List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness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 2018-12-11 · Effective 2019-01-10 · 83 FR 63569
Document
Document number
2018-26712
Federal Register citation
83 FR 63569
CFR reference
21 CFR 216
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2018-12-11
Effective date
2019-01-10
HHS docket
Docket No. FDA-2016-N-2462
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.