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HHS/FDA RIN: 0910-AA61 Publication ID: Fall 1997 
Title: Export Requirements for Drugs for Investigational Use in Other Countries 
Abstract: FDA is proposing to amend its regulations on investigational new drug products to streamline requirements for exports of unapproved drugs for investigational use to foreign countries. The proposed rule would permit an unapproved drug product to be exported under three different options. The first option would permit exportation of a drug under an approved investigational new drug application (IND). This would be consistent with the preexisting rule. The second option would permit exportation of a drug to a country other than one specified in section 802 (b)(1)(A) of the Federal Food, Drug, and Cosmetic Act, without an IND or prior FDA approval, provided that adverse event information is reported to the FDA. This would represent a significant change from the existing rule and reflects FDA's experience with drugs exported for investigational use (whereby a minute percentage of all drugs exported for investigational use result in any safety concerns). The third option would permit exportation of drugs for investigational use to one of the countries specified in section 802(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act without an IND or prior FDA approval. This third option would implement part of the FDA Export Reform and Enhancement Act. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 312.110   
Legal Authority: 21 USC 331    21 USC 351 to 352    21 USC 355 to 357    21 USC 360    21 USC 360b    21 USC 360aa to 360dd    21 USC 371 to 372    21 USC 374    21 USC 379e    21 USC 379g    21 USC 381 to 382    21 USC 393    42 USC 216    42 USC 241    42 USC 242l   
Timetable:
Action Date FR Cite
NPRM  To Be Determined    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Included in the Regulatory Plan: No 
Agency Contact:
Linda Horton
Director, International Policy Staff, Office of Policy (HF-23)
Department of Health and Human Services
Food and Drug Administration
5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-3344
Email: lhorton@bangate.fda.gov