Regulations Governing the Allocation and Purchase Limitation of Schedule 1 and 2 Controlled Drugs Article 4
For human medicine manufacturers and veterinary medicine manufacturers, the purchase of schedule 1 and 2 controlled drugs in the form of raw material drug to produce drugs containing controlled drug component, they shall fill out application form. The purchased quantities are limited by the production plan required raw material drug quantities. If the raw material drugs inventory exceeds 50% of the previous purchased quantity, the FDA may limit its purchase quantity.If the above-mentioned applications for drugs in the form of raw material drugs are to produce schedule 3 and 4 controlled drugs, it shall follow Article 20 of this Act to apply for controlled drug production agreement form. If they are used to produce non-controlled drug, it shall be reported monthly, in accordance to the final retail sales objects' data of that drug, to the FDA and local health administration at each sales locality.
中文原文 第一級第二級管制藥品限量核配辦法第4條
西藥製造業及動物用藥品製造業購買第一級、第二級管制藥品原料藥用以製造含管制藥品成分之製劑者，應填具申請書，其每次可購數量依核定之生產計畫需用原料藥品量為限。
但其原料藥之結存量逾前次購藥量一半以上者，食品藥物署得限制其購藥量。
前項業者申購之原料藥係用以產製第三級、第四級管制藥品製劑者，應依本條例第二十條規定，申請核發管制藥品製造同意書；如係用以產製非屬管制藥品製劑者，應按月列報該製劑之最終零售銷售對象資料予食品藥物署及各銷售地衛生主管機關。
但其原料藥之結存量逾前次購藥量一半以上者，食品藥物署得限制其購藥量。
前項業者申購之原料藥係用以產製第三級、第四級管制藥品製劑者，應依本條例第二十條規定，申請核發管制藥品製造同意書；如係用以產製非屬管制藥品製劑者，應按月列報該製劑之最終零售銷售對象資料予食品藥物署及各銷售地衛生主管機關。