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# FDA Denies Methscopolamine Petition
- URL: https://www.fdaweb.com/fda-denies-methscopolamine-petition/
- Published: 2020-02-19T12:00:00.000Z
- Updated: 2026-09-14T16:03:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146122

FDA has denied a 2/2/19 petition submitted by a Philadelphia law firm asking that the agency ensure that all manufacturers of methscopolamine bromide tablets adhere to the agency’s 2016 *Botanical Drug Development* guidance and take enforcement action against non-compliant manufacturers. The agency [response](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-0537-0004&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that FDA generally cannot require compliance with a guidance and, more specifically, the considerations in the botanical drug guidance generally do not apply to methscopolamine bromide. In addition, it says, requests for specific enforcement actions are not appropriate for a citizen petition since the agency determines enforcement actions on a case-by-case basis.