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HHS/FDA RIN: 0910-AA61 Publication ID: Fall 2004 
Title: Investigational New Drugs: Export Requirements for Unapproved New Drug Products 
Abstract: The final rule would amend the regulations on the exportation of unapproved new drug products, including biological products, for investigational use. In general, the rule would provide four different routes for exporting an unapproved new drug product for investigational use. One route would permit exportation, if the drug is the subject of an investigational new drug application (IND) and is being exported for use in the investigation. A second route would permit exportation, without prior Food and Drug Administration (FDA) approval and without an IND, if the product is to be exported for use in a clinical investigation and has received marketing authorization in certain developed countries. The third route would permit exportation, without prior FDA approval and without an IND, if the product is to be exported for use in a clinical investigation in certain specified developed countries. The fourth route would permit exportation without an IND, to any country provided that the exporter sends a written certification to FDA at the time the drug is first exported. Drugs exported under any of the first three routes would, however, be subject to certain statutory requirements, such as not conflicting with the foreign country's laws and not being sold or offered for sale in the United States. Drugs exported under either the second or third routes would be subject to additional statutory requirements, such as being in substantial conformity with the current good manufacturing practices and certain labeling requirements. These provisions would implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 312.110   
Legal Authority: 21 USC 321    21 USC 381    21 USC 382    21 USC 393    42 USC 241    42 USC 243    42 USC 262    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/19/2002  67 FR 41642   
Final Action  02/00/2005    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Philip L. Chao
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23), Center for Food Safety and Applied Nutrition, 5001 Campus Drive,
College Park, MD 20740
Phone:240 400-4053
Email: philip.chao@fda.hhs.gov