Most pharmaceutical distribution wholesalers are familiar with the Verified-Accredited Wholesale Distributors (VAWD) program and know that attaining the accreditation is no easy feat without the proper software. It is an extensive and complex process that can take over six months to complete, so why go through the hassle to get the accreditation? VAWD is more than a “nice to have” accreditation - it establishes your business as a trustworthy trading partner in the U.S. pharmaceutical market. It indicates that your company has met the most rigorous verification and requirements and adheres to the best practices of the industry. Since pharmaceutical wholesale businesses that are VAWD accredited also have increased visibility and control over their inventory, distribution, operations and procedures, more and more buying partners, insurance organizations, manufacturers etc. require their wholesale suppliers to have the accreditation to safeguard their relationship, creating a high demand for accreditation.
What exactly is VAWD?
VAWD is an accreditation that is issued by the National Association of Boards of Pharmacy (NABP) to pharmaceutical wholesale drug distribution facilities. The accreditation verifies that distributing facilities are in compliance with state and federal laws which ultimately helps to prevent counterfeit drugs from entering the U.S. market. It is currently recognized by 24 states in the U.S., and is a requirement in Indiana, North Dakota, Iowa and Wyoming. Other states require VAWD as a condition of license renewal for disciplinary cases.
2021 UPDATE: As of February 2020, VAWD is now referred to as the NABP Drug Distributor Accreditation program.
The accreditation is certainly not an overnight process. Candidates must meet dozens of criteria in a number of different categories such as Licensure, Facility, Personnel, Policies and Procedures, Record Keeping, Authentication and Verification etc.
As accreditation often takes several months to complete, it makes it all the more important for candidates to be fully prepared for the rigorous reviews to avoid having to re-apply. The time it takes to complete the program is greatly impacted by a facility’s readiness.
Where does software come in?
Having the right pharmaceutical ERP software with advanced abilities for “maintaining inventories and records of all transactions regarding the receipt and distribution or other disposition of all drugs and devices”, helps to meet the VAWD criteria faster. The industry specific functionality in pharmaceutical ERP helps businesses to not only comply with DEA, FDA and DSCSA requirements but also can be leveraged to become VAWD accredited.
Before we explore specific pharmaceutical ERP software features that come into play, here are some of the VAWD criteria that the right software will help to address:
Wholesale distributors must:
- Establish and maintain inventories and records of all transactions from receipt and distribution to identifying the source of the product (product type, packing slips, shipping records, sales invoices in the distributors name and address).
- Keep records for inspection and photocopying by any authorized official of any state, federal or local government agency for a period of 3 years.
- Have lot level documentation saved for the past 6 years in the form of transaction information (TI), transaction history (TH), and transaction statement (TS).
- Provide records at the inspection site and have them readily available for inspection during the retention period. Records kept at a central location must be available for inspection within two working days of a request and should be securely stored to protect the integrity of data.
- Must record full contact list of persons with whom the wholesale distributor conducts business.
- Processes in place for monitoring the purchase activity of customers and identifying ordering patterns that identify potential diversion or criminal activity in accordance with state and federal law.
Policies & Procedures
Wholesale distributors must:
- Have systems in place for the receipt, security, storage, inventory, transport, shipping, and distribution of drugs, including and procedures for, identifying, recording, and reporting losses or thefts or for correcting all errors and inaccuracies in inventories, and for ensuring the oldest approved stock of a prescription drug product is distributed first.
- A procedure to be followed for handling recalls and written withdrawals of drugs and devices.
- Be in accordance with the Food, Drug, and Cosmetic (FD&C) Act and have systems in place for product tracing, authorized trading partners, verification, wholesaler and 3PL reporting.
- Business must also have a procedure in place for investigating discrepancies involving counterfeit, suspected of being counterfeit, contraband, or suspected of being contraband prescription drugs, and reporting such discrepancies within three (3) business days to the board of pharmacy or appropriate state regulatory agency and appropriate federal agency.
Automating Processes with Pharmaceutical ERP Software
Automation: Manual methods for shipping, receiving, tracking and sharing information are prone to human errors and are time-consuming. Pharmaceutical ERP software with robust inventory and accounting functionality can not only automate these processes but has the ability to store historical data such as who the product was purchased from and who it was shipped to, types of product and related information, expiration dates, creating/printing packing slips, saving shipping records, creating sales invoices containing your businesses’ name and address- all from one system.
You can also save and retrieve past purchase, shipping, and contact information using various tools. Documents can be sent directly from the pharmaceutical ERP software to be shared/copied etc if asked to be inspected. Security features within the system such as login credentials and user specific windows ensures the integrity of the data.
Traceability: Sophisticated traceability and transaction reporting functionality allows users to print lot numbers on documents including invoices and packing slips. TI, TH, and TS information that are also part of the DSCSA Transaction Report requirements, can be generated for the purposes of VAWD accreditation by pulling specific existing data directly from the system. Transaction information such as the name of product, strength and dosage, NDC#, lot number etc., can easily be turned into a Transaction Report (T3). Transaction History (TH), previously known as a Pedigree report, is the recording of the product’s entire transaction history. This allows a business to track the drug’s owners all the way back to the manufacturer using extensive reporting functionality in the system. Transaction Information (TI) records data on trading partners transferring ownership of the specific product and adheres to DSCSA requirements- all data which can be stored and quickly accessed in the system.
Strong traceability features also come into play when there is a need for recall reporting. It enables quick notification to trading partners that sold the recalled products and accounts for all other quantities of the recalled product.
Order Tracking: When it comes to suspect ordering, functionality within pharmaceutical ERP software monitors sales orders for ordering patterns and prevents the order from being shipped before further analysis of the anomaly can be performed.
Maintaining your VAWD accreditation
In order for businesses to maintain their VAWD accreditation, specific renewal documentation is required and an on-site examination will happen once every three years. The NABP may also elect to survey the wholesale distributor facility at any time if NABP receives information indicating that the wholesale distributor may be out of compliance with any of the VAWD criteria.
It’s best for VAWD accredited businesses to have the appropriate robust compliance solution in place, and feel confident that in the event of an inspection by any party, they can quickly produce the "Transaction Report" (Transaction History, Information, and Statement) documentation associated with any product that has flowed through their possession.
Want to grow your pharmaceutical distribution business? Learn how IPD grew sales by 42.5% in 1 month and achieved their VAWD Acceditation with Blue Link's pharmaceutical ERP CSOS software.