piperonyl butoxide - 相关文章 - 美国FDA/OTC/NDC/申报认证

21 CFR Part 358 - Miscellaneous External Drug Products for Over-the-Counter Human Use

21CFR 2026-07-27

21 CFR Part 358 - Miscellaneous External Drug Products for Over-the-Counter Human UsePART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:55 FR 33255, Aug. 14, 1990,

M031 灭虱 OTC 药品合规解读：只有一组活性复方，且必须为非气雾剂

OTC申报 2026-07-18

2026年FDA OTC专论M031仅允许pyrethrum extract提供0.17%–0.33% pyrethrins并与2%–4% piperonyl butoxide组合的非气雾复方，标签须包含检查、10分钟处理、梳卵、7–10天复治和环境清洁。中国出口企业须按药品cGMP完成每批双活性检测及稳定性，完成FDA注册与NDC列名。