Circular No. 30/2021/TT-BYT stipulates the compounding activities for treating patients at medical examination and treatment facilities.

CIRCULAR

Regulations on compounding medicines

for treating patients at medical examination and treatment facilities

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Medical Examination and Treatment,

The Minister of Health issues this Circular to regulate the compounding of medicines for treating patients at medical examination and treatment facilities.

Article 1. Scope of Regulation

1. This Circular stipulates principles and technical standards to ensure good practice in compounding medicines (excluding traditional herbal medicines, traditional medicines, and traditional medicine ingredients) for treating patients at medical examination and treatment facilities.

2. This Circular does not regulate the preparation of powdered injection drugs and the mixing of injection drugs with infusion solutions by nursing staff according to doctors' prescriptions in treatment rooms for immediate use on patients.

Article 2. Scope of Compounding Medicines Activities

1. Compounding medicines activities to meet the treatment needs of patients at medical examination and treatment facilities (hereinafter referred to as the facility) must be consistent with the approved scope of medical examination and treatment activities according to the laws on medical examination and treatment.

2. Compounding medicines from raw materials when such medicines have not been registered for circulation in Vietnam or have been registered but are not supplied or insufficiently supplied to meet treatment needs.

3. Compounding from finished medicines when diluting drug concentrations, mixing different types of drugs, pre-dividing doses, combining dilution with mixing, dilution with dose division, changing dosage forms according to treatment requirements.

Article 3. Scope of Responsibilities of the Person in Charge, Direct Compounder, and Quality Control Inspector

1. The person in charge of compounding medicines is responsible for organizing and supervising all activities related to compounding medicines at the facility, reviewing all compounding records and quality control records before, during, and after compounding. The facility assigns this task to individuals with a bachelor's degree or higher in pharmacy.

2. The direct compounder is responsible for compounding medicines according to approved formulas, ensuring compliance with compounding instructions and mandatory conditions regarding compounding, hygiene, and safety, completing compounding records and quality control before dispensing the medicines. The facility assigns this task to individuals with a bachelor's degree or higher in pharmacy for cases specified in Clause 2, Article 2 of this Circular and for compounding finished medicines that are controlled substances, and assigns this task to individuals with an associate degree or higher in pharmacy for cases specified in Clause 3, Article 2 of this Circular.

3. The quality control inspector is responsible for ensuring the implementation of quality control and supervision of medicines according to quality assurance regulations and procedures, testing the quality of medicines according to approved quality standards. The quality control inspector cannot simultaneously be the person in charge or the direct compounder. The facility assigns this task to individuals with a bachelor's degree or higher in relevant fields (chemistry, biochemistry, pharmacy, microbiology).

4. The direct compounders and quality control inspectors at the facility are trained to understand and grasp the regulations and procedures for compounding medicines and quality control at the facility.

Article 4. Compounding, Storage, and Testing Areas for Medicines

1. The compounding, storage, and testing areas for medicines shall be designed in accordance with the scale of compounding, storage, and testing activities (if applicable). Specialized compounding areas for toxic and radioactive medicines must be arranged to minimize risks of exposure to compounding personnel. Specifically as follows:

a) Separate spaces with appropriate sizes for compounding activities shall be provided.

b) The layout shall follow a logical sequence corresponding to the compounding process, designed on a unidirectional principle, facilitating cleaning, maintaining hygiene conditions, repair, maintenance, and ensuring microbial control and cross-contamination prevention.

c) Temperature, humidity, and lighting conditions shall be maintained according to the requirements of each type of compounded medicine. Temperature and humidity conditions shall be monitored and recorded thoroughly. Lighting equipment shall be installed and checked to ensure adequate illumination for all compounding activities.

d) A clean water supply shall be maintained.

đ) Refer to the World Health Organization's Good Manufacturing Practice principles and standards regarding cleanroom levels and air pressure to ensure microbial control in the compounding area and protect healthcare workers from exposure.

e) Specialized compounding areas for toxic and radioactive medicines shall be labeled with warning signs and appropriate signage.

2. Raw materials, semi-finished products, and finished compounded medicines shall be stored separately in warehouses according to the requirements of each type of raw material, semi-finished product, and finished compounded medicine. If the facility does not have such conditions, they may be stored in separate areas within the warehouse.

3. Quality Testing Area

a) A separate space isolated from the compounding area, with suitable size and design to control microbial contamination, prevent confusion, cross-contamination, and facilitate operations, sample storage, reference substances, solvents, reagents, and testing records.

b) Biological and microbiological testing areas shall be separated and equipped with independent air handling systems.

c) Adequate equipment, tools, chemicals, solvents, and reagents shall be provided to test quality parameters of raw materials, semi-finished products, and finished products.

Article 5. Management and Use of Equipment and Tools for Medicine Compounding

1. Appropriate equipment and tools for each type of compounded medicine.

2. Compounding equipment and tools shall be regularly maintained according to the manufacturer's recommendations, ensuring safe use, preventing microbial contamination, dust accumulation, and avoiding impacts on medicine quality.

3. Scales and measuring devices shall be calibrated, calibration results shall be recorded and stored in accordance with Circular No. 07/2019/TT-BKHCN dated July 26, 2019, amending and supplementing certain provisions of Circular No. 23/2013/TT-BKHCN dated September 26, 2013, issued by the Minister of Science and Technology on metrology for Group 2 measuring instruments.

4. The facility shall issue guidelines for the use, cleaning, and maintenance of equipment and tools, following instructions and fully documenting usage logs.

5. Defective or unused equipment shall be removed from the compounding area.

Article 6. Ensuring Sanitation

1. The facility must have regulations and procedures for sanitation and ensure their full implementation. These regulations and procedures must be reviewed periodically and approved by the head of the facility.

2. Regulations, procedures, and methods for sanitation in the compounding area

a) Sanitation for equipment must be appropriate to the requirements of each level of maintaining a clean environment, type of equipment, and compounding process.

b) Measures for regularly handling waste from the compounding section, waste containers must be clearly marked, emptied and cleaned at least once a day.

c) The contents of sanitation regulations and procedures must be suitable for sanitation before or after compounding, changing batches, or types of drugs.

3. Personal hygiene requirements

a) Staff working in the compounding sections must be trained on hygiene practices and compliance with the facility's sanitation procedures and regulations, ensuring the hygiene conditions of the compounding area, equipment, tools, and personal hygiene.

b) Protective clothing for staff during compounding includes: protective goggles, powder-free surgical gloves, single-use waterproof coveralls with long sleeves covering the wrists, hairnets, masks, and shoe covers.

Article 7. Establishing Regulations, Procedures, Recording, and Storing Documentation on Drug Compounding

1. Establishing regulations and procedures to ensure drug quality

a) The facility bases its compounding procedures and quality assurance regulations on drug management regulations, labeling, medical waste management, and Good Manufacturing Practice principles and standards set by the World Health Organization.

b) The compounding procedure includes basic elements such as the compounding formula, raw material standards and requirements, compounding process, packaging, inspection, control during compounding, finished product quality standards, labeling, and storage.

c) Compounding regulations and procedures for ensuring drug quality must be reviewed and approved by the facility’s drug committee (if available) and then approved by the facility head.

2. Quality standards for drug compounding as stipulated in Clause 2, Article 2 of this Circular

a) The facility must apply quality standards (either internal standards or the Vietnamese Pharmacopoeia or another reference pharmacopoeia) for all compounded drugs.

b) Quality standards must meet regulatory requirements for drug quality management and be approved by the facility head or authorized to be implemented.

3. Compounding records

a) A compounding record must be established for each compounding session, including the name of the drug, concentration, quantity of the product, compounding date, compounding formula, quantity of finished products, compounding personnel, and quality inspection personnel.

b) Compounding records must clearly indicate the time and be signed off by the compounding personnel and quality inspection personnel, and kept at the workplace. Compounding records must be stored for at least one year after the drug's expiration date.

Article 8. Quality Control During Drug Compounding

1. For drug compounding as specified in Clause 2, Article 2 of this Circular, quality control during compounding shall be carried out as follows:

a) Raw materials used for compounding must be of assured quality (within their shelf life, accompanied by test certificates and invoices allowing traceability).

b) Packaging materials and printed labels must be stored separately and issued according to compounding needs.

c) Semi-finished products awaiting packaging must be labeled and stored according to regulations until quality testing is completed before proceeding to subsequent steps.

d) Compounding process control - Control in the raw material weighing area: Before weighing and issuing raw materials, environmental conditions regarding sanitation, temperature, and humidity must be checked to ensure the weighing and issuance areas are clean and accurate. Sterile materials must be weighed and issued in sterile areas; - Control during compounding activities: The number of compounding staff must be appropriate, and measures must be taken to monitor all compounding operations. Staff must wear protective gear as required to perform compounding tasks, and the environment and compounding conditions must comply with regulations. All compounding equipment must be inspected for cleanliness before use throughout the compounding process. All raw materials, semi-finished product packaging, precision instruments, packaging rooms, and lines in use must be labeled with the name of the compounded drug and batch number. Inspection, control, and recording of all testing results during compounding and environmental control must be conducted according to the compounding procedure.

đ) Labeling and packaging activity control: Directly control packaging materials and pre-printed labels before compounding, labeling, and packaging activities must be physically separated to prevent confusion between products and packaging materials, and separate secure storage areas must be arranged for finished products awaiting release.

2. For drug compounding as specified in Clause 3, Article 2 of this Circular, compounding process control shall be carried out as follows:

a) Finished products before being compounded must be visually inspected for quality and still within their shelf life.

b) Compounding, packaging, and labeling process control shall be performed by one person compounding and another person inspecting.

Article 9. Quality Testing of Compounded Medicines

1. Compounded medicines specified in Clause 2, Article 2 of this Circular, if compounded in batches, shall be subject to 100% quality testing for each batch according to the quality standards approved by the head of the establishment.

2. The establishment may conduct its own testing or send samples for testing at another legally authorized medicine testing facility.

Article 10. Compounding and Dosing of Radioactive Medicines Permitted for Use at the Establishment

1. The compounding and dosing of radioactive medicines must comply with the provisions set forth in Articles 3, 4, 5, 6, 7, 8, and 9 of this Circular.

2. The person responsible for compounding, those directly involved in compounding, and those conducting quality checks on radioactive medicines and radionuclides must have been trained in radiation safety, possess the necessary expertise and vocational skills, and fully adhere to all legal regulations in the field of atomic energy.

3. The compounding and dosing of radioactive medicines must be carried out at an establishment holding a Radiation Work Permit, implementing regulations concerning radiation control and ensuring radiation safety during occupational and public exposure as stipulated in Circular No. 19/2012/TT-BKHCN dated November 8, 2012, issued by the Minister of Science and Technology regarding radiation control and ensuring radiation safety during occupational and public exposure.

4. The compounding and dosing areas must be designed and equipped with radiation protection devices and apply radiation safety measures as prescribed in Joint Circular No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014, and Circular No. 13/2018/TT-BKHCN dated September 5, 2018, amending and supplementing certain articles of Joint Circular No. 13/2014/TTLT-BKHCN-BYT of the Minister of Science and Technology and the Minister of Health regarding ensuring radiation safety in healthcare.

5. Simultaneous compounding with other medicines is prohibited to avoid contamination, confusion, and loss.

6. Radioactive medicines after compounding must be labeled and clearly marked with the following information: name of the establishment, address of the establishment, date of production, name of the medicine, radionuclide, chemical form, total radioactivity, date of radioactivity measurement, carrier substance, preparer, batch number of preparation, volume of the radiopharmaceutical solution if it is in liquid form, expiration date, and other information required by law for drug labeling.

7. Radioactive medicines after compounding, dosing, and passing quality checks must be packaged, stored in specialized lead containers, and kept in separate areas with measures and equipment to ensure radiation safety and nuclear security as prescribed by law on ensuring radiation safety.

8. Establishments compounding radioactive medicines must maintain and retain records of the disposal of unused compounded radioactive medicines along with the handling methods as prescribed in Circular No. 22/2014/TT-BKHCN dated August 22, 2014, issued by the Minister of Science and Technology regarding the management of radioactive waste and used radioactive sources.

Article 11. Effective Date

1. This Circular takes effect from March 1, 2022.

2. Repeal Clause 3, Article 4, Article 12, and Article 18 of Circular No. 22/2011/TT-BYT dated June 10, 2011, issued by the Minister of Health regarding the organization and operation of hospital pharmacy departments from the effective date of this Circular.

Article 12. Transitional Provisions

1. Establishments currently compounding medicines in accordance with Clause 3, Article 2 of this Circular may continue compounding and must fully comply with the provisions of this Circular before January 1, 2023.

2. Establishments currently compounding medicines in accordance with Clause 2, Article 2 may continue compounding and must fully comply with the provisions of this Circular before June 1, 2023.

3. For raw materials for compounding medicines within the scope of compounding medicines as specified in Clause 2, Article 2 of this Circular that were already in stock at the establishment prior to the effective date of this Circular, the establishment may continue compounding medicines until the raw material stock is exhausted within twelve months from the effective date of this Circular.

Article 13. Reference Provisions

In cases where referenced documents in this Circular are replaced or amended, they shall be applied according to the replacing or amended documents.

1. The Minister, Heads of Ministries equivalent to ministries, Heads of government agencies, Chairmen of provincial People's Committees under the central government, and related agencies, units, and individuals are responsible for implementing this Circular.

1. The Department of Medical Examination and Treatment under the Ministry of Health is responsible for guiding, organizing implementation, inspecting, and evaluating the implementation of this Circular.

2. Provincial Departments of Health under centrally governed cities and health departments under ministries and sectors are responsible for organizing implementation, inspecting, and evaluating the implementation of this Circular within their respective jurisdictions.

3. Establishments compounding medicines are responsible for:

a) Issuing a list of compounded medicines serving treatment needs at the establishment;

b) Issuing compounding procedures for medicines listed in the compounded medicines list at the establishment;

c) Accounting for costs to determine and publicly disclose the price of compounded medicines in accordance with regulations;

d) Submitting annual reports on the organization of compounding medicines at the establishment, including the list of compounded medicines, quantity of finished products sent to the direct health administration body (Ministry of Health, Provincial Department of Health, Health Bureau of the Ministry of Public Security, Military Hospital Bureau of the Ministry of National Defense) by January 15 of the following year.

4. The Director of the Office of the Ministry, the Inspector General of the Ministry, the Heads of the General Departments, Bureaus, and Divisions under the Ministry of Health, the Directors of Provincial Departments of Health under centrally governed cities, and related agencies, organizations, and individuals are responsible for implementing this Circular. Any difficulties or issues encountered during implementation should be promptly reported to the Ministry of Health (Department of Medical Examination and Treatment) for consideration and resolution.

Any difficulties or issues encountered during implementation should be promptly reported to the Ministry of Health (Department of Medical Examination and Treatment) for consideration and resolution./.