Enforcement Rules for the Controlled Drugs Act Article 5

The term "drugs, containing ingredients of controlled drugs, designated by physicians, pharmacists, and assistant pharmacists" as used in Article 11 of this Act shall mean drugs containing ingredients of controlled drugs that have been approved and publicly announced by the Executive Yuan in accordance with the provision of Article 3 Paragraph 2 of this Act, that also are designated drugs to physicians, pharmacists, and assistant pharmacists. However, if the ingredients of the controlled drugs fall into any to the following categories, this Article does not apply:1. The Executive Yuan has announced to the public that only the drugs in the form of raw materials are regulated.2. The level of concentration or dosage falls under the limit announced by the Central Health authority.
中文原文 管制藥品管理條例施行細則第5條
本條例第十一條所稱含管制藥品成分屬醫師、藥師、藥劑生指示藥品,指含有行政院依本條例第三條第二項規定所核定公告之各級管制藥品成分之製劑,且為醫師、藥師、藥劑生指示用藥者。
但所含管制藥品成分有下列情形之一者,不適用之:
一、行政院僅公告管制其原料藥。
二、其濃度或劑量單位在中央衛生主管機關公告之限量以下。

English translation for reference only; the Chinese text prevails. Not legal advice.