Safeguarding High-Risk OTC Device Distribution
The OTC Medical Device Distributor Accreditation, formerly VDIP, is for business entities that distribute diagnostic over-the-counter (OTC) medical devices that may be dispensed pursuant to a prescription. 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- and on-site reviews of the business entity’s policies and procedures and operations.
OTC Medical Device Distributor Accreditation is a resource for industry and regulatory bodies that establishes uniform safeguards meant to protect the public health. To become accredited, business entities must operate legitimately and also employ best practices driven by the OTC Medical Device Distributor Accreditation criteria, Code of Federal Regulations (CFRs), and the Federal and State Food, Drug, and Cosmetic (FD&C) Acts in their daily operations.
Please see the FAQ section for more information and for the definitions to common terms.
If you need a facility e-Profile ID, you will need to contact email@example.com.
Why Was the Accreditation Created?
OTC medical device distribution is largely unregulated in the United States. So, NABP started an accreditation for business entities that distribute medical devices which are often designated as medium-to-high risk by the Food and Drug Administration (FDA). The OTC Medical Device Distributor Accreditation program helps protect patients that rely on these medical devices to treat sometimes life-threatening illnesses.
If you have any additional questions, please email VDIP@nabp.pharmacy.