Get Form Ffcl-1a. Report On Receipt Of Drug - Guide For Reporting ... - Fws

This guide provides essential instructions for filling out the FORM FFCL-1a, which is required for reporting the receipt of investigational new animal drugs. Follow these detailed steps to ensure accurate and compliant submissions.

Follow the steps to successfully complete the FORM FFCL-1a.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred editor.
2. Begin by entering the date of receipt at the top of the form. This should reflect the actual date you received the drug.
3. Fill in the INAD No. (Investigational New Animal Drug Number) as provided by the regulatory agency; ensure it is accurate.
4. In the next field, input the name of the drug being reported. In our example, this is Aquaflor®.
5. Specify the trial number associated with the drug shipment; if there isn't one, indicate it as 'NA'.
6. Record the lot number of the drug received. This information is vital for tracking purposes.
7. State the proposed use of the drug. In this case, it is for the treatment of certain bacterial diseases in lobsters.
8. Enter the date of the CVM authorization letter that permitted this shipment.
9. Indicate the date the drug was received and the amount of the drug received in the relevant fields.
10. Provide the name of the feed manufacturer and their address, ensuring it is typed or printed clearly.
11. Indicate whether the study is pivotal or nonpivotal by marking the appropriate box.
12. If applicable, provide information on the study number and protocol associated with the drug study.
13. Include details on the maximum dose and duration of the drug administration.
14. Note the method(s) of administration and the withdrawal period that is applicable.
15. Lastly, if the investigation is discontinued, confirm your obligation to notify the FDA regarding the reason and disposition of the drug.
16. Sign and date the form in the section titled Feed Manufacturer (Authorized Representative).
17. After completing the form, you may save changes, download, print, or share it as needed.

Complete the FORM FFCL-1a online today to ensure accurate reporting of drug receipt!