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HHS/FDA RIN: 0910-AA61 Publication ID: Spring 1998 
Title: Investigational New Drugs: Export Requirements for Unapproved New Drug Products 
Abstract: The proposed rule would amend the regulations on the exportation of unapproved new drug products, including biological products, for investigational use. The proposed rule would create 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). 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 developed countries specified in the rule. The fourth route would permit exportation only if FDA authorized shipment of the investigational drug; such authorization would be obtained through submission of a written request to export the drug. 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 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 recent 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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 312.110   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 356    21 USC 357    21 USC 371    21 USC 381    21 USC 382    21 USC 393    42 USC 241    42 USC 243    42 USC 262   
Timetable:
Action Date FR Cite
NPRM  05/00/1998    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
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