Regulations on Good Practices for Drug Dispensation Article 27
No drug compounded by a medical institution or pharmacy shall have the same active ingredients, contents and dosage form as any licensed pharmaceutical preparation.However, under any of the following circumstances, the foregoing limitation shall not apply as long as it is determined as necessary by any physician through clinical assessment:1. Where the drug is announced in shortage by the central competent health authority, and compounding thereof is suggested.2. Where the drug has the same active ingredients, contents and dosage form as any licensed pharmaceutical preparation which does not contain any preservatives.3. Where positron emission tomography drugs are compounded by a medical institution in accordance with the Regulations on Good Practices for Positron Emission Tomography Drug Dispensation.
中文原文 藥品優良調劑作業準則第27條
醫療機構或藥局調製藥品之品項，不得與領有藥品許可證之製劑具相同有效成分、含量及劑型。
但有下列情形之一，並經醫師臨床評估有必要者，不在此限：
一、經中央衛生主管機關公告短缺，且建議調製。
二、與領有藥品許可證之製劑具相同有效成分、含量及劑型，而不含防腐劑。
三、依斷層掃描用正子放射同位素優良調劑作業準則，由醫療機構調製之斷層掃描用正子放射同位素。
但有下列情形之一，並經醫師臨床評估有必要者，不在此限：
一、經中央衛生主管機關公告短缺，且建議調製。
二、與領有藥品許可證之製劑具相同有效成分、含量及劑型，而不含防腐劑。
三、依斷層掃描用正子放射同位素優良調劑作業準則，由醫療機構調製之斷層掃描用正子放射同位素。