|You engage in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological or medical supply.
This includes distributors or wholesalers that hold title to a covered drug, device, biological, or medical supply.
|You exist under common ownership with a Type 1 applicable manufacturer
You provide assistance or support to such an entity with respect to the production, preparation, propagation, compounding, sale, or distribution of a covered drug, device, biological, or medical supply.
|You produce at least one product reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program (CHIP).
If the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer
If the product is a device or medical supply, and it requires premarket approval or premarket notification by the Food and Drug Administration (FDA).
- Applicable manufacturers and GPOs with less than 10 percent of revenues from covered products do not need to report all payments or other transfers of value. They are, however, required to report payments or other transfer of value that are related to one or more covered drugs, devices, biologicals or medical supplies
- Foreign entities that may contribute to the manufacturing process of a covered product are exempt if they have no business presence in the United States.
- Entities that only manufacture raw materials or components, which are not themselves covered products, are not required to report unless the entity are under common ownership with an applicable manufacturer and assist such manufacturer with the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply.
- Entities such as hospitals, hospital-based pharmacies, and laboratories are exempt if they manufacture a covered product solely for use by or within the entity itself or by an entity’s own patients.
- Wholesalers or distributors that do not hold the title of a covered product are not subject to the reporting requirements, unless they are under common ownership with an applicable manufacturer and provide assistance or support with respect to a covered drug, device, biological, or medical supply.
- If an applicable manufacturer does not manufacture a covered drug, device, biological, or medical supply (except pursuant to a written agreement to manufacture the covered product for another entity), does not hold the FDA approval, licensure or clearance for the product, and is not involved in the sale, marketing or distribution of the product, then the manufacturer is only required to report payments or other transfers of value related to the covered product. This is described in the regulatory text at §403.904(b)(4).