Exports: Notification and Recordkeeping Requirements
other · Food and Drug Administration · Rule · Published 2001-12-19 · Effective 2002-03-19 · 66 FR 65429
Document
Document number
01-31026
Federal Register citation
66 FR 65429
CFR reference
21 CFR 1
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-12-19
Effective date
2002-03-19
HHS docket
Docket No. 98N-0583
Abstract
The Food and Drug Administration (FDA) is issuing a final rule that establishes the notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States. These regulations implement recent changes in the statutory requirements applicable to certain exports, and also codify recordkeeping requirements for exports of products that cannot be marketed or sold in the United States generally.