All compound drugs containing phenobarbital and chlordiazepoxide are to be classed as Schedule 4 controlled substances by default under new rules to be implemented as early as September, the Food and Drug Administration (FDA) announced on Saturday.
The FDA’s announcement comes after four doctors in Kaohsiung were fined and had their licenses temporarily suspended for improperly prescribing phenobarbital to patients, including children under the age of two, to treat colds and acute respiratory infections.
The decision to tighten controls for compound drugs was reached after a thorough discussion and examination of other countries’ regulations on June 27, FDA Deputy Director-General Chen Hui-fang (陳惠芳) told a news conference.
Photo courtesy of the Pingtung County Government via CNA
Although phenobarbital, an anti-seizure medication, and chlordiazepoxide, a benzodiazepine primarily prescribed for anxiety, are already classed as Schedule 4, compound drugs containing the two substances are classified separately.
Under the changes proposed by the FDA, all compound drugs containing phenobarbital or chlordiazepoxide would be classed as Schedule 4 controlled substances by default.
The changes mean institutions using substances that contain phenobarbital or chlordiazepoxide would be required to apply for a registration certificate and keep usage records, the Cabinet said in a statement on July 3.
Those wanting to use the drugs for research would have to apply for and receive approval, the Cabinet said.
Importing, exporting, manufacturing, selling or purchasing any substance containing phenobarbital or chlordiazepoxide must be in accordance with the Controlled Drugs Act (管制藥品管理條例), it added.
Chen said 17,562 businesses or institutions hold licenses for controlled pharmaceuticals nationwide, with 15 holding licenses for phenobarbital-related substances.
Among them, six licenses pertain to single-component drugs, that are all classified as Schedule 4 controlled substances and are used to treat epilepsy, she said, adding that the remaining nine licenses are for compound drugs.
In Taiwan, usual government practice involves publicly disclosing proposed new or revised regulations 60 days prior to their implementation — referred to as “the announcement period.”
During this period, stakeholders are invited to provide feedback for the consideration of the authorities.
However, Chen said that the announcement period has been shortened to 14 days, in light of the urgency of the situation.
“Considering the duration of the procedural requirements by the Ministry of Justice and other relevant authorities, which is estimated to be roughly 14 days, [we aim to implement the change] as fast as possible,” she said.
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