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Regulations Governing the Allocation and Purchase Limitation of Schedule 1 and 2 Controlled Drugs
1.中華民國八十九年二月十四日行政院衛生署（89）衛署管藥字第 89008 657 號令訂定發布全文 6 條；並自發布日起施行 2.中華民國九十二年一月十四日行政院衛生署衛署授管字第 092996603 號令修正發布第 2 條條文之附表 3.中華民國九十九年七月二日行政院衛生署署授食字第 0991800580 號令 修正發布全文 6 條；並自九十九年一月一日施行 中華民國一百零二年七月十九日行政院院臺規字第 1020141353 號公告 第 2 條第 2 項、第 4 條、第 5 條所列屬「行政院衛生署食品藥 物管理局」、「食品藥物局管制藥品製藥工廠」之權責事項，自一百零 二年七月二十三日起分別改由「衛生福利部食品藥物管理署」、「食品 藥物署管制藥品製藥工廠」管轄 4.中華民國一百零二年十一月八日衛生福利部部授食字第 1021850245 號 令修正發布全文 6 條；並自發布日施行 5.中華民國一百零三年六月三十日衛生福利部部授食字第 1031800418 號 令修正發布第 2 條條文之附表 6.中華民國一百零五年八月九日衛生福利部部授食字第 1051800495 號令 修正發布第 2 條條文之附表 7.中華民國一百零七年二月十三日衛生福利部衛授食字第 1071800091 號 令修正發布第 2 條條文之附表 8.中華民國一百十一年九月二十日衛生福利部衛授食字第 1111800351 號 令修正發布第 2 條條文之附表 9.中華民國一百十四年九月十一日衛生福利部衛授食字第 1141800312 號 令修正發布第 2 條條文之附表
資料來源：全國法規資料庫（ChOrder.json，版本 2026/7/24 上午 12:00:00）・政府資料開放授權
The regulations are issued in accordance with Article 22 of the Controlled Drugs Act (hereinafter "this Act").
1For medical institutions, drug stores, veterinarian institutions and pasturage veterinarian institutions, the yearly (from January 1 to December 31 of the same year) purchases of schedule 1 and 2 controlled drugs quantities shall not exceed the requirement of the attached table. If the drug inventory exceeds half the annual quota, the purchase quantity shall be restricted.
2The institutions in the preceding Paragraph, if the actual requirement exceeds the quota listed in the attached table, may submit controlled drugs quota increase application form and relevant data and apply to the Food and Drug Administration, Ministry of Health and Welfare (hereinafter "FDA"). After approval, the annual quota will follow the new approved quota.Attached table Quota of yearly purchases of schedule 1 and 2 controlled drugs table.pdf
For research laboratories, the purchases of schedule 1 and 2 controlled drugs shall follow Article 6 of this Act approved medicine education and research experiment program required quantity restriction.
1For 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.
2If 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.
The total quantities of schedule 1 and 2 controlled drugs for basic military medical units, shall be estimated annually (from January 1 to December 31 of the same year) by the military medical control organization. After the application to the FDA is approved, the purchases shall be in batches and made to the controlled drugs pharmaceutical plant of the FDA.
The regulations shall come into force from the date of their promulgation.