美国药房临方配制制剂监管政策分析及启示

李海剑; 邓安琪; 郭晴; 刘伟

doi:10.6039/j.issn.1001-0408.2026.14.04

您当前的位置：

首页 >

文章列表页 >

美国药房临方配制制剂监管政策分析及启示

药事管理 | 更新时间：2026-07-28

- 美国药房临方配制制剂监管政策分析及启示
- Regulatory policy analysis of pharmacy compounding drug products in the United States and its implications
- 中国药房 2026年37卷第14期页码：1819-1825
- 作者机构：
  
  1.河南省药品审评查验中心（河南省疫苗检查中心），郑州;450008
  2.郑州大学药学院，郑州　450001
- 作者简介：
  
  副主任药师，硕士。研究方向：药物政策、药品监管。E-mail：408521142@qq.com
  教授，博士。研究方向：药物警戒、合理用药。E-mail：liuweiyxy@zzu.edu.cn
- 基金信息：
  
  河南省科技发展计划(242400411140)
- DOI：10.6039/j.issn.1001-0408.2026.14.04
  中图分类号： R95;R94
- 收稿：2026-01-27，
  
  修回：2026-06-10，
  
  录用：2026-07-02，
  
  网络首发：2026-07-24，
  
  纸质出版：2026-07-30
- 稿件说明：
移动端阅览
李海剑,邓安琪,郭晴,等.美国药房临方配制制剂监管政策分析及启示 [J].中国药房,2026,37(14):1819-1825.

LI Haijian,DENG Anqi,GUO Qing,et al.Regulatory policy analysis of pharmacy compounding drug products in the United States and its implications[J].ZHONGGUO YAOFANG,2026,37(14):1819-1825.
李海剑,邓安琪,郭晴,等.美国药房临方配制制剂监管政策分析及启示 [J].中国药房,2026,37(14):1819-1825. DOI： 10.6039/j.issn.1001-0408.2026.14.04.

LI Haijian,DENG Anqi,GUO Qing,et al.Regulatory policy analysis of pharmacy compounding drug products in the United States and its implications[J].ZHONGGUO YAOFANG,2026,37(14):1819-1825. DOI： 10.6039/j.issn.1001-0408.2026.14.04.

摘要

目的

系统梳理美国药房临方配制制剂的核心监管要点，为完善我国药房临方配制制剂管理制度、保障公众用药安全可及提供参考。

方法

采用文献研究法，归纳美国《联邦食品、药品和化妆品法案》第503A条款对药房临方配制制剂的监管要点与实践特征；结合美国监管经验，分析我国临方配制制剂发展现状及存在的问题，并提出针对性建议。

结论

美国依托503A条款构建了系统的临方配制制剂监管体系，覆盖处方管理、原料药管理、已撤市或退市药品清单管理、配制困难药物清单管理、记录保存管理、跨州销售管理等维度，通过全流程规范配制、与专家委员会协同共治，有效平衡了个体化用药需求与药品质量安全。我国临方配制制剂目前局限于中药领域，存在缺乏法律法规支撑、质量管控薄弱、行业标准体系建设滞后、专业人才不足等问题。建议我国应构建分层法规体系、制定全流程技术标准、搭建本土化监管框架、推动技术创新发展并强化专业人才培养，以更好地平衡公众用药合法权益与药品安全性、有效性，促进公众健康。

Abstract

OBJECTIVE

To systematically review the key regulatory requirements for pharmacy compounding drug products in the United States， and to provide references for improving the management framework of pharmacy compounding drug products in China， thereby ensuring the safety and accessibility of medication use.

METHODS

A literature revi

ew was conducted to summarize the regulatory requirements and practical characteristics of pharmacy compounding drug products under Section 503A of the United States

Federal Food， Drug， and Cosmetic Act

. Based on regulatory experience of the United States， current status and existing deficiencies in pharmacy compounding drug products in China were analyzed， and targeted recommendations were proposed.

RESULTS &CONCLUSIONS

The United States has established a systematic regulatory framework for pharmacy compounding drug products under Section 503A， covering prescription management， active pharmaceutical ingredient management， list management of withdrawn or removed drugs and drugs that present demonstrable difficulties for compounding， recordkeeping management， interstate distribution and so on. Through standardized regulation of the entire compounding process and collaborative governance with expert advisory committees， this framework effectively balances individualized medication needs with drug quality and safety. In contrast， pharmacy compounding drug products in China remain largely confined to traditional Chinese medicine and face several challenges， including the lack of legal and regulatory support， inadequate quality control， lagging development of industry standards， and shortages of specialized personnel. It is recommended that China should establish a tiered regulatory system， develop comprehensive technical standards， build a localized regulatory framework， promote technological innovation， and strengthen professional talent cultivation to better balance the legitimate rights and interests of public medication use with drug safety and efficacy， thereby enhancing public health.

关键词

Keywords

references

FDA . Human drug compounding [EB/OL ] .（ 2025-05-15 ）[ 2025-11-07 ] . https：//www.fda.gov/drugs/guidance-com-pliance-regulatory-information/human-drug-compounding https://www.fda.gov/drugs/guidance-com-pliance-regulatory-information/human-drug-compounding .

Carvalho M ， Almeida I F . The role of pharmaceutical compounding in promoting medication adherence [J ] . Pharmaceuticals （Basel）， 2022 ， 15 （ 9 ）： 1091 .

Landry É K ， Autmizguine J ， Bérubé S ， et al . Drug prescriptions requiring compounding at a Canadian university affiliated pediatric hospital：a cross-sectional study [J ] . Children （Basel）， 2023 ， 10 （ 1 ）： 147 .

洪燕龙，王优杰，沈岚，等 . 中药临方制剂的应用现状、问题分析和发展对策 [J ] . 中国中药杂志， 2021 ， 46 （ 15 ）： 3739 - 3745 .

卫生部，国家中医药管理局，国家食品药品监督管理局 . 关于印发加强医疗机构中药制剂管理意见的通知 [EB/OL ] .（ 2010-08-24 ）[ 2026-06-20 ] . http：//www.natcm.gov.cn/yizhengsi/gongzuodongtai/2018-03-24/3064.html http://www.natcm.gov.cn/yizhengsi/gongzuodongtai/2018-03-24/3064.html .

鞠晓宇，赵越，赵倩，等 . 基于SWOT分析法的河北省中药临方制剂发展策略研究 [J ] . 中国医院， 2023 ， 27 （ 11 ）： 52 - 54 .

李莹，李文君，卢梦情，等 . 美国临方配制制剂及其对我国的借鉴意义 [J ] . 中国医院药学杂志， 2020 ， 40 （ 16 ）： 1776 - 1780 .

国务院 . 中华人民共和国药品管理法实施条例 [EB/OL ] . （ 2026-01-16 ）[ 2026-06-20 ] . https：//www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20260127172639127.html https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20260127172639127.html .

FDA . Prescription requirement under section 503A of the FDA guidance for industry [EB/OL ] .（ 2016-12-28 ）[ 2025-11-07 ] . https：//www.fda.gov/media/97347/download https://www.fda.gov/media/97347/download .

USP . USP compounding standards [EB/OL ] .（ 2025-01-21 ）[ 2026-06-20 ] . https：//www.usp.org/compounding https://www.usp.org/compounding .

FDA . Section 503A bulks list final rule questions and answers guidance for industry [EB/OL ] .（ 2019-05-23 ）[ 2025-11-07 ] . https：//www.fda.gov/media/126110/download https://www.fda.gov/media/126110/download .

FDA . Amendments to the list of bulk drug substances that can be used to compound drug products in accordance with section 503A of the FDA [EB/OL ] .（ 2019-09-05 ）[ 2025-11-07 ] . https：//www.govinfo.gov/content/pkg/FR-2019-09-05/pdf/2019-18951.pdf https://www.govinfo.gov/content/pkg/FR-2019-09-05/pdf/2019-18951.pdf .

FDA . Drug products withdrawn or removed from the market for reasons of safety or effectiveness [EB/OL ] .（ 2018-12-11 ）[ 2025-11-07 ] . https：//www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.24 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.24 .

FDA . List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness [EB/OL ] .（ 2018-12-11 ）[ 2025-11-07 ] . https：//www.govinfo.gov/content/pkg/FR-2018-12-11/pdf/2018-26712.pdf https://www.govinfo.gov/content/pkg/FR-2018-12-11/pdf/2018-26712.pdf .

FDA . Drug products or categories of drug products that present demonstrable difficulties for compounding under sections 503A or 503B of the federal food，drug，and cosmetic act [EB/OL ] .（ 2024-03-20 ）[ 2025-11-07 ] . https：//www.govinfo.gov/content/pkg/FR-2024-03-20/pdf/2024-05801.pdf https://www.govinfo.gov/content/pkg/FR-2024-03-20/pdf/2024-05801.pdf .

FDA . Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the FDA guidance for industry [EB/OL ] .（ 2018-01-18 ）[ 2025-11-07 ] . https：//www.fda.gov/media/98973/download https://www.fda.gov/media/98973/download .

FDA . Final standard memorandum of understanding addressing certain distributions of compounded drug pro-ducts between the insert state board of pharmacy or other appropriate state agency and the US . Food and Drug Administration[EB/OL ] .（ 2020-10-27 ）[ 2025-11-07 ] . https：//www.fda.gov/media/143283/download https://www.fda.gov/media/143283/download .

FDA . Extension of the period before the Food and Drug Administration intends to begin enforcing the statutory 5 percent limit on out-of-state distribution of compounded human drug products [EB/OL ] .（ 2022-10-21 ）[ 2025-11-07 ] . https：//www.govinfo.gov/content/pkg/FR-2022-10-21/pdf/2022-22876.pdf https://www.govinfo.gov/content/pkg/FR-2022-10-21/pdf/2022-22876.pdf .

Traynor K . Compounding oversight a work in progress for states，FDA [J ] . Am J Health Syst Pharm ， 2016 ， 73 （ 7 ）： 424 - 425 .

The Pew Charitable Trusts . State oversight of drug compounding major progress since 2015，but opportunities remain to better protect patients [EB/OL ] .（ 2018-02-26 ）[ 2025-11-07 ] . https：//www.pew.org/en/research-and-analysis/reports/2018/02/state-oversight-of-drug-compounding https://www.pew.org/en/research-and-analysis/reports/2018/02/state-oversight-of-drug-compounding .

FDA . Pharmacy compounding of human drug products under section 503A of the FDA guidance [EB/OL ] .（ 2016-06-30 ）[ 2025-11-07 ] . https：//www.fda.gov/media/94393/download https://www.fda.gov/media/94393/download .

FDA . Compounding certain beta-lactam products in shortage under section 503A of the federal food，drug，and cosmetic act [EB/OL ] .（ 2022-11-30 ）[ 2025-11-07 ] . https：//www.fda.gov/media/163367/download https://www.fda.gov/media/163367/download .

FDA . Temporary policies for compounding certain parenteral drug products guidance for industry [EB/OL ] .（ 2024-10-11 ）[ 2025-11-07 ] . https：//www.fda.gov/media/182632/download https://www.fda.gov/media/182632/download .

Woerdenbag H J ， van Basten B ， Oussoren C ， et al . Extemporaneous compounding，pharmacy preparations and related product care in the Netherlands [J ] . Pharmaceutics ， 2025 ， 17 （ 8 ）： 1005 .

FDA . List of bulk drug substances that can be used to compound drug products in accordance with section 503A of the FDA [EB/OL ] .（ 2019-02-19 ）[ 2025-11-07 ] . https：//www.govinfo.gov/content/pkg/FR-2019-02-19/pdf/2019-02367.pdf https://www.govinfo.gov/content/pkg/FR-2019-02-19/pdf/2019-02367.pdf .

国家中医药管理局办公室 . 三级中医医院评审标准实施细则：2017年版 [EB/OL ] .（ 2017-09-13 ）[ 2026-06-20 ] . http：//www.natcm.gov.cn/yizhengsi/zhengcewenjian/2018-03-24/3151.html http://www.natcm.gov.cn/yizhengsi/zhengcewenjian/2018-03-24/3151.html .

全国人民代表大会常务委员会 . 中华人民共和国药品管理法 [EB/OL ] .（ 2019-08-26 ）[ 2026-06-20 ] . https：//www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html .

国家药品监督管理局 . 关于政协第十三届全国委员会第五次会议第00797号（医疗卫生类073号）提案答复的函 [EB/OL ] .（ 2022-10-21 ）[ 2025-11-07 ] . https：//www.nmpa.gov.cn/zwgk/jyta/zhxta/20221021141823192.html https://www.nmpa.gov.cn/zwgk/jyta/zhxta/20221021141823192.html .

国家药品监督管理局综合司 . 关于开展化妆品个性化服务第二阶段试点工作的通知 [EB/OL ] .（ 2025-09-16 ）[ 2026-06-20 ] . https：//www.nmpa.gov.cn/hzhp/hzhpjgdt/20250917113949126.html?type=pc&m= https://www.nmpa.gov.cn/hzhp/hzhpjgdt/20250917113949126.html?type=pc&m= .

王优杰，林晓，沈岚，等 . 中药临方制剂生产规范与质量管理体系的思考 [J ] . 中国中药杂志， 2024 ， 49 （ 3 ）： 580 - 586 .

国家市场监督管理总局 . 药品生产监督管理办法 [EB/OL ] .（ 2020-01-22 ）[ 2026-06-20 ] . http：//www.gov.cn/gongbao/content/2020/content_5515280.htm http://www.gov.cn/gongbao/content/2020/content_5515280.htm .

国家药品监督管理局 . 医疗机构制剂配制质量管理规范：试行 [EB/OL ] .（ 2001-03-13 ）[ 2026-06-20 ] . https：//www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_15d8c2f6e8444b2bb9e1efc6e17ccf21.html https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_15d8c2f6e8444b2bb9e1efc6e17ccf21.html .

卫生部 . 药品生产质量管理规范：2010年修订 [EB/OL ] .（ 2011-01-17 ）[ 2026-06-20 ] . https：//www.gov.cn/gongbao/content/2011/content_1907093.htm https://www.gov.cn/gongbao/content/2011/content_1907093.htm .

鞠晓宇，赵越，关胜江，等 . 河北省中药临方制剂开展现状与需求调查 [J ] . 中国处方药， 2022 ， 20 （ 12 ）： 75 - 78 .

广东省药学会 . 中药临方加工与合理使用专家共识 [EB/OL ] .（ 2025-07-25 ）[ 2026-06-20 ] . http：//www.sinopharmacy.com.cn/uploads/file1/20250724/6881efba49084.pdf http://www.sinopharmacy.com.cn/uploads/file1/20250724/6881efba49084.pdf .

胡志强，鲜洁晨，楚世慈，等 . 中药临方制剂技术的发展现状及研究策略 [J ] . 中国中药杂志， 2019 ， 44 （ 1 ）： 28 - 33 .

Englezos K ， Wang L X ， Tan E C K ， et al . 3D printing for personalised medicines：implications for policy and practice [J ] . Int J Pharm ， 2023 ， 635 ： 122785 .

Hussain A ， Shrewsbury R P ， Mattingly A ， et al . Compounding education in US PharmD curricula [J ] . Am J Pharm Educ ， 2023 ， 87 （ 10 ）： 100117 .

浏览量

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

我国公立医院药房改革路径探讨

信迪利单抗致免疫相关内分泌毒性的影响因素分析

急性髓系白血病患者维奈托克血浆谷浓度的影响因素及其与疗效的关系研究

基于“五级定位”理念的药品货位智能定位软件设计及管理方案实践研究

基于JAK2/STAT3、PI3K/AKT双通路研究清热安胎方改善血热型先兆流产大鼠妊娠结局的作用机制