What is a prescription drug establishment?
• which is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other, and • at which one or more prescription drug products are manufactured in final dosage form. For purposes of user fees, the term manufactured does not include packaging. table of contents 9. What does final dosage form mean? Final dosage form means a finished dosage form which is approved for administration to a patient without substantial further manufacturing. PRODUCT FEES 10. What are product fees? For Fiscal Year 2002 and before: Prescription drug product fees are assessed annually for eligible products. The product fees are assessed on products for each person who • is named as the applicant in a human drug application for a prescription drug product that has been submitted for listing under section 510 of the FD&C Act, and • had a human drug application or supplement pending after September 1, 1992. For FY 2003 and after: Prescription drug product fees a
