OTC Medical Device Distributor
Show customers your facility’s dedication to safely distributing diagnostic OTC medical devices.
With over-the-counter (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 role in securing the medical supply chain by helping to protect the public from certain diverted or counterfeit medical devices.
This 3-year accreditation is for business entities that distribute diagnostic OTC medical devices that may be dispensed pursuant to a prescription.
Bundle Distributor Accreditations to Save Time and Money
Maximize your investment by also applying for our Drug Distributor Accreditation. Check eligibility requirements for your facility and contact our team for the discount code needed during the application process.
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.
To apply for an NABP accreditation, you must meet basic eligibility requirements. To be qualified to apply for the OTC Medical Device Distributor Accreditation, your facility must be an OTC medical device distributor. Review the eligibility requirements listed below.
- You are compliant with program criteria and requirements at the time you apply, throughout the application process, and during the accreditation term.
- You are appropriately licensed and operating in the United States with current and active licenses in all jurisdictions in which you are conducting business (unless licensure is not required by law).
- You are operational in all medical device distribution activities for at least 30 days and compliant with all state regulations, laws, and rules (eg, federal, state, local, and jurisdictional requirements) applicable to the business.
- You completed our prerequisite Supply Chain Inspection within the past 12 months and received an OTC Medical Device Distributor Accreditation eligibility letter.
Click on the links below to learn about each criterion: