Regulations on Good Practices for Positron Emission Tomography Drug Dispensation
2025-12-29
手機睡眠
語音選擇
Article 1
These Regulations have been established in accordance with Article 37, Paragraph 1 of the Pharmaceutical Affairs Act.
Article 2
The dispensation of positron emission tomography radiopharmaceuticals (PET drugs) shall comply with these Regulations. Matters not provided for herein shall be governed by the Regulations on Good Practices for Drug Dispensation.
Article 3
The terms used in these Regulations are defined as follows:
I. PET drugs, as described in these Regulations, shall mean drugs containing radionuclides that undergo decay by positron emission and are used for therapy or for tomographic imaging examinations, and that are identical to drugs approved in the Republic of China (Taiwan) or in any of the A10 countries recognized by Taiwan, or positron radiopharmaceuticals listed in the Chinese Pharmacopoeia, the United States Pharmacopeia, or the European Pharmacopoeia.
II. Radioactive positron nuclide generator, as described in these Regulations, shall mean an apparatus capable of immobilizing a parent radionuclide, from which a positron-emitting daughter radionuclide is generated and obtained through elution or other methods, for use in compounding PET drugs.
III. Kit for compounding PET drugs, as described in these Regulations, shall mean a commercial kit that combines all components required for compounding a PET drug, other than the radionuclide.
IV. Dispensation, as described in these Regulations, shall mean the activities performed during the period from the time when the prescription is received to the time when the patient uses the PET drug, including prescription verification, prescription registration, assessment of the appropriateness of the prescription, compounding, re-verification, confirmation of the drug recipient and drug handover, instructions for drug administration, and other related activities.
V. Compounding, as described in these Regulations, shall mean the activities performed in accordance with a prescription that involve changing the original dosage form of a PET drug or creating a new product.
VI. Dispensing site, as described in these Regulations, shall mean any place within a medical institution or a pharmacy where PET drugs are dispensed and stored, and where dispensing instruments, equipment, and other necessary items are kept.
VII. Compounding site, as described in these Regulations, shall mean any place within a medical institution or a pharmacy where PET drugs are compounded.
I. PET drugs, as described in these Regulations, shall mean drugs containing radionuclides that undergo decay by positron emission and are used for therapy or for tomographic imaging examinations, and that are identical to drugs approved in the Republic of China (Taiwan) or in any of the A10 countries recognized by Taiwan, or positron radiopharmaceuticals listed in the Chinese Pharmacopoeia, the United States Pharmacopeia, or the European Pharmacopoeia.
II. Radioactive positron nuclide generator, as described in these Regulations, shall mean an apparatus capable of immobilizing a parent radionuclide, from which a positron-emitting daughter radionuclide is generated and obtained through elution or other methods, for use in compounding PET drugs.
III. Kit for compounding PET drugs, as described in these Regulations, shall mean a commercial kit that combines all components required for compounding a PET drug, other than the radionuclide.
IV. Dispensation, as described in these Regulations, shall mean the activities performed during the period from the time when the prescription is received to the time when the patient uses the PET drug, including prescription verification, prescription registration, assessment of the appropriateness of the prescription, compounding, re-verification, confirmation of the drug recipient and drug handover, instructions for drug administration, and other related activities.
V. Compounding, as described in these Regulations, shall mean the activities performed in accordance with a prescription that involve changing the original dosage form of a PET drug or creating a new product.
VI. Dispensing site, as described in these Regulations, shall mean any place within a medical institution or a pharmacy where PET drugs are dispensed and stored, and where dispensing instruments, equipment, and other necessary items are kept.
VII. Compounding site, as described in these Regulations, shall mean any place within a medical institution or a pharmacy where PET drugs are compounded.
Article 4
Where a medical institution or pharmacy dispenses PET drugs and performs compounding, it shall, depending on the items to be compounded, complete an application form and submit it to the central competent health authority with the following documents and data:
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs:
(1) A photocopy of the practice license of the medical institution or the pharmacy license.
(2) Basic information on the compounding site (Site Master File).
(3) Documentary proof that the personnel performing compounding have received aseptic operation training; and documentary proof of ionizing radiation protection training as designated by the Nuclear Safety Commission.
(4) Quality control data for raw materials, including their sources and specifications.
(5) A complete compounding process flow and corresponding record formats, with critical process steps clearly identified.
(6) A validation plan for critical process steps; for sterile drug preparations, a sterilization validation plan shall also be provided.
(7) Compounding records for three consecutive batches.
(8) The formula composition and content of the finished dosage form.
(9) Product testing specifications and the basis on which such specifications are established.
(10) Analytical methods and method validation data. Where an official compendium method is adopted, confirmatory data is provided.
(11) Certificates of analysis for the finished dosage form.
(12) Labeling information for the container of the finished dosage form.
(13) Stability study report.
II. For compounding using a radioactive positron nuclide generator or a kit for compounding PET drugs:
(1) A photocopy of the practice license of the medical institution or the pharmacy license.
(2) The following basic information on the aseptic compounding site:
1. The workplace and equipment.
2. Documentary proof that the personnel performing compounding have received aseptic operation training; and documentary proof of ionizing radiation protection training as designated by the Nuclear Safety Commission.
3. Standard operating procedures related to aseptic compounding.
4. Records of environmental cleaning, disinfection, and monitoring.
5. Test documents for the finished dosage form.
6. Labeling information for the container of the finished dosage form.
(3) Package inserts approved by domestic or foreign competent health authorities for the generator and the kit for compounding PET drugs.
(4) Other documents and data as designated by the central competent health authority.
Where the documents and data submitted by the applicant are incomplete or contain omissions, the central competent health authority shall notify the applicant to make corrections within a prescribed time limit; failure to do so shall result in summary rejection of the application.
Upon receipt of an application under Paragraph 1, the central competent health authority shall, after reviewing the documents and data and conducting an inspection of the dispensing site, issue an approval document if the requirements of these Regulations are satisfied. A medical institution or pharmacy may commence compounding only after the approval document has been issued.
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs:
(1) A photocopy of the practice license of the medical institution or the pharmacy license.
(2) Basic information on the compounding site (Site Master File).
(3) Documentary proof that the personnel performing compounding have received aseptic operation training; and documentary proof of ionizing radiation protection training as designated by the Nuclear Safety Commission.
(4) Quality control data for raw materials, including their sources and specifications.
(5) A complete compounding process flow and corresponding record formats, with critical process steps clearly identified.
(6) A validation plan for critical process steps; for sterile drug preparations, a sterilization validation plan shall also be provided.
(7) Compounding records for three consecutive batches.
(8) The formula composition and content of the finished dosage form.
(9) Product testing specifications and the basis on which such specifications are established.
(10) Analytical methods and method validation data. Where an official compendium method is adopted, confirmatory data is provided.
(11) Certificates of analysis for the finished dosage form.
(12) Labeling information for the container of the finished dosage form.
(13) Stability study report.
II. For compounding using a radioactive positron nuclide generator or a kit for compounding PET drugs:
(1) A photocopy of the practice license of the medical institution or the pharmacy license.
(2) The following basic information on the aseptic compounding site:
1. The workplace and equipment.
2. Documentary proof that the personnel performing compounding have received aseptic operation training; and documentary proof of ionizing radiation protection training as designated by the Nuclear Safety Commission.
3. Standard operating procedures related to aseptic compounding.
4. Records of environmental cleaning, disinfection, and monitoring.
5. Test documents for the finished dosage form.
6. Labeling information for the container of the finished dosage form.
(3) Package inserts approved by domestic or foreign competent health authorities for the generator and the kit for compounding PET drugs.
(4) Other documents and data as designated by the central competent health authority.
Where the documents and data submitted by the applicant are incomplete or contain omissions, the central competent health authority shall notify the applicant to make corrections within a prescribed time limit; failure to do so shall result in summary rejection of the application.
Upon receipt of an application under Paragraph 1, the central competent health authority shall, after reviewing the documents and data and conducting an inspection of the dispensing site, issue an approval document if the requirements of these Regulations are satisfied. A medical institution or pharmacy may commence compounding only after the approval document has been issued.
Article 5
The approval document referred to in Article 4, Paragraph 3 shall specify the following:
I. The name and address of the medical institution or pharmacy.
II. The compounding site.
III. The items approved for compounding.
Changes to the address under Subparagraph 1 of the preceding paragraph and the compounding site under Subparagraph 2, and the addition of compounding items under Subparagraph 3, shall be handled mutatis mutandis in accordance with the provisions of the preceding Article.
Where there is a change to the name under Paragraph 1, Subparagraph 1, or a change to the address limited to house-number re-designation, an application for change shall be submitted to the central competent health authority within ninety (90) days from the date the change occurs, together with a photocopy of the practice license of the medical institution or the pharmacy license.
I. The name and address of the medical institution or pharmacy.
II. The compounding site.
III. The items approved for compounding.
Changes to the address under Subparagraph 1 of the preceding paragraph and the compounding site under Subparagraph 2, and the addition of compounding items under Subparagraph 3, shall be handled mutatis mutandis in accordance with the provisions of the preceding Article.
Where there is a change to the name under Paragraph 1, Subparagraph 1, or a change to the address limited to house-number re-designation, an application for change shall be submitted to the central competent health authority within ninety (90) days from the date the change occurs, together with a photocopy of the practice license of the medical institution or the pharmacy license.
Article 6
Where an approval document has been issued under Article 4, Paragraph 3, and any of the following changes occurs to the submitted documents or data, the applicant shall reapply in accordance with Article 4, Paragraph 1. Compounding may commence only after a new approval document has been issued:
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs, where there are changes to raw material quality control data, the compounding process, drug testing specifications, or analytical methods.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs, where there are changes to the compounding procedures stated in the package insert or to the drug brand.
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs, where there are changes to raw material quality control data, the compounding process, drug testing specifications, or analytical methods.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs, where there are changes to the compounding procedures stated in the package insert or to the drug brand.
Article 7
Where a medical institution or pharmacy compounds PET drugs using a radioactive positron nuclide generator and a kit for compounding PET drugs, and such PET drugs are limited to use by patients of that institution, it is exempt from filing an application under Article 4 in any of the following circumstances:
I. The radioactive positron nuclide generator for compounding and the kit for compounding PET drugs have obtained drug licenses in Taiwan, and the method of compounding conforms to that stated in the relevant licenses.
II. The radioactive positron nuclide generator for compounding and the kit for compounding PET drugs have been registered as items with insufficient supply pursuant to Article 27-2 of the Pharmaceutical Affairs Act, and items specially approved on a case-by-case basis by the central competent health authority are used.
I. The radioactive positron nuclide generator for compounding and the kit for compounding PET drugs have obtained drug licenses in Taiwan, and the method of compounding conforms to that stated in the relevant licenses.
II. The radioactive positron nuclide generator for compounding and the kit for compounding PET drugs have been registered as items with insufficient supply pursuant to Article 27-2 of the Pharmaceutical Affairs Act, and items specially approved on a case-by-case basis by the central competent health authority are used.
Article 8
The central competent health authority shall conduct an on-site inspection of medical institutions and pharmacies that have obtained the approval document under Article 4, Paragraph 3 at least once every two (2) years. Medical institutions and pharmacies shall not evade, obstruct, or refuse such inspections.
Article 9
A medical institution or pharmacy that compounds PET drugs shall implement quality assurance operations, as follows:
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs: the requirements set forth in Appendix 1 (Quality Assurance Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs, the requirements set forth in Appendix 2 shall be satisfied.
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs: the requirements set forth in Appendix 1 (Quality Assurance Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs, the requirements set forth in Appendix 2 shall be satisfied.
- Appendix 1：Quality Assurance Standards.PDF
- Appendix 2：Quality Assurance Standards for Compounding Using a Radioactive Positron Nuclide Generator and a Kit for Compounding PET Drugs.PDF
Article 10
The facilities and equipment of a PET drug compounding site of a medical institution or pharmacy shall comply with the following:
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs, the requirements set forth in Appendix 3 (Facility and Equipment Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs, the requirements set forth in Appendix 4 shall be satisfied.
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs, the requirements set forth in Appendix 3 (Facility and Equipment Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs, the requirements set forth in Appendix 4 shall be satisfied.
- Appendix 3：Facility and Equipment Standards.PDF
- Appendix 4：Standards for Compounding Site and Equipment for Compounding Using a Radioactive Positron Nuclide Generator and a Kit for Compounding PET Drugs.PDF
Article 11
Where a medical institution or pharmacy compounds PET drugs without using a radioactive positron nuclide generator or a kit for compounding PET drugs, the raw materials, containers, and closures used shall comply with the requirements set forth in Appendix 5 (Raw Materials, Containers, and Closures Standards).
- Appendix 5：Standards for Raw Materials, Containers, and Closures.pdf
Article 12
The process controls for compounding PET drugs by a medical institution or pharmacy shall comply with the following:
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs: the requirements set forth in Appendix 6 (Compounding Process Control Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs: the requirements set forth in Appendix 7 shall be satisfied.
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs: the requirements set forth in Appendix 6 (Compounding Process Control Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs: the requirements set forth in Appendix 7 shall be satisfied.
- Appendix 6：Standards for Compounding Process Control.pdf
- Appendix 7：Standards for Compounding Operations for Compounding Using a Radioactive Positron Nuclide Generator and a Kit for Compounding PET Drugs.pdf
Article 13
Where a medical institution or pharmacy compounds PET drugs without using a radioactive positron nuclide generator or a kit for compounding PET drugs, the laboratory performing quality control operations shall comply with the requirements set forth in Appendix 8 (Laboratory Control Standards).
- Appendix 8：Laboratory Control Standards.pdf
Article 14
Where a medical institution or pharmacy compounds PET drugs without using a radioactive positron nuclide generator or a kit for compounding PET drugs, the control and release of such drugs shall comply with the requirements set forth in Appendix 9 (Final Product Control and Release Standards).
- Appendix 9：Standards for Final Product Control and Release.pdf
Article 15
The labeling and packaging of PET drugs compounded by a medical institution or pharmacy shall comply with the following:
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs: the requirements set forth in Appendix 10 (Labeling and Packaging Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs: the requirements set forth in Appendix 11 shall be satisfied.
I. For compounding not using a radioactive positron nuclide generator or a kit for compounding PET drugs: the requirements set forth in Appendix 10 (Labeling and Packaging Standards) shall be satisfied.
II. For compounding using a radioactive positron nuclide generator and a kit for compounding PET drugs: the requirements set forth in Appendix 11 shall be satisfied.
- Appendix 10：Labeling and Packaging Standards.PDF
- Appendix 11：Labeling Standards for Compounding Using a Radioactive Positron Nuclide Generator and a Kit for Compounding PET Drugs.PDF
Article 16
The distribution of PET drugs compounded by a medical institution or pharmacy shall comply with the requirements set forth in Appendix 12 (Distribution Standards).
- Appendix 12：Distribution Standards.pdf
Article 17
Complaint handling for PET drugs compounded by a medical institution or pharmacy shall comply with the requirements set forth in Appendix 13 (Complaint Handling Standards).
- Appendix 13：Complaint Handling Standards.pdf
Article 18
Records and documents relating to the compounding of PET drugs by a medical institution or pharmacy shall comply with the requirements set forth in Appendix 14 (Records and Documentation Standards).
- Appendix 14：Record and Document Standards.pdf
Article 19
Where a medical institution provides PET drugs compounded pursuant to the approval under Article 4, such drugs may be provided to other medical institutions in any of the following circumstances, in addition to being provided for use by patients of the original institution:
I. No drug license has been issued in Taiwan for such PET drugs.
II. The holder of the drug license is unable to supply the drug due to annual maintenance, accidental events, or emergency events.
III. Other circumstances recognized by the central competent health authority as affecting, or likely to affect, patients’ rights and interests in medication use.
Before providing its compounded PET drugs for use by other medical institutions, the medical institution shall confirm that the circumstances under the preceding paragraph are satisfied, and shall retain relevant supporting documents and data in accordance with the preceding Article.
I. No drug license has been issued in Taiwan for such PET drugs.
II. The holder of the drug license is unable to supply the drug due to annual maintenance, accidental events, or emergency events.
III. Other circumstances recognized by the central competent health authority as affecting, or likely to affect, patients’ rights and interests in medication use.
Before providing its compounded PET drugs for use by other medical institutions, the medical institution shall confirm that the circumstances under the preceding paragraph are satisfied, and shall retain relevant supporting documents and data in accordance with the preceding Article.
Article 20
Where a medical institution or pharmacy violates these Regulations and such violation affects, or is likely to affect, the quality of PET drugs, the central competent health authority may, depending on the nature and severity of the violation, order suspension of part or all of its dispensation operations. Where improvements are feasible, it shall notify the medical institution or pharmacy to make improvements within a prescribed time limit. Where no improvements are made within the prescribed time limit or improvements are not feasible, the approval for compounding may be revoked.
Article 21
The Regulations herein shall be implemented at the date of promulgation.