OTC Medical Device Distributor
Show customers your facility’s dedication to safely distributing diagnostic over-the-counter (OTC) medical devices to pharmacies and other institutions.
With OTC medical device distribution being largely unregulated in the United States, we created an accreditation for distributors of medical devices that are often designated as medium and high risk by the Food and Drug Administration. Our OTC Medical Device Distributor Accreditation plays a pivotal role in securing the medical supply chain by helping to protect the public from certain diverted or counterfeit medical devices.
This three-year accreditation is best suited for business entities that distribute diagnostic OTC medical devices that may be dispensed pursuant to a prescription. Review and familiarize yourself with the accreditation criteria before applying.
Bundle Accreditations to Maximize Your Investment
Save time and money by bundling our distributor accreditations together. When completing your OTC Medical Device Distributor Accreditation application, maximize your investment by also applying for our Drug 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.
To become an accredited OTC Medical Device Distributor and display the accredited-facilities seal, business entities must undergo a criteria compliance review, which includes both off-site and on-site reviews of the business entity’s policies and procedures and operations.
How do I get started?
The first step is to review the eligibility requirements. If you determine your business meets requirements for accreditation, then apply for a Supply Chain Inspection indicating your interest in OTC Medical Device Distributor Accreditation. Based on the Supply Chain Inspection report, we will confirm you are eligible to apply for OTC Medical Device Distributor Accreditation.
Interested in learning more?
Practices that demonstrate compliance in preventing counterfeit devices from entering the United States (US) medical supply can earn this voluntary accreditation to better position their business. Complete the accreditation form to request more information.
Eligibility
To apply for an accreditation, businesses must meet basic eligibility requirements. To avoid unnecessary delays, review the eligibility requirements listed below.
To qualify to apply for the OTC Medical Device Distributor Accreditation, the facility must be an OTC medical device distributor and:
- Review and self-assess its eligibility which includes:
- If the business only passes title of OTC medical devices subject to this accreditation
- The facility taking possession of and shipping these products on the facility’s behalf must also hold OTC Medical Device Distributor Accreditation
- Any facility taking possession of OTC medical devices subject to this accreditation on behalf of the applicant must maintain proper storage
- Be compliant with program criteria and requirements at the time of application submission and throughout the application and accreditation period
- Be appropriately licensed and 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 an OTC Medical Device Distributor Accreditation eligibility letter
- Complete and submit an OTC Medical Device Distributor Accreditation application and applicable payment
Criteria
Click on the links below to learn about each criterion:
- Licensure
- Facility
- Virtual Manufacturers and Wholesale Distributors
- Personnel
- Record Keeping
- Authentication and Verification
- Returned, Damaged, and Outdated Drugs
- Policies and Procedures
Apply
Seeking OTC Medical Device Distributor Accreditation is a collaborative effort between businesses entities and NABP. With preparation and compliance throughout the application process, your business entity can expect a 3 to 6-month path to accreditation. If extensive follow-up is required, you can expect a longer process.
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 the 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 OTC Medical Device 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 device 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 vdip@nabp.pharmacy within 30 days after the change is final, and you must send the following documentation:
Ownership Changes
- 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 OTC Medical Device Distributor Accreditation.
Maintaining Accreditation
OTC Medical Device Distributor Accreditation has a three-year cycle; a facility undergoes an annual review coinciding with its first and second anniversary date. 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.