Regulations on Good Practices for Drug Dispensation Article 28
A medical institution or pharmacy shall perform compounding with pharmaceutical preparations manufactured or imported upon approval by the central competent health authority.For the compounding as described in the preceding Paragraph, as long as it meets the following requirements announced by the central competent health authority, the source of compounded drug may not be limited to the pharmaceutical preparations:1. Name of the compounded drug.2. Name, content and quality specifications of the active ingredients.3. Specifications for compounding personnel and the environment.For those not compounded with pharmaceutical preparations as described in the preceding Paragraph, the medical institution or pharmacy shall report the quantity of each compounded item to the central competent health authority each year.
中文原文 藥品優良調劑作業準則第28條
醫療機構或藥局調製藥品，應使用經中央衛生主管機關核准製造或輸入之製劑為之。
前項調製，符合中央衛生主管機關公告之下列事項者，其調製來源，得不以製劑為限：
一、調製藥品之名稱。
二、有效成分之名稱、含量及品質規範。
三、調製人員及環境規範。
前項不以製劑調製者，醫療機構或藥局，每年應向中央衛生主管機關申報各品項之調製數量。
前項調製，符合中央衛生主管機關公告之下列事項者，其調製來源，得不以製劑為限：
一、調製藥品之名稱。
二、有效成分之名稱、含量及品質規範。
三、調製人員及環境規範。
前項不以製劑調製者，醫療機構或藥局，每年應向中央衛生主管機關申報各品項之調製數量。