Thông tư 20/2017/TT-BYT

CIRCULAR

ELABORATING SOME ARTICLES ON CONTROLLED DRUGS AND MEDICINAL INGREDIENTS OF THE LAW ON PHARMACY AND THE GOVERNMENT'S DECREE NO. 54/2017/ND-CP

Pursuant to the Law No. 105/2016/QH13 on Pharmacy dated April 06, 2016;

Pursuant to the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 elaborating the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”);

Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Drug administration of Vietnam,

The Minister of Health promulgates a Circular to elaborate some Articles on drugs and medicinal ingredients subject to special control of the Law on Pharmacy and the Government's Decree No. 54/2017/ND-CP.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for:

1. Lists of drugs and medicinal ingredients subject to special control, including:

a) The List of narcotic active ingredients in Appendix I hereof; maximum permissible concentrations of narcotic active ingredients in combined drugs in Appendix IV hereof;

b) The List of psychotropic active ingredients in Appendix II hereof; maximum permissible concentrations of psychotropic active ingredients in combined drugs in Appendix V hereof;

c) The List of drug precursors in Appendix III hereof; maximum permissible concentrations of drug precursors in combined drugs in Appendix VI hereof;

d) The List of drugs and active ingredients banned from certain fields in Appendix VII hereof.

2. Storage, production, concoction, dispensing, use, destruction, delivery, transport, reporting of drugs and medicinal ingredients subject to special control.

3. Supply of radiopharmaceuticals.

4. Documents about drugs and medicinal ingredients subject to special control, and retention thereof.

Article 2. Regulated entities

1. Regulations of this Circular on lists of controlled drugs and medicinal ingredients, documents about controlled drugs/medicinal ingredients apply to all pharmacy business establishments and the entities specified in Clause 2 of this Article.

2. Regulations of this Circular on storage, production, concoction, dispensing, use, destruction, delivery, transport, reporting of controlled drugs and medicinal ingredients only apply to the following entities:

a) Health facilities;

b) Rehabilitation centers;

c) Pharmacy research and training institutions;

d) Organizations having non-commercial pharmacy-related activities.

3. Regulations of this Circular on supply of radiopharmaceuticals only apply to health facilities that produce radiopharmaceuticals.

Article 3. Classification of controlled drugs

1. Narcotic drugs include:

a) Any drug that contains one or some narcotic active ingredients; any drug that contains both active ingredients and psychotropic active ingredients regardless of availability of drug precursors specified in Appendices I, II, III hereof.

b) Any drug that contains active ingredients (regardless of availability of psychotropic active ingredients or drug precursors) combined with active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors where the concentration of the narcotic active ingredient exceeds the limits specified in Appendix IV hereof.

2. Psychotropic drugs include:

a) Any drug that contains one or some psychotropic active ingredients; any drug that contains both psychotropic active ingredients and drug precursors specified in Appendices II and III hereof.

b) Any drug that contains psychotropic active ingredients (regardless of availability of narcotic active ingredients or drug precursors) combined with active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors where the concentration of the narcotic active ingredient (if any) does not exceed the limits specified in Appendix IV hereof.

3. Precursor drugs include:

a) Any drug that contains one or some drug precursors specified in Appendix III hereof;

b) Any drug that contains drug precursors (regardless of availability of narcotic active ingredients or psychotropic active ingredients) combined with active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors with where the concentration of the drug precursor exceeds the limits specified in Appendix VI hereof, the concentration of the narcotic active ingredient (if any) does not exceed the limits specified in Appendix IV hereof and the concentration of the psychotropic active ingredient (if any) does not exceed the limits specified in Appendix V hereof.

4. A combined drug that contains narcotic active ingredients is a drug that:

b) contains narcotic active ingredients or both narcotic active ingredients and psychotropic active ingredients, regardless of availability of drug precursors, where the concentrations of the narcotic active ingredients, psychotropic active ingredients and drug precursors do not exceed the limits specified in Appendix IV, V and VI hereof; and

b) contains active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors.

5. A combined drug that contains psychotropic active ingredients is a drug that:

a) contains psychotropic active ingredients or both psychotropic active ingredients and drug precursors where the concentrations of psychotropic active ingredients and drug precursors do not exceed the limits specified in Appendix V and VI hereof; and

b) contains active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors.

6. A combined drug that contains precursors is a drug that:

a) contains drug precursors where the concentrations of drug precursors do not exceed the limits specified in Appendix VI hereof; and

b) contains active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors.

7. Drugs and active ingredients banned from certain fields:

Drugs and active ingredients banned from certain fields are identified according to the criteria specified in Clause 2 Article 41 of Decree No. 54/2017/ND-CP.

Chapter II

STORAGE, PRODUCTION, CONCOCTION, DISPENSING, USE, DESTRUCTION, DELIVERY, TRANSPORT, REPORTING OF CONTROLLED DRUGS AND MEDICINAL INGREDIENTS

Article 4. Storage

1. Health facilities, rehabilitation centers, pharmacy research or training institutions, organizations having non-commercial pharmacy-related activities shall comply with Good Storage Practice standards. To be specific:

a) Narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors must be stored in separated and locked warehouses or cabinet. If separate warehouses or cabinets are not available, narcotic drugs may be stored in the same cabinet as psychotropic drugs and precursor drugs but they must be marked and separated from each other; Psychotropic drugs of a local medical station must be stored in locked cabinet and monitored by a specific person;

b) Combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors must be stored in a separate area;

c) Radiopharmaceuticals must be stored in a locked warehouse or cabinet which ensures radiation safety, prevention of environmental radiation exposure in accordance with atomic energy laws;

d) Toxic drugs and toxic medicinal ingredients must be stored in a separate area and arranged to avoid confusion;

dd) Narcotic drugs, psychotropic drugs, precursor drugs in the emergency drug cabinet must be placed in a separate slot and dispensed by the nurse on watch according to prescriptions. The emergency drug cabinet must be safely locked; The quantities and categories of controlled drugs therein shall be specified in writing by the head of the facility. When changing shift, the person working the previous shift must inform the person working the next shift of the quantities of drugs and the drug logbook, which has to bear their signatures.

2. The drug manager's qualifications must be suitable for the controlled drugs under his/her management. To be specific:

a) Regarding narcotic drugs and narcotic active ingredients, the manager of the hospital pharmacy shall have a bachelor’s degree in pharmacy or a higher degree, the managers of other facilities specified in Clause 2 Article 2 of this Circular shall have an associate degree in pharmacy or a higher degree;

b) Regarding psychotropic drugs, precursor drugs, medicinal ingredients that are psychotropic active ingredients and drug precursors, the manager shall have an associate degree in pharmacy or a higher degree.

If no one in a local medical station has the required qualification, the head of the medical station shall assign, in writing, a person who has a medical assistant qualification or higher;

c) Regarding radiopharmaceuticals, the manager shall have at least an associate degree in pharmacy or a higher degree, or be a physician, technician or nurse who has been trained in radiation safety and assigned in writing by the head of the facility.

Article 5. Production and concoction

The production and concoction of controlled drugs, including radiopharmaceuticals, shall comply with Circular No. 22/2011/TT-BYT dated June 10, 2011 of the Minister of Health on organization and operation of hospital pharmacies.

Article 6. Dispensing, use and destruction

1. In health facilities other than facilities providing opium replacement therapy, controlled drugs shall be dispensed and used in accordance with Circular No. 23/2011/TT-BYT dated June 10, 2011 of the Minister of Health (hereinafter referred to as “Circular No. 23/2011/TT-BYT").

2. In rehabilitation centers and facilities providing opium replacement therapy:

a) The treating and diagnosing departments shall complete the medication request form (MRF) according to the specimen No. 1 enclosed with Circular No. 23/2011/TT-BYT;

b) The dispensary shall dispend drugs to treating and diagnosing departments according to the MRFs, log the quantities of dispensed, received and remaining narcotic drugs, psychotropic drugs and precursor drugs according to the specimen in Appendix VIII hereof;

c) After receiving the drugs, the persons in charge of the treating and diagnosing departments shall check the drug names, concentrations, expiry dates and quantities before and after administering or give the drugs to the patients;

d) Unused narcotic drugs, psychotropic drugs and precursor drugs shall be returned to the dispensary. Such return must be recorded in writing. The dispensary manager shall decide whether to reuse or destroy the drugs, prepare and retain a record;

dd) The dispensary manager shall have at least an associate degree in pharmacy and be assigned in writing the be head of the facility to sign the MRFs;

e) The managers or deputy managers, if authorized in writing by the managers, of treating departments and diagnosing departments shall sign the MRFs.

3. A health facility, rehabilitation center, pharmacy research or training institution or an organization having non-commercial pharmacy-related activities, before buying narcotic drugs, psychotropic drugs, precursor drugs, combined drugs that contain precursors, shall prepare an application for supply of drugs in accordance with Article 53 of Decree No. 54/2017/ND-CP and send it to Department of Health of the same province, provided an auction is not mandatory.

4. A health facility, rehabilitation center, pharmacy research or training institution or an organization having non-commercial pharmacy-related activities, may only destroy narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors, and radiopharmaceuticals after a written consent is issued by the Department of Health of the same province according to Article 48 of Decree No. 54/2017/ND-CP

Article 7. Delivery and transport

1. Requirements to be satisfied by the deliverer of controlled drugs and medicinal ingredients:

a) Facilities participating in the delivery of radiopharmaceuticals shall have the license to do radiological works; the persons who send, deliver and receipt radiopharmaceuticals shall have the certificate of training in radiation safety in accordance with regulations of the Ministry of Science and Technology;

b) The deliverer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors must bring the assignment letter of the head of the facility, identification paper, the sale invoice or delivery note.

2. Requirements for delivery of controlled drugs and medicinal ingredients:

a) A delivery record made according to the specimen in Appendix IX hereof must be prepared when delivering narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors;

b) The deliverer and the recipient shall check the name, ingredients, concentrations, quantity, batch number, expiry date and quality of the drug or medicinal ingredient, and sign the delivery note;

a) It is required to ensure security during the transport of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors.

Article 8. Reporting

1. Periodic reports:

a) Before January 15, every health facility, rehabilitation center, pharmacy research or training institution and organization having non-commercial pharmacy-related activities shall prepare a report on sale, purchase, inventory and use of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors to the Department of Health of the same province according to the specimen in Appendix X hereof;

b) Before February 15, the Department of Health of each province shall submit a report on use of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors by the facilities in their province to the Ministry of Health according to the specimen in Appendix XI hereof.

2. Unscheduled reports:

Within 48 hours from the discovery of a mistake or loss of a narcotic drug, psychotropic drug, precursor drug or a medicinal ingredient that is a narcotic active ingredient, psychotropic active ingredient or drug precursor, the facility shall submit a report to the Ministry of Health according to the specimen in Appendix XII hereof.

3. The reports mentioned in Clause 1 and Clause 2 of this Article shall be submitted only as soon as the management system of the Ministry of Health is available.

Chapter III

SUPPLY OF RADIOPHARMACEUTICALS

Article 9. Supply of radiopharmaceuticals

A health facility permitted to produce radiopharmaceuticals may supply radiopharmaceuticals for other health facilities if the following requirements are satisfied:

1. The quantity of radiopharmaceuticals produced exceeds the demand of the producing facility.

2. The Ministry of Health (Drug Administration of Vietnam) has issued a written consent.

Article 10. Composition of the application for permission to supply radiopharmaceuticals

1. An application form in Appendix XIII hereof.

2. A report on production and use of radiopharmaceuticals to be supplied, including information about productivity, production, quantity of patients, quantity of unused drugs according to the specimen in Appendix XIV hereof (the report must bear the seal of the applying facility).

Article 11. Procedures for granting permission to supply radiopharmaceuticals

1. 01 application shall be submitted to Drug Administration of Vietnam in person or by post.

2. After receiving the application, Drug Administration of Vietnam shall give the applicant a confirmation of application receipt according to the specimen in Appendix XV hereof.

3. If the application is satisfactory, Drug Administration of Vietnam shall issue a written permission for supply of radiopharmaceuticals within 15 days from the date written on the confirmation of application receipt. If the application is not satisfactory, Drug Administration of Vietnam shall request the applicant to complete it.

4. After the applicant submits the supplemented application, Drug Administration of Vietnam shall give the applicant a confirmation of application receipt according to the specimen in Appendix XV hereof.

a) If the supplemented application is still unsatisfactory, Drug Administration of Vietnam shall inform the applicant in writing according to Clause 3 of this Article;

b) If the supplemented application is satisfactory, Drug Administration of Vietnam shall issue a written permission for supply of radiopharmaceuticals according to Clause 3 of this Article.

5. The applicant shall submit the supplemented application within 60 days from the day on which the receiving authority sends a request. If the applicant fails to submit a supplemented application or the satisfactory application is not submitted within 90 days from the day on which the first application is submitted, it will be invalidated.

Chapter IV

RETENTION OF DOCUMENTS ABOUT CONTROLLED DRUGS AND MEDICINAL INGREDIENTS

Article 12. Documents prepared by manufacturers

1. A manufacturer of narcotic drugs, psychotropic drugs, precursor drugs or medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall prepare the following documents:

a) Records of production of the narcotic drugs, procedures and precursor drugs according to the specimen in Appendix XVI hereof;

b) Records of sale, purchase, inventory of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors according to the specimen in Appendix VIII hereof;

c) Notes of delivery of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors according to the specimen in Appendix XVII hereof;

d) Documents about sale and purchase of narcotic drugs, psychotropic drugs, precursor drugs or medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors.

2. A manufacturer of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients or active ingredients on the list of drugs and active ingredients banned from certain fields shall prepare the following documents:

a) Records of sale, purchase and inventory of drugs according to the specimen in Appendix XVIII hereof;

b) Notes of delivery of medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors according to the specimen in Appendix XVII hereof;

c) Documents about sale and purchase of medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors, combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients and active ingredients on the list of drugs and active ingredients banned from certain fields.

3. A manufacturer of radiopharmaceuticals shall prepare the following documents:

a) Records of production of radiopharmaceuticals according to the specimen in Appendix XIX hereof;

b) Records of sale, purchase and inventory of radiopharmaceuticals according to the specimen in Appendix VIII hereof;

c) Notes of deliver of radiopharmaceuticals according to the specimen in Appendix XVII hereof;

d) Documents about sale and purchase of radiopharmaceuticals.

Article 13. Documents prepared by exporters and importers

1. An exporter or importer of narcotic drugs, psychotropic drugs, precursor drugs or medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall prepare the following documents:

a) Records of sale, purchase, inventory of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors according to the specimen in Appendix VIII hereof;

b) Notes of delivery of narcotic drugs, psychotropic drugs and precursor drugs according to the specimen in Appendix XVII hereof;

c) Documents about export, import, sale and purchase of narcotic drugs, psychotropic drugs and precursor drugs.

2. An exporter or importer of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients or active ingredients on the list of drugs and active ingredients banned from certain fields shall prepare the following documents:

a) Records of sale, purchase and inventory of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients or active ingredients on the list of drugs and active ingredients banned from certain fields according to the specimen in Appendix XVIII hereof;

b) Documents about the export, import, sale and purchase of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients and active ingredients on the list of drugs and active ingredients banned from certain fields.

3. An exporter or importer of radiopharmaceuticals shall prepare the following documents:

a) Records of sale, purchase and inventory of radiopharmaceuticals according to the specimen in Appendix VIII hereof;

b) Notes of delivery of radiopharmaceuticals according to the specimen in Appendix XVII hereof;

c) Documents about export, import, sale and purchase of radiopharmaceuticals.

Article 14. Documents prepared by wholesalers

1. A wholesaler of narcotic drugs, psychotropic drugs or precursor drugs shall prepare the following documents:

a) Records of sale, purchase and inventory of the narcotic drugs, procedures and precursor drugs according to the specimen in Appendix VIII hereof;

b) Notes of delivery of narcotic drugs, psychotropic drugs and precursor drugs according to the specimen in Appendix XVII hereof;

c) Documents about sale and purchase of narcotic drugs, psychotropic drugs and precursor drugs.

2. A wholesaler of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients or active ingredients on the list of drugs and active ingredients banned from certain fields shall prepare the following documents:

a) Records of sale, purchase and inventory of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients or active ingredients on the list of drugs and active ingredients banned from certain fields according to the specimen in Appendix XVIII hereof;

b) Documents about sale and purchase of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients and active ingredients on the list of drugs and active ingredients banned from certain fields.

3. A wholesaler of radiopharmaceuticals shall prepare the following documents:

a) Records of sale, purchase and inventory of radiopharmaceuticals according to the specimen in Appendix VIII hereof;

b) Notes of delivery of radiopharmaceuticals according to the specimen in Appendix XVII hereof;

c) Documents about sale and purchase of radiopharmaceuticals.

Article 15. Documents prepared by retailers

1. A retailer of narcotic drugs, psychotropic drugs or precursor drugs shall prepare the following documents:

a) Records of sale, purchase and inventory of the narcotic drugs, procedures and precursor drugs according to the specimen in Appendix VIII hereof;

b) Notes of delivery of narcotic drugs, psychotropic drugs and precursor drugs from the suppliers;

c) Prescriptions for narcotic drugs and psychotropic drugs that are sold;

d) Records of receipt of narcotic drugs according to the specimen in Appendix XX hereof;

dd) Records of buyers according to the specimen in Appendix XXI hereof;

2. A retailer of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, shall prepare records of buyers according to the specimen in Appendix XXI hereof.

Article 16. Documents prepared by providers of drug storage services, clinical trial services, bioequivalence study services and testing services

1. Regarding narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors:

a) Records of sale, purchase, inventory of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors according to the specimen in Appendix VIII hereof;

b) Notes of delivery of narcotic drugs, psychotropic drugs and precursor drugs according to the specimen in Appendix XVII hereof.

2. Regarding combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors, toxic drugs, toxic medicinal ingredients or active ingredients on the list of drugs and active ingredients banned from certain fields: inventory records according to the specimen in Appendix XVIII hereof.

3. Regarding radiopharmaceuticals: inventory records according to the specimen in Appendix VIII hereof.

Article 17. Documents prepared by health facilities, rehabilitation centers, pharmacy research or training institutions, organizations having non-commercial pharmacy-related activities

1. Health facilities, pharmacy research or training institutions and organizations having non-commercial pharmacy-related activities, except for facilities providing opium replacement therapy, shall prepare the following documents:

a) Records of production of the narcotic drugs, procedures, precursor drugs and radiopharmaceuticals according to the specimen in Appendix XVI and Appendix XIX hereof;

b) Records of inventory of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, drug precursors and radiopharmaceuticals according to the specimen in Appendix VIII hereof.

2. Rehabilitation centers and facilities providing opium replacement therapy shall prepare the documents specified in Clause 1b of this Article.

Article 18. Document retention

1. Pharmaceutical-trading establishments, health facilities, rehabilitation centers, pharmacy research or training institutions, organizations having non-commercial pharmacy-related activities shall retain physical or electronic documents about controlled drugs/medicinal ingredients for at least 02 years since the expiry dates of drugs. Prescriptions for narcotic drugs and psychotropic drugs shall be retained in accordance with Circular No. 05/2016/TT-BYT.

2. At the end of the retention period, the head of the facility shall establish a council to destroy the documents, issue a document destruction record and retain it.

Chapter V

IMPLEMENTATION

Article 19. Effect

1. This Circular comes into force from July 01, 2017.

2. Circular No. 19/2014/TT-BYT dated June 02, 2014 of the Minister of Health on management of narcotic drugs, psychotropic drugs and drug precursors is annulled from the effective date of this Circular.

Article 20. Transition clauses

1. Pharmacy research or training institutions that are supplying radiopharmaceuticals for health facilities may keep supplying radiopharmaceuticals until the end of their contracts or July 01, 2019, whichever is sooner. After that, they have to obtain the certificate of eligibility to produce radiopharmaceuticals specified in Section 4 Chapter III of Decree No. 54/2017/ND-CP.

2. The software system for monitoring inventory of controlled drugs of the facilities specified in Article 43 of Decree No. 54/2017/ND-CP must be connected to the Internet after the Ministry of Health launches the national management system.

Article 21. Reference clauses

In the cases where a legislative document or a regulation referred to in this Circular is amended or replaced, the newer one shall apply.

Article 22. Responsibility for implementation

The Chief of the Ministry Office, the Director of the Drug administration of Vietnam, Directors of Departments of the Ministry of Health, Director of General Office for Population and Family Planning, heads of affiliates of the Ministry of Health, Directors of Departments of Health of provinces, heads of health authorities of relevant ministries are responsible for implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Drug Administration of Vietnam) for consideration./.