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| HHS/FDA | RIN: 0910-AC01 | Publication ID: Fall 2000 |
| Title: Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness | |
| Abstract: The final rule will amend 21 CFR 216.24 by adding two drug products, aminopyrine and astemizole, to the list of drug products that may not be used for pharmacy compounding under the exemptions provided by section 503A of the Federal Food, Drug, and Cosmetic Act because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 216.24 | |
| Legal Authority: 21 USC 353a | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: No | Federalism: No |
| Included in the Regulatory Plan: No | |
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Agency Contact: Wayne H. Mitchell Regulatory Counsel, Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7, Rockville, MD 20857 Phone:301 594-2041 Fax:301 827-0951 Email: wayne.mitchell@fda.hhs.gov |
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