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# Petition to Amend External Analgesic Drug Monograph
- URL: https://www.fdaweb.com/petition-to-amend-external-analgesic-drug-monograph/
- Published: 2016-10-25T12:00:00.000Z
- Updated: 2026-09-14T21:42:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137166

Metabolic Therapy, Austin, TX, has submitted a citizen petition asking that FDA amend the OTC External Analgesic Drug Products monograph for active ingredients to indicate that melatonin and inositol hexaphosphate are safe and effective for external analgesic drug products. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-3509-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says the monograph should indicate that topical external analgesic drug products containing melatonin and inositol hexophosphate are covered by the monograph instead of being considered new drugs for which manufacturers would have to complete an NDA.