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Application Instructions
[overview]
Working Your Way through the Online Application
Contact NABP at vawd@nabp.net for further guidance with the VAWD application. This section provides guidance and additional information on fields that applicants must respond to in the VAWD application.
Wholesale Distributor (WD) Information Page
- Legal Business Name is the name that will appear on the listing of VAWD-accredited facilities that NABP maintains.
- Web site URL (if any) must be the Internet address for the wholesale distributor’s (WD) home page and is 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.
Wholesale Distributor Information (continued) Page
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Contact person is responsible for the following:
- Completing the application form
- Coordinate responses and revisions to policies and procedures if necessary
- Schedule on-site surveys
- Coordinate annual renewal of accreditation
Designated Representative Page
- Designated Representative (DR) oversees the day-to-day operations of the WD facility. In most facilities, the DR is the warehouse manager.
- DR Supervisor should be at least one level above the DR and the person to whom the DR reports to. The DR supervisor must be actively involved in, and aware of, the daily operations of the distribution facility.
Ownership Information Page
- Ownership Information applies to any for-profit or not-for-profit legal entity that owns or contracts for the WD’s services. It is the ultimate controlling or parent company.
- Executive Officers apply to officers, directors, and other persons who are in charge of the operations of the WD facility.
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Major Investors include silent partners, venture capitalists, and any person, partnership, or corporation who directly or indirectly owns greater than 10% equity position in the ownership or controlling interest of the WD organization and/or greater than 10% voting interest in such 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 on the application’s Upload Files page during the online application process. Doing so expedites the process. See the list of required supplemental documentation below.
If there is any delay in submitting required documents, applicants must contact VAWD to request a time extension. Time extension requests may be subject to administrative fees. Failure to notify NABP of any delay may result in 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 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. Proof of 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.
2. Copy of general and product liability certificate of insurance (certificate must indicate date of issuance and expiration, and type and amount of coverage). Both general and product must be covered in the policy. If the certificate is held under the corporate name and location, it must state the coverage includes all subsidiaries or specifically state the name and address of the facility.
3. Organizational chart that includes the following information:
a. Warehouse operations management, including names and job titles.
b. Warehouse staff, including names and job titles, or the number of staff under each manager.
c. Administrative staff whose duties include vendor and/or customer verification, product ordering, or are involved with controlling the movement of prescription drugs.
d. 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.
4. Graphical layout of the WD facility.
5. Brief description of the security alarm system. In addition, if your facility has a freezer/cooler area, please describe how it is tied-in with your security alarm system. If it does not have a freezer/cooler area, please note that in the description of the security alarm system.
6. Copies of inspection reports and notices. 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 the fact.
a. State inspection report
b. Drug Enforcement Administration (DEA) inspection notice
7. Copy of document evidencing rightful ownership or possession of the property. This document must show the actual address of the facility applying for VAWD.
Documents that meet this requirement (submit one of the following):
- Current lease agreement
- Property deed
- Current tax bill
- Current utility bill
8. Current list of licenses on an Excel (.xls) file (see example) that include the following:
a. State WD and controlled substance license, and DEA registration, including any pending state license applications
b. License numbers
c. Type of License
d. Date license acquired
e. Expiration date
f. DR license number, date acquired, and expiration date (California and Florida licensees only)
Download the current list of licenses example. (Microsoft Excel) This Excel file can be used as a template when creating your own list.
9. Current list of customers, including city and state, on an Excel (.xls) file. Information must be separated in rows and columns; see example below.
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Customers – businesses to whom applicant is selling and/or shipping prescription drug products and devices
Download the current list of customers template. (Microsoft Excel) This Excel file can be used as a template when creating your own list.
10. Current list of vendors, including city and state, on an Excel (.xls) file. Information must be separated in rows and columns; see example below.
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Vendors – businesses from whom applicant is buying and/or obtaining prescription drug products and devices
Download the current list of vendors template. (Microsoft Excel) This Excel file can be used as a template when creating your own list.
11. If your facility has Authorized Distributor of Record (ADR) status for all manufacturers, submit proof of ADR status (i.e., copies of written agreement with the manufacturer).
12. DR resume, including 10-year working history and educational background.
13. DR Photo Submission Form must be scanned in color and e-mailed to NABP (only required for DR, and only if the facility has applied or is in the process of applying for an Indiana or North Dakota license).
- Download the DR Photo Form (PDF).
14. Kroll Background Check Release Forms for:
a. DR
b. DR’s supervisor
c. Owners/principals with greater than 10% ownership interest
d. Download the Kroll Background Check Release Form (PDF).
Authorization and release forms for background checking must be completed and signed by the individual whose criminal and financial background must be checked. In addition to the Kroll Background Check Release form, 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, Idaho, Iowa, Louisiana, New Hampshire, New Mexico, Rhode Island, Virginia
Other Countries: Canada.
All other countries, please contact NABP for more information.
Policies and Procedures
The VAWD P&P Guidance Checklist (Checklist) will be provided to applicants upon submission of application and fees.
Copies of all policies and procedures (P&Ps), as set forth in the Checklist must be provided electronically to NABP within 90 days from the date NABP sent the Checklist 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 required Policies and Procedures:
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Copies of actual P&Ps (drafts are not accepted) evidencing compliance, as set forth in the Checklist, are required. P&Ps not submitted in accordance with the Checklist will delay processing of the application.
The Checklist must be completed and submitted. It is important that references made on the Checklist 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 Checklist as SOP5.31 – Licensing. The Checklist will allow you to type your answers on each page and save your additions.
To help expedite the application process NABP strongly encourages the following:
- Submit P&P as Microsoft Word files
- Submit each P&P as an individual file.
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Include an index of the P&Ps submitted. This helps identify if P&Ps are shared with any other facility that is applying for VAWD accreditation or is currently accredited as well as helps to identify if any of the processes do not take place on site. The information should be submitted on an Excel (xls) file.
Download the template P&P Index. (Microsoft Excel) This Excel file can be used as a template when creating your own index.
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
To expedite the application process, supplemental documentation should be submitted electronically as individual files during the online application process.
When uploading documents to the VAWD application, please select the appropriate title of the document from the drop-down menu.
E-mail and Mail Submission
Alternatively, the documents may be submitted by one of the following methods:
- E-mailing 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.
- Mailing 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 pharmacy, and name the documents according to the examples below:
- Example 1: For Supplemental Document #c, name electronic file document as “Organizational Chart”
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Example 2: For Policy and Procedure, name electronic file and label 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 by 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 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 application submission.
Cancelled 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 applicant’s accreditation application and/or any denial of accreditation.
