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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.

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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.

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Practices that demonstrate compliance in preventing counterfeit devices and devices from entering the United States medical supply can earn this voluntary accreditation and better position their business. Complete the form to request more information.

OTC Medical Device Distributor Eligibility

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.

  • Review and self-assess your eligibility.
  • 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.

Criteria

Click on the links below to learn about each criterion:

Learn How to Get StartedReview the steps you’ll need to take before submitting your application.