Controlled Drugs Act Article 4

The pharmaceutical plant of the Food and Drug Administration (hereinafter "FDA") shall handle the import, export, manufacture and selling of the Schedule 1 and 2 controlled drugs, as necessary, FDA may commission another pharmaceutical firms to manufacture it.The pharmaceutical plant referred to in the preceding Paragraph may be established as a company. The establishment of the said company shall be stipulated by law separately.Regulations concerning the qualifications, conditions, management and other matters of compliance of being the commissioned pharmaceutical firms referred to the first paragraph shall be prescribed by the central competent health authority.
中文原文 管制藥品管理條例第4條
第一級、第二級管制藥品之輸入、輸出、製造及販賣,應由衛生福利部食品藥物管理署(以下稱食品藥物署)之製藥工廠為之;必要時,其製造得由食品藥物署委託藥商為之。
前項製藥工廠得以公司方式設置;其設置另以法律定之。
第一項受託藥商之資格、條件、管理及其他應遵行事項之辦法,由中央衛生主管機關定之。

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