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Application Instructions
[overview]
Working Your Way through the Online Application
General Guidance
- The online application is for new Verified-Accredited Wholesale Distributors (VAWD) applications only. Reaccreditation or renewal materials cannot be submitted via the online application.
- Information in the application is saved by selecting the “Save” or “Next Page” buttons. Users may log out and return to any page that was completed as long as the application has been saved, but not yet submitted for review by NABP.
- Once the “Save” or “Next Page” button has been clicked, the information entered on that page can only be updated by NABP staff. If a correction is needed, please contact NABP at vawd@nabp.net prior to moving forward in the application.
- Prior to submitting the application, a verification page that allows the user to verify the entire application is available. NABP recommends the user print this page for his or her records.
- Users will no longer be able to log in or access an application once it has been submitted to NABP for review.
- If at any time during the accreditation process any information submitted on the VAWD application changes, NABP must be notified within 48 hours to avoid any delays in processing the application.
Contact NABP at vawd@nabp.net for further guidance with the VAWD application. The following section provides guidance and additional information on the fields that applicants must complete in the VAWD application.
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 also the applicant’s contact person. This person may use his or her login to create and complete multiple applications and will be the steward of future applications for that particular company. Should the person charged with submitting the application be changed, please contact NABP directly via e-mail at vawd@nabp.net.
Wholesale Distributor (WD) Information Page
- Doing Business As Name is the name that the company uses that is different than the Legal Business Name.
- 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 legal business name must also be the name used on the state licenses held by the WD.
- Web Site 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.
- Physical Address of WD Establishment is the actual location of the WD applying for VAWD and should 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 (Parent) Entity field automatically fills in from the Legal Business Name field.
- Corporate (Parent Entity) Address is the location where the Legal Business is registered with the IRS. This address may or may not be the same address as the Physical Address of the WD.
Wholesale Distributor Information (Continued) 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 renewal of accreditation
Designated Representative Page
- The Designated Representative (DR) oversees the day-to-day operations of the WD 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
- Executive Officers refers to officers, directors, and other persons who are in charge of the operations at the WD 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 through the application’s "Upload Files" page, as doing so expedites the process. See the list of required supplemental documentation below.
To avoid cancellation, if there is any delay in submitting required documents, applicants must contact VAWD to request a time extension. Requests for a time extension 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 P&Ps believed by NABP to be essential to meeting the intent of the VAWD criteria. You will be notified, via e-mail, if NABP finds any of the submitted materials unacceptable or in need of clarification. When requested, please send mocked-up forms with fictitious information so that the data demonstrates how the form is actually used. Do not send blank forms. Completed forms help NABP interpret how a form is actually used.
Upload Documentation
List of Required Supplemental Documentation:
1. 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 (wholesale distributor, third-party logistics provider, manufacturer, pharmacy, reverse distributor, repackager, virtual wholesale distributor or manufacturer, etc)
- Any specialty and/or unique services that are offered (distribution of samples, compounding, etc)
- The estimated number of products distributed per day
- The types of customers to whom products are distributed (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 (oral, injectable, topical, etc)
- The types of products that have storage requirements (for example, refrigeration for vaccines and insulin, and using Controlled Room Temperature (CRT) of 68°F to 77°F)
2. Provide 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. Include a copy of a general and product liability certificate of insurance (the certificate must indicate the date of issuance and 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. List 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, the names of the owners of the legal entities must be listed, 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. Provide a current list of licenses — state wholesale distributor, state controlled substance, manufacturer, Food and Drug Administration (FDA) registration, Drug Enforcement Administration (DEA) registration, or another license relating to prescription products — in an 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 (Microsoft Excel). This template is the required format for the list of licenses. Any other format will not be acceptable.
6. A current list of customers, including their city and state, and identifying the customers as wholesale distributor or non-wholesale distributor, should be entered into an Excel (.xlsx) file. Information must be separated in rows and columns, be specific to the facility applying, and only include customers as defined by NABP (see template below).
- Customers include businesses to whom the applicant is selling
and/or shipping prescription drug products and prescription devices.
Download the current list of customers template (Microsoft 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, including their city and state, and identifying the vendors as manufacturer or non-manufacturer, should be entered into an Excel (.xlsx) file. Information must be separated in rows and columns, be specific to the facility applying, and should only include vendors as defined by NABP (see template below).
- Vendors include businesses from whom the applicant is buying
and/or obtaining prescription drug products and prescription devices.
Download the current list of vendors template (Microsoft 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. 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 (Microsoft Excel). While this template does not have to be used, the information provided to NABP must be in the same format shown in the template.
9. The 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. Please submit a Background Investigation Disclosure and Authorization Form for the following individuals:
- The DR
- The DR supervisor
- Owners/principals with greater than
10% ownership interest
Download the Consumer Disclosure and Authorization Form – Disclosure Regarding Background Investigation (PDF).
Please review the entire document linked above. The Authorization of Background Investigation Form is located on page four, and the form for providing identifying information is on page five. The forms must be reviewed, completed, and signed by the individual whose background must be investigated. 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.
- Other Countries: Canada.
- All Other Countries: Please contact NABP for more information.
Please note that in the near future, applicants will submit information for their background check directly to Kroll Background America, Inc.
Supplemental Documentation That May be Required at a Later Date
1. An organizational chart that includes the following information may be requested:
- 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 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 site's 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 location of sensors and cameras will be checked during the on-site VAWD survey.
4. A brief description of the Heating, Ventilation, and Air Conditioning (HVAC) system. Include a description of the equipment utilized for temperature and humidity monitoring and recording, as well as the total square footage of the applicant’s 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
The VAWD P&P Assessment (Assessment) will be provided to applicants upon submission of the application and fees.
Copies of all P&Ps, as set forth in the Assessment, must be provided electronically to NABP within 90 days from the date NABP sent the Assessment or the application may be canceled. (Note: All supplemental documents are due within 30 days from the application submission date 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 only after NABP confirms that all P&Ps are compliant with VAWD criteria.
Submit All of These Required P&Ps:
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Copies of actual 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 in 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.
Additionally, if you have P&Ps that are shared and utilized at other locations, please include an index of the P&Ps submitted. This helps to easily identify the shared P&Ps and if any of the processes do not take place on site. The information should be submitted in an Excel (.xlsx) file.
Download the template P&P Index (Microsoft Excel). While this template does not have to be used, the information provided to NABP must be in the same format shown in the template.
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.
- Submit the P&P index even if the P&Ps are not shared or utilized at other locations.
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
At this time, NABP is not accepting supplemental documents through the online application process. Please submit electronic documents via e-mail or standard mail.
- 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, and include the facility name, city, and state; or
- Mail a CD of the documents along with a copy of the 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 the documents, please include appropriate identifying information about the facility, and name the documents according to the examples below:
- Example 1: For Supplemental Document #c, name the electronic file document as “Organizational Chart.”
- Example 2: For a Policy and Procedure, name the electronic file and label the paper document as “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.
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 the applicant’s accreditation application and/or any denial of accreditation.
