A medical institution or pharmacy may set up the following site with clearly separated independent spaces:
1. Sites for dispensing and storage of radiopharmaceutical drugs.
2. Sterile compounding sites.

Vaccines, blood products or other special drugs announced by the central competent health authority shall be stored in separate layers and shelves, with clearly labeled names of the drugs.

During the period after any drug is unpacked and before it is dispensed, a pharmaceutical personnel shall pay attention to the packaging materials and storage conditions for the professionally packaged drug. The label shall indicate the name, unit strength and expiration date of the drug.

No drug compounded by a medical institution or pharmacy shall have the same active ingredients, contents and dosage form as any licensed pharmaceutical preparation.
However, under any of the following circumstances, the foregoing limitation shall not apply as long as it is determined as necessary by any physician through clinical assessment:
1. Where the drug is announced in shortage by the central competent health authority, and compounding thereof is suggested.
2. Where the drug has the same active ingredients, contents and dosage form as any licensed pharmaceutical preparation which does not contain any preservatives.
3. Where positron emission tomography drugs are compounded by a medical institution in accordance with the Regulations on Good Practices for Positron Emission Tomography Drug Dispensation.

A medical institution or pharmacy shall perform compounding with pharmaceutical preparations manufactured or imported upon approval by the central competent health authority.
For the compounding as described in the preceding Paragraph, as long as it meets the following requirements announced by the central competent health authority, the source of compounded drug may not be limited to the pharmaceutical preparations:
1. Name of the compounded drug.
2. Name, content and quality specifications of the active ingredients.
3. Specifications for compounding personnel and the environment.
For those not compounded with pharmaceutical preparations as described in the preceding Paragraph, the medical institution or pharmacy shall report the quantity of each compounded item to the central competent health authority each year.

A medical institution or pharmacy that performs compounding shall take relevant measures on the following matters:
1. Safety protection for compounding personnel.
2. Prevention of compounding errors.
3. Prevention of cross-contamination.

Any measuring instrument used by a medical institution or pharmacy to perform compounding shall be maintained and calibrated on a regular basis, and records shall be made accordingly.
The records as described in the preceding Paragraph shall be kept by the medical institution or pharmacy for at least three years in writing or electronic form.

A medical institution or pharmacy shall establish standard operating procedures for compounding.
The standard operating procedures as described in the preceding Paragraph shall include the following matters:
1. Steps in the compounding process.
2. Confirmation of the correctness of the compounding process.
3. Making and keeping records of the compounding process.

A pharmaceutical personnel shall perform compounding practice in accordance with the procedures as described in the preceding Article, Paragraph 1 and make records accordingly; the contents of the records shall include the following matters:
1. Name of the compounding pharmaceutical personnel.
2. Date of compounding.
3. Name and quantity of the drugs used for the compounding.
4. Quantity of the finished compounded drugs.
The records as described in the preceding Paragraph shall be kept by the medical institution or pharmacy for at least three years in writing or electronic form.

When performing compounding, a pharmaceutical personnel shall complete appropriate training as required for the compounding practice, and shall be evaluated as competent for the operation by the medical institution or pharmacy with which such pharmaceutical personnel serves. The training shall include standard operating procedures for compounding.
The implementation time and contents of the training and evaluation as described in the preceding Paragraph shall be made into records and the records shall be kept in writing or electronic form for at least three years by the medical institution or pharmacy.

A pharmaceutical personnel shall label the following information on the container or package of any compounded drug:
1. Name of the drug.
2. Date of compounding.
3. Beyond-use date.
4. Storage conditions.
For any compounded drug that is not used in any medical institution, the name and unit strength of each drug used for compounding shall also be labeled.

When handing over a compounded drug, the pharmaceutical personnel shall inform the recipient that the drug is compounded according to the prescription, or label the information on the container or package of the drug as described in the preceding Article.

A medical institution or pharmacy that performs sterile compounding shall apply for approval from the central competent health authority before practice. However, this provision shall not apply to those hospitals that have qualified for the accreditation in accordance with the Medical Care Act.

The application form and following documents and data are required for the application as described in the preceding Article:
1. A photocopy of the practice license of the medical institution or the pharmacy license.
2. The following master file about the sterile compounding site:
(1)Facilities and equipment.
(2)Records of training and evaluation of personnel engaged in sterile compounding.
(3)Standard operating procedures related to sterile compounding.
(4)Records of environmental cleaning, disinfection and monitoring.
3. Other documents and data designated by the central competent health authority.

The air cleanliness of any sterile compounding site of a medical institution or pharmacy shall meet the following requirements in accordance with the ISO 14644-1 international standard:
1.Sterile compounding areas:
(1)For central intravenous nutrition infusion: at least ISO class 7.
(2)For drugs other than those listed above: at least ISO class 8.
2.Sterile laminar airflow workbenches: at least ISO class 5.

When a medical institution or pharmacy performs sterile compounding, those involved in aseptic manipulations shall operate within a sterile laminar airflow workbench.

A medical institution or pharmacy that performs sterile compounding shall establish standard operating procedures for personnel cleaning and garbing, including the provision that the personnel shall wear hygiene clothes, caps and gloves when entering the sterile compounding area.
Those entering the sterile compounding area shall follow the standard operating procedures as described in the preceding Paragraph.

A medical institution or pharmacy that performs sterile compounding shall establish standard operating procedures for the following matters regarding its sterile compounding areas and sterile laminar airflow workbenches respectively, and implement them in accordance with the prescribed procedures:
1. Airborne particle monitoring.
2. Microbiological monitoring.
3. Environmental cleaning and disinfection.
When a medical institution or pharmacy implements the matters as described in the preceding Paragraph, the records shall be made accordingly and be kept for at least three years in writing or electronic form.

When a medical institution or pharmacy dispenses any radiopharmaceutical drugs, its personnel, materials, facilities and equipment shall comply with provisions under the Ionizing Radiation Protection Act.

A medical institution or pharmacy shall establish standard operating procedures for dispensing radiopharmaceutical drugs.
The standard operating procedures as described in the preceding Paragraph shall include the following matters:
1. Steps in the dispensing process.
2. Confirmation of the correctness of the dispensing process.
3. Making and keeping records of the dispensing process.

A pharmaceutical personnel shall dispense any radiopharmaceutical drugs in accordance with the procedures as described in the preceding Article, Paragraph 1 and make records accordingly; the contents of the records shall include the following matters:
1. Name of the dispensing pharmaceutical personnel.
2. Date of dispensation.
3. Name and radioactivity of the radionuclide used for the dispensation.
4. Radioactivity and quantity of the finished radiopharmaceutical drugs.
The records as described in the preceding Paragraph shall be kept by the medical institution or pharmacy for at least three years in writing or electronic form.