Regulatory policy analysis of pharmacy compounding drug products in the United States and its implications
- VernacularTitle:美国药房临方配制制剂监管政策分析及启示
- Author:
Haijian LI
1
;
Anqi DENG
2
;
Qing GUO
1
;
Wei LIU
2
Author Information
1. Henan Center for Drug Evaluation and Inspection （Henan Center for Vaccine Inspection），Zhengzhou 450008，China
2. School of Pharmaceutical Sciences，Zhengzhou University，Zhengzhou 450001，China
- Publication Type:Journal Article
- Keywords:
compounding drug products;
traditional Chinese medicine compounding drug products;
regulatory policy;
pharmacy
- From:
China Pharmacy
2026;37(14):1819-1825
- CountryChina
- Language:Chinese
-
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under Section 503A， covering prescription management， active pharmaceutical ingredient management， list management of withdrawn or removed drugs and drugs that present demonstrable difficulties for compounding， recordkeeping management， interstate distribution and so on.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.
