Botanical preparations may be intravenous, topical, or inhalation formulations. Are these non-oral formulations evaluated any differently than oral formulations under the Botanical Guidance?
The Botanical Guidance applies to all dosage forms of botanical products. As with conventional chemical drugs, the type of quality testing for botanical products varies from dosage form to dosage form. For example, injectable products are required to be sterile and pyrogen-free whereas oral tablets may not. In addition, the human experience of an orally administered dietary supplement may not be applicable to an identical botanical product with the same ingredient(s) when given by a non-oral route of administration.
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