Drug Distributor Accreditation
NABP’s Drug Distributor Accreditation plays a pivotal role in preventing counterfeit drugs and devices from entering the United States medical supply. The US supply of prescription drugs and devices is produced and delivered to patients via a complex distribution path, and this accreditation seeks to ensure that accredited facilities operate legitimately, are licensed in good standing, are employing, and display best practices for safely storing, handling, and shipping prescription drugs and devices. NABP’s Drug Distributor Accreditation is best suited for participants in the medical supply chain that store, handle, and ship prescription drugs and devices.
The state boards of pharmacy play an important role in regulating the medical supply chain. State laws and regulations, often developed by the boards, help protect the public from receiving medications and devices that can lead to patient harm. In some states it may be necessary to possess NABP accreditation to obtain a license. For further information on state-specific licensing requirements, inquire with each of the states in which your facility conducts business.
How do I get started?
The first step in the process is to confirm that the program meets your business entity’s needs and that your business entity is able to demonstrate compliance through the eligibility requirements, standards, and on-site survey. Once you deem your business ready for accreditation, you will need to apply.
Once your application, supplemental documentation, and specified fees have been received, we will:
Verify your facility’s and designated representatives’ licenses
Screen your business entity against the NABP Clearinghouse for disciplinary or other actions
Review your facility’s policies and procedures for compliance with accreditation eligibility requirements and standards
Conduct an on-site survey of your business entity
Interested in learning more?
Practices that demonstrate compliance in preventing counterfeit drugs and devices from entering the United States medical supply can earn this voluntary accreditation to better position their business. Complete the accreditation form to request more information.
To apply for an NABP accreditation, businesses must meet basic eligibility requirements. To avoid unnecessary delays, review the Drug Distributor Accreditation eligibility requirements below to determine if you are qualified to apply.
- Must be one of the following business types:
- Wholesale distributor, 3PL, reverse distributor, manufacturer, virtual distributor, virtual manufacturer, repackager, outsourcing facility
- Must be fully operational, receiving and shipping prescription product and/or devices, prior to scheduling the onsite survey.
- If the business only passes titles of prescription drugs or devices (sealing and not taking possession of), the facility taking possession of and shipping these products on the business’s behalf must hold Drug Distributor Accreditation.
- The location must maintain proper storage requirements for drugs and devices in accordance with the labeling of the product and within the definitions contained in the United States Pharmacopeia-National Formulary.
- Distribution of prescription drug products requires compliance with section 582 of the Food, Drug, and Cosmetic (FD&C) Act, including both the receipt and passage of transaction history, information, and statements.
- Processes and systems to detect and prevent the receipt and distribution of Suspect Products must be in place, including due diligence measures which routinely ensure that all sources supplying the facility with prescription drugs are: (1) engaged in legitimate transactions and (2) are not supplying the facility with prescription drugs which are potentially the subject of fraudulent transactions, counterfeit, diverted, or stolen.
NABP advises applicants to not complete the application if their business location had an application cancelled by NABP in the past 180 days for non-compliance with Standards.
Click on the links below to learn about each criterion.
- Virtual Manufacturers and Wholesale Distributors
- Record Keeping
- Authentication and Verification
- Returned, Damaged, and Outdated Drugs
- Policies and Procedures
- History of Criteria Revisions
Information for Nontraditional Business Models
Some business models not designated as “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 following steps must be completed before applying:
- Confirm your eligibility
- Review the criteria and Policy and Procedures (P&P) Assessment to confirm that the program meets your facility’s needs
- Create and complete a business e-Profile account
- Visit the Help section if you have questions about creating or completing a business e-Profile
- Once your request has been submitted, it may take up to three business days for processing. You can track the status of your request in e-Profile
- Gather appropriate supporting documents
- Submit the application for one or multiple accreditations
For basic instructions and tips on creating your business e-Profile and submitting your application, read the Application Basics document.
Use the Apply link to log in to NABP e-Profile and start the application process.
Contact us to combine distribution products at a cost that recognizes your facility’s commitment to demonstrating its compliance.
- Application Fee: $5,500
- Annual Participation Fee: $1,000
Credit card payments may be made online during the application process. Payments in the form of certified check, cashier’s check, money order, or company check may be sent via mail. A submission is not a complete application until a payment has been processed. Refer to the Application Instructions for additional payment details.
Drug Distributor Accreditation has a three-year cycle; a facility undergoes an annual review coinciding with its anniversary date for each of the three years. In year three of the accreditation cycle, the annual review will include both a P&P review and an on-site survey, and the facility will be in “reaccreditation” pending the completion of the annual review.
- As part of maintaining accreditation, a survey is performed once every three years. You will be contacted by program staff with all necessary renewal documents prior to your facility’s accreditation anniversary date.
- See the Fees section above for information on the annual participation fee.
Has your Facility Relocated?
Accredited drug distributors and current applicants must notify us if their facility relocates, submit a new application that provides updated facility information, and pay the applicable fees.