Chapter II: Administering and Dispensing of Controlled Drugs
Article 5
Controlled drugs may not be administered by other than physicians, dentists, veterinarians, assistant veterinarians, or approved medical or educational researchers.
Assistant veterinarians’ use of controlled drugs is limited by Article 16 Paragraph 2 of the Veterinarian Law.
Article 6
Physicians, dentists, veterinarians, or assistant veterinarians may not use controlled drug for illegitimate medical purposes.
Medical or educational researchers may not use controlled drugs on research projects without the central competent health authority’s approval.
Article 7
Physicians, dentists, veterinarians, or assistant veterinarians may not administer Schedule 1, 2 or 3 controlled drugs or write special prescription form for controlled drugs without the controlled drugs prescription license for the use of controlled drugs issued by the FDA.
Any changes in the registered items of the controlled drugs prescription license mentioned in the preceding Paragraph shall be reported to the FDA for the record of the changes within 15 days after the day of the changes made.
If the controlled drugs prescription license was lost or damaged, a new one could be obtained by submitting an application to the FDA.
Regulations governing the issuance, alteration of registration, re-issuance, replacement, and management of the controlled drugs prescription license shall be prescribed by the central competent health authority.
Article 8
Physicians and dentists administering Schedule 1, 2 or 3 controlled drugs shall utilize approved special prescription form.
Veterinarians and assistant veterinarians administering controlled drugs shall record in the medical records: the names and addresses of the parties responsible for the animal(s), the species and weight of the animal(s), the treatment dates, symptoms, diagnosis, and the treatment plan. In addition the names, dosage(s) and usage of the prescribed controlled drugs shall be recorded.
The specific scope of controlled drugs used in Paragraph 1 and the format and contents of the special prescription form shall be set forth and announced to the public by the central competent health authority and published in the Government Gazette.
Article 9
Only physicians, dentists, pharmacists or assistant pharmacists may dispense controlled drugs.
Assistant pharmacists may dispense controlled drugs, but not including said drugs containing narcotic drugs.
Physicians and dentists shall dispense controlled drugs according to the regulations set by Article 102 of the Act of Pharmaceutical Affairs.
Article 10
Physicians, dentists, pharmacists, and assistant pharmacists may not dispense Schedule 1, 2 and 3 controlled drugs without utilizing the special prescription form for controlled drugs signed by a physician or dentist.
The controlled drugs administered per the above Paragraph shall only be received to persons upon a showing of that person’s identity card and upon the person’s signature.
The special prescription for Schedule 1 and 2 controlled drugs shall not be refilled.
Article 11
When supplying drugs, containing ingredients of controlled drugs, designate only by physicians, pharmacists and assistant pharmacists, the supplier shall maintain a detailed record of the names, addresses of the receivers, the amount received, and the date of receipt. Transfers recorded in medical records by medical institutions are exempt from this requirement.
Article 12
Without the approval of the central competent health authority, medical institutions may not use Schedule 1 and 2 controlled drugs for the treatment of addiction to controlled drugs (hereinafter “drug addiction”).
Article 13
The FDA may use the drugs confiscated by judiciary agencies or the seizure authorities for the purposes of medical and scientific research.