美国FDA、OTC、NDC化妆品申报认证行业资讯，助力企业合规出海
21 CFR Part 358 Subpart B -- Wart Remover Drug ProductsSubpart B—Wart Remover Drug Products§ 358.101 Scope.(a) An over-the-counter wart remover drug product in a form suitable for topical application is generally recognized as safe and effective and
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,
2026年FDA OTC专论M028仅允许水杨酸作为疣去除活性成分，贴剂12%–40%、成膜液5%–17%和刺梧桐胶贴膏15%分别绑定三种载体，最长疗程12周，仅覆盖寻常疣和足底疣。面部、生殖器、黏膜、痣和胎记均被排除。中国出口企业须按药品cGMP完成每批检测与NDC列名。
2026年多款去疣剂产品通过FDA的NDC注册成功进入美国市场，OTC专论M028是去疣剂合规的核心依据。去疣剂唯一允许的活性成分为水杨酸，浓度因剂型不同分为5%至40%三档。出口企业须完成FDA企业注册、NDC产品列名、Drug Facts标签合规及cGMP验证，方可合法销售。本文详解全流程实操要点。
