VAWD Program Update
April 2009
VAWD Criteria Changes, Revisions, or Updates:
- As a result of NABP’s Task Force on Prescription Drug Diversion from Common Carriers, NABP updated the Model Rules for the Licensure of Wholesale Distributors, and subsequently, VAWD Program Criteria. Updated Criteria addresses:
- Common Carrier standards
- Definition for “Significant Loss” of prescription drugs
- Policy & procedure (P&P) and operation standards for verifying security processes of common carriers used by wholesale distributors
- Existing accredited facilities will be grandfathered at this time, but will be required to demonstrate compliance with the new criteria at the point of their three-year reaccreditation. NABP staff will notify current VAWD-accredited facilities.
- All facilities applying for VAWD after July 1, 2009, will be expected to implement compliance with criteria prior to accreditation.
2009 Policy & Procedure Requirements
- The required VAWD P&Ps are intended to evidence compliance with VAWD program criteria.
- NABP is pleased to provide VAWD facilities with a new program tool in response to customer feedback for ways to continue enhancing and improving the VAWD program.
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The VAWD Policies & Procedures (P&P) Guidance Checklist includes a checklist of the documentation needed when applying to and continuing VAWD accreditation, and represents a self-appraisal tool to gauge your readiness for accreditation.
- As noted in the P&P Guidance Checklist, polices and procedures will be re-evaluated against the checklist to ensure all accredited entities are in full compliance with VAWD Criteria.
- Effective in 2009, all applicants and customers renewing accreditation will be expected to adhere to the P&P standards outlined within the P&P Guidance Checklist, which will be provided to applicants upon submitting application with fees.
- Accredited facilities will be provided with the P&P Guidance Checklist at time of annual compliance review and be expected to meet these standards at time of three-year reaccreditation.
- Careful consideration of the P&P Guidance Checklist will assist you in turning around documents to meet VAWD compliance.
1. What is VAWD?
Verified-Accredited Wholesale Distributors (VAWD) is an accreditation program of the National Association of Boards of Pharmacy® (NABP® ) for wholesale distributors.
2. What prompted the development of VAWD?
NABP developed VAWD in response to the Food and Drug Administration's Counterfeit Drug Task Force findings and recommendation that NABP update its Model Rules for the Licensure of Wholesale Distributors.
As a result, NABP revised its Model Rules for the Licensure of Wholesale Distributors, which were originally developed in 1987 to assist states with the implementation of the Prescription Drug Marketing Act, and created an accreditation program and information clearinghouse for wholesale distributors to combat counterfeit drugs.
3. What are the benefits of VAWD accreditation?
VAWD identifies legitimate and legally operating wholesale distributors and verifies compliance with state and federal laws for wholesale distribution to ultimately help protect the public from the threat of counterfeit drugs, which could infiltrate the United States medication supply. Additionally, VAWD accreditation relieves wholesale distributors of the burden of seller-to-buyer due diligence as may be required by law.
4. Where can a wholesale distributor find information regarding the VAWD program?
Detailed information about the VAWD program, including an application and program criteria, is available on the VAWD section of the NABP Web site.
5. What entities may apply for VAWD accreditation?
Wholesale distributors of prescription drugs and devices that reside within the United States are eligible to apply for VAWD accreditation.
6. What are the steps required for a wholesale distributor to become VAWD accredited?
- An application must be submitted to NABP along with all required documentation and the specified fee.
- Wholesale distributor and designated representatives' licenses (if applicable) are verified.
- The NABP Disciplinary Clearinghouse for Wholesale Distributors is checked.
- Applicable criminal and financial background checks are performed.
- Policies and procedures for the operation of the wholesale distributor are reviewed.
- An on-site survey is scheduled and completed. Surveys and surveyors will be managed directly through NABP.
Once NABP verifies that an applicant meets the appropriate federal and state laws and VAWD program criteria and has successfully completed background and NABP Clearinghouse checks, as well as the on-site survey, accreditation will be awarded.
7. What is the first step a wholesale distributor should take to begin the VAWD accreditation process?
Review the VAWD criteria, application instructions, and documentation requirements. We strongly encourage applicants to have all documentation prepared and ready to submit when applying for VAWD. Submitting an incomplete application will impede the accreditation process.
The application instructions, fee information, and criteria can be accessed within the VAWD section of the Web site.
8. How long will it take a wholesale distributor to become VAWD accredited after the application is submitted?
It varies. VAWD accreditation will be completed in a timely manner and depends on the organization of application materials and operation of the wholesale distributor. Providing NABP with a complete application and all accompanying documentation will expedite the process. Previous experience indicates that it takes an average of seven months for a wholesale distributor to become VAWD accredited. Entities whose initial documentation was complete and whose on-site surveys found no deficiencies were accredited in as little as three months. Facilities who lacked complete documentation or whose surveys revealed deficiencies have taken as long as 10 months to become accredited.
9. When should a wholesale distributor apply for VAWD accreditation?
NABP is currently accepting VAWD applications and encourages eligible wholesale distributors to apply early in order to comply with state boards of pharmacy wholesale distributor licensure renewal cycles and/or if they are seeking a new license in a state requiring accreditation. The sooner a wholesale distributor applies for accreditation the more likely that wholesale distributor will receive its preferred survey dates and minimize travel expenses.
10. How can a wholesale distributor prepare for VAWD accreditation?
The VAWD criteria, which can be accessed on the NABP Web site, outlines the components of the accreditation program that are used, in conjunction with existing state law, to determine accreditation. Applicants should use the VAWD criteria as their guideline in preparing policies and procedures, and evaluating their facilities, security, record-keeping practices, distribution processes, and personnel. In addition, the VAWD Application Instructions provides a comprehensive list of documentation that is required for accreditation.
11. How often are VAWD facilities resurveyed?
Once a wholesaler is VAWD accredited, a scheduled on-site survey will occur once every three years. However, NABP may elect to survey the wholesale distributor facility at any time, after giving notice and consulting with the wholesale distributor, if NABP receives information indicating that the wholesale distributor may be out of compliance with any of the VAWD criteria. NABP may also resurvey the facility if it has moved to a new location.
12. Is there a list of wholesale distributors that are VAWD accredited?
Click here to access the list of accredited wholesale distributor facilities.
13. Who should I contact at NABP for specific questions?
VAWD staff is available to answer any questions for which you did not find an answer on our Web site. Contact VAWD staff at vawd@nabp.net.
14. What states require VAWD accreditation for wholesale distributors?
Indiana, North Dakota, and Wyoming require VAWD accreditation as a requirement for licensure.
15. What states recognize VAWD or third party accreditation?
Many states have passed legislation or regulations that recognize VAWD or third-party accreditation and/or inspection. Please contact the state boards of pharmacy directly to confirm licensing requirements and accreditation recognition.
16. Do wholesale distributors need to submit applications for licensure or licensure renewal to the state board of pharmacy if VAWD-accredited or if seeking VAWD accreditation?
Initial licensure and renewal applications and fees must be submitted to the applicable state boards of pharmacy. Initial licensure and state licensure renewal are not included in the VAWD application process.
17. Does NABP have information about surety bonds, including companies that sell surety bonds?
Surety bond information, including companies that offer surety bonds, is available on the following Web sites:
Please note that NABP provides the above referrals for your consideration. NABP does not endorse these organizations.
18. Does the wholesale distributor need to obtain a bond in each state in which they hold a license?
Surety bond requirements vary across states. Please contact the state boards of pharmacy for specific requirements.
UPDATE June 2008
Indiana and North Dakota will recognize/accept surety bonds payable to other states, as long as the wholesaler is accredited by VAWD. The policy would apply for new and renewal applicants.
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