Pharmaceutical Good Manufacturing Practice Regulations Article 53
Chinese herbal medicine factories shall properly identify and separately store returned products. If there are any doubts regarding a product’s safety, ingredients, contents, quality or purity due to storage or shipping conditions, the condition of the product, container, packaging or labeling, or any other relevant circumstances either before or after the product is returned, unless the product’s safety, ingredients, contents, quality and purity are confirmed to be in compliance with established specifications through testing or investigation, aforesaid product shall be destroyed. However, where aforesaid product can be brought into compliance with established specifications through remanufacturing, remanufacturing may be carried out.
中文原文 藥物優良製造準則第53條
中藥廠對於退回之產品，應予鑑識並分別儲存。
藥廠如因退回前或退回過程之儲存、運送條件，或因產品、容器、包裝、標示或其他狀況，致對產品之安全性、成分、含量、品質或純度發生疑慮時，非經檢驗或調查確定其符合既定之規格者，該產品應予銷毀。
前項應銷毀之產品，如經再製後能符合既定規格，得同意其進行再製。
藥廠如因退回前或退回過程之儲存、運送條件，或因產品、容器、包裝、標示或其他狀況，致對產品之安全性、成分、含量、品質或純度發生疑慮時，非經檢驗或調查確定其符合既定之規格者，該產品應予銷毀。
前項應銷毀之產品，如經再製後能符合既定規格，得同意其進行再製。