What Defines a Manufacturer and When do they Need a Distributors License?
A manufacturer is defined as a facility that produces, transfills, repackages, relabels, prepares, propagates, compounds, converts, or processes a controlled substance, drug, device, or cosmetic. A manufacturer who sells or ships prescription and/or controlled substances to another facility or business, including those owned by the same corporations, must also apply under the Licensure Act. A manufacturer or transfiller of oxygen/medical gases selling all their products directly to the ultimate user or patient does not need to apply for licensure. Back To Top Do Commercial Warehouses Need to Register? Yes, even though commercial warehouses do not own the products, they are still storing and acting as a distributor and should register as such. Back To Top What Other Drug or Device Registrations Will I Need? For facilities handling controlled substances, registration with the Federal Drug Enforcement Agency (DEA) is required. For facilities manufacturing drugs, devices, or medical gases,
