美國醫院藥局調製相關規範

Regulations of the Hospital Pharmacy Compounding in the United States

林書巧(Shu-Chiao Lin) ； 楊秀琍(Hsiu-Li Yang) ； 吳以安(Yi-An Wu) ； 林慧玲(Fe-Lin Lin) ； 沈麗娟(Li-Jiuan Shen) ； 王春玉(Chun-Yu Wang) ； 王雪如(Hseuh-Ju Wang)

《臺灣臨床藥學雜誌》 23卷3期 (2015/09) Pp. 181-187

https://doi.org/10.6168/FJCP.2015.2303.03

摘要

當部分特殊病人群所需的藥品沒有市售品可供使用時，即需藉由藥師的調製來滿足臨床醫療需求，因此藥局調製藥品至今仍是不可或缺的。然而，調製藥品是藥局作業中風險最高的活動之一。在美國，人用藥品之調製除需遵守聯邦食品、藥品和化妝品法案第503A節規範外，也要依循美國藥典無菌製劑及非無菌製劑準則辦理。我們希望藉由美國對人用藥品調製法規與聯邦法中藥局調製諮議委員會職權等相關重要法規的回顧，以及對美國藥典無菌製劑及非無菌製劑規範的整理，了解訂定這些法案及規範的精神，進而歸納出我國藥局調製規範的制訂方向。

關鍵字

藥局調製藥品 ； 美國調製規範 ； 調製諮議委員會

並列摘要

When commercial products could not fulfill the clinical needs of some special patients, it is necessary for pharmacists to take the practice of compounding. Pharmacy compounding is still an important activity in the modern health care system. However, pharmaceutical compounding is one of the highest risk activities among pharmacy practice. In the United States, pharmacy compounding of human drug products not only has to comply with the regulations in section 503A of the Federal Food, Drug, and Cosmetic Act, but also needs to follow the sterile preparations and non-sterile preparations guidelines in the U.S. Pharmacopeia (USP). By reviewing the regulations of pharmacy compounding in the U.S. code and the standing of pharmacy compounding advisory committee in the Code of Federal Register, along with coordinating the general chapters of pharmaceutical compounding in the USP, we strive to find out the spirit of these Acts and regulations, and aim to develop the regulations of pharmacy compounding in Taiwan.

並列關鍵字

Pharmacy Compounding ； U.S. Regulations ； Advisory Committee