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| HHS/FDA | RIN: 0910-AB57 | Publication ID: Fall 2001 |
| Title: Bulk Drug Substances for Use in Pharmacy Compounding | |
| Abstract: Section 127 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and Cosmetic Act (21 U.S.C. 353a). Section 503A governs the application of Federal law to the practice of pharmacy compounding. Under section 503A(b)(1)(A), FDA may issue by regulation a list of bulk drug substances that may be used in compounding that are not covered by a United States Pharmacopeia (USP) or National Formulary (NF) monograph and are not components of FDA-approved drugs. Bulk drug substances that do not appear on the list may not be used in compunding under section 127 unless such substances are covered by USP or NF monograph or are components of approved drugs. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 216 | |
| Legal Authority: PL 105-115, sec 127; 21 USC 351; 21 USC 352; 21 USC 353a; 21 USC 355; 21 USC 371 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
| 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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