The Ministry of Health has issued Circular No. 30/2025/TT-BYT, providing guidance on the application of quality standards, testing of drugs and drug ingredients, and the recall and handling of non-compliant drugs.
The circular stipulates that drug destruction shall be conducted in the following cases such as expired drugs, drugs damaged during production, storage, or transportation, sample drugs that have exceeded the designated storage period. Moreover, the circular also includes drugs recalled due to Level 1 or Level 2 violations, counterfeit drugs, smuggled drugs, drugs of unknown origin, or drugs containing prohibited substances. In addition, drugs manufactured from raw materials that fail to meet quality standards, except where the non-compliant parameters are addressed during production without impacting the production process or drug quality will also be destroyed as per the Ministry's circular.
The Ministry of Health has clarified that the disposal of drugs at manufacturing, importing, and wholesaling facilities, as well as drug testing centers, hospitals, and inpatient institutions, occurs when the head of the facility decides to form a drug destruction council. This council is responsible for organizing the drug disposal process, determining the method of destruction, and overseeing the actual destruction of the drugs. The council must consist of at least three members, including one representative who is the professional responsible for the establishment.
The drug disposal process must prioritize safety for individuals and animals, while also preventing environmental pollution, in accordance with the legal requirements for environmental protection.
The establishment that is responsible for the drug disposal must take full accountability for the destruction process and is required to submit a report including the minutes of the drug destruction to local health departments for safe disposal of unwanted and unusable drugs.
The Ministry of Health mandates that drug destruction at retail establishments, clinics, and medical facilities must be conducted under a contract with an authorized industrial waste treatment facility. The individual responsible for the professional operations of the retail establishment, or heads of clinics or medical treatment facilities are accountable for overseeing the drug destruction process, supervising the destruction activities, and maintaining records related to drug destruction.
