U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec. 442.100 New Drugs - Export
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

CPG Sec. 442.100 New Drugs - Export October 1980

Final
Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: None found.

Back to Top