Circular No. 10/2010/TT-BYT guiding activities related to addictive drugs

CIRCULAR

Guidelines for activities related to addictive drugs

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Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

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

Pursuant to the Anti-Narcotics Law No. 23/2000/QH10 dated December 19, 2000;

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. 67/2001/NĐ-CP dated October 1, 2001 of the Government on the issuance of lists of narcotic substances and precursors;

Pursuant to Decree No. 58/2003/NĐ-CP dated May 19, 2003 of the Government on the control of importation, exportation, and transit through Vietnam of narcotic substances, precursors, addictive drugs, and psychotropic drugs;

Pursuant to Decree No. 133/2003/NĐ-CP dated November 6, 2003 of the Government supplementing some substances to the list of narcotic substances and precursors issued together with Decree No. 67/2001/NĐ-CP dated October 1, 2001 of the Government;

Pursuant to Decree No. 163/2007/NĐ-CP dated November 12, 2007 of the Government amending the names, supplementing, transferring, and removing some substances from the list of narcotic substances and precursors issued together with Decree No. 67/2001/NĐ-CP dated October 1, 2001 of the Government;

The Ministry of Health guides activities related to addictive drugs used in Vietnam.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. This Circular guides activities related to addictive drugs used in the medical field and in analysis, testing, and scientific research as specified in the List of Addictive Drugs (Annex I, Annex II) issued together with this Circular.

Article 2. Finished drug products containing multiple active ingredients, where the formula includes one addictive ingredient combined with another ingredient (which is not an addictive drug, a psychotropic drug, or a precursor used as a drug), with the addictive ingredient's concentration being equal to or less than the concentration specified in the List of Addictive Drugs in combination form (Annex II) are exempted from implementing certain clauses of this Circular except for the following: Clause 4, point b of Clause 1 of Article 7, Clause 2 of Article 9, Clause 1 and Clause 3 of Article 11, Clause 2 and Clause 4 of Article 12, Article 15, Clause 1 of Article 20.

Article 2. Applicability

This Circular applies to individuals and organizations both inside and outside Vietnam that engage in activities related to addictive drugs used in the medical field and in analysis, testing, and scientific research in Vietnam.

Article 3. Prescription

Prescribing addictive drugs for outpatients shall be carried out in accordance with the "Regulations on Outpatient Drug Prescriptions" issued by the Minister of Health.

Article 4. Drug Labeling

Shall be implemented in accordance with the Circular guiding drug labeling issued by the Minister of Health.

Article 5. Delivery and Receipt

When delivering and receiving addictive drugs: a thorough check must be conducted to verify the drug name, concentration, quantity, production batch number, expiration date, and visual quality; the deliverer and receiver must sign and clearly write their names on the warehouse exit and entry documents.

Article 6. Transportation

Clause 1. During transportation: Addictive drugs must be packaged, sealed, and measures taken to ensure safety, preventing loss during transportation; the packaging must clearly indicate the place of origin, destination, drug name, and quantity.

Clause 2. The head of the facility with addictive drugs must issue a written document assigning a person from the facility to be responsible for transporting the addictive drugs; the person responsible for transporting the addictive drugs must carry the aforementioned document, identity card (or other valid identification), sales invoice, or warehouse exit slip; they are responsible for the type, quantity, and visual quality of the drugs during transportation and must hand over the drugs fully to the person responsible for storing the addictive drugs.

Clause 3. In cases where a drug business entity needs to hire someone to transport addictive drugs: the hiring party and the transportation service provider must enter into a written contract specifying the conditions related to storage, transportation, delivery, and receipt of addictive drugs 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 are responsible for issues related to the transportation of addictive drugs.

Article 7. Reporting

1. Export and Import Reports:

a) Narcotic drugs: Within ten days from the date of export or import, the exporting or importing entity shall report (Form No. 1A, Form No. 1B) to the Ministry of Health (Department of Drug Management) and the Ministry of Public Security (Office for Combating Drugs);

b) Finished narcotic drugs combined as specified in Clause 2, Article 1 of this Circular: Annually, the entity shall report the quantity of exported and imported drugs (Form No. 2A, Form No. 2B) to the Ministry of Health (Department of Drug Management); at the latest by January 15 of the following year.

2. Inventory and Usage Reports:

a) Entities engaged in trading and using narcotic drugs must inventory and prepare reports on the stock of narcotic drugs monthly, every six months, and annually (Form No. 3A, Form No. 3B) to the authority responsible for budget planning and licensing; at the latest by the 15th day of the month following the reporting period (for monthly reports), July 15 (for mid-year reports), and January 15 of the following year (for annual reports);

b) Provincial Departments of Health under central cities shall report annually on the usage of narcotic drugs by entities within their jurisdiction (Form No. 4), while the Military Medical Department of the Ministry of National Defense shall report annually on the usage of narcotic drugs by their sector (Form No. 3A) to the Ministry of Health (Department of Drug Management); at the latest by January 30 of the following year.

3. Emergency Reporting:

Entities engaged in trading and using narcotic drugs must urgently report to the authority responsible for budget planning in cases of error, loss, or suspicion of loss. Upon receiving such urgent reports, the authority responsible for budget planning must conduct an audit and take appropriate measures;

Provincial Departments of Health under central cities must compile and urgently report to the Ministry of Health (Department of Drug Management).

Article 8. Retention of Records and Ledgers

1. Entities engaged in trading, compounding, and dispensing narcotic drugs must record, monitor, and retain records, ledgers, and related documents concerning raw materials for narcotic drugs and finished narcotic drugs after their expiration date for at least two years.

2. After the retention period, the head of the entity shall establish a committee to destroy these records, create a destruction record, and keep it at the entity.

Article 9. Destruction of Drugs

1. Raw materials for narcotic drugs, finished narcotic drugs past their expiration date, substandard drugs, samples retained beyond the retention period, drugs returned from treatment departments, and drugs returned due to patient death must be destroyed. The entity shall carry out drug destruction as follows:

a) Submit a written request for drug destruction to the authority responsible for budget planning. The request must clearly state the name of the drug, concentration-strength, quantity, reason for destruction, and method of destruction. Drug destruction can only be carried out after approval by the authority responsible for budget planning;

b) Establish a drug destruction committee decided by the head of the entity. The committee must consist of at least three members, including a staff member responsible for the entity;

c) Create a drug destruction record and retain it at the entity;

d) After destroying the drugs, submit a report on the destruction to the authority responsible for budget planning (with the attached destruction record).

2. By-products and waste generated during the production of narcotic drugs that need to be destroyed must be collected and destroyed according to the provisions of points b and c of Clause 1 of this Article.

3. Unused direct packaging for narcotic drugs must be collected and destroyed according to the provisions of points b and c of Clause 1 of this Article.

4. The destruction of narcotic drugs must be separate from other drugs; it must ensure thoroughness, safety for people and animals, and prevent environmental pollution in accordance with laws on environmental protection.

Article 10. Compounding and Using Narcotic Drugs at Research and Training Institutions in the Medical and Pharmaceutical Field

1. Research and training institutions in the medical and pharmaceutical field may compound and use narcotic drugs for teaching and scientific research purposes; they must have a university pharmacist supervise the compounding process and be responsible for recording the compounding logbook, narcotic drug entry and exit logbook, and reporting in accordance with the provisions of this Circular.

2. Once compounded, narcotic drugs must be immediately packaged and labeled to avoid confusion. The label must contain at least the following information: name of the institution, name of the drug, preparation form, active ingredient, concentration or quantity, volume, preparer, supervisor, date of compounding.

3. Narcotic drugs must be stored in a separate cabinet; equipped with safety devices and measures to prevent loss.

Chapter II

TRAFFICKING IN NARCOTIC DRUGS

Article 11. General Principles

1. Production, export, import, wholesale, and retail establishments of narcotic drugs must meet the conditions for drug trading as stipulated in Chapter II of the Drug Law and Chapter IV of Decree No. 79/2006/NĐ-CP dated August 9, 2006, detailing certain provisions of the Drug Law, and comply with the provisions of this Circular.

2. Establishments dealing in narcotic drugs must develop and implement standard operating procedures (SOPs) in writing for all professional activities appropriate to each type of business so that relevant employees can apply them; at minimum, the following procedures must be included:

a) Export, import, purchase, and sale of narcotic drugs;

b) Storage of narcotic drugs;

c) Delivery, transportation of narcotic drugs;

d) Destruction of narcotic drugs (raw materials, finished products, residues, waste, direct packaging).

The development of SOPs must comply with the following requirements:

- Ensuring safety, preventing loss of narcotic drugs;

- Each stage must have handover records, signed confirmations to clearly define the responsibility of each individual in each stage;

3. All individuals involved in the trafficking of narcotic drugs must undergo initial and continuous training on regulatory documents and standard operating procedures related to narcotic drugs; training records must be kept at the establishment.

4. Storage: Production, export, import, and wholesale establishments must have warehouses meeting Good Storage Practice (GSP) standards issued by the Ministry of Health; among which, the warehouse storing narcotic drugs must be securely locked, with safety measures to prevent loss. If there is no separate warehouse, narcotic drugs must be stored in a designated area within a GSP-compliant warehouse, securely locked, and with safety measures to prevent loss.

Article 12. Production

1. Annually, the Ministry of Health (Drug Administration Department) will base on actual circumstances to issue a list of establishments permitted to produce narcotic drugs.

2. Establishments producing narcotic drugs must comply with the following regulations:

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

b) Personnel:

- Warehouse manager: university pharmacist;

- Supervisor of the research, production, analysis, and testing processes, and responsible for recording and reporting systems: university pharmacist with at least two years of practice experience at the drug-producing establishment;

c) Documents and record books:

- Narcotic drug compounding logbook (Form No. 5);

- Narcotic drug entry and exit tracking logbook (Form No. 6A);

- Narcotic drug finished product combination form tracking logbook as stipulated in Clause 2 of Article 1 of this Circular (Form No. 6B);

- Narcotic drug warehouse dispatch slip (Form No. 7);

3. Scope of operation of narcotic drug production establishments:

a) Purchase and import raw materials for producing drugs containing narcotic substances for their own enterprise;

b) Export narcotic drugs produced by their own enterprise;

c) Sell narcotic drug finished products produced by themselves to establishments specified in Clause 1 of Article 13 of this Circular.

4. When there is a need for raw materials for researching and producing new items for registration, the establishment must submit a request for purchasing/importing raw materials (Form No. 8A), and report in detail the quantity of raw materials used for research and trial production (Form No. 8B).

Article 13. Export, Import - Wholesale

1. The Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, Central Pharmaceutical Company 3, Saigon Pharmaceutical Company, Ho Chi Minh City Medical and Health Import-Export Joint Stock Company (YTECO), Hanoi Pharmaceutical and Medical Equipment Joint Stock Company (HAPHARCO) shall be responsible for supplying raw materials and finished narcotic drugs to business establishments and users throughout the country.

2. Personnel: The warehouse manager must be a university graduate pharmacist.

3. Documents and ledgers:

a) Narcotic drug import/export tracking book (Form No. 6A);

b) Narcotic drug export warehouse release form (Form No. 7);

c) Relevant documents related to the export, import, purchase, and sale of narcotic drugs.

4. Scope of Activities:

a) Exporting and importing raw materials and finished narcotic drugs;

b) Purchasing narcotic drugs from production establishments;

c) Selling finished narcotic drugs to wholesale and retail establishments, healthcare facilities, research centers, specialized medical training institutions, and detoxification centers nationwide;

d) Selling raw materials for narcotic drugs to permitted production and compounding establishments.

5. Provincial and centrally-administered city pharmaceutical companies (including state-owned enterprises and state-owned enterprises after shareholding reform) may purchase finished narcotic drugs from the pharmaceutical companies specified in Clause 1 of this Article to supply healthcare facilities, research centers, specialized medical training institutions, and detoxification centers within their jurisdiction.

6. University graduate pharmacists directly engage in the wholesale of narcotic drugs.

Article 14. Retail

1. The Department of Health of provinces and centrally-administered cities shall be responsible for organizing and directing pharmacies to provide sufficient finished narcotic drugs to meet the needs of outpatients on their territory.

2. Pharmacies selling narcotic drugs must meet good pharmacy practice standards (GPP).

3. The university graduate pharmacist owner of the pharmacy shall directly manage and sell narcotic drugs at retail.

4. Storage: Narcotic drugs must be stored in a separate locked cabinet with safety measures to prevent loss.

If the quantity of narcotic drugs is small, they may be stored together with psychotropic drugs and precursors used as medicines but must be kept in separate compartments to avoid confusion; they must be securely locked and have safety measures to prevent loss.

5. Documents and ledgers:

a) Narcotic drug import/export tracking book (Form No. 6A);

b) Narcotic drug export warehouse release form from the supplier;

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;

5. Scope of operation:

a) Purchase and sell finished narcotic drugs at retail according to the prescription regulations for outpatient treatment;

b) Not allowed to purchase or sell raw materials for narcotic drugs.

Chapter III

PREPARATION, DISTRIBUTION, USE, AND STORAGE OF NARCOTIC DRUGS

AT HEALTHCARE FACILITIES AND DETOXIFICATION CENTERS

Article 15. Preparation

1. Healthcare facilities that compound narcotic drugs must arrange a preparation area meeting the following conditions:

- Having an emergency resuscitation room;

- Preparation room: has dust-proof ceiling, floor and wall made of easy-to-clean material, capable of sterilization when necessary. The room must be built in a well-ventilated, isolated, safe location away 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;

- Must have appropriate equipment for compounding, storing, and testing drugs;

b) Personnel: The supervisor responsible for record-keeping, reporting, quality control, and post-compounding management of narcotic drugs must be a university graduate pharmacist.

c) Packaging, labeling, storage:

- Compounded narcotic drugs must be immediately packaged and labeled to avoid confusion. The label must include at least the following information: name of establishment, drug name, dosage form, active ingredient, concentration or content, preparer, supervisor, date of preparation;

- Compounded narcotic drugs must be stored in a separate cabinet; safety measures and equipment must be in place to ensure security and prevent loss;

d) Files and ledgers:

- Narcotic drug compounding logbook (Form No. 5);

- 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 based on prescriptions for patients undergoing inpatient and outpatient treatment at the same facility;

b) Only drugs with approved formulas, compounding processes, and quality standards by the head of the facility, who is responsible for the safety and efficacy of the drugs, may be compounded.

c) Injectable drugs cannot be compounded.

Article 16. Issuance and Use

1. The Pharmacy Department shall issue narcotic drugs to treatment departments based on the Narcotic Drug Withdrawal Form (Form No. 9) and directly issue drugs to outpatients undergoing treatment. The Head of the Pharmacy Department or a licensed pharmacist authorized in writing by the department head shall sign off on the withdrawal forms for treatment 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.

Any surplus narcotic drugs not used up or returned by patients due to hospital transfer or death must be returned to the Pharmacy Department with a return certificate. The Head of the Pharmacy Department shall decide on reusing or destroying such drugs according to regulations based on specific conditions and record this in the Pharmacy Department's logbook;

The Pharmacy Department must monitor and record in detail the quantities of narcotic drugs issued, received, and stored (Form No. 6A).

2. For direct duty drug cabinets and emergency drug cabinets in departments within healthcare facilities that use narcotic drugs: the duty nurse shall keep and issue narcotic drugs based on medical orders. When changing shifts, the duty nurse from the previous shift must hand over the drugs and the monitoring logbook to the duty nurse of the next shift.

3. Detoxification Centers: if there is no licensed pharmacist, the Center Director shall authorize in writing (no more than 12 months each time) a pharmacy technician to receive, manage, and issue narcotic drugs.

Article 17Storage

1. Storage of narcotic drugs at the Pharmacy Department:

a) Physical infrastructure: Narcotic drugs must be stored in warehouses in compliance with good storage practices for pharmaceuticals; the Pharmacy Department of hospitals must implement the "Good Storage Practices" (GSP) principles as stipulated by the Ministry of Health;

Warehouses and cabinets storing narcotic drugs must have secure locks and be equipped appropriately to ensure safety and prevent loss. If separate warehouses or cabinets are unavailable, narcotic drugs may be stored together with psychotropic drugs and precursors but must be arranged separately to avoid confusion.

b) Warehouse Manager: a licensed pharmacist or pharmacy technician authorized in writing (the head of the facility authorizes in writing, each authorization not exceeding 12 months).

2. Storage of narcotic drugs at direct duty drug cabinets and emergency drug cabinets:

Narcotic drugs in direct duty drug cabinets and emergency drug cabinets must be kept in a separate compartment or drawer with a secure lock. The quantity and types of narcotic drugs stored in these cabinets are determined in writing by the head of the facility.

Chapter IV

RECORDS AND PROCEDURES FOR FORECASTING, PURCHASING, EXPORTING, AND IMPORTING

Article 18. Forecasting

1. Annually, businesses and entities using narcotic drugs must prepare forecasts for purchasing narcotic drugs (Form No. 10). The forecast must be made in four copies (the approving authority retains two copies, the entity retains one copy, and the seller retains one copy).

2. Businesses and entities using narcotic drugs are only permitted to purchase, sell, issue, and use narcotic drugs when their forecast has been approved according to Article 19 of this Circular.

3. The head of the entity is responsible for the quantity of narcotic drugs forecasted; the quantity of narcotic drugs must match the entity's usage needs; if the forecasted quantity exceeds 50% compared to the previous period's usage: the entity must clearly explain the reasons;

In cases where the purchased quantity of narcotic drugs based on the forecast does not meet the needs, entities can supplement the forecast and provide clear explanations.

4. Within seven working days of receiving a valid forecast, the approving authority will review and approve the forecast or issue a letter explaining the reasons for disapproval.

Article 19. Approval of Procurement Plans

1. The Ministry of Health (the Drug Administration Department):

a) Approves procurement plans for narcotic raw materials for pharmaceutical production facilities, healthcare facilities, research facilities, and specialized medical-pharmaceutical training institutions;

b) Approves procurement plans for finished narcotic drugs for facilities specified in Clause 1, Article 13 of this Circular;

c) Approves procurement plans for narcotic drugs for entities not under the health sector's management but with a need to purchase narcotic drugs for scientific research. When preparing the procurement plan, the entity must submit a letter explaining the reasons and obtain confirmation from the head of the agency at the Bureau or Department level or higher with direct management authority;

d) Approves procurement plans for finished narcotic drugs for the Military Medical Service - Ministry of National Defense.

2. Provincial/Municipal Health Departments approve procurement plans for finished narcotic drugs for wholesale and retail drug facilities, healthcare facilities, research facilities, specialized medical-pharmaceutical training institutions, and detoxification centers within their jurisdiction. Depending on each locality, the Health Department may delegate or authorize district, county, or town health offices or district, county, or town health centers (if they have pharmaceutical professionals) to approve procurement plans for finished narcotic drugs for commune, ward, or town health stations.

3. The Military Medical Service - Ministry of National Defense approves procurement plans for finished narcotic drugs for hospitals and units under the Ministry of National Defense.

4. The head of the treatment department and the outpatient clinic director sign off on the requisition form for narcotic drugs for their respective departments (Form No. 9). The head of the pharmacy department signs off on the requisition form for narcotic drugs for the pharmacy's on-call shift.

Article 20. Documentation and Procedures for Export and Import Permits

1. Documentation and procedures for export and import permits for narcotic drugs shall be carried out in accordance with the current Circular guiding the export and import activities of drugs and direct contact drug packaging issued by the Ministry of Health.

2. Export and import permits for narcotic raw materials and finished narcotic drugs are issued for each import or export transaction and are valid for a maximum period of 01 year from the date of issuance.

3. Export and import permits are sent to the enterprise applying for import or export; the Office of the Permanent Secretariat of Vietnam Anti-drug Agency, the Customs Sub-Department at the border gate where the export or import procedures are conducted; the Ministry of Finance; the International Narcotics Control Board; and the regulatory authority of the importing country (for export permits).

4. Narcotic raw materials and finished narcotic drugs can only be exported or imported through international border gates of Vietnam.

Chapter V

INSPECTION - AUDIT - VIOLATION HANDLING

Article 21Inspection, audit

1. The Drug Administration Department and the Ministry of Health Inspectorate organize inspections and audits of the implementation of this Circular according to their authority over organizations and individuals involved in activities related to narcotic drugs on the territory of Vietnam.

2. Provincial/Municipal Health Departments are responsible for inspecting and auditing the implementation of this Circular within their jurisdiction.

Article 22.

Any violation of this Circular will be subject to administrative penalties or suspension, revocation of licenses, or criminal prosecution depending on the severity and nature of the violation as stipulated by law.

Chapter VI

IMPLEMENTING PROVISIONS

Article 23. Implementation Organization

For pharmacies belonging to enterprises specified in Clause 5, Article 13 of this Circular, if they do not yet have a bachelor-level pharmacist, the head of the facility may authorize a diploma-level pharmacist in writing to sell finished narcotic drugs until the mandatory implementation deadline for the "Good Pharmacy Practice" principles and standards as prescribed by the Ministry of Health.

Article 24. Effective Date

1. This Circular takes effect 45 days from the date of signature. Decisions No. 2033/1999/QD-BYT dated July 9, 1999, of the Minister of Health on the issuance of the Regulation on Narcotic Drug Management, List of Narcotic Drugs, and Combined Narcotic Drug List, and Decision No. 1442/2002/QD-BYT dated April 25, 2002, of the Minister of Health amending and supplementing certain Articles of the Narcotic Drug Management Regulation issued together with Decision No. 2033/1999/QD-BYT dated July 9, 1999, of the Minister of Health are hereby repealed.

2. The Drug Administration Department, subordinate units of the Ministry of Health, Provincial/Municipal Health Departments, Vietnam Pharmaceutical Corporation; organizations and individuals engaged in activities related to narcotic drugs and foreign organizations and individuals supplying narcotic drugs to Vietnam; healthcare facilities, research facilities, and specialized medical-pharmaceutical training institutions are responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, the relevant units are requested to report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.