The question has been raised as to whether or not a drug for which an NDA has been submitted, could legally be exported for commercial distribution before the NDA was approved.
Section 801(d) of the Act provides an exemption from the adulteration and misbranding provisions only and does not authorize exportation of a new drug that is not covered by an approved NDA.
However, under the provisions of 21 CFR 312.1, a new drug, limited to investigational use may be exported only for purposes of clinical investigation and not where the drug is intended for commercial marketing, or use in routine medical practice.
NOTE: See CPG 7150.11 (See Sec. 110.200 for this CPG.) covering export of FDA controlled products (including NDA/IND drugs) from Foreign Trade Zones.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.