Removal of Regulations Regarding Certification of Antibiotic Drugs
other · Food and Drug Administration · Rule · Published 1998-05-12 · Effective 1998-09-24 · 63 FR 26066
Document
Document number
98-12543
Federal Register citation
63 FR 26066
CFR reference
21 CFR 430
Type
Rule
Action
Direct final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-05-12
Effective date
1998-09-24
HHS docket
Docket No. 98N-0211
Abstract
The Food and Drug Administration (FDA) is repealing its regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.