List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
other · Food and Drug Administration · Rule · Published 1999-03-08 · Effective 1999-04-07 · 64 FR 10944
Document
Document number
99-5517
Federal Register citation
64 FR 10944
CFR reference
21 CFR 216
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-03-08
Effective date
1999-04-07
HHS docket
Docket No. 98N-0655
Abstract
The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).