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Chapter Law Content

Title: Controlled Drugs Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Attachment:
Chapter IV: Control
Article 26
A person who has obtained a controlled drugs registration license shall apply for the local competent health authority’s approval to destroy controlled drugs. Such destruction shall be in the presence of that the local competent health authority.
The residue of the controlled drugs from the dispensing and administering of a registrant shall be destroyed by its manager and related people, and records kept for future reference.
Article 27
Upon the loss of controlled drugs, the responsible manager shall immediately report the loss to the local competent health authority for inspection, and submit relevant documents from the local competent health authority to the FDA within 7 days. When all or part of the lost controlled drugs is seized, the same procedures shall be followed.
If the loss of controlled drugs referred to in the preceding Paragraph, includes loss due to mislaying, theft and other criminal cases, the reporting party shall enclose the documents of the report of the loss to the local police agencies.
Article 28
A person who has obtained a controlled drugs registration license shall maintain records at their business department. Said records shall include the daily increase and decrease of stocks, destruction, loss and inventory of controlled drugs.
The records mentioned in the proceeding Paragraph shall follow the regulations of the central competent health authority concerning both methods and timeliness. Periodical reports shall be made to the local competent health authority and the FDA.
Article 29
A person who has obtained a controlled drugs registration license shall follow the following procedures in the event of having their practice license, drug company permission license, registration license or other authorizing documents revoked, cancelled or suspended:
1. Report the increase and decrease of stocks, destruction loss and inventory to the local competent health authority and the FDA within 15 days of the start of the revocation, cancellation or suspension.
2. Books, receipts and special prescription forms for controlled drugs shall be kept by the original persons in charge.
3. The inventory of controlled drugs of a person whose license is revoked, canceled, shall be transferred to other registrants within 60 days of the reporting date prescribed in Subparagraph 1. A report shall then be made to the local competent health authority and the FDA for their inspection. In the alternative, a report shall be made to the local competent health authority, and after the controlled drugs are destroyed with the presence of the local competent health authority, a report shall be made to the FDA for inspection.
4. Registrants who are suspended shall handle the inventory in accordance with the preceding Paragraph or retained by themselves.
Article 30
Upon an application to permanent or temporary suspend their business related to controlled drugs, a registrant shall follow these procedures:
1. Report the increase and decrease of stocks, destruction, loss and inventory to the local competent health authority and the FDA.
2. A registrant applying to permanently suspend business shall transfer the inventory of controlled drugs to other registrants, and report to the local competent health authority for that agency’s inspection, or in the alternative destroy the inventory of controlled drugs and file a report of such action with the local competent health authority for their inspection prior to the suspension of the business.
3. A registrant applying for temporary suspension shall handle the inventory according to the preceding Subparagraph or retain the stock of controlled drugs in their safekeeping.
Upon permission for permanent or temporary suspension of business or upon the acceptance of the application referred to in Subparagraph 1 of the preceding Paragraph, the local competent health authority shall submit to the FDA a report and notification as soon as possible.
Article 31
Schedule 1 and 2 controlled drugs shall not be lent and transferred. However, transfer as prescribed by the preceding two Articles shall be permitted.
Article 32
The books, receipts and special prescription forms for controlled drugs required by this Act shall be retained for 5 years.
Article 33
The competent health authorities and the FDA may inspect and oversee the import, export, manufacture, selling, purchasing, administering, dispensing, and management of controlled drugs. Upon a showing of proper documentation the inspectors may sampling for testing. Said samples shall be limited to the amount of controlled drug needed for examination.
Article 34
All government bodies and related agencies shall set aside a budget for publicizing the danger of abusing controlled drugs and information concerning relevant laws. Government agencies may request the assistance from public welfare groups in these endeavors.
The competent health authorities of all levels or medical institutions, mental rehabilitation institutions, or relevant welfare groups appointed by the central competent health authority may establish consulting groups aimed at the prevention and cure of drug addiction.
Article 34-1
The central competent health authority, to monitor and regulate drug misuse and to conduct early warning public education, should set up monitoring and early warning reporting systems, and reward medical and other related organizations, groups and personnel that report drug misuse cases; regulations about the subjects to report to, reporting content and procedures and related rewarding measures are set up by the central competent health authority.
Article 35
The competent health authorities of all levels, and medical institutions and mental rehabilitation institutions appointed by the central competent health authority may as needed assign special personnel in consulting services for drug addiction prevention and cure.
Article 36
The central competent health authority may, upon consideration of the situation, suspend physicians, dentists, pharmacists, assistant pharmacists, veterinarians, assistant veterinarians, who violate this Act. Said suspensions may involve both fine and suspension of the authority to write prescriptions, administering or dispensing controlled drugs. Said punishments may extend from 6 months to 2 years starting from the date of penalty assessment. A person who is prosecuted for violating the Statue for Narcotics Hazard Control shall be suspended from writing prescription, administering or dispensing controlled drugs from the start of prosecution. If acquitted, the person may apply for restoration of rights.