Circular No. 19/2014/TT-BYT on the management of narcotic drugs, psychotropic substances, and precursor chemicals used for drug production

CIRCULAR

Regulations on the management of addictive drugs, psychotropic drugs, and precursors used as drugs.

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Pursuant to the Medicine Law No. 34/2005-QH-11 dated June 14, 2005;

Pursuant to the Law on Prevention and Control of Narcotics No. 23/2000/QH10 dated December 19, 2000, and the Law Amending and Supplementing Certain Provisions of the Law on Prevention and Control of Narcotics No. 16/2008/QH12 dated June 3, 2008;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

Pursuant to Decree No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending and supplementing certain provisions of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

Pursuant to Decree No. 80/2001/NĐ-CP dated November 5, 2001 of the Government guiding the control of lawful activities related to narcotics within the country;

Pursuant to Decree No. 58/2003/NĐ-CP dated May 19, 2003 of the Government stipulating the import, export, and transit control of narcotic substances, precursors, addictive drugs, and psychotropic drugs;

Pursuant to Decree No. 82/2013/NĐ-CP dated July 19, 2013 of the Government promulgating lists of narcotic substances and precursors;

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

At the proposal of the Director of the Drug Administration Department;,

The Minister of Health issues this Circular regulating the management of addictive drugs, psychotropic drugs, and precursors used as drugs.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

This Circular regulates activities related to addictive drugs, psychotropic drugs, precursors used as drugs, and finished pharmaceutical products containing addictive substances, finished pharmaceutical products containing psychotropic substances, and finished pharmaceutical products containing precursors used in the medical field and in analysis, testing, and scientific research conducted by domestic and foreign agencies, organizations, and individuals.

Article 2. Definitions

In this Circular, the following terms are understood as follows:

1. Addictive drugs b) Explanation and calculation of cost components and profit of Electricity Corporation i, including:

a) Raw materials containing addictive substances specified in Appendix I attached hereto.

b) Semi-finished products containing addictive substances specified in Appendix I attached hereto.

c) Finished pharmaceutical products containing addictive substances specified in Appendix I at all concentrations and quantities.

d) Finished pharmaceutical products containing addictive substances combined with other substances where the concentration and quantity of addictive substances exceed those specified in Appendix II attached hereto.

đ) Finished pharmaceutical products containing addictive substances combined with other addictive substances; or finished pharmaceutical products containing addictive substances combined with psychotropic substances; or finished pharmaceutical products containing addictive substances combined with precursors used as drugs; or finished pharmaceutical products containing addictive substances combined with psychotropic substances and precursors used as drugs where the addictive substances, psychotropic substances, and precursors used as drugs are present at all concentrations and quantities.

2. Finished pharmaceutical products containing addictive substances are the drugs specified in points c, d, and đ of Clause 1 of this Article.

3. Finished pharmaceutical products containing combined addictive substances are finished pharmaceutical products that meet the following conditions simultaneously:

a) Containing non-narcotic substances, non-psychotropic substances, and not precursors used as medicines;

b) Containing addictive substances; or containing addictive substances combined with psychotropic substances; or containing addictive substances combined with precursors used as drugs; or containing addictive substances combined with psychotropic substances and precursors used as drugs;

c) The concentrations and quantities of addictive substances, psychotropic substances, and precursors used as drugs are all less than or equal to those specified in Appendices II, IV, and VI attached hereto.

4. Psychotropic drugs b) Explanation and calculation of cost components and profit of Electricity Corporation i, including:

a) Raw materials containing psychotropic substances specified in Appendix III attached hereto.

b) Semi-finished products containing psychotropic substances specified in Appendix III attached hereto.

c) Finished pharmaceutical products containing psychotropic substances specified in Appendix III attached hereto at all concentrations and quantities.

d) Finished pharmaceutical products containing psychotropic substances combined with other substances where the concentration and quantity of psychotropic substances exceed those specified in Appendix IV attached hereto.

đ) Finished pharmaceutical products containing psychotropic substances combined with other psychotropic substances; or finished pharmaceutical products containing psychotropic substances combined with precursors used as drugs where the psychotropic substances and precursors used as drugs are present at all concentrations and quantities.

5. TFinished pharmaceutical products containing psychotropic substances are the drugs specified in points c, d, and đ of Clause 4 of this Article.

6. Finished pharmaceutical products containing combined psychotropic substances are finished pharmaceutical products that meet the following conditions simultaneously:

a) Containing non-narcotic substances, non-psychotropic substances, and not precursors used as medicines;

b) Containing psychotropic substances or containing psychotropic substances combined with precursors used as medicines;

c) The concentrations and quantities of psychotropic substances and precursors used as drugs are all less than or equal to those specified in Appendices IV and VI attached hereto.

7. Precursors used as drugs b) Explanation and calculation of cost components and profit of Electricity Corporation i, including:

a) Raw materials containing precursors used as drugs specified in Appendix V attached hereto.

b) Semi-finished products containing precursors used as drugs specified in Appendix V attached hereto.

c) Finished pharmaceutical products containing precursors used as drugs specified in Appendix V attached hereto at all concentrations and quantities.

d) Finished pharmaceutical products containing precursors used as drugs combined with other substances where the concentration and quantity of precursors used as drugs exceed those specified in Appendix VI attached hereto.

đ) Finished pharmaceutical products containing precursors used as drugs combined with other precursors used as drugs at all concentrations and quantities.

8. Finished pharmaceutical products containing precursors are the drugs specified in points c, d, and đ of Clause 7 of this Article.

9. Finished pharmaceutical products containing combined precursors are finished pharmaceutical products that meet the following conditions simultaneously:

a) Containing non-narcotic substances, non-psychotropic substances, and not precursors used as medicines;

b) Containing precursors used as drugs at concentrations and quantities less than or equal to those specified in Appendix VI attached hereto.

Chapter II

PHARMACEUTICAL BUSINESS

Article 3. General Principles

1. Production bases, export bases, import bases, wholesale bases, retail bases, service supply bases related to addictive drugs, psychotropic drugs, precursor substances for drug production, finished drug products containing addictive active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances must comply with the conditions for drug business as stipulated in Chapter II of the Drug Law and Chapter IV of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government and Decree No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending and supplementing certain articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of some provisions of the Drug Law and the regulations set forth in this Circular.

2. Production bases, export bases, import bases, wholesale bases, service supply bases related to addictive drugs, psychotropic drugs, and precursor substances for drug production must establish and implement standard operating procedures (SOPs) specific to addictive drugs, psychotropic drugs, and precursor substances for drug production to manage export, import, purchase, sale, storage, receipt and dispatch, transportation, and destruction of drugs. The establishment of SOPs must ensure safety and prevent loss; each stage must be documented in ledgers and signed off to clearly define the responsibility of each individual at each stage.

3. Production bases, export bases, import bases, wholesale bases, service supply bases related to finished drug products containing addictive active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances must have standard operating procedures for activities as specified in Clause 2 of this Article. These SOPs may be separate or combined with SOPs for other drugs.

4. Individuals involved in the business of addictive drugs, psychotropic drugs, precursor substances for drug production, and finished drug products containing addictive active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances must undergo initial training and updates on relevant regulatory documents and standard operating procedures; training records must be kept at the base.

Article 4. Production

1. Production bases currently permitted to produce addictive drugs, psychotropic drugs, and precursor substances for drug production may continue to produce these drugs.

Before November 30 each year, production bases requiring permission to produce addictive drugs, psychotropic drugs, and precursor substances for drug production must submit a written request to the Drug Administration under the Ministry of Health. The Drug Administration under the Ministry of Health will issue amendments and supplements to the list of production bases permitted to produce addictive drugs, psychotropic drugs, and precursor substances for drug production based on actual circumstances.

2. Production bases producing addictive drugs, psychotropic drugs, and precursor substances for drug production must comply with the following requirements:

a) Meeting Good Manufacturing Practice (GMP) standards appropriate to each formulation for at least two years;

b) Personnel:

- The warehouse manager responsible for storing addictive drugs must hold a bachelor's degree in pharmacy and have at least two years of practice experience at a drug production base.

- The warehouse manager responsible for storing psychotropic drugs and precursor substances for drug production must hold a bachelor's or associate degree in pharmacy and be authorized (authorized in writing by the head of the base, with each authorization not exceeding twelve months).

- Key personnel responsible for record-keeping and reporting must hold a bachelor's degree in pharmacy and have at least two years of practice experience at a drug production base;

c) Documentation and ledgers: Production bases producing addictive drugs, psychotropic drugs, and precursor substances for drug production must establish and maintain complete ledgers as follows:

- A ledger for compounding addictive drugs, psychotropic drugs, and precursor substances for drug production according to Model No. 01 issued together with this Circular;

- A ledger for tracking the export and import of addictive drugs, psychotropic drugs, and precursor substances for drug production according to Model No. 02 issued together with this Circular;

- An export warehouse receipt for addictive drugs, psychotropic drugs, and precursor substances for drug production according to Model No. 03 issued together with this Circular;

3. Production bases producing finished drug products containing addictive active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances must comply with the following requirements:

a) Meeting Good Manufacturing Practice (GMP) standards appropriate to each formulation for at least two years;

b) Personnel:

- The warehouse manager responsible for storing raw materials and semi-finished products containing addictive active ingredients must hold a bachelor's degree in pharmacy and have at least two years of practice experience at a drug production base.

- The warehouse manager responsible for storing raw materials and semi-finished products containing psychotropic active ingredients and raw materials and semi-finished products containing precursor substances must hold a bachelor's or associate degree in pharmacy and be authorized (authorized in writing by the head of the base, with each authorization not exceeding twelve months).

- Key personnel responsible for record-keeping and reporting must hold a bachelor's degree in pharmacy and have at least two years of practice experience at a drug production base.

c) Documentation and ledgers: Production bases producing finished drug products containing addictive active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances must maintain complete ledgers for tracking the import and export of finished drug products containing addictive active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances according to Model No. 4 issued together with this Circular.

4. Production bases producing addictive drugs, psychotropic drugs, and precursor substances for drug production may:

a) Purchase and import raw materials and semi-finished products containing addictive active ingredients; raw materials and semi-finished products containing psychotropic active ingredients; and raw materials and semi-finished products containing precursor substances for their own drug production;

b) Export addictive drugs, psychotropic drugs, and precursor substances for drug production produced by their own base.

c) Sell finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs produced by their own facility to the facilities specified in Clause 1 of Article 5 of this Circular.

5. Facilities producing combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors shall be:

a) Purchase and import raw materials and semi-finished products containing addictive active ingredients; raw materials and semi-finished products containing psychotropic active ingredients; and raw materials and semi-finished products containing precursor substances for their own drug production;

b) Exporting combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors;

c) Selling directly combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors produced by their own facility to medical examination and treatment establishments, pharmacies meeting Good Pharmacy Practice (GPP) standards throughout the country;

d) Selling combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors to only one wholesale drug distributor with a Drug Business License on the territory of one province for sale to medical examination and treatment establishments, pharmacies meeting Good Pharmacy Practice (GPP) standards in that province.

6. When there is a need to purchase, import raw materials containing narcotic substances, raw materials containing psychotropic substances, or raw materials containing precursors for research and production of new registered products, the facility must submit a request according to the form number 05 issued together with this Circular and must report in detail the quantity of raw materials used for research and trial production according to the form number 06 issued together with this Circular.

Article 5. Exporting and Importing

1. Enterprises are responsible for exporting, importing, and supplying narcotic drugs, psychotropic drugs, and drug precursors to business and usage establishments nationwide as specified in Appendix VII issued together with this Circular.

Before November 30 each year, enterprises wishing to export or import narcotic drugs, psychotropic drugs, and drug precursors must send a written request to the Department of Medicine Management - Ministry of Health. The Department of Medicine Management - Ministry of Health will review and report recommendations to the leadership of the Ministry. Based on actual circumstances, the Department of Medicine Management - Ministry of Health will issue amendments and supplements to the list of enterprises permitted to export, import narcotic drugs, psychotropic drugs, and drug precursors for supply to business and usage establishments nationwide.

2. Enterprises exporting and importing narcotic drugs, psychotropic drugs, and drug precursors must comply with the following regulations:

a) Personnel: The warehouse manager must have a bachelor's degree in pharmacy with at least two years of practice experience in pharmaceutical production or trading facilities.

b) Documents and ledgers: Enterprises exporting and importing narcotic drugs, psychotropic drugs, and drug precursors must establish and record all types of documents and ledgers as follows:

- A ledger tracking the export and import of narcotic drugs, psychotropic drugs, and drug precursors according to the form number 02 issued together with this Circular;

- An export warehouse receipt for addictive drugs, psychotropic drugs, and precursor substances for drug production according to Model No. 03 issued together with this Circular;

- Relevant documents related to the export, import, purchase, and sale of narcotic drugs, psychotropic drugs, and drug precursors.

3. Enterprises exporting and importing narcotic drugs, psychotropic drugs, and drug precursors as stipulated in Clause 1 of this Article may:

a) Export and import narcotic drugs, psychotropic drugs, and drug precursors;

b) Purchase narcotic drugs, psychotropic drugs, and drug precursors, combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors from production facilities;

c) Sell finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs to wholesale businesses specified in Clause 1 of Article 6 of this Circular, pharmacies specified in Clause 1 of Article 7 of this Circular, medical examination and treatment establishments, research and testing facilities, educational-labor-social welfare centers, drug addiction treatment facilities using substitute drugs, and specialized medical-pharmaceutical training institutions throughout the country.

d) Sell raw materials and semi-finished products containing narcotic substances; raw materials and semi-finished products containing psychotropic substances; raw materials and semi-finished products containing precursors to facilities permitted to produce and compound narcotic drugs, psychotropic drugs, and drug precursors.

đ) Only allowed to import directly, not allowed to buy or sell narcotic drugs, psychotropic drugs, and drug precursors from other exporting and importing enterprises. In cases where sufficient drugs cannot be supplied to patients, the exporting and importing enterprise must report to the Department of Medicine Management - Ministry of Health for consideration and resolution.

4. Facilities meeting the conditions for drug business as prescribed in Chapter II of the Drug Law, Chapter IV of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government, and Decree No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending and supplementing some articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Drug Law may export and import combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors; they must establish and record the following documents:

a) A ledger tracking the import and export of combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors according to the form number 04 issued together with this Circular;

b) Relevant documents related to the export, import, purchase, and sale of combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors.

5. Export and import pharmaceutical enterprises may only sell directly finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursor substances to:

a) Medical examination and treatment facilities and pharmacies meeting Good Pharmacy Practice (GPP) standards nationwide;

b) One wholesale drug enterprise with a Drug Business Qualification Certificate within a province to sell finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursor substances to medical examination and treatment facilities and pharmacies meeting GPP standards within that province.

Article 6. Wholesale

1. Pharmaceutical enterprises in provinces and centrally-administered municipalities currently supplying narcotic finished drugs, psychotropic finished drugs, and precursor finished drugs may continue to purchase narcotic finished drugs, psychotropic finished drugs, and precursor finished drugs from enterprises specified in Clause 1 of Article 5 of this Circular for supply within their province.

In cases where pharmaceutical enterprises in provinces and centrally-administered municipalities cannot adequately supply drugs to medical examination and treatment facilities within their administrative areas, the Department of Health of the province or centrally-administered municipality shall be responsible for reporting to the Drug Administration under the Ministry of Health to designate another wholesale drug enterprise with a Drug Business Qualification Certificate to supply narcotic finished drugs, psychotropic finished drugs, and precursor finished drugs within the province.

2. Enterprises specified in Clause 1 of this Article must comply with the following requirements:

a) Personnel: The warehouse manager must have a bachelor's degree in pharmacy and at least two years of experience working in a pharmaceutical production or trading company.

b) Documentation and records:

- A ledger tracking the export and import of narcotic drugs, psychotropic drugs, and drug precursors according to the form number 02 issued together with this Circular;

- An export warehouse receipt for addictive drugs, psychotropic drugs, and precursor substances for drug production according to Model No. 03 issued together with this Circular;

- Relevant documents related to the export, import, purchase, and sale of narcotic drugs, psychotropic drugs, and drug precursors.

3. Enterprises specified in Clause 1 of this Article are entitled to:

a) Purchase narcotic finished drugs, psychotropic finished drugs, and precursor finished drugs from export and import pharmaceutical enterprises specified in Clause 1 of Article 5 of this Circular;

b) Sell narcotic finished drugs, psychotropic finished drugs, and precursor finished drugs to pharmacies meeting GPP standards specified in Clause 1 of Article 7 of this Circular, medical examination and treatment facilities, research and testing facilities, education-labor-society centers, opiate substitution therapy facilities, and specialized medical and pharmaceutical training institutions within the province.

4. Facilities that meet the conditions for drug business operations as stipulated in Chapter II of the Pharmacy Law, Chapter IV of Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government, and Decree No. 89/2012/ND-CP dated October 24, 2012 of the Government amending and supplementing certain articles of Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law are permitted to buy and sell finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursor substances; they must establish and record all of the following documents:

a) A logbook for tracking the entry and exit of finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursor substances, implemented according to Model No. 04 issued together with this Circular;

b) Relevant documentation related to the purchase and sale of finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursor substances.

5. Wholesale enterprises selling finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursor substances within a province must notify the Department of Health of the province or centrally-administered municipality about the products they are currently trading, and must provide updated notifications when there are changes; they may only supply to medical examination and treatment facilities and pharmacies meeting GPP standards within that province.

Article 7. Retail Sale

1. Pharmacies that meet Good Pharmacy Practice (GPP) standards may retail finished narcotic drugs, finished psychotropic drugs, finished precursor drugs, and finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursors for outpatients.

Pharmacies that organize the sale of finished narcotic drugs must register with the Department of Health within their jurisdiction and comply with the provisions of this Circular.

2. The pharmacy owner and the professional manager must directly manage and retail finished narcotic drugs.

3. A pharmacist with a secondary education or higher must manage and retail finished psychotropic drugs and finished precursor drugs.

4. Pharmacies specified in Clause 1 of this Article may purchase finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs from pharmaceutical exporting and importing enterprises as stipulated in Clause 1 of Article 5 of this Circular, and from pharmaceutical wholesale enterprises as stipulated in Clause 1 of Article 6 of this Circular, and may retail them according to regulations.

For finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursors listed in the List of Drugs Not Requiring Prescriptions issued by the Ministry of Health, they can be sold to patients without prescriptions as prescribed. Detailed customer information must be recorded each time a sale is made.

5. Pharmacies are not allowed to buy or sell raw materials or semi-finished products containing narcotic substances, raw materials or semi-finished products containing psychotropic substances, or raw materials or semi-finished products containing precursors.

6. Pharmacies retailing finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must establish and record all of the following types of files:

a) A logbook for tracking the import and export of narcotic drugs, psychotropic drugs, and precursors used as medicines, implemented according to Model No. 02 attached to this Circular;

b) An outbound warehouse receipt for narcotic drugs, psychotropic drugs, and precursors used as medicines from the supplying entity;

c) A prescription retained at the facility after sale;

d) A receipt for the return of finished narcotic drugs submitted by the patient's family;

đ) A logbook for detailed customer information, implemented according to Model No. 07 attached to this Circular.

Chapter III

PRESCRIPTION, COMPOUNDING, DISTRIBUTION AND USE OF DRUGS

Article 8. Prescription

1. The prescription of finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for outpatients shall be carried out in accordance with the "Regulations on Prescription Writing for Outpatient Treatment" issued by the Minister of Health.

2. The prescription of finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for inpatients shall be carried out in accordance with the "Circular on Guidelines for Drug Use in Healthcare Facilities with Beds" issued by the Minister of Health.

3. Finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursors listed in the List of Drugs Not Requiring Prescriptions issued by the Minister of Health can be sold to patients without prescriptions as prescribed.

4. Finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursors not listed in the List of Drugs Not Requiring Prescriptions issued by the Minister of Health can only be used when there is a prescription from a doctor with a medical practice certificate. The drug seller can only sell to patients when there is a prescription from a doctor with a medical practice certificate.

Article 9. Compounding of drugs in hospitals

1. Hospitals compounding finished narcotic drugs, finished psychotropic drugs, finished precursor drugs, and finished combination drugs containing narcotic substances, finished combination drugs containing psychotropic substances, and finished combination drugs containing precursors must arrange compounding areas meeting the following conditions:

- Having an emergency resuscitation room;

- Compounding room: has a dust-proof ceiling, floor and wall made of easy-to-clean material, which can be disinfected if necessary. The room must be built in a well-ventilated, separate, safe location, far from pollution sources. The minimum floor area is 10 square meters. Equipment must be arranged in a one-way flow principle;

- Hand washing facilities and equipment washing facilities;

- Adequate equipment suitable for compounding, storing, and testing drugs.

b) Human resources:

- The supervisor responsible for recording, reporting, and quality control of compounded drugs must have a bachelor's degree in pharmacy.

- The manager of compounded finished narcotic drugs must have a bachelor's degree in pharmacy.

- The manager of compounded finished psychotropic drugs and finished precursor drugs must have a secondary education in pharmacy or higher.

c) Packaging, labeling, storage:

- Finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must be immediately packaged and labeled upon completion to avoid confusion. The label must include the following information: name of the facility, name of the drug, dosage form, active ingredient, concentration or content, preparer, supervisor, date of preparation, expiration date of the drug.

- Narcotic drugs, psychotropic drugs, and precursors used as drugs must be stored in a separate cabinet; measures and equipment must be taken to ensure safety and prevent loss.

d) Files and ledgers:

- A compounding ledger for narcotic drugs, psychotropic drugs, and precursors used as drugs (Model No. 1);

- A quality control ledger;

- A compounding procedure based on prescriptions;

- Standard Operating Procedures (SOPs) for compounding must be established.

2. Scope of activities:

a) Compounded drugs can only be sold or distributed according to prescriptions to inpatients and outpatients of the same facility;

b) Only drugs with formulas, compounding procedures, and quality standards approved by the head of the facility and responsible for the safety and efficacy of the drugs can be compounded;

c) Injectable drugs cannot be compounded.

Article 10. Compounding and Using Drugs at Research and Training Institutions in the Field of Medicine and Pharmacy

1. Research and training institutions in the field of medicine and pharmacy are permitted to compound and use narcotic drugs, psychotropic substances, precursor substances for drug production, and finished combination drugs containing narcotic active ingredients, finished combination drugs containing psychotropic active ingredients, and finished combination drugs containing precursor substances for teaching and scientific research purposes; university pharmacy graduates supervise compounding activities and are responsible for recording compounding logs, tracking the entry and exit of narcotic drugs, psychotropic substances, and precursor substances for drug production, and reporting in accordance with the provisions of this Circular.

2. Finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must be packaged, labeled, and stored according to the provisions set forth in point c, Clause 1, Article 9 of this Circular upon completion of compounding.

Article 11. Distribution and Use

1. The Department of Pharmacy distributes drugs to treatment departments based on the Finished Narcotic Drug Receipt Form, Finished Psychotropic Drug Receipt Form, and Finished Precursor Drug Receipt Form (Form No. 8 issued together with this Circular), and directly distributes drugs to outpatients.

The Head of the Department of Pharmacy or a university pharmacy graduate authorized in writing by the Head of the Department approves the receipt forms for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs submitted by treatment departments; and approves the receipt forms for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for the pharmacy's night shift.

2. The Head of the Treatment Department and the Head of the Outpatient Clinic approve the receipt forms for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for their respective departments.

In treatment departments, after receiving drugs from the Department of Pharmacy, the assigned nurse must verify the name of the drug, concentration, dosage, and quantity before administering it or distributing it to patients.

Excess finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs that remain unused due to patient transfer or death must be returned to the Department of Pharmacy by the treatment department. The Head of the Department of Pharmacy will decide on reusing or destroying these drugs according to regulations and record this in the pharmacy logbook.

The Department of Pharmacy must monitor and record the quantities of finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs entering, exiting, and remaining in stock, following the provisions set forth in Form No. 02 issued together with this Circular.

The custodian managing narcotic drugs must have a bachelor's degree in pharmacy or a diploma in pharmacy, authorized in writing by the head of the institution (each authorization not exceeding 12 months).

The custodian managing psychotropic drugs and precursor substances for drug production must have a diploma in pharmacy or higher.

2. Treatment Departments in Medical and Healthcare Facilities: Finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs in emergency medicine cabinets and emergency cabinets must be kept separately by the assigned nurse and distributed according to medical orders. When changing shifts, the nurse handing over the shift must hand over the drugs and the tracking logbook to the incoming nurse.

3. Educational-Labor-Social Centers, Compulsory Drug Rehabilitation Centers, and Treatment Centers for Opioid Dependence using Medication Substitution Therapy: Finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs are managed, distributed, and tracked in logbooks by a university pharmacy graduate or a diploma pharmacy graduate (authorized in writing by the head of the institution each time not exceeding 12 months).

4. Health Stations in Communes, Wards, and Towns: Finished psychotropic drugs under the community mental health program are managed and distributed by personnel with a pharmaceutical assistant level or higher, or a medical assistant level or higher, and must maintain tracking logs.

Chapter IV

HANDOVER, TRANSPORTATION, AND STORAGE OF DRUGS

Article 12. Delivery and Receipt

1. When delivering or receiving narcotic drugs, psychotropic drugs, precursor substances for drug production, finished pharmaceutical products containing narcotic active ingredients, finished pharmaceutical products containing psychotropic active ingredients, or finished pharmaceutical products containing precursor substances: The deliverer and receiver must check and verify the name of the drug, concentration, quantity, batch number, expiration date, and sensory quality of the drug; they must sign and clearly write their full names on the warehouse exit and entry documents.

2. The deliverer and receiver of narcotic drugs, psychotropic drugs, and precursor substances for drug production must have graduated from secondary pharmacy school or higher.

Article 13. Transportation

1. Narcotic drugs, psychotropic drugs, precursor substances for drug production, finished pharmaceutical products containing narcotic active ingredients, finished pharmaceutical products containing psychotropic active ingredients, or finished pharmaceutical products containing precursor substances must be packaged, sealed, and measures to ensure safety must be taken to prevent loss during transportation; the packaging must clearly indicate the place of origin, destination, name of the drug, and quantity.

2. The head of the facility must assign tasks in writing to personnel who have graduated from secondary pharmacy school or higher within the facility responsible for transporting narcotic drugs, psychotropic drugs, and precursor substances for drug production; the person responsible for transportation must carry the written assignment, national identity card (or other valid identification), sales invoice or warehouse exit slip; they are responsible for the type, quantity, and sensory quality of the drug during transportation and must deliver it fully to the recipient.

3. In cases where a business entity must hire transportation for narcotic drugs, psychotropic drugs, and precursor substances for drug production: The hiring party and the transportation service provider must enter into a written contract specifying conditions related to storage, transportation, delivery of narcotic drugs, psychotropic drugs, and precursor substances for drug production as prescribed. The transportation service provider must meet these conditions during transportation to ensure that the drugs are not lost.

The hiring party and the transportation service provider must be responsible for issues related to narcotic drugs, psychotropic drugs, and precursor substances for drug production during transportation.

The deliverer and receiver of narcotic drugs, psychotropic drugs, and precursor substances for drug production at business entities must have graduated from secondary pharmacy school or higher.

Article 14Storage

1. Pharmaceutical enterprises producing drugs must have a dedicated warehouse meeting the "Good Storage Practices for Drugs" standards issued by the Minister of Health to store raw materials and finished narcotic drugs, finished psychotropic drugs, finished precursor drugs; finished pharmaceutical products containing narcotic active ingredients, finished pharmaceutical products containing psychotropic active ingredients, and finished pharmaceutical products containing precursor active ingredients. The warehouse must have secure doors and locks, and measures to ensure safety must be taken to prevent loss.

2. Enterprises exporting and importing drugs as stipulated in Clause 1 of Article 5 of this Circular must have a dedicated warehouse meeting the "Good Storage Practices for Drugs" standards appropriate to the scale of business operations but with a minimum area of 100 square meters² and a minimum volume of 300 cubic meters³; the warehouse must have secure doors and locks, and measures to ensure safety must be taken to prevent loss.

3. Wholesale pharmaceutical enterprises as stipulated in Clause 1 of Article 6 of this Circular must have a warehouse meeting the "Good Storage Practices for Drugs" standards, where the warehouse storing finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must have secure locks and measures to ensure safety to prevent loss. If there is no dedicated warehouse, finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must be stored in a separate area within a warehouse meeting the "Good Storage Practices for Drugs" standards.

4. Exporting and importing enterprises, wholesale pharmaceutical enterprises dealing in finished pharmaceutical products containing narcotic active ingredients, finished pharmaceutical products containing psychotropic active ingredients, and finished pharmaceutical products containing precursor substances must have warehouses meeting the "Good Storage Practices for Drugs" standards, with measures to ensure safety to prevent loss.

5. Pharmacies must be equipped with separate cabinets with secure locks to store finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs.

If the quantity of finished narcotic drugs is small, they may be stored together with finished psychotropic drugs and finished precursor drugs in the same cabinet but must be placed in separate compartments to avoid confusion; the cabinet must have secure locks and measures to ensure safety to prevent loss.

Finished pharmaceutical products containing narcotic active ingredients, finished pharmaceutical products containing psychotropic active ingredients, and finished pharmaceutical products containing precursor substances must be stored in separate areas.

6. Emergency medicine cabinets, first aid cabinets:

Finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs in emergency medicine cabinets and first aid cabinets must be stored in separate compartments, and the cabinets must have secure locks. The quantity and types of finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs stored in emergency medicine cabinets and first aid cabinets shall be specified in writing by the head of the facility.

7. Pharmacy Department: Finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must be stored in warehouses in compliance with the "Good Storage Practices for Drugs"; hospital pharmacy departments must implement the "Good Storage Practices for Drugs" (GSP) according to the schedule prescribed by the Ministry of Health, with measures to ensure safety to prevent loss.

Warehouses and cabinets storing finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must have secure locks. If there is no dedicated warehouse or cabinet, finished narcotic drugs may be stored together with finished psychotropic drugs and finished precursor drugs but must be arranged separately to avoid confusion.

Finished pharmaceutical products containing narcotic active ingredients, finished pharmaceutical products containing psychotropic active ingredients, and finished pharmaceutical products containing precursor substances must be stored in separate areas.

8. Research institutions, training facilities, and other related units: Narcotic drugs, psychotropic drugs, and precursor substances for drug production must be stored in separate compartments or drawers in locked cabinets with safety measures to prevent loss. Finished products containing narcotic substances, finished products containing psychotropic substances, and finished products containing precursors must be kept in separate areas.

9. Commune health stations: Psychotropic drug finished products must be arranged in locked counters or cabinets with safety measures to prevent loss.

Chapter V

RECORDS, PERMIT PROCEDURES, REPORTS AND DESTRUCTION REGIMES FOR DRUGS

Article 15. ESTIMATE

1. Wholesale enterprises, retail establishments, and drug-using facilities must prepare an estimate for purchasing finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs in accordance with Model Number 09 issued together with this Circular.

2. Drug manufacturing enterprises producing finished narcotic drugs, finished psychotropic drugs, finished precursor drugs, finished combination products containing narcotic substances, finished combination products containing psychotropic substances, and finished combination products containing precursors must prepare purchase orders for raw materials and semi-finished products containing narcotic substances; raw materials and semi-finished products containing psychotropic substances; raw materials and semi-finished products containing precursors in accordance with Model Number 10 issued together with this Circular, or import orders for raw materials and semi-finished products containing narcotic substances; raw materials and semi-finished products containing psychotropic substances; raw materials and semi-finished products containing precursors in accordance with the Circular guiding the export and import of drugs and direct contact drug packaging issued by the Minister of Health.

3. Export and import enterprises must prepare export and import orders for narcotic drugs, psychotropic drugs, and precursor substances for drug production in accordance with the current Circular guiding the export and import of drugs and direct contact drug packaging issued by the Minister of Health.

4. The estimate must be made in four copies (the approving authority retains two copies, the unit retains one copy, and the selling entity retains one copy).

5. Wholesale enterprises, retail establishments, and drug-using facilities may only purchase, sell, distribute, and use finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs when the estimate has been approved.

6. The head of the enterprise is responsible for the quantity of estimated finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs; the quantity of estimated drugs must be consistent with the usage needs of the facility; the quantity of estimated narcotic drugs, psychotropic drugs, and precursor substances for drug production may exceed fifty percent of the previous usage quantity only in cases of shortage, emergency, natural disasters, and epidemics.

7. Manufacturing, exporting, importing enterprises, wholesale enterprises, retail establishments, and drug-using facilities producing finished combination products containing narcotic substances, finished combination products containing psychotropic substances, and finished combination products containing precursors are not required to prepare estimates according to the above regulations.

8. Within seven working days from receiving a valid estimate, the authority reviewing the estimate will examine and approve the estimate or issue a letter stating the reasons for disapproval.

Article 16APPROVAL OF ESTIMATES

1. The Department of Medicines Management - Ministry of Health:

a) Approves estimates for narcotic drugs, psychotropic drugs, and precursor substances for drug production for pharmaceutical companies, medical examination and treatment facilities, research facilities, testing facilities, and specialized healthcare and pharmaceutical training facilities;

b) Approves export and import orders for narcotic drugs, psychotropic drugs, and precursor substances for drug production for pharmaceutical export and import companies as stipulated in Clause 1 of Article 5 of this Circular;

c) Approves estimates for narcotic drugs, psychotropic drugs, and precursor substances for drug production for entities outside the healthcare sector but have a need to purchase narcotic drugs for scientific research based on approved scientific research frameworks by competent state management authorities;

d) Approves estimates for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for the Military Hospital Administration - Ministry of National Defense.

2. Provincial/Municipal Health Departments under the Central Government approve estimates for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for wholesale companies, retail establishments, medical examination and treatment facilities within and outside the healthcare sector (excluding units under the Ministry of National Defense and the Ministry of Transport), research facilities, and specialized healthcare and pharmaceutical training facilities. Depending on each locality, the Health Department may delegate approval of estimates for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for commune health stations to district/county health offices or district/county health centers (if there is a graduate pharmacist).

3. The Military Hospital Administration - Ministry of National Defense approves estimates for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for hospitals and units under the Ministry of National Defense.

4. The Health Administration - Ministry of Transport approves estimates for finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs for hospitals and units under the Ministry of Transport.

Article 17RECORDS AND PROCEDURES FOR EXPORT AND IMPORT LICENSES

1. Records and procedures for obtaining export and import licenses for narcotic drugs, psychotropic drugs, precursor substances for drug production, and finished combination products containing narcotic substances, finished combination products containing psychotropic substances, and finished combination products containing precursors shall be carried out in accordance with the Circular guiding the export and import of drugs and direct contact drug packaging issued by the Minister of Health.

2. The export and import permit for yellow narcotic drugs, blue psychotropic drugs, and pink precursor substances for drug production shall be issued for each individual import or export transaction and shall be valid for a maximum period of one year from the date of issuance.

3. The export and import permit for narcotic drugs, psychotropic drugs, and precursor substances for drug production shall be sent to the enterprise applying for import or export; the Office of the Permanent Steering Committee on Crime Prevention and Drug Control under the Ministry of Public Security; the Customs Sub-Department at the border gate where the export or import procedures are carried out; the Ministry of Finance (Anti-Smuggling Investigation Department under the General Administration of Customs); the International Narcotics Control Board; and the competent authority of the importing country (for export permits).

4. Narcotic drugs, psychotropic drugs, and precursor substances for drug production may only be exported or imported through international border gates of Vietnam.

Article 18. Recordkeeping

1. Production facilities, import-export enterprises, wholesalers, retailers, users, preparers, distributors, and service providers related to narcotic drugs, psychotropic drugs, and precursor substances for drug production must record, monitor, and retain records and documents related to these substances for at least two years after their expiration date. Prescription forms N shall be retained according to the "Regulation on Prescription Writing in Outpatient Treatment" issued by the Minister of Health.

2. Production facilities preparing finished products containing narcotic active ingredients, finished products containing psychotropic active ingredients, and finished products containing precursors must record, monitor, and retain records and documents related to raw materials and semi-finished products containing narcotic active ingredients; raw materials and semi-finished products containing psychotropic active ingredients; and raw materials and semi-finished products containing precursors for at least two years after the expiration date of the drugs.

3. After the retention period, the head of the facility shall establish a committee to destroy the records, prepare a destruction report, and retain the destruction report at the facility.

Article 19.

1. Export and Import Reports:

a) Narcotic drugs, psychotropic drugs, and precursor substances for drug production: Within ten days after export or import, the exporting or importing facility must submit reports according to Form 11A and Form 11B attached to this Circular to the Drug Management Department under the Ministry of Health and the Office of the Permanent Steering Committee on Crime Prevention and Drug Control under the Ministry of Public Security.

b) Annually, exporting and importing enterprises must submit reports on the quantity of exported and imported finished products containing narcotic active ingredients, finished products containing psychotropic active ingredients, and finished products containing precursors according to Form 12A and Form 12B attached to this Circular to the Drug Management Department under the Ministry of Health, no later than January 15 of the following year.

2. Inventory and Usage Reports:

a) Exporting and importing enterprises, wholesalers, retail outlets, and facilities using narcotic drugs, psychotropic drugs, and precursor substances for drug production must conduct inventory checks and submit monthly, six-monthly, and annual reports on the quantity of drugs in stock before July 15 and January 15 of the following year, respectively, according to Form 13A and Form 13B attached to this Circular to the approval and licensing authority.

b) Exporting and importing enterprises, wholesalers, and retail outlets selling finished products containing narcotic active ingredients, finished products containing psychotropic active ingredients, and finished products containing precursors must conduct inventory checks and submit reports on the quantity purchased, imported, in stock, sold, remaining, and customer addresses every six months before July 15 and annually before January 15 of the following year to the Department of Health in their locality.

c) Enterprises producing and importing finished products containing narcotic active ingredients, finished products containing psychotropic active ingredients, and finished products containing precursors must conduct inventory checks and submit reports on the quantity purchased, imported, in stock, sold, and customer names and addresses for each procurement and importation of raw materials for drug production and annually before January 15 of the following year (annual report) to the Drug Management Department under the Ministry of Health; they must also notify the Department of Health in provincial-level cities about the products designated for sale in their localities and update them when there are changes.

d) Departments of Health in provinces and centrally-administered municipalities must submit annual reports on the usage of narcotic drugs, psychotropic drugs, and precursor substances for drug production by facilities in their localities according to Form 14 attached to this Circular.

e) The Military Medical Service under the Ministry of National Defense must submit annual reports on the usage of narcotic drugs by their sector according to Form 11A attached to this Circular to the Drug Management Department under the Ministry of Health, no later than January 30 of the following year.

3. Reports on Errors, Losses, or Suspected Losses:

Domestic and foreign individuals and organizations involved in activities related to narcotic drugs, psychotropic drugs, precursor substances for drug production, finished products containing narcotic active ingredients, finished products containing psychotropic active ingredients, and finished products containing precursors must urgently report to the approval and licensing authority in cases of errors, losses, or suspected losses. Upon receiving urgent reports, the approval and licensing authority must investigate and take appropriate measures.

Departments of Health in provinces and centrally-administered municipalities must compile and urgently report such incidents to the Drug Management Department under the Ministry of Health.

Article 20. Destruction of Drugs

1. Raw materials and semi-finished products containing narcotic active ingredients; raw materials and semi-finished products containing psychotropic active ingredients; raw materials and semi-finished products containing precursors; expired, substandard narcotic finished products, psychotropic finished products, and precursor finished products; samples retained after the retention period; drugs returned from treatment departments; and drugs returned due to patient death must be destroyed. The facility responsible for destroying the drugs shall carry out the destruction as follows:

a) Submit a request to cancel the drug to the agency responsible for reviewing the budget estimate. The cancellation request must clearly state the name of the drug, concentration-content, quantity, reason for cancellation, and method of cancellation. Cancellation can only be carried out after approval from the agency responsible for reviewing the budget estimate;

b) Establish a committee to cancel drugs, decided by the head of the facility. The committee must consist of at least three people, including a staff member responsible for the facility;

c) Prepare a record of drug cancellation and retain it at the facility;

d) After cancelling the drug, submit a report on the cancellation to the agency responsible for reviewing the budget estimate (along with the record of drug cancellation).

2. By-products and waste products generated during the production of narcotic drugs, psychotropic drugs, and precursor substances used in drugs, finished drug combinations containing narcotic active ingredients, finished drug combinations containing psychotropic active ingredients, and finished drug combinations containing precursor substances must be collected and cancelled as stipulated in points b and c of Clause 1 of this Article.

3. Drug manufacturing and trading enterprises: Direct contact packaging materials for narcotic drugs, psychotropic drugs, and precursor substances used in drugs that are no longer in use must be collected and cancelled as stipulated in points b and c of Clause 1 of this Article.

Drug using facilities: Direct contact packaging materials for drugs, including bottles, tubes, jars containing narcotic drugs, psychotropic drugs, and precursor substances used in drugs that are no longer in use must be collected and cancelled as stipulated in points b and c of Clause 1 of this Article.

4. The cancellation of narcotic drugs, psychotropic drugs, precursor substances used in drugs, finished drug combinations containing narcotic active ingredients, finished drug combinations containing psychotropic active ingredients, and finished drug combinations containing precursor substances must be separate from other drugs; ensuring complete safety for people and animals and avoiding environmental pollution according to laws on environmental protection.

Chapter VI

IMPLEMENTING PROVISIONS

Article 21. Implementation Provisions

1. This Circular takes effect from July 15, 2014.

2. Circular No. 10/2010/TT-BYT dated April 29, 2010, guiding activities related to narcotic drugs issued by the Minister of Health, and Circular No. 11/2010/TT-BYT dated April 29, 2010, guiding activities related to psychotropic drugs and precursor substances used in drugs issued by the Minister of Health shall cease to be effective from the date this Circular takes effect.

During the implementation process, if there are difficulties or obstacles, the units are requested to report to the Ministry of Health (Drug Administration) for examination and resolution./.