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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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/07/1999  64 FR 996   
NPRM Comment Period End  03/23/1999    
Final Action  To Be Determined    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
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