These Regulations have been established in accordance with Article 37, Paragraph 1 of the Pharmaceutical Affairs Act (hereinafter referred to as “the Act”).

A pharmaceutical personnel, as described in the Regulations, shall mean any legally practicing pharmacist or assistant pharmacist.

Dispensation, as described in the Regulations, shall mean the activities performed by any pharmaceutical personnel that involve prescription verification, prescription registration, assessment of the appropriateness of drug administration, drug preparation or compounding, drug verification, confirmation of the drug recipient, drug handover and instructions for drug administration during the period from the time when the pharmaceutical personnel receives any prescription to the time when the patient acquires the drug.

A pharmaceutical site, as described in the Regulations, shall mean the pharmacy department of any medical institution or any pharmacy established with approval from the competent health authority.

A dispensing site, as described in the Regulations, shall mean any place designed for dispensation of prescriptions and storage of medicines to be prescribed by physicians, dispensing instruments, equipment and other necessary items.

Preparation, as described in the Regulations, shall mean the activities during the dispensing process that involve selection of the correct drug, calculation of the correct quantity, writing or printing information on the drug bag, labeling and packaging in accordance with any prescription.

Compounding, as described in the Regulations, shall mean the activities during the dispensing process that involve changing the original dosage form or creating any new product in accordance with any prescription.

Radiopharmaceutical drugs, as described in the Regulations, shall mean drugs with radioactive substances used in the human body for diagnosis, monitoring, treatment, alleviation of diseases or achieving other medical efficacies after distribution in the body.

All pharmaceutical personnel at any pharmaceutical site shall wear practice licenses.

A pharmaceutical site shall have washing facilities.

A dispensing site shall have an area of at least 6m2 reserved for work performance, and the area shall be clearly separated from other working sites.
The area of 6m2 reserved for work performance, as described in the preceding Paragraph, does not apply to any pharmaceutical site established before October 21, 2002.

A dispensing site shall have a refrigerator or freezer for drugs as needed. The refrigerator and freezer shall be equipped with a thermometer and kept clean.

A medical institution or pharmacy shall keep the source evidences and relevant documents or data of any drugs it dispensed for at least three years.
The documents and data as described in the preceding Paragraph may be kept in electronic form.

Drugs shall be stored based on the storage conditions and be kept away from direct light exposure. Besides, the rodent and insect prevention measures shall be taken.
For drugs that need to be refrigerated or frozen, the storage temperature of the drugs shall be monitored on a daily 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 one year in writing or electronic form.

Medicines to be prescribed by physicians shall not be displayed on open shelves.

The site for drug storage shall be separated from the dispensing site.
No one shall enter the sites for storage and dispensing as described in the preceding Paragraph, unless authorized by the medical institution or pharmacy.

Drugs that have deteriorated, expired, or have been off-the-shelf upon recall shall be labeled and placed at clearly separated positions, and shall be disposed of according to laws and regulations.

Before replenishing any drug, it shall be checked to ensure its consistency with the label on the drug container to be refilled. It shall be checked again after replenishment.

Upon receipt of a prescription, a pharmaceutical personnel shall verify its legality, completeness and the validity of its expiration date.
The prescription verification as described in the preceding Paragraph shall include the following information:
1.Name, age and gender of the patient and the disease he/she suffers from.
2.Name and signature or seal of the prescribing physician, and name, address and telephone number of the medical institution he/she works for; the controlled drug prescription license number if the drug is a controlled drug.
3.Name, dosage form and unit strength of the drug.
4.Quantity or weight of the drug.
5.Instructions for dosage and drug administration.
6.Date of prescription issue.
7.Instructions for refillable prescription.
The instructions for refillable prescription as described in the preceding Paragraph, Subparagraph 7 shall include the frequency and interval of dispensation for a refillable prescription.

The container or package of any drug handed over may not be re-used. Containers with safety caps shall be used when necessary.

A pharmaceutical personnel shall ensure that none of the drugs handed over is beyond the expiration date on the drug label during the treatment of the patient.

When handing over any drug, a pharmaceutical personnel shall verify the correctness of the information contents on the drug bag or label, type of the drug, quantity of the drug and prescription instructions.

When handing over any drug, a pharmaceutical personnel shall make sure that the recipient is the one who handed over the prescription.