Get Biennial Drug Manufacturing License Renewal Application Form

The Biennial Drug Manufacturing License Renewal Application Form is essential for ensuring that drug manufacturing facilities maintain compliance with regulatory standards. This guide provides clear, step-by-step instructions to help users complete the form accurately and efficiently online.

Follow the steps to successfully complete your renewal application.

1. Click ‘Get Form’ button to obtain the Biennial Drug Manufacturing License Renewal Application Form and open it for editing.
2. Enter the legal name of the firm in the designated field. This should be the full name of the business applying for the license.
3. If applicable, provide any additional 'doing business as' (DBA) names in the corresponding field.
4. Fill out the facility address, including the number, street, city, state, and ZIP code for the manufacturing location.
5. Complete the mailing address section if it differs from the facility address, including any necessary P.O. Box details.
6. Provide the name and title of the facility operator responsible for managing operations at this location.
7. Input the facility's telephone number in the specified format.
8. Include the facility's fax number, if applicable.
9. List a 24-hour emergency telephone number for use in urgent situations.
10. Enter the facility's email address for communication purposes.
11. Identify the correspondent for this application, providing their name and title.
12. Input the correspondent's telephone number for inquiries.
13. If your facility is located outside the United States, specify the country.
14. If applicable, include the website URL for your business.
15. Indicate the types of interstate commerce your business engages in by selecting the appropriate checkboxes.
16. Choose the correct type of ownership for your facility from the available options.
17. If your facility is a corporation, provide the corporate name and state of incorporation.
18. List the names and titles of owners or officers associated with the facility, attaching additional sheets if necessary.
19. Mention the size of the facility in square feet and the number of employees working at this location.
20. Select the current stage of manufacture for your products and indicate all that apply.
21. Mark the intended drug destinations for your manufactured products according to the options provided.
22. Select all applicable types of drug products being manufactured.
23. Specify the drug products manufactured at the facility by checking the relevant boxes.
24. List the manufacturing processes being undertaken, indicating whether they will be performed in-house or contracted out.
25. Provide the payment code depending on your application type and calculate the total fees due according to the specified guidelines.
26. Review the application to ensure all sections are completed and accurate, as unsigned or incomplete applications will be returned.
27. Sign, print your name, title, and the date at the designated section to validate the application.
28. Save changes, and if necessary, download, print, or share the completed form as required.

Start filling out your Biennial Drug Manufacturing License Renewal Application Form online today to ensure a smooth renewal process.