Application Instructions

[overview]

Completing the Online Application

General Guidance Prior to Application Completion

  • The online application is for new Verified-Accredited Wholesale Distributors® (VAWD®) applications only.
  • Select the “Save” or “Next Page” buttons to save information in the application. Once the “Save” or “Next Page” button has been pressed, the information entered on that page cannot be changed. If a correction is needed, please contact NABP at cvaccreditation@nabp.net prior to moving forward in the application.
  • Users may log out and resume filling out the application at the point of the last submitted entry.
  • Prior to final submission, a verification page for application review will display. Applicants are unable to make changes to this page. However, should any errors be discovered, contact cvaccreditation@nabp.net and describe the needed change(s). NABP recommends printing this page for your records.
  • You will no longer be able to access an application once it has been submitted to NABP.
  • If during the accreditation process any information submitted on the VAWD application changes, NABP must be notified in writing within 48 hours. Submit changes via e-mail to vawd@nabp.net.

If you have any additional questions about completing the VAWD application, please e-mail vawd@nabp.net.

Application Completion

Create NABP User Account Page

  • The NABP VAWD application requires the applicant to create a User Account. It is strongly recommended that the person completing the application is the individual who will serve as the facility’s primary contact person during the accreditation process. This person may use his or her login to complete multiple applications and will be the steward of future applications for that particular company. Should the wholesale distributor (WD) wish to change the person charged with submitting the applications, please contact NABP directly via e-mail at vawd@nabp.net

Wholesale Distributor Information Page

  • The Legal Business Name is the name under which the company files its tax returns with the Internal Revenue Service (IRS) or the name included on the business’s articles of incorporation. 
  • The Doing Business As Name is the name that the company uses that is different than the Legal Business Name.
  • The Website URL (if any) must be the Internet address for the WD’s home page and is the site address that will be used to display the VAWD Seal upon accreditation.
  • The Physical Address of the WD Establishment is the commercial, non-residential, location of the facility applying for VAWD accreditation and must be the same address used on the WD’s state licenses. 

Ownership Information Page

  • Business Organization applies to any for-profit or not-for-profit legal entity, such as a partnership, corporation, limited liability company, or sole proprietorship that owns or contracts for the WD’s services.
  • The Name of Corporate Entity field automatically fills in from the Legal Business Name.
  • The Corporate Address is the location where the Legal Business Name is registered with the IRS. This address may or may not be the same address as the Physical Address of the WD establishment.

Wholesale Distributor Information Page 

The Contact Person is responsible for the following:

  • Coordinating responses and revisions to policies and procedures (P&Ps) if necessary
  • Scheduling on-site surveys
  • Coordinating the annual accreditation renewal

While not required, NABP strongly recommends that the contact person also have a working knowledge of the facility’s P&Ps and the authority to make any necessary P&P revisions. This can help ensure a smooth process.

Designated Representative Page

  • The Designated Representative (DR) oversees the day-to-day operations of the applicant facility. In most facilities, the DR is the warehouse manager.
  • The DR Supervisor should be at least one level above the DR and the person to whom the DR reports. The DR supervisor must be actively involved in, and aware of, the daily operations of the distribution facility.   

 Executive Officers Page

  • The Executive Officers field refers to officers, directors, and other persons who are in charge of the operations of the applicant facility.  

Major Investor Page

  • Major Investors include silent partners, venture capitalists, and any person, partnership, or corporation who directly or indirectly owns greater than 10% equity in the ownership or controlling interest of the WD organization and/or greater than 10% voting interest in the organization.

Supplemental Documentation

All required supplemental documentation must be provided to NABP within 30 days from the application submission date or the application may be canceled. However, NABP recommends that supplemental documentation be submitted in tandem with the application using the online application’s “Upload Files” option. The only exception to this is the Background Investigation Disclosure and Authorization Form. NABP will provide the relevant parties with the information they require to complete this as a separate step in the process. More details are provided below.

If there is any delay in submitting the required documents, you must contact VAWD to request a time extension to avoid a cancellation of your application. Requests for time extensions may be subject to administrative fees. Failure to notify NABP of any delay may result in the cancellation of your application. 

Required Documentation Demonstrating Compliance with Criteria 

The VAWD application includes a list of criteria for which NABP requires documentation that demonstrates the applicant’s compliance. . NABP reviews the submitted documents and specifically looks for certain policies and procedures (P&Ps) NABP believes are essential to meeting the intent of the VAWD criteria.  For much of the requested information, NABP provides templates for your use. When submitting information for which NABP has provided a template, it may be utilized or you may provide Microsoft Excel files that are similarly formatted. Do not send blank templates. You will be notified via e-mail if NABP finds any of the submitted materials unacceptable or in need of clarification.

Upload Documentation 

List of Required Supplemental Documentation:

  1. Description of the Business Model
  2. Proof of a Surety Bond
  3. Copy of General and Product Liability Certificate of Insurance
  4. List of Ownership Information 
  5. List of Licenses
  6. List of Customers
  7. List of Vendors
  8. List of Manufacturers
  9. DR Photo Submission Form
  10. Background Investigation Disclosure and Authorization Forms

1. A brief description of the business model. Please provide a description of your business model to help NABP better understand the operations of the warehouse. This should include the following information, as applicable:

  • The type of operation. Examples: wholesale distribution, third-party logistics provider, manufacturing, reverse distribution, repackaging, etc
  • Any specialty and/or unique services that are offered. Examples: sample distribution, compounding, providing drugs for clinical trials, etc
  • The estimated number of products distributed per day
  • The types of customers to whom products are distributed. Examples: pharmacies, hospitals, practitioners, etc
  • The types of prescription products that are offered (human, veterinarian, or both)
  • The types of prescription dosage forms that are used. Examples: oral, injectable, topical, etc
  • A list of the storage requirements for the products that are distributed, as defined in the United States Pharmacopeia (USP) Chapter <797>. Example: Controlled Room Temperature (CRT) refrigeration of 68°F to 77°F is used for most dosage forms of products such as vaccines and insulin 

2. A proof of a surety bond in an amount of at least $100,000 (examples of acceptable proof include evidence of insurance, a statement showing that funds have been deposited in a trust account or financial institution, or an irrevocable letter of credit). If your facility has a state license that requires a surety bond, and the amount is at least $100,000, with the beneficiary being the state board of pharmacy, a copy of this surety bond is acceptable.

3. A copy of general and product liability certificate of insurance (the certificate must indicate the date of issuance and its expiration, and the type and amount of coverage). Both general and product liability must be covered in the policy. If the certificate is held under the corporate name and location, it must state that the coverage includes all subsidiaries or specifically state the name and address of the facility.

4. A list of ownership information that includes an organizational chart outlining the legal business entities from the ultimate parent company to, and including, the WD applicant. The organizational chart should include, as defined for the VAWD application, the legal business name, doing business as name, corporate address, and the type of ownership for each legal business entity on the organizational chart. Additionally, list the names of the owners of the legal entities, including:

  • If a sole proprietorship, the full name of the sole proprietor and the home address of the individual.
  • If a partnership, the full name of each individual and the home address of the individuals.
  • If a corporation, the name and title of each corporate officer and director and the name of the state of incorporation.
  • If a limited liability company, the name of each member, the name of each manager, and the name of the state in which the limited liability company was organized.

5. A current list of licenses that the facility holds (for example, state WD, state controlled substances, manufacturer, Food and Drug Administration (FDA) registration, Drug Enforcement Administration (DEA) registration, or other licenses relating to prescription products) in a Microsoft Excel (.xlsx) file that includes the following:

  • The state issuing the license
  • The name that appears on the license
  • License numbers
  • The type of license
  • The date the license was acquired
  • The expiration date of the license
  • The DR license number, the date acquired, and the expiration date (California and Florida licensees only)

The current list of licenses should only include licenses that are applicable to the WD applying and any pending licenses where an application has been or will be submitted, but not issued.

Download the Current List of Licenses template (Excel). This template is the required format for the list of licenses. Any other format will not be accepted.

6. A current list of customers that includes their cities and states and whether they are wholesale distributors or non-wholesale distributors. Using Excel, the information must be separated in rows and columns, be specific to the facility applying, and only include customers as NABP defines them (see template below).

Customers are only businesses to whom the applicant sells and/or ships prescription drug products and prescription devices.  

Download the Current List of Customers template (Excel). While this template does not have to be used, the information provided to NABP must be in the same format as shown in the template. 

7. A current list of vendors that includes their cities and states and whether they are manufacturers or non-manufacturers. Using Excel, information must be separated in rows and columns, be specific to the facility applying, and should only include vendors as NABP defines (see template below). 

Vendors are only businesses from whom the applicant buys and/or obtains prescription drug products and prescription devices.

Download the Current List of Vendors template (Excel). While this template does not have to be used, the information provided to NABP must be in the same format as shown in the template.

8. List your manufacturers in an Excel file. If your facility has Authorized Distributor of Record (ADR) status for a manufacturer, please submit a list of all manufacturers with whom the facility has ADR status and indicate whether the ADR status includes all prescription drugs or specific ones. 

If you are a manufacturer, please submit a list of all facilities to which you have granted ADR status and indicate whether the ADR status includes all prescriptions drugs or specific ones.

Download the Current List of ADR Status template (Excel). While this template does not have to be used, the information provided to NABP must be in the same format as shown in the template.

9. A DR Photo Submission Form must be scanned in color and e-mailed to NABP (this is only required for DRs, and only if the facility has applied for or is in the process of applying for an Indiana or North Dakota license). 

Download the DR photo form (PDF).

10. Complete a Background Investigation Disclosure and Authorization Form for:  

  • The DR
  • The DR supervisor
  • Owners/principals with greater than 10% ownership interest

Note: This form is not submitted with the initial application.

NABP will send an e-mail communication directly to the DR, DR Supervisor, and owners/principals with greater than 10% interest as identified on the application. The e-mail will provide all information necessary for the relevant individuals to electronically submit their forms directly to Kroll Background America, Inc.

Submit payment for background checks to NABP.

In addition, applicants are also required to complete and submit to NABP a special Statewide/International Authorization and Release Form if they previously and/or currently reside in a state or country listed below. (Contact VAWD staff to request the special form.)

  • United States: Arkansas, Iowa, Massachusetts, New Hampshire, New Mexico, Rhode Island, and Virginia
  • Canada
  • All Other Countries: Please contact NABP for more information.

Supplemental Documentation That May Be Required at a Later Date

NABP may find it necessary to request documentation in addition to what the applicant has initially submitted. This can occur for a number of reasons. The request is intended to facilitate accreditation consideration based on a thorough understanding of the applicant’s business.

  1. Organizational Chart
  2. DR’s Résumé
  3. Description of the Security Alarm System
  4. Description of the Environmental System
  5. State Inspection Reports
  6. Facility Ownership Documents

1. An organizational chart that includes the following information:

  • Warehouse operations management, including names and job titles
  • Warehouse staff, including names and job titles, or the number of staff under each manager
  • Administrative staff whose duties include vendor and/or customer verification, product ordering, or who are involved with controlling the movement of prescription drugs
  • The DR and DR supervisor must be appropriately charted

Download the organizational chart example (Microsoft Word) for help creating your chart.  This Word file can be used as a template when creating an organizational chart.

2. The DR's résumé, including a 10-year work history and educational background.

3. A brief description of the security alarm system. Please provide a general description of the security alarm system to help NABP better understand the security in place. This should include the following information:

  • The alarm company used
  • Confirmation that all possible entry into the facility is alarmed. Potential access points are doors, windows, skylights, etc
  • Any cameras
  • Any cooler and freezer temperature monitors that are part of the alarm system

Please note that the above-requested information should be general. Specific details such as the locations of sensors and cameras will be checked during the on-site VAWD survey.

4. Indicate if the facility is air conditioned and provide a brief description of the heating, ventilation, and air conditioning (HVAC) system (for WDs with product on its premises). Include a description of the HVAC equipment utilized for temperature and humidity monitoring and recording as well as the total square footage of the facility and the square footage utilized for drug storage and handling. 

5. Copies of state inspection report. In the event your facility has not been inspected, or you are unable to obtain a copy of the inspection report from the appropriate agency, you must submit a written attestation of this fact.

6. Copy of a document evidencing the rightful ownership or possession of the property. This document must show the actual address of the facility applying for VAWD accreditation. Documents that meet this requirement include one of the following:

  • A current lease agreement
  • A property deed
  • A current tax bill
  • A current utility bill

Policies and Procedures

NABP will provide the VAWD P&P Assessment (Assessment) after submission of the application and all fees. The Assessment is a Microsoft Word document that enables an applicant to delineate which of its organizational P&Ps fulfill the VAWD criteria.  The document clearly lays out the P&Ps necessary to meet VAWD accreditation and enables the applicant to enter either the name or number and the page number for the P&P demonstrating compliance.  

The Assessment also enables applicants utilizing corporate P&Ps, P&Ps shared with another location, or that have business partners responsible for off-site processes relative to the VAWD criteria to provide a map of how their documents and processes are used and shared.

The Assessment, along with complete copies of all the P&Ps it references, must be provided electronically to NABP within 90 days from the date NABP sent the Assessment or the application may be canceled.

P&Ps will be reviewed only after NABP confirms that all supplemental documentation is acceptable. 

An on-site survey will be scheduled for all locations relevant to the application only after NABP confirms that all P&Ps are compliant with VAWD criteria.

Submit All of These Required P&Ps:

  • Licensing and Compliance with Laws/Regulations
  • Operations
  • Security
  • Housekeeping
  • Vendor Authentication
  • Inbound Product and Receiving
  • Temperature Standards
  • Humidity Standards
  • Inventory Controls
  • Customer Authentication
  • Outbound Product
  • Common Carrier
  • Reporting Suspicious/Criminal Activities
  • Recalls
  • Quarantine, Disposition, Returns, and Disposal
  • Records
  • Crisis Operations

Copies of operational P&Ps (drafts are not accepted) evidencing compliance, as set forth in the Assessment, are required. P&Ps not submitted in accordance with the Assessment will delay processing the application.

The Assessment must be completed and submitted. It is important that references made on the Assessment and the actual electronic files that are submitted to support the references use the same names. For example, if the electronic file is named SOP5.31 – Licensing, it should be referenced on the Assessment as SOP5.31 – Licensing. The Assessment will allow you to type your answers on the page and save your additions.

To help expedite the application process, NABP strongly encourages the following: 

  • Submit P&Ps as Microsoft Word files.
  • Submit each P&P as an individual file.

Additional Notes on Submitting Documents to NABP

All documents should be gathered and submitted at one time rather than individually, whether submitted online, via e-mail, or via standard mail.

Online Submission

NABP only accepts supplemental documents utilizing the “Upload Files” option during application submission. Documents not submitted with the online application must be submitted via e-mail or standard mail. If the applicant desires, items sent via standard mail can be submitted on a CD-ROM or USB flash drive.

  • E-mail the documents as attachments to vawd@nabp.net. In the e-mail, please mention that the attached documents are for a new application. Include the facility name, city, and state; or
  • Mail a CD of the documents along with a copy of the application receipt page (issued following completion of the online application) via a land carrier to:

ATTN: VAWD
National Association of Boards of Pharmacy
1600 Feehanville Drive
Mt Prospect, IL 60056 

When e-mailing or mailing supplemental documents, please include appropriate identifying information about the facility, and name the documents in accordance with what NABP has requested. For example, our request for a brief description of a business model should be named, “Business Model Description.” 

When e-mailing or mailing P&Ps, the file name should include both the document’s number and name. For example, “P&P 45.3 – Temperature & Humidity Control.”

Payment

NABP recommends that the application, survey, annual participation, and background check fees be paid via credit card (MasterCard, Visa, or American Express) at the time the application is submitted. If a credit card is not available, a prepaid debit/credit card, available for purchase at any banking institution, may be used to pay the VAWD fees. Payment in the form of a certified check, cashier’s check, money order, or company check may also be sent via mail; NABP must receive such payments within 14 days of the application submission.

Mail checks to:

ATTN: VAWD
National Association of Boards of Pharmacy
1600 Feehanville Drive
Mt Prospect, IL 60056 

Canceled or withdrawn applications are subject to administrative fees.

Disclaimer

Please note that NABP reserves the right to share information with its member boards of pharmacy or appropriate regulatory or law enforcement authorities concerning the status of an applicant’s accreditation application and/or any denial of accreditation.