Center for Drug Evaluation and Research growing crisis around HIV testing and treatment and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator) led to the split. In its original form, CDER was composed of six offices: Management, Compliance, Drug Standards, Drug Evaluation I, Drug Evaluation II, Epidemiology and Biostatistics, and Research Resources. The Division of Antiviral Products was added in 1989 under Drug Evaluation II due to the large amount of drugs proposed for treating AIDS. The Office of Generic Drugs was also formed. In 2002,
Botanical drug defined in the United States Federal Food, Drug, and Cosmetic Act (FD&C) as a botanical drug that is marketed as diagnosing, mitigating, treating, or curing a disease; a botanical product in turn, is a finished, labeled product that contains vegetable matter as ingredients. Chemicals that are purified from plants, like paclitaxel or artemisinin, and highly purified products of industrial fermentation, like biopharmaceuticals, are not considered to be botanical products. The FD&C act separately regulates uses of botanical products as food (including dietary supplements), medical devices (e.g., gutta-percha), and cosmetics. Like other drugs, botanical drugs may be sold over the counter