VAWD Frequently Asked Questions
- 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?
- What entities may apply for VAWD accreditation?
- Does VAWD allow applicants to utilize consultants?
- 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?
- How long will it take a wholesale distributor to become VAWD-accredited after the application is submitted?
- After an application is canceled, how long must facilities wait before submitting a new one?
- How often are VAWD facilities resurveyed?
- Do I need to make NABP aware of an address change if it is not accompanied by a facility move?
- How do I report a facility relocation?
- How do I report an ownership and/or name change for our facility?
NABP E-Profile Assistance
1. What states require VAWD accreditation for wholesale distributors?
Indiana, North Dakota, and Wyoming require VAWD accreditation as a requirement for licensure.
2. 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.
3. 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.
4. 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. Some distinctive business models, while eligible for VAWD accreditation, are subject to considerations consistent with their operations.
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 or must be able to substantiate ongoing communication with FDA towards resolution.. 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 record-keeping 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.
Third Party Logistics Providers (3PLs)
Any 3PL seeking and maintaining VAWD accreditation may distribute only on behalf of FDA-registered manufacturers or VAWD-accredited wholesale distributors.
5. Does VAWD allow applicants to utilize consultants?
Yes, facilities are welcome to use a consultant to assist with the accreditation process. However, the facilities themselves are responsible for the content and implementation of its P&Ps and all correspondence with NABP. Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications and the type of service they provide.
6. 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 websites:
Please note that NABP provides the above referrals for your consideration. NABP does not endorse these organizations.
7. 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.
8. How long will it take a wholesale distributor to become VAWD-accredited after the application is submitted?
Many facilities complete the VAWD accreditation process within three to six months. However, the amount of time is greatly impacted by a facility’s readiness as an applicant. Specifically, whether the facility is prepared to meet the VAWD criteria via its policies and procedures (P&Ps) and the on-site survey impact the time required. Unprepared candidates should anticipate a longer timeline for completion. To gauge readiness, you can review the VAWD criteria and the P&P Assessment. The P&P Assessment provides you with the specifics of how NABP expects your facility to meet the criteria. A completed P&P Assessment is one of the documents required to be provided with an application’s submission.
9. After an application is canceled, how long must facilities wait before submitting a new one?
When NABP cancels a facility’s application based on its inability to demonstrate compliance with VAWD criteria, the facility must wait 180 days to submit a new application.
10. 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 if NABP receives information indicating that the wholesale distributor may be out of compliance with any of the VAWD criteria.
11. Do I need to make NABP aware of an address change if it is not accompanied by a facility move?
If your facility’s address is changed due to a zoning or postal restructure the facility must advise NABP within 30 days of the occurrence. Provide a copy of the notice received from the US Postal Service via email to firstname.lastname@example.org.
12. How do I report a facility relocation?
Send notification to email@example.com. NABP will contact your facility to discuss the specifics of its move. Please note: NABP policy states that a relocating facility must surrender its accreditation and reapply at the new location. The one exception to this policy is a virtual manufacturer. A virtual manufacturer may transfer its accreditation to the new location.
13. How do I report an ownership and/or name change for our facility?
All changes must be reported to firstname.lastname@example.org within 30 days after the change is final. As stated in the Letter of Agreement, accreditation may not be reassigned without NABP’s approval. Facilities experiencing new ownership may be required to reapply for VAWD accreditation.
Send the following with your facility’s notification — all documents noted below must be received before NABP will begin its review:
- A completed “Ownership Change Form” and the form’s listed documents (not required for name changes)
- Any paperwork your organization has filed with the state
- Any documents supporting changes in operations previously communicated to NABP (if applicable, include any revised policies and procedures)
Once the official request is received by NABP, the facility will be invoiced the following fees:
- Ownership change – $500.00
- Name change – $250.00
NABP E-Profile Assistance
1. What is an e-Profile?
The NABP e-Profile system allows individuals to easily manage their participation in NABP programs. At present, the system is used by pharmacists, pharmacy technicians, and pharmacy students to easily manage their participation in NABP programs and to track continuing pharmacy education. They are all provided with a unique e-Profile ID when they create their account.
Additionally, states may require facilities to provide e-Profile IDs so that they may access discipline and other information that is shared between states and managed by NABP in the e-Profile system. (See FAQ #2 below for information on obtaining a facility e-Profile ID.)
2. I am a facility, not an individual. How do I obtain an e-Profile ID?
At present, it is not possible for a facility to create its own e-Profile ID. However, NABP can assist your facility by creating the number, if necessary. It is possible that, unbeknownst to a facility, it may have already been assigned an e-Profile ID. To determine if your facility either has an e-Profile or if NABP needs to create one on your facility’s behalf, please send the following information to email@example.com:
- Legal Business Name (typically filled with resident state’s Secretary of State)
- Doing Business as Name
- Facility Address
- NCPDP ID (if applicable)
- Resident State License Number