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# FDA Amends Drug Registration/Listing Regulations
- URL: https://www.fdaweb.com/fda-amends-drug-registration-listing-regulations/
- Published: 2016-08-31T12:00:00.000Z
- Updated: 2026-09-14T21:28:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136671

*Federal Register* Final rule: FDA is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients alone or together with one or more other ingredients. This rule is effective on 11/29\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-31/pdf/2016-20471.pdf?ref=fdaweb.com)