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What is a Botanical Drug?
2014-09-18 15:07:25
A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.   
A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof. 
A botanical drug product may be available as (but not limited to) a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection. 
Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products.
A botanical drug's special features require consideration and adjustment during the FDA review process. CDER issued a Guidance for Industry-Botanical Drug Products (PDF - 437KB) to take into consideration these features and to facilitate development of new therapies from botanical sources. The Botanical Guidance applies to only botanical products intended to be developed and used as drugs.
Up to this date, one botanical product that fulfills the Botanical Guidance definition of a botanical drug product has been approved for marketing as a prescription drug.  There are some botanical drugs, including cascara, psyllium, and senna, that are included in the over-the-counter (OTC) drug review.  For a botanical drug substance to be included in an OTC monograph, there must be published data establishing a general recognition of safety and effectiveness, including the results of adequate and well-controlled clinical studies.  
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