Why is my facility ineligible for Supply Chain Inspection?
You may be ineligible for the Supply Chain Inspection because of your facility’s business model. Current eligible facilities include:
- prescription drug wholesale distributors,
- prescription medical device distributors,
- active pharmaceutical ingredient (API) distributors,
- API repackagers,
- repackagers of finished prescription drugs,
- veterinary prescription drug distributors,
- reverse distributors,
- sample distributors,
- investigational drug distributors,
- virtual distributors and manufacturers, and
- third-party logistics (3PL) providers.
Business models that are not eligible include FDA-registered outsourcing facilities (503B) and over-the-counter medical device distributors.
Alternatively, your facility may be deemed ineligible because information is incomplete within its business e-Profile. In this instance, please ensure the following fields have been provided within the e-Profile:
- demographic information (doing business as, business address, business email, website, etc.),
- ownership (unless publicly traded),
- supply chain (sources and customers),
- business hours,
- storefront, and
Please review and ensure all required fields are completed.