Regulations on Good Practices for Drug Dispensation Article 36

A medical institution or pharmacy that performs sterile compounding shall apply for approval from the central competent health authority before practice. However, this provision shall not apply to those hospitals that have qualified for the accreditation in accordance with the Medical Care Act.
中文原文 藥品優良調劑作業準則第36條
醫療機構或藥局執行無菌調製,應申請中央衛生主管機關核准後,始得為之。
但依醫療法規定評鑑合格之醫院,不在此限。

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