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, and are employing and displaying quality 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.
Bundle Accreditations to Maximize Your Investment
Save time and money by bundling our distributor accreditations together. When completing your Drug Distributor Accreditation application, maximize your investment by also applying for our OTC Medical Device Distributor Accreditation. Review program eligibility requirements to see if your facility qualifies, then contact our team for the code that must be provided to obtain a discount when completing the application.
The state boards of pharmacy, or other state agencies, 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 is to review the eligibility requirements for the Drug Distributor Accreditation. If you determine your business meets these requirements for accreditation, then apply for a Supply Chain Inspection indicating your interest in Drug Distributor Accreditation. Based on the Supply Chain Inspection report, we will confirm you are eligible to apply for Drug Distributor Accreditation.
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 eligibility requirements listed below.
- Review and self-assess its eligibility
- Be compliant with program criteria and requirements at time of application submission and throughout the application and accreditation period
- Be appropriately licensed, located in the United States, with current and active licenses in good standing, in all jurisdictions in which it is conducting business (unless licensure is not required by law)
- Be operational in all its activities for at least 30 days and compliant with all regulations, laws, and rules (eg, federal, state, local, and jurisdictional requirements) applicable to the business
- Complete our prerequisite Supply Chain Inspection within the past 12 months and received a Drug Distributor Accreditation eligibility letter
- Complete and submit a Drug Distributor Accreditation application and applicable payment
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.
Their unique requirements can be located by selecting the listed business model to access the FAQs section. In the program criteria, select “Virtual Manufacturers and Wholesale Distributors.”
Before you apply, learn more about the process by watching our on-demand webinar. Then, follow the steps below.
- Confirm your facility meets eligibility to begin the process
- Review the accreditation criteria
- Log in to your business e-Profile and apply for a Supply Chain Inspection
- Review the information needed when creating your business e-Profile
- Read the basic instructions on creating a new business e-Profile
- Use this guide to request access to additional Business e-Profile Accounts, after creating your initial e-Profile
- Complete the Supply Chain Inspection and receive an accreditation eligibility letter
- Log in to your business e-Profile and apply for Drug Distributor Accreditation
- Provide any requested documents to evidence compliance and/or remediation of inspection findings
For basic instructions on submitting your application, read the Application Basics document.
Interested in pricing?
Log in to your business e-Profile account and visit the Instructions and FAQs section to access pricing. Don’t have an account? Create your free business e-Profile account today.
Has your Facility Relocated?
Accredited drug distributors and current applicants must notify us if their facility intends to relocate and the date the facility is no longer operational so the accreditation may be closed. If the company wishes to have accreditation at the new facility, it must go through the accreditation process as a new applicant, which begins with a Supply Chain Inspection application.
Has your Facility had an Ownership Change?
All changes must be reported to firstname.lastname@example.org within 30 days after the change is final, and you must send the following documentation:
- A completed Ownership Change Form, including the documents requested in the form.
Ownership and Name Changes
- Any paperwork you have filed with the state.
- Any documents supporting changes in operations, if applicable, including any revised policies and procedures.
- Once the official request is received, you will be required to pay ownership change and name change fees. As stated in the Letter of Agreement, accreditation may not be reassigned without our approval. Facilities under new ownership may be required to reapply for Drug Distributor Accreditation.
Drug Distributor Accreditation has a three-year cycle; a facility undergoes an annual review coinciding with its first and second anniversary dates. Prior to the end of the third year of accreditation, we will send notification of the need to have another Supply Chain Inspection and to go through the full reaccreditation process if the facility desires to continue its accreditation for another three years. Failure to promptly reply to the completion of reaccreditation deliverables may result in the loss of accreditation.
- Log in to your business e-Profile and visit the Instructions and FAQs section to review the Fees section for information on the annual participation fee.