First, 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 if you are eligible to apply for OTC Medical Device Distributor Accreditation.
On December 18, 2024, NABP is adjusting the pricing for certain accreditation and inspection programs. To apply under current pricing, your application and payment must be submitted on or before 6 PM CST on December 18, 2024. Log in to your business e-Profile account to access pricing.
Seeking OTC Medical Device Distributor Accreditation is a collaborative effort between business entities and NABP. Before you apply, learn more about the process by obtaining and watching our on-demand webinar. Then, follow the steps below.
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.
Review the Device Distributor Accreditation process overview infographic:
After completing a Supply Chain Inspection, you will be notified of your eligibility to apply for accreditation. If eligible, submit an online application and pay the program fees. You may receive a Post-Survey Letter outlining corrective actions and/or P&Ps to submit. Once your facility meets the accreditation standards, you will be awarded OTC Medical Device Distributor Accreditation (or reaccreditation). This marks the start of your 3-year accreditation.
Prior to your accreditation anniversary date, you will start your annual compliance review, which includes submitting a renewal application, paying program fees, and attesting with the accreditation standards. We will reach out to you to start this review process.
Prior to your accreditation anniversary date, you will start your annual compliance review, which includes submitting a renewal application, paying program fees, and attesting with the accreditation standards. We will reach out to you to start this review process.
We will contact you several months prior to your 3-year accreditation end date to start the reaccreditation process.
To maintain your OTC Medical Device Distributor Accreditation status, keep these tips in mind:
OTC Medical Device Distributor Accreditation is issued for a 3-year term.
NABP requires an annual compliance review during years 2 and 3 of the accreditation process.
Prior to the end of the 3-year accreditation, you will need to start the reaccreditation process, noted below.
The reaccreditation process is similar to the initial OTC Medical Device Distributor Accreditation steps:
Apply and complete the Supply Chain Inspection.
Receive a reaccreditation letter to apply.
Submit the reaccreditation application for one or multiple accreditations with your business e-Profile account.
OTC Medical Device Distributors must begin the reaccreditation process before their current accreditation expires. We encourage facilities to seek reaccreditation for a new, 3-year period during the third year of their OTC Medical Device Distributor Accreditation.
Prior to your accreditation anniversary date (expiration date of your current 3-year accreditation), we will contact you to begin the reaccreditation process and will provide guidelines to help you with the process.
