Official Dispatch 1824/QLD-CL 2025 compliance with regulations on destruction of drugs and drug materials

Recent reports in the press and other media outlets have revealed instances in which certain manufacturers and traders have failed to properly comply with regulations on the destruction of drugs and drug materials. Specifically, drugs have been destroyed without adherence to prescribed order and procedures, by improper methods, and in a manner inconsistent with applicable regulations on drug and drug material destruction and environmental safety.

To ensure full compliance with regulations on the management of drugs and drug materials, safeguard public health, and conform with governing laws on environmental protection, the Drug Administration of Vietnam hereby advises as follows:

1. Regulations on the destruction of drugs:

1.1. Clause 6, Article 15 of Circular No. 11/2018/TT-BYT, dated …, of the Ministry of Health, which prescribes standards of drug and drug material quality, provides:

“6. Destruction of drugs:

a) The head of the establishment possessing drugs subject to destruction shall issue a decision to establish a Drug Destruction Council to organize the destruction, determine the method of destruction, and supervise the destruction process. The Council shall comprise at least 3 members, including one representative who is the person in charge of professional operations of the establishment.

b) The destruction of drugs must ensure safety for people and animals and not pollute the environment in accordance with the law on environmental protection.

The establishment possessing drugs subject to destruction shall bear full responsibility for all matters related to the destruction and shall submit a report, accompanied by the minutes of destruction, to the provincial-level Department of Health, using Form No. 06 of Appendix III to this Circular.

c) Regulations on the destruction of vaccines:

- At least 7 days prior to the destruction of vaccines, the establishment destroying vaccines shall submit a written notification of the destruction plan to the provincial-level Department of Health. Such notification must contain information on the name, quantity, concentration or content of each vaccine to be destroyed, the reason for destruction, time of destruction, place of destruction, and method of destruction. The provincial-level Departments of Health shall be responsible for supervising the destruction of vaccines.

- The procedure for vaccine destruction and the destruction itself shall comply with Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015, of the Minister of Health and the Minister of Natural Resources and Environment, on medical waste management, and Circular No. 36/2015/TT-BTNMT dated June 30, 2015, of the Minister of Natural Resources and Environment, on management of hazardous waste.

- Within 7 days from the date of completion of the vaccine destruction, the establishment shall submit a written report on the destruction of vaccines, accompanied by the minutes of destruction, to the provincial-level Department of Health and the Drug Administration of Vietnam. Such minutes shall be prepared in accordance with Form No. 06 of Appendix III to this Circular.

d) The destruction of drugs subject to special control shall be carried out in accordance with Article 48 of Decree No. 54/2017/ND-CP.”

1.2. The Government's Decree No. 54/2017/ND-CP dated May 8, 2017, as amended and supplemented in 2018, prescribes that:

a) Article 48. Provisions on destruction of drugs under special control

1. An establishment requesting destruction of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall make a written request for destruction, clearly stating the drug name, materials, concentration or content and quantity, reason for destruction, and destruction method.

2. Procedures for permitting destruction of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall be carried out as follows:

a) The requesting establishment shall submit directly or send by post its dossier to the Ministry of Health, for manufacturers, exporters and importers, or to the provincial-level Department of Health of the locality where it is headquartered, other pharmaceutical business establishments, except those specified above; or at the Military Medicine Department (the Ministry of National Defence), for establishments under the Ministry of National Defence’s management;

b) After receiving a dossier, the receiving agency shall issue the requesting establishment a dossier receipt slip made according to Form No. 01 in Appendix I to this Decree;

c) If having no request for modification or supplementation of the dossier, within 20 days after the date written on the dossier receipt slip, the dossier- receiving agency shall issue a written permission for the destruction;

d) If requesting any modification or supplementation to the dossier, within 20 days after the date written on the dossier receipt slip, the dossier-receiving agency shall issue a written request for such modification or supplementation;

dd) After the establishment submits a modified or supplemented dossier, the dossier-receiving agency shall issue the former a receipt slip of the modified or supplemented dossier according to Form No. 01 in Appendix I to this Decree. If no further modification or supplementation is required, the receiving agency shall issue a written permission for the destruction under Point c of this Clause. In case the modified or supplemented dossier remains unsatisfactory, the receiving agency shall issue a notice thereof to the establishment under Point d of this Clause.

3. Habit-forming drugs, psychotropic drugs, precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs may only be destroyed after written permission is issued by the Ministry of Health or the provincial-level Department Health of the locality where the requesting establishment is located, or the Military Medicine Department (the Ministry of National Defence).

4. Habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall be destroyed as follows:

a) The head of an establishment shall establish a Drug Destruction Council of at least 3 members, including the person in charge of professional operations of the establishment. The Council shall organize the destruction, decide on the destruction method and supervise the destruction;

b) Drugs and drug materials shall be destroyed in the presence of a representative of the provincial-level Department of Health or the Military Medicine Department (the Ministry of National Defence), and the destruction shall be recorded in writing according to Form No. 16 in Appendix II to this Decree;

c) Within 10 days after completing the destruction of drugs or drug materials, the establishment shall send to the Ministry of Health or the provincial-level Department of Health or the Military Medicine Department (the Ministry of National Defence) a report on drug destruction according to Form No. 17 in Appendix II to this Decree together with the drug destruction record.

5. Radioactive drugs and packages in direct contact with radioactive drugs which are no longer used shall be temporarily stored prior to destruction in accordance with the law on atomic energy.

6. Waste originated from radioactive drugs shall be managed in accordance with the law on atomic energy.

7. When destructing redundant or defective products containing habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drug in the manufacture process; combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors and packages in direct contact with habit-forming drugs, psychotropic drugs, precursor drugs, habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs which are no longer used, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields at drug trading establishments, establishments shall gather and destroy them under Point a, Clause 4 of this Article, and keep destruction dossiers at their establishments.”

b) Article 104. Disposal of recalled drug materials:

“1. Recalled drug materials being medicinal materials and pharmaceutical ingredients shall be destroyed in the following cases:

a) Recalled drug materials are manufactured not for human use but are labeled for human use;

b) Recalled drug materials have their certificates of free sale granted based on forged documents;

c) Recalled drug materials are of unclear origin;

d) Pharmaceutical ingredients are manufactured, presented or labeled in the name of another manufacturer, country of manufacture or country of origin;

dd) Fake medicinal materials;

e) Medicinal materials have no certificate of free sale or whose quality standards are not announced as prescribed;

g) Recalled drug materials are used for manufacturing drugs which are recommended by the World Health Organization to be unsafe and ineffective for their users.

5. Procedures for destroying drug materials:

a) The head of the establishment that has drug materials to be destroyed shall issue a decision to form a council for destruction of drug materials, which shall be composed of at least 3 (three) members including the head and the person responsible for professional pharmacy activities of the establishment;

b) The destruction of drug materials must ensure long-term safety for people and animals and not pollute the environment in accordance with the law on environmental protection;

c) The establishment that trades in violating drug materials shall bear all expenses for the destruction thereof;

d) The destruction of drug materials under special control must comply with the provisions of Article 48 of this Decree.”

2. Drug and drug material manufacturing and trading establishments are required to strictly comply with the law on destruction of drugs and drug materials and on environmental protection, specifically:

- Review internal procedures concerning the collection and segregation of drugs and drug materials that do not meet conditions for free sale (expired drugs, substandard drugs, drugs damaged during manufacturing, storage, or transportation, etc.), residual drugs, and drug packaging and drug materials;

- Carry out the destruction of drugs and drug materials in cases where the establishment has sufficient conditions to do so, or enter into contracts for destruction of drugs and drug materials with establishments specializing in waste treatment or holding a hazardous waste treatment permit in accordance with the law on environmental protection;

- Establishments possessing drugs and drug materials subject to destruction shall bear full responsibility for all matters related to the destruction of such drugs and drug materials.

3. Departments of Health of provinces and centrally-run cities are requested to disseminate and communicate the provisions of law on destruction of drugs and drug materials to establishments manufacturing, trading, and using drugs within their localities; to inspect and supervise the implementation; to handle or coordinate with relevant competent authorities in inspecting and handling violations committed by drug manufacturing, trading, and using establishments with respect to the law on destruction of drugs and drug materials and environmental protection; and to submit reports to the Drug Administration of Vietnam.

The Drug Administration of Vietnam hereby notifies relevant entities for their information and implementation./.