Article 1A pharmacist is to contribute to the improvement and promotion of public health by administering the dispensing of medicine, supply of medicine and other pharmaceutical health and sanitation services, thereby ensuring the healthy living of citizens.

Article 2A person who intends to be a pharmacist must obtain a license from the Minister of Health, Labour and Welfare.

Article 3A pharmacist license (hereinafter referred to as "License") is to be granted to a person who has passed a national examination for pharmacists (hereinafter referred to as the "Examination").

Article 4The License will not be granted to a minor, adult ward, or person under curatorship.

Article 5The License might not be granted to a person who falls under any of the following items:

Article 6The Ministry of Health, Labour and Welfare maintains the register of pharmacists, in which the date of registration, matters concerning any disposition made pursuant to the provisions of Article 8, paragraph (1) or (2), and other matters concerning the License are registered.

Article 7(1)Licensure is performed by registering a person who has passed the Examination in the register of pharmacists, in response to an application filed by said person.

(2)The Minister of Health, Labour and Welfare issues a pharmacist license certificate when the Minister has granted a License.

Article 7-2When the Minister of Health, Labour and Welfare finds that a person applying for a License falls under item (i) of Article 5, and decides not to grant him/her a License pursuant to the provisions of the same Article, the Minister of Health, Labour and Welfare must notify said applicant to that effect in advance and cause an official designated by him/her to hear the opinions of said applicant at the request of said applicant.

Article 8(1)When a pharmacist becomes an adult ward or person under curatorship, the Minister of Health, Labour and Welfare will revoke the pharmacist's License.

(2)When a pharmacist falls under any item of Article 5 or acts in a way that may damage the standing as a pharmacist, the Minister of Health, Labour and Welfare may make any of the following dispositions:

(3)When a prefectural governor finds it necessary to make any of the dispositions set forth in the preceding two paragraphs against a pharmacist, the prefectural governor must inform the Minister of Health, Labour and Welfare to that effect.

(4)A person whose License has been revoked pursuant to the provisions of paragraph (1) or (2) (in the case of a person whose License has been revoked pursuant to the provisions of paragraph (2) as falling under Article 5, item (iii) or (iv), or as acting in a way that may damage the standing as a pharmacist, excluding one for whom five years have not elapsed from the date of revocation) may be regranted a License when said person ceases to fall under the case which gave rise to the revocation or when it becomes deemed appropriate to regrant him/her a License due to other subsequent circumstances.In this case, the provisions of Article 7 apply mutatis mutandis.

(5)Prior to making any of the dispositions prescribed by paragraph (1), paragraph (2), and the preceding paragraph, the Minister of Health, Labour and Welfare must hear the opinions of the Medical Ethics Council.

(6)When the Minister of Health, Labour and Welfare intends to make a disposition to revoke a License pursuant to the provisions of paragraph (1) or (2), the Minister may request the prefectural governor to hear the opinions of the person subject to said disposition, and may substitute said hearing of opinions with the Minister's own hearing.

(7)The provisions of Section 2, Chapter III of the Administrative Procedure Act (Act No. 88 of 1993) (excluding Articles 25, 26 and 28) apply mutatis mutandis to the case where the prefectural governor holds a hearing of opinions pursuant to the provisions of the preceding paragraph. In this case, the term "hearings" in the same Section is deemed to be replaced with "hearing of opinions"; the term "administrative agencies" in Article 15, paragraph (1) of the same Act with "prefectural governors"; the phrase "Administrative agencies may" in paragraph (3) of the same Article (including the cases where it is applied mutatis mutandis in Article 22, paragraph (3) of the same Act) with "Prefectural governors may", the phrase "of their offices" in the same paragraph with "of the offices of the prefecture", and the phrase "the administrative agency will" with "the prefectural governor will"; the term "the administrative agencies" in Article 16, paragraph (4) of the same Act with "the prefectural governor"; the phrase "from the administrative agency" in Article 18, paragraph (1) of the same Act with "from the prefectural governor" and the phrase "administrative agencies may not" in the same paragraph with "prefectural governors may not"; the term "Administrative agencies" in Article 18, paragraph (3) of the same Act with "Prefectural governors"; the phrase "an official designated by the administrative agencies or such other persons as may be provided for by a Cabinet Order" in Article 19, paragraph (1) of the same Act with "an official designated by the prefectural governor"; the term "the administrative agency" in Article 20, paragraphs (1), (2) and (4) of the same Act with "the prefecture"; and the term "administrative agencies" in paragraph (6) of the same Article with "prefectural governors"; the term "the administrative agency" in Article 24, paragraph (3) of the same Act with "the prefectural governor"; and the term "administrative agencies" in Article 27, paragraph (1) of the same Act with "prefectural governors".

(8)When the documents to prove the fact giving rise to the disposition and other documents necessary for holding a hearing of opinions are requested by a prefectural governor, the Minister of Health, Labour and Welfare must promptly send them to the prefectural governor.

(9)When a hearing of opinions is held pursuant to the provisions of paragraph (6), and the prefectural governor receives, pursuant to the provisions of Article 24, paragraph (3) of the Administrative Procedure Act as applied mutatis mutandis by replacing certain terms in paragraph (7), a record set forth in paragraph (1) of the same Article or a written report set forth in paragraph (3) of the same Article, the prefectural governor must keep it, draw up a written opinion in which the prefectural governor states the opinion on the disposition, and submit said opinion to the Minister of Health, Labour and Welfare with a copy of said record and written report attached thereto.

(10)When the Minister of Health, Labour and Welfare finds it necessary in light of the circumstances arising after the conclusion of hearing of opinions, the Minister may return to the prefectural governor the written opinion submitted pursuant to the provisions of the preceding paragraph and request him/her to order the presiding official to reopen the hearing of opinions. The provisions of the main clause of Article 22, paragraph (2) and paragraph (3) of the Administrative Procedure Act apply mutatis mutandis to this case.

(11)The Minister of Health, Labour and Welfare must fully consider the details of the written opinion and a copy of the record and written report submitted pursuant to the provisions of paragraph (9) when the Minister makes a decision on the disposition.

(12)When the Minister of Health, Labour and Welfare intends to issue an order for suspension of services pursuant to the provisions of paragraph (2), the Minister may request the prefectural governor to hear the explanations of the person who is subject to said disposition, and may substitute said hearing of explanations with the granting of an opportunity for explanation by the Minister of Health, Labour and Welfare.

(13)When an explanation hearing is held pursuant to the provisions of the preceding paragraph, the prefectural governor must notify the person who is subject to the disposition of the following matters in writing, within a reasonable period of time prior to the date and time for the explanation hearing:

(14)In addition to the cases prescribed by paragraph (12), the Minister of Health, Labour and Welfare may cause a member of the Medical Ethics Council to hear the explanations of the person who is subject to the disposition, in lieu of the granting of an opportunity for explanation by the Minister of Health, Labour and Welfare.In this case, the provisions of the preceding paragraph applies by replacing the term "the preceding paragraph" in the same paragraph with "the following paragraph" and the term "the prefectural governor" with "the Minister of Health, Labour and Welfare".

(15)A person who has received the notification set forth in paragraph (13) (including the cases where it is applied by replacing certain terms pursuant to the provisions of the second sentence of the preceding paragraph) may cause the person's agent to appear and submit documentary evidence or articles of evidence.

(16)When a prefectural governor or a member of the Medical Ethics Council has held an explanation hearing pursuant to the provisions of paragraph (12) or the first sentence of paragraph (14), the prefectural governor or the member must prepare and keep a hearing report, draw up a written report in which the prefectural governor or the member states the opinion on the disposition, and submit said report to the Minister of Health, Labour and Welfare.

(17)When a prefectural governor holds a hearing of opinions or an explanation hearing pursuant to the provisions of paragraph (6) or (12), the Minister of Health, Labour and Welfare must notify the prefectural governor of the following matters in advance:

(18)The notice set forth in Article 15, paragraph (1) of the Administrative Procedure Act as applied mutatis mutandis by replacing certain terms in paragraph (7) for a hearing of opinions held pursuant to the provisions of paragraph (6), or the notification set forth in paragraph (13) for an explanation hearing held pursuant to the provisions of paragraph (12) must be based on the contents of the respective notifications made pursuant to the preceding paragraph.

(19)With regard to a disposition where a hearing of opinions or an explanatory hearing is held by a prefectural governor pursuant to the provisions of paragraph (6) or (12), or where an explanatory hearing is held by a member of the Medical Ethics Council pursuant to the provisions of the first sentence of paragraph (14), the provisions of Chapter III of the Administrative Procedure Act (excluding Articles 12 and 14) do not apply.

Article 8-2(1)The Minister of Health, Labour and Welfare may order a pharmacist who has become subject to the disposition set forth in item (i) or (ii) of paragraph (2) of the preceding Article or a person who intends to reobtain a License pursuant to the provisions of paragraph (4) of the same Article to receive the training specified by Ordinance of the Ministry of Health, Labour and Welfare concerning the maintenance of ethics as a pharmacist or the knowledge and skills required of a pharmacist (hereinafter referred to as "Re-education and Training").

(2)The Minister of Health, Labour and Welfare registers in the register of pharmacists the completion of Re-education and Training by a person who has completed the Re-education and Training pursuant to the provisions of the preceding paragraph, in response to an application filed by said person.

(3)The Minister of Health, Labour and Welfare issues a registration certificate for completion of re-education and training when the Minister has made a registration set forth in the preceding paragraph.

(4)A person who intends to be registered as set forth in paragraph (2) or a person who intends to obtain a replacement or reissuance of registration certificate for completion of re-education and training must pay fees in the amount specified by a Cabinet Order taking into account the actual costs.

(5)The provisions of paragraphs (12) through (19) of the preceding Article (excluding paragraph (14)) apply mutatis mutandis to the cases where the Minister of Health, Labour and Welfare intends to issue an order pursuant to the provisions of paragraph (1).In this case, any necessary technical replacement of terms and phrases will be specified by a Cabinet Order.

Article 8-3(1)When the Minister of Health, Labour and Welfare finds it necessary to investigate whether a disposition should be made against a pharmacist pursuant to the provisions of Article 8, paragraph (2), the Minister may collect the opinions of or reports from any person connected with the relevant case or any witness, order the owner of dispensing records and other articles to submit them, and cause a relevant official to enter the pharmacy or any other location connected with the relevant case and to inspect the dispensing records and other articles.

(2)The official who intends to conduct an on-site inspection pursuant to the provisions of the preceding paragraph must carry the identification certificate and present the same at the request of any relevant person.

(3)The authority of on-site inspection prescribed by the provisions of paragraph (1) must not be constructed as being granted for the purpose of criminal investigation.

Article 9A pharmacist must notify the Minister of Health, Labour and Welfare of the pharmacist's name, address and other particulars specified by Ordinance of the Ministry of Health, Labour and Welfare as of December 31 of every second year specified by Ordinance of the Ministry of Health, Labour and Welfare, via the prefectural governor of the region where the domicile of the pharmacist is located, on or before January 15 of the following year.

Article 10Beyond what is provided for in this Chapter, matters necessary for application for a License, registration, correction and deletion in and from the register of pharmacists as well as issuance, replacement, reissuance and return of a license certificate will be specified by a Cabinet Order, and matters necessary for conducting the Re-education and Training set forth in Article 8-2, paragraph (1), the registration in the register of pharmacists set forth in paragraph (2) of the same Article as well as the issuance, replacement and reissuance of the registration certificate for completion of re-education and training will be specified by Ordinance of the Ministry of Health, Labour and Welfare.

Article 11The Examination is conducted with respect to the knowledge and skills required of a pharmacist.

Article 12(1)The Examination is conducted by the Minister of Health, Labour and Welfare at least once every year.

(2)When the Minister of Health, Labour and Welfare intends to determine the subjects of Examination, or the method of conducting the Examination or of deciding successful examinees, the Minister must hear the opinions of the Medical Ethics Council in advance.

Article 13(1)The position of Pharmacist Examiner is established in the Ministry of Health, Labour and Welfare to administer affairs related to the Examination.

(2)Necessary matters concerning the Pharmacist Examiner will be specified by a Cabinet Order.

Article 14The Pharmacist Examiner and any other person administering affairs related to the Examination must maintain a strict and fair attitude and avoid any wrongful act in the administration of said affairs.

Article 15No person other than one who falls under either of the following items is qualified to take the Examination:

Article 16(1)A person who intends to take the Examination must pay examination fees in the amount specified by a Cabinet Order by taking into account the actual costs.

(2)The examination fees paid pursuant to the provisions of the preceding paragraph will not be refunded even if the relevant person does not take the Examination.

Article 17When there is any wrongful act related to the Examination, the person involved in the misconduct may be stopped from taking the Examination, or the Examination of said person may be invalidated.In this case, said person may be barred from taking the Examination for a specified period.

Article 18Beyond what is provided for in this Chapter, the subjects of Examination, procedures for taking the Examination and other necessary matters concerning the Examination will be specified by Ordinance of the Ministry of Health, Labour and Welfare.

Article 19No person other than a pharmacist may dispense medicine for the purpose of sale or provisions thereof; provided, however, that this does not apply where a medical practitioner or dental practitioner dispenses medicine according to the practitioner's own prescription in either of the following cases, or where a veterinarian dispenses medicine according to the veterinarian's own prescription:

Article 20No person other than a pharmacist may use the title of pharmacist or any other confusingly similar title.

Article 21A pharmacist engaged in the dispensing of medicine may not reject any request for the dispensing of medicine without justifiable reason.

Article 22Except for the cases where a pharmacist performs those dispensing services which are specified by Ordinance of the Ministry of Health, Labour and Welfare at the home of a person receiving medical care or other location (meaning the home or other location specified by Ordinance of the Ministry of Health, Labour and Welfare) according to a prescription issued by a medical practitioner or dental practitioner at said home or other location, the pharmacist may not dispense medicine at any location other than a pharmacy for the purpose of sale or provisions thereof; provided, however, that this does not apply where a pharmacist dispenses medicine at a dispensing room of a hospital or clinic, or of a medical facility for human-reared animals (meaning a medical facility prescribed by Article 2, paragraph (2) of the Veterinary Practice Act (Act No. 46 of 1992) and including the address of a person who causes a veterinarian to practice medicine for human-reared animals only by visiting them; hereinafter the same applies in this Article) according to a prescription issued by a medical practitioner or dental practitioner, or veterinarian engaged in medical care at said hospital or clinic, or medical facility for human-reared animals, where a pharmacist is unable to dispense medicine at a pharmacy due to a disaster or other special event, or where there are other special circumstances specified by Ordinance of the Ministry of Health, Labour and Welfare.

Article 23(1)A pharmacist may dispense medicine for the purpose of sale or provisions thereof only according to a prescription issued by a medical practitioner, dental practitioner, or veterinarian.

(2)A pharmacist must not dispense medicine by making any change in the medicine described in a prescription, except otherwise agreed by a medical practitioner, dental practitioner, or veterinarian who has issued the prescription.

Article 24In case of any uncertain point in a prescription, a pharmacist may dispense medicine according thereto only after contacting the medical practitioner, dental practitioner, or veterinarian who has issued the prescription and resolving said uncertain point.

Article 25A pharmacist must indicate the name of the patient and instructions on usage and dosage described in the prescription and other particulars specified by Ordinance of the Ministry of Health, Labour and Welfare on the container or package of the medicine dispensed for the purpose of sale or provisions thereof.

Article 25-2When a pharmacist dispenses medicine for the purpose of sale or provisions thereof, for the purpose of ensuring proper use of the medicine dispensed the pharmacist must provide the patient or a person caring for the patient with necessary information and give said patient or person necessary guidance based on pharmaceutical knowledge.

Article 26When a pharmacist has dispensed medicine, the pharmacist must describe in the relevant prescription the fact that the dispensing of medicine has been completed (or, if the dispensing of medicine as described in said prescription has not been completed by said dispensing, the amount of medicine dispensed), the dispensing date, and other particulars specified by Ordinance of the Ministry of Health, Labour and Welfare, and must affix the pharmacist's name and seal, or signature thereto.

Article 27An establisher of a pharmacy must keep each prescription according to which the dispensing of medicine has been completed at its pharmacy, for three years from the completion date of dispensing.

Article 28(1)An establisher of a pharmacy must keep and maintain dispensing records at its pharmacy.

(2)When a pharmacist has dispensed medicine at a pharmacy, the pharmacist must describe in the relevant dispensing record the particulars specified by Ordinance of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply where the dispensing of medicine as described in said prescription has been completed by said dispensing.

(3)An establisher of a pharmacy must keep each dispensing record set forth in paragraph (1) for three years from the date on which the final description therein was made.

Article 28-2The Minister of Health, Labour and Welfare makes public the names of pharmacists and other particulars specified by Cabinet Order so as to help a person receiving medical care or any other citizen confirm the qualifications of a pharmacist and make appropriate selection concerning medical care.

Article 28-3Affairs required to be administered by each prefecture pursuant to the provisions of Article 8, paragraph (6) and the first sentence of paragraph (10); paragraphs (12) and (13) of the same Article (including the cases where these provisions are applied mutatis mutandis in Article 8-2, paragraph (5)); Article 15, paragraphs (1) and (3) of the Administrative Procedure Act (including the cases where they are applied mutatis mutandis in Article 22, paragraph (3) of the same Act), and Article 16, paragraph (4), Article 18, paragraphs (1) and (3), Article 19, paragraph (1), Article 20, paragraph (6), and Article 24, paragraph (3) of the same Act, as applied mutatis mutandis in Article 8, paragraph (7); Article 15, paragraph (3) of the same Act as applied mutatis mutandis in Article 22, paragraph (3) of the same Act as applied mutatis mutandis in the second sentence of Article 8, paragraph (10); and Article 9 are regarded as the Type 1 statutory entrusted functions set forth in Article 2, paragraph (9), item (i) of the Local Autonomy Act (Act No. 67 of 1947).

Article 29A person who has violated the provisions of Article 19 (excluding a medical practitioner, dental practitioner or veterinarian) will be punished by imprisonment with work for not more than three years or a fine of not more than one million yen, or both.

Article 30A person who falls under either of the following items will be punished by imprisonment with work for not more than one year or a fine of not more than five hundred thousand yen, or both:

Article 31A person who has divulged the examination questions in advance intentionally or through gross negligence or who has given unfair scores intentionally, in violation of the provisions of Article 14, will be punished by imprisonment with work for not more than one year or a fine of not more than five hundred thousand yen.

Article 32A person who falls under any of the following items will be punished by a fine of not more than five hundred thousand yen:

Article 33When a representative of a corporation, or an agent, employee or other worker of a corporation or of an individual has committed a violation under item (ii) or (vi) of the preceding Article (limited to the portion pertaining to Article 27 or Article 28, paragraph (1) or (3)) with regard to the business of the corporation or the individual, not only the offender himself/herself but also the corporation or the individual will be punished by the fine prescribed in the preceding Article.