor of Wholesale De Verified Accredited (VAWD) State. As of October 1, 2010, non-governmental wholesalers in states that are not “essentially comparable to Maryland” must be accredited by a board-recognized accreditation body. According to the Maryland Regulations (COMAR 10.34.22.01) code, a wholesaler is defined as “anyone working in the wholesale trade of drugs or prescription devices in Maryland.” Non-state virtual producers are clearly covered by the broad definition of the state. As a result, these companies must apply for VAWD accreditation. There is only one problem – the Maryland Pharmacological Board of Directors, VAWD Accreditation, the National Association of Boards of Pharmacy (NABP), is not going to accredit a virtual manufacturer. This issue was brought to the attention of the leader in life science by Jennifer Schneider, vice president of customer services for the License Servicing (SLS) state in Warwick, NY. SLS manages the government licensing portfolios of several life sciences manufacturers and distributors. Schneider is a certified civil party and has been practising corporate law, pharmaceutical patents and regulatory affairs for 22 years.
In September 2010, she received a letter from the Maryland Board of Pharmacy announcing the amendment of the Wholesale Distribution Permitting and Prescription Drug Integrity Act in Maryland. Schneider then approached the Maryland Board of Pharmacy for clarification. In her letter to the General Manager of the Pharmacy Board, she refers to the government`s definition of a wholesaler. In addition, Schneider points out that a virtual manufacturer is not entitled to be accredited vawd because it does not physically take possession of the drugs, a necessary criterion for NABP VAWD accreditation. Ronald W. Buzzeo, RPh, said Schneider agreed with Virtuals and said, “There is no VAWD process for virtual manufacturers.” Buzzeo helped NABP develop the VAWD inspection program. As a pharmacist by training, Buzzeo worked for the New York State Narcotic Bureau and the DEA before setting up his own business, operational, regulatory and outsourcing services for controlled substances, I-Chemicals listing issues, Development and Management Association (PDMA), VAWD and state requirements and helping companies obtain and maintain their government licenses. Buzzeo`s company was acquired by Cegedim, where he currently serves as Chief Compliance Officer. I had the opportunity to interview him and Schneider for this article. What is VAWD? The process of obtaining a prescription drug from the manufacturer at your local pharmacy, hospital or care home involves a complex distribution path.
In 2004, NABP created VAWD to make available to government and federal regulators – as well as the public – a way to easily identify sellers of large licensees.