Accreditation Process for Drug Distributors
Before you start the accreditation process as a new facility:
- Review the criteria to confirm that the program meets your facility’s needs.
- Review the Policy and Procedures (P&P) Assessment to confirm your facility is able to demonstrate compliance with the criteria through its P&P submission and the on-site survey.
- Review the Drug Distributor Accreditation FAQs in the Help section.
Next, please complete and submit the online application, provide supporting documentation, and pay the applicable fee. Then NABP will:
- Verify your facility and designated representative’s licenses;
- Screen your facility against the NABP Clearinghouse for disciplinary or other actions;
- Review your facility’s policies and procedures for compliance with the accreditation criteria; and
- Conduct an on-site survey of your facility.
Review the Accreditation Process Details document to learn more.
Information for Non-Traditional Business Models
Some business models not designated “wholesale distributors” may have unique requirements. These business models include:
- Outsourcing Facilities,
- Wholesale Distributors co-located with Pharmacies,
- Third-Party Logistics Providers (3PLs),
- Reverse Distributors,
- Virtual Distributors, and
- Virtual Manufacturers.
The Drug Distributor Accreditation is renewable annually following an update provided by your facility and reverification of licensure information status. As part of maintaining accreditation, a survey is performed once every three years. You will be contacted by the program with all necessary renewal documents prior to your facility’s accreditation anniversary date. See the Fees section below for information on the annual participation fee.
Instructions for New Applicants
The online application is only for new applicants. Please take the time to thoroughly review the Drug Distributor Accreditation Application Instructions before applying.
The Application Instructions will take you through information that your facility must provide to complete the application process, including:
- General guidance prior to completing the application
- Information that you will need to have on hand during the application process, including:
- Wholesale Distributor Information
- Ownership Information
- Designated Representative Information
- Facility Information
- Executive Officers List
- Major Investors List
- Supplemental Documents
- Application Documentation that is Not Eligible for Upload
- Supplemental Documents that May Be Required at a Later Date
- Payment Details
Application fee: $1,500
Survey fee: $3,000
Annual participation fee (year 1): $1,000
Year 1 subtotal: $5,500
Annual participation fee (year 2): $1,000
Annual participation fee (year 3): $1,000
Estimated total for three-year accreditation: $7,500
The fee schedule shown above will be repeated every three years.
NABP will, as necessary, levy administrative fees for extraordinary processing related to an application. Common occurrences leading to administrative fees include:
- Time extension requests
- Protracted policy and procedure (P&P) reviews
- Protracted survey remediation
- Ownership change processing
This list is not all-inclusive.
Payment for year 1, which includes the application fee, survey fee, and participation fee, is due when the application is submitted. Payment of the annual participation fee for years 2 and 3 must be made before accreditation is renewed. Facilities that cancel or withdraw an application will be subject to a handling fee. The handling fee is based on the progress the facility has made towards completion of their new accreditation, reaccreditation, or annual compliance review application.
Credit card payment may be made online during the application process. Payments 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. Please refer to the Application Instructions for additional payment details.
Has Your Facility Relocated?
Accredited Drug Distributors and current applicants must notify NABP if their facility relocates, then submit a new application that provides updated facility information and pay the applicable fees. Effective as of June 30, 2012.