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| | Guidance for Industry Botanical Drug Products |
 | | Fermentation products (i.e., products produced by fermentation of yeast, bacteria, and other microscopic organisms, including when plants are used as a substrate, and products produced by fermentation of plant cells), even if such products are previously approved for drug use or accepted for food use in the United States (e.g., antibiotics, amino acids, and vitamins). |
 | | Botanical drug products that are derived from a single part of a plant (e.g., leaves, stems, roots, or seeds), or from a single species of alga or macroscopic fungus (e.g., a mushroom), are not considered to be fixed-combination drugs within the meaning of 21 CFR 300.50 and 330.10(a)(4)(iv). |
 | | For a botanical product that is prepared according to traditional methodology, the nature of clinical pharmacology information needed should be determined on a case-by-case basis, depending on the indications, extent of human experience, target patient population, and projected length of clinical use. |
| www.fda.gov /cder/guidance/4592fnl.htm (9429 words) |
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