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, NABP created an accreditation for distributors of medical devices that are often designated as medium and high risk by the Food and Drug Administration. NABP’s 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 counterfeited 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.
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 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 business entity’s licenses
Screen your business entity against the NABP Clearinghouse for disciplinary or other actions
Review your business entity’s policies and procedures for compliance with OTC Medical Device Distributor Accreditation eligibility requirements
Conduct an on-site survey of your business entity
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.
To apply for an NABP accreditation, businesses must meet basic eligibility requirements. To avoid unnecessary delays, review the OTC Medical Device Distributor Accreditation eligibility requirements below to determine if you are qualified to apply.
- Must be an OTC medical device distributor
- Must be fully operational, receiving and shipping OTC medical devices subject to this accreditation, prior to scheduling an onsite survey.
- Must purchase the OTC medical device from the manufacturer or a distributor who purchased the OTC medical device from the manufacturer
- 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 requirements for devices in accordance with the labeling of the product and within the definitions contained in the United States Pharmacopeia-National Formulary
- Must have processes and systems to detect and prevent the receipt and distribution of diverted, misbranded, counterfeit, stolen, or otherwise fraudulent or illegitimate OTC medical devices subject to this accreditation must be in place, including due diligence measures which routinely ensure that all sources supplying the applicant facility with such product are: (1) engaged in legitimate transactions and (2) are not supplying the facility with OTC medical devices subject to this accreditation which are potentially diverted, misbranded, counterfeit, stolen, or otherwise fraudulent or illegitimate
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.
OTC Medical Device Distributor Accreditation Criteria
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
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.
If your business entity has never been OTC Medical Device Distributor accredited or is currently accredited but has relocated, a new OTC Medical Device Distributor application is required.
Get started on your path to accreditation by following the steps below:
- Confirm your eligibility
- Review the criteria and Policy and Procedures (P&P) Assessment to to confirm that the program meets your business’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 3 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.
OTC Medical Device 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 on-site survey and the facility will be in “reaccreditation” pending the completion of the annual review.
Annual Compliance Review Fees: $1,000