- What is VAWD?
- What prompted the development of VAWD?
- What are the benefits of VAWD accreditation?
- Where can a wholesale distributor find information regarding the VAWD program?
- What entities may apply for VAWD accreditation?
- What are the steps required for a wholesale distributor to become VAWD accredited?
- What is the first step a wholesale distributor should take to begin the VAWD accreditation process?
- How long will it take a wholesale distributor to become VAWD accredited after the application is submitted?
- When should a wholesale distributor apply for VAWD accreditation?
- How can a wholesale distributor prepare for VAWD accreditation?
- How often are VAWD facilities resurveyed?
- What states require VAWD accreditation for wholesale distributors?
- What states recognize VAWD or third party accreditation?
- 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?
- Does NABP have information about surety bonds, including companies that sell surety bonds?
- Does the wholesale distributor need to obtain a bond in each state in which they hold a license?
Verified-Accredited Wholesale Distributors (VAWD) is an accreditation program for wholesale distributors.
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.
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.
Detailed information about the VAWD program, including an application and program criteria, is available on the VAWD section of the NABP Web site.
Wholesale distributors of prescription drugs and devices that reside within the United States are eligible to apply for VAWD accreditation. Some distinctive business models are addressed as follows:
Prior to applying for VAWD accreditation, outsourcing facilities must meet all of the below conditions.
- Must be registered with FDA as an outsourcing facility
- Must be the recipient of an inspection that occurred subsequent to registration with FDA that indicates compliance with current Good Manufacturing Practices and required provisions of the Federal Act
- Must have no open FDA actions. This includes unresolved 483s, warning letters, or recalls
- Must not be the subject of serious FDA regulatory actions or any criminal investigation prior to registration
- Must ship in accordance with their home state’s (and states to which they ship product) current license requirements for outsourcing facilities (pharmacy, wholesaler, or both)
Failure to meet these conditions may result in the application being closed or loss of the VAWD accreditation.
Pharmacy Co-located with Wholesale Distributor
Co-located pharmacies and wholesale distributors are subject to additional scrutiny, potentially requiring the submission of additional documentation to demonstrate they are in compliance with the below stated state and federal laws and VAWD criteria. This might lengthen the time it takes to become accredited.
- The pharmacy cannot meet the definition of a public or private hospital pharmacy or other health care entity.
- The pharmacy must comply with state recordkeeping and audit trail laws for prescription drugs, including authorized trading partners and transaction documents.
- The wholesale distributor and pharmacy must have physical separation adequate for securing drugs.
- The pharmacy and wholesale distributor transactions must employ separate account numbers to distinguish prescription drug purchases made by the two entities.
- Wholesale distributors cannot sell drugs that were at any time purchased by a pharmacy. Specifically, wholesale distributors that have a license issued in the same name and address as a pharmacy cannot sell drugs purchased under the pharmacy account.
- Pharmacies purchasing drugs as part of a Group Purchasing Organization or certain programs such as the federal 340B Drug Pricing Program must demonstrate they are not limited in the use of drugs purchased under these contracts.
- 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.
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 12 months to become accredited.
The timeline of the VAWD accreditation process, including evaluation and survey, can take eight to 12 months depending on scheduling availability and completeness of the wholesale distributor’s documentation and responses.
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.
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. The VAWD Policies & Procedures Guidance Checklist will be provided to paid applicants to assist wholesale distributors in preparing policies and procedures.
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.
Indiana, North Dakota, and Wyoming require VAWD accreditation as a requirement for licensure.
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.
14. 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.
Surety bond information, including companies that offer surety bonds, is available on the following Web sites:
- National Association of Surety Bond Producers www.nasbp.org
- The Surety & Fidelity Association of America www.surety.org
Please note that NABP provides the above referrals for your consideration. NABP does not endorse these organizations.
16. 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.
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.