Definition on "Botanical Drug"

The term botanicals means products that include plant materials, algae, macroscopic fungi, and combinations thereof. It does not include:

Products that contain animals or animal parts (e.g., insects and annelids) and/or minerals, except when these are a minor component in a traditional botanical preparation (e.g., traditional Chinese medicine, Ayurvedic medicine).

Materials derived from botanical species that are genetically modified with the intention of producing a single molecular entity (e.g., by recombinant DNA technology or cloning).

Products produced by fermentation of yeast, bacteria, plant cells, or other microscopic organisms, including plants used as substrates, if the objective of the fermentation process is to produce a single molecular entity (e.g., antibiotics, amino acids, and vitamins).

Highly purified substances, either derived from a naturally occurring source (e.g., paclitaxel) or chemically modified (e.g., estrogens synthesized from yam extracts).

​​If the botanical material is derived from traditional cultivation or breeding techniques (e.g., not genetically modified), or if fermentation of a botanical raw material is part of the manufacturing process to produce a product that is a natural mixture consisting of multiple active constituents, then appropriate provisions in this guidance will apply.

When a drug product contains a botanical drug substance in combination with either a (1) synthetic or highly purified drug or (2) biotechnology-derived or other naturally derived drug, this guidance can generally be applied to the botanical portion of the product.

Philadelphia, USA