An index is provided of the contents of the sections of Title 21, Code of Federal Regulations 201, and other selected sections of Title 21 which cover the content of prescription drug package inserts and other aspects of labeling required of United States drug manufacturers.
Title 21, Code of Federal Regulations.U.S. Government Printing Office, Washington, DC; 1995.
2.
Part VII Department of Health and Human Services. Food and Drug Administration, 21 CFR 201, et al. Prescription Drug Product Labeling; Medication Guide Requirements; Proposed Rule. Federal Register. August 24, 1995;44182–44252.
3.
Guideline for Postmarketing Reporting of Adverse Drug Experiences.Food and Drug Administration, Washington, DC; March 1992.
