Sec. 442.100 New Drugs - Export (CPG 7132c.01)
BACKGROUND:
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.
POLICY:
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.
Issued: 10/1/80