Pharmaceutical Affairs Act Article 21
The term “substandard drugs” as used in this Act shall refer to the approved drugs that are found to fall within any of the following circumstances after inspection or testing:1. The drugs that add non-statutory coloring agents, preservatives, aromatics, flavoring agents, and excipients without prior approval;2. The quality, quantity, or potency of the active ingredients contained in the drugs are inconsistent with those previously approved;3. The whole or part of the drugs contain filthy or peculiar objects;4. The drugs apparently demonstrate color change, turbidity, precipitation, hydrolysis, or have decomposed due to corrosion;5. The main therapeutic efficacy of the drugs is inconsistent with that previously approved;6. The duration of validity or expiration date of the drugs has expired;7. The drugs have deteriorated as a result of overtime storage or improper methods of storage;8. The drugs are kept in containers made of deleterious substances or in recycled containers.
中文原文 藥事法第21條
本法所稱劣藥，係指核准之藥品經稽查或檢驗有左列情形之一者：
一、擅自添加非法定著色劑、防腐劑、香料、矯味劑及賦形劑者。
二、所含有效成分之質、量或強度，與核准不符者。
三、藥品中一部或全部含有污穢或異物者。
四、有顯明變色、混濁、沈澱、潮解或已腐化分解者。
五、主治效能與核准不符者。
六、超過有效期間或保存期限者。
七、因儲藏過久或儲藏方法不當而變質者。
八、裝入有害物質所製成之容器或使用回收容器者。
一、擅自添加非法定著色劑、防腐劑、香料、矯味劑及賦形劑者。
二、所含有效成分之質、量或強度，與核准不符者。
三、藥品中一部或全部含有污穢或異物者。
四、有顯明變色、混濁、沈澱、潮解或已腐化分解者。
五、主治效能與核准不符者。
六、超過有效期間或保存期限者。
七、因儲藏過久或儲藏方法不當而變質者。
八、裝入有害物質所製成之容器或使用回收容器者。