1. Drugs@FDA. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed April 11, 2011
2. OTC human drugs that are generally recognized as safe and effective and not misbranded. 21 CFR §§330-358 (2010).
3. Federal Food, Drug, and Cosmetic Act, Sect 201(p), Chap II—Definitions, 21 USC §321 (2011).
4. Federal Food, Drug, and Cosmetic Act, Sect 505, New Drugs, 21 USC §355 (2011).
5. Adequate and well-controlled studies. 21 CFR §314.126 (2010).