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Instructions for completing form fda 3911, which is used to notify the food and drug administration (fda) of illegitimate or potentially illegitimate pharmaceutical products. The form includes sections for reporting the type of notification, product information, drug description, dosage form, quantity of drug, ndc number, serial number, lot number, expiration date, event description, and company information. The document also lists various reporting mechanisms and contact information for the company making the notification.
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1. Type of Report – Indicate the type of report by checking the appropriate box. - Initial Notification – Your first notification to the FDA of an illegitimate product or product with a high risk of illegitimacy - Follow-up Notification – subsequent notification to FDA, related to an initial notification already submitted to FDA - Request for Termination – request for consultation with FDA to terminate a notification of an illegitimate product or product with a high risk of illegitimacy 2. Incident Number – This number will be assigned by FDA when the initial notification is received by FDA and sent to the reporter with the FDA receipt acknowledging the initial notification. Please utilize the incident number that corresponds to the initial notification in all future correspondence with the FDA about the notification, including the request for termination. 3. Date of Initial Notification to FDA – Enter the date that you are submitting the initial notification to FDA. For follow-up notifications or a request for termination, enter the date the initial notification was submitted to FDA. Use the calendar function or enter the date in MM/DD/YYYY format. If you do not have the incident number, then providing the date of initial notification will allow FDA to associate any follow-up notification or request for termination with the initial notification. 4. Date Illegitimate Product Was Determined by Company – Use the calendar function or enter the date in MM/DD/YYYY format that the product was determined to be illegitimate or to have a high risk of illegitimacy (manufacturers only). 5. Classification of Notification – Select the appropriate classification of the illegitimate product or product with a high risk of illegitimacy (manufacturers only). - Counterfeit – A product is determined to be counterfeit, or has a high risk of being counterfeit. - Diverted – A product is determined to be a diverted product, or has a high risk of being a diverted product. - Stolen – A product is determined to be a stolen product, or has a high risk of being a stolen product. - Intentional adulteration – A product is determined to be intentionally adulterated such that use of the product would result in serious adverse health consequences or death to humans, or has a high risk of it. - Unfit for distribution – A product appears otherwise unfit for distribution such that use of the product would be reasonably likely to result in serious adverse health consequences or death to humans, or has a high risk of it. - Fraudulent transaction – A product in your possession or control is determined to be the subject of a fraudulent transaction, or has a high risk of it.
6. Name of Product as it appears on the label – Indicate the name of the product as it appears on the label. 7. Primary Ingredient(s) – List active pharmaceutical or biological ingredient(s) if known and not listed in item 6 above. 8. Drug Use – Select the approved use of the product. If “other” is selected, please provide a description in your response to item 17 or 18. Note: Section 582 of the FD&C Act notifications are for human-use products only - Human use - Other
FORM FDA 3911 SUPPLEMENT (5/1 7 ) – FORM INSTRUCTIONS Page 1 of 3 PSC Publishing Services (301) 443-6740 EF
9. Drug Description – Select the most specific description available from the list that describes the illegitimate product or product with high risk of illegitimacy (manufacturers only). - Finished prescription drug - Vaccine - Plasma derivative (coagulation factors, immunoglobulins, albumin) - Allergenic (standardized and non-standardized) - Multiple 10. Strength of Drug – Provide the strength of the product, including the unit of measure (e.g., 500 mg, 1g/10mL). 11. Dosage Form – Select the dosage form that best describes the product. If “OTHER” is selected, provide a description in your response to item 17 or item 18. - Tablet - Capsule - Aerosol - Oral Liquid - Sublingual - Injectable - Topical - Suppository - Other - Multiple 12. Quantity of Drug (Number and Unit) – Provide the quantity of product involved, including the number and unit of measure (e.g., 6 cases, 20 bottles, etc.). Additional information may be included in item 17 or item
13. NDC Number – Provide the National Drug Code of the product as identified on the product that is subject to the notification if known. 14. Serial Number – Provide the serial number as identified on the product that is subject to the notification if known. 15. Lot Number(s) – Provide any relevant lot numbers of the product that is subject to the notification if known. Separate multiple numbers using a comma. 16. Expiration Date(s) – Provide expiration date(s) as identified on the product that is subject to the notification if known. Separate multiple expiration dates using a comma. 17. For Notification, Description of Event/Issue – Describe the circumstances surrounding the event that prompted the notification including, when, where in the supply chain, where geographically, and how the product was found. If you are a trading partner other than a manufacturer, you may indicate which manufacturer you have coordinated with to make the determination that the product is illegitimate here. If this notification is for a product with a high risk of illegitimacy (manufacturers only), indicate it here. 18. For Request for Termination of Notification: Description of why notification is no longer necessary
FORM FDA 3911 SUPPLEMENT (5/1 7 ) – FORM INSTRUCTIONS Page 2 of 3