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Draft Guidance : Modified Risk Tobacco Product Applications Resources : Importers and the import trade community for additional information on importing tobacco products, including information on filing an entry, please refer to the following resources: Entry Submission Process Importing and Exporting Tobacco Products FDA Import Program Imported Tobacco VIDEO: Tobacco Entries: Updated Information For Filing ENDS Products for Import in the Automated Commercial Environment (ACE) VIDEO: Tobacco Product Compliance Policy: Updates for Importers VIDEO: Importing Tobacco Products: Updates for Importers Small Business Assistance for Tobacco Product Industry 1-877-287-1373 (9am - 4pm ET) [email protected] Contact CTP Request a meeting with CTP's Office of Science 5 Additional Resources Electronic Submissions for Tobacco Products Tobacco Registration and Listing Next Generation (TRLM NG) Instructions FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products CTP Glossary Tobacco Compliance Webinars 1

An advantage of this approach is that the denominator would represent sales that are ultimately dispensed in retail community pharmacy settings and in outpatient settings (whereas, as mentioned previously, unit reporting under the MDRP represents units typically dispensed only in the retail community pharmacy setting)

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