FDA企业注册与工厂登记2026实操指南
2026年美国OTC药品须完成FDA企业注册(Establishment Registration)与工厂登记,作为上市前置条件。本文详解注册主体、邓白氏码要求、系统填报要点与年度更新节奏,帮助出口企业避开常见申报失误。
美国FDA、OTC、NDC化妆品申报认证行业资讯,助力企业合规出海
2026年美国OTC药品须完成FDA企业注册(Establishment Registration)与工厂登记,作为上市前置条件。本文详解注册主体、邓白氏码要求、系统填报要点与年度更新节奏,帮助出口企业避开常见申报失误。
米诺地尔外用生发产品以2%与5%两种浓度在美国作为OTC药品销售,须符合FDA专论并标注Drug Facts。5%适用于男性,2%多用于女性,均须完成NDC注册与工厂登记。中国防脱发产品出口美国若宣称促生发,须按药品路径合规,不可归入普通化妆品。
2026年中国去屑洗护出口美国需遵循FDA OTC专论M032,煤焦油、二硫化硒、水杨酸、硫磺及吡硫翁锌(ZPT)均为合规活性成分。与欧盟2022年禁用ZPT不同,美国仍将ZPT列为合法OTC去屑成分。企业须按专论浓度与Drug Facts标签要求申报,并办理NDC注册。
21 CFR Part 331 -- Antacid Products for Over-the-Counter (OTC) Human UsePART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:39 FR 19874, June 4, 1974, unless otherwise noted.Subpa
21 CFR Part 333 Subpart B - First Aid Antibiotic Drug ProductsSubpart B—First Aid Antibiotic Drug Products§ 333.101 Scope.(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized
21 CFR Part 347 - Skin Protectant Drug Products for Over-the-Counter Human UsePART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:58 FR 54462, Oct. 21, 1993, unless otherwi
21 CFR Part 333 Subpart D—Topical Acne Drug ProductsSubpart D—Topical Acne Drug ProductsSource:56 FR 41019, Aug. 16, 1991, unless otherwise noted.§ 333.301 Scope.(a) An over-the-counter acne drug product in a form suitable for topical application is
21 CFR Part 350 - Antiperspirant Drug Products for Over-the-Counter Human UsePART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:68 FR 34291, June 9, 2003, unless otherwise
21 CFR Part 352 - Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:64 FR 2768
21 CFR Part 355 - Anticaries Drug Products for Over-the-Counter Human UsePART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:60 FR 52507, Oct. 6, 1995, unless otherwise noted.Ed