1. Action Plan for the Provision of Useful Prescription Medicine Information. Report submitted to the Secretary of the US Department of Health and Human Services, December 1996. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ReportsBudgets/UCM163793.pdf. Accessed November 18, 2011.
2. US Department of Health and Human Services and the Food and Drug Administration. Guidance: useful written consumer medication information (CMI). July 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080602.pdf. Accessed November 18, 2011.
3. Medication guides for prescription drug products. In: Code of Federal Regulations. Washington, DC:US Department of Health and Human Services; 2009. 21 CRF 208.
4. Patient package inserts for estrogens. In: Code of Federal Regulations. Washington, DC:US Department of Health and Human Services; 2009. 21 CRF 310.515.
5. Public Law 104–180, Title VI, Sec 601 Effective Medication Guides, 110 Stat 1593 (1996).