深度解读：美国OTC专论路径的底层逻辑与出口合规启示
2020年发表于《中国药事》的学术论文系统梳理了美国OTC专论路径的建立背景、27个治疗分类、GRASE三分类评价体系及ANPR-TFM-FM三阶段制定程序，并对比日本许可标准制度。本文基于该研究核心发现，为跨境电商及出口企业解读美国OTC药品监管的制度逻辑与合规实践要点。
21 CFR Part 331 -- Antacid Products for Over-the-Counter (OTC) Human Use
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 Products
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 332 - Antiflatulent Products for Over-the-Counter Human Use
21 CFR Part 332 - Antiflatulent Products for Over-the-Counter Human UsePART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:39 FR 19877, June 4, 1974, unless otherwise noted.Subpar
21 CFR Part 333 Subpart C—Topical Antifungal Drug Products
21 CFR Part 333 Subpart C—Topical Antifungal Drug ProductsSubpart C—Topical Antifungal Drug ProductsSource:58 FR 49898, Sept. 23, 1993, unless otherwise noted.§ 333.201 Scope.(a) An over-the-counter antifungal drug product in a form suitable for topi
21 CFR Part 347 - Skin Protectant Drug Products for Over-the-Counter Human Use
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 Products
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 Use
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]
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 Use
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
