I hereby promulgate the Pharmaceutical Affairs Law. Signed:HIROHITO, Seal of the Emperor This twenty-ninth day of the seventh month of the twenty-third year of Showa (July 29, 1948) Prime Minister ASHIDA Hitoshi Law No.197 Pharmaceutical Affairs Law Chapter I. General Rule

(Purpose of the Law) Article 1. The purpose of this Law is to control and regulate pharmaceutical affairs.

(Definition) Article 2. The term "pharmaceutical affairs" in this Law means any act or contributing factor relating to or having to do with manufacture, preparation, sale or other distribution of drugs, devices and cosmetics. The term "pharmacist" in this Law means any person duly licensed by the Minister of Welfare to engage in the practice of pharmacy which shall mean chiefly the art or practice of preparing, assaying, preserving, compounding and dispensing drugs. The term "pharmacy" in this Law means any place where a pharmacist engages in the practice of compounding, and which is registered by the prefectural governor. The term"drugs in this Law means the following articles, excluding devices or their components, parts, or accessories: 1. Articles recognized in the official compendium; 2. Articles intended for use in the dagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; 3. Articles (other than food) intended to affect the structure or any function of the body of man or other animals; 4. Articles intended for use as a component of any articles specified in Item (1), (2), or (3). The term "new drug" in this Law means any drug the composition and application of which are not generally recognized. The term "devices" in this Law means instruments, apparatus, and contrivances, intended: 1. For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; 2. To affect the structure or any function of the body of man or other animals. The term "cosmetics" in this Law means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or other wise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and articles intended for use as a component of any such articles. The term "official compendium" in this Law means the official Pharmacopoeia, the official National Formulary, or any supplement to either of them. The term "Pharmacopoeia" in this Law means the latest edition of the official Japanese Pharmacopoeia and the term "Formulary" means the latest edition of the official National Formulary. The term "label" in this Law means a display of written, printed, or graphic matter upon the immediate container of drugs, devices, or cosmetics, not including package liners.(A requirement made by or under authority of this Law that any word, statement, or other information should appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if therebe any, of the retail package of such article, or is easily legible through the outside container or wrapper.) The term "labeling" in this Law means all labels and other written, printed, or graphic matter put upon drugs, devices, or cosmetics or any of their containers or wrappers, or accompanying such articles. The term "poison or powerful drug" in this Law means any drug which, when applied to the body of man or other animals, ingested or inhaled within the body of man or other animals, causes or may cause damage or disturbance to any function of the body of man or other animals because its maximum dose is almost equal to its fatal dose, it has a strong cumulative effect, or it causes an unfavorable reaction in body tissue, and shall be designated as a poison or a powerful drug by the Minister of Welfare.

Chapter II. Pharmacist

(License) Article 3. Any person who intends to be a pharmacist shall be licensed by the Minister of Welfare upon payment of the license fee, according to the Ministerial Ordinance issued by the Minister of Welfare under authority of this Law. License of a pharmacist shall not be given to any person who does not fall under one of the following classifications: 1. A person who has passed the National Pharmacist Examination; 2. A person who is licensed as a pharmacist in a foreign country designated by the Minister of Welfare, and is deemed proper by the Minister of Welfare. Any person who has not been licensed as a pharmacist shall not use the name of a pharmacist.

Article 4. The license of a pharmacist shall not be granted to a person who comes under one of the following classifications: 1. A person under 20 years of age, an incompetent, or a quasi-incompetent person; 2. A lunatic; 3. A deaf, dumb or blind person.

Article 5. The license of a pharmacist may not be granted to a person who comes under one of the following classifications: 1. A person who has been punished by a fine or any heavier penalty; 2. A person who has violated the provisions of this Law or of the regulations issued by the Minister of Welfare under the authority of this Law.

(Delivery of License) Article 6. The Minister of Welfare shall, when he has given any person the license of a a pharmacist, register the licensed pharmacist on the List of Pharmacists and shall give him a license as a pharmacist. The license shall become invalid unless the licensed pharmacist renews annually his license before December 31 by registering with the Minister of Welfare, through the prefectural governor, under whose jurisdiction his address is located, as provided for by Ministerial Ordinance.

Chapter III. National Board of Pharmacy

(National Board of Pharmacy) Article 7. National Board of Pharmacy shall be organized for the purpose of submitting an original draft to the Minister of Welfare concerning revision of official compendiums and their supplements, for the purpose of conducting National Pharmacist Examinations, and for the purpose of making recommendations to the Minister of Welfare concerning new and non-official drugs and other pharmaceutical affairs as defined in this Law.

Article 8. The Board of Pharmacy shall consist of at least 51 members appointed by the Minister of Welfare from among the presidents and professors of pharmaceutical, modical, dental or veterinary colleges and universities, from among the government and public officials of the offices concerned, and from among recognized specialists in the practical fields of pharmacy, medicine, dentistry and veterinary medicine. Recommendations of the National Board of Pharmacy to the Minister of Welfare shall be made by a majority vote of the executive committee elected from among the members of the National Board of Pharmacy. Tenure of office of the members of the National Board of Pharmacy shall be two years or until replaced;provided, that the Minister of Welfare shall have the authority to dismiss any member of such Board with the approval of the National Board of Pharmacy if such member is found to have mental or physical incapacity to perform his duties or to have acted prejudically to the interest of the National Board of Pharmacy.

Article 9. Remuneration and travelling expenses for the services rendered by the members of the National Board of Pharmacy shall be provided for by Ministerial Ordinance.

(Subcommittees and Special Subcommittees) Article 10. The National Board of Pharmacy shall have the following subcommittees: 1. National Pharmacist Examination Subcommittee; 2. Official Compendium Subcommittee; 3. New and Non-official During Subcommittee. The National Board of Pharmacy may have special subcommittees when it considers necessary to do so. The National Board of Pharmacy shall elect an executive committee from among the members of the Board to make recommendations to the Minister of Welfare and to conduct other business of the National Board of Pharmacy.

(National Pharmacist Examination) Article 11. The National Board of Pharmacy shall held a National Pharmacist Examination at least once each year under the supervision of the Minister of Welfare as provided for by Ministerial Ordinance.

Article 12. The Minister of Welfare shall decide the place and date of the Examination, the time limit for presentation of a written application to qualily for the Examination and shall give public notice of the information at least three months prior to the date of the Examination.

Article 13. The National Pharmacist Examination shall include a theoretical examination and a practical examination. The National Pharmacist Examination shall test the knowledge and skill of the candidates for pharmacists as provided for by Ministerial Ordinance. Only a person who has passed the theoretical examination shall be permitted to take the practical examination.

Article 14. Any person who does not come under any of the following classifications shall not be permitted to take the National Pharmacist Examination: 1. A arson who has graduated from the regular pharmaceutical course of an accredited university or college; 2. A person who is licensed as a pharmacist in a foreign country designated by the Minister of Welfare and who does not fall under the provision of Art.3, Par.2, Item 2; 3. A person who has graduated from a pharmaceutical college in a foreign country or a person who has been licensed as pharmacist in a foreign country other than those designated by the Minister of Welfare.

Article 15. A person who intends to take the National Pharmacist Examination shall pay the fee as provided for by Ministerial Ordinance. The National Board of Pharmacy shall present a certified list of the successful candidates who have passed the National Pharmacist Examination to the Minister of Welfare. The Minister of Welfare shall issue for the successful candidates in the National Pharmacist Examination the license to practice pharmacy according to the certified list mentioned in the preceding paragraph.

(Revision of Official Compendium, etc.) Article 16. The National Board of Pharmacy shall submit an original draft to the Minister of Welfare concerning the revision of the Japanese Pharmacopoeia at least every ten years and its supplement at least every two and a half years.

(Revision, etc. of National Formulary) Article 17. The National Board of Pharmacy shall submit an original draft to the Minister of Welfare concerning the revision or supplement of the National Formulary, when it is considered necessary to do so.

Article 18. The National Board of Pharmacy shall be authorized to order official agencies or those persons who are concerned with pharmaceutical affairs to submit necessary reports, information or any other data. The National Board of Pharmacy shall be authorized to request any necessary investigations by official agencies, by those who are concerned with pharmaceutical affairs, or by any other person, when it is considered necessary to do so.

(Provisions for Enforcement) Article 19. The organization of the National Board of Pharmacy and other necessary matters concerning the Board other than as provided for in this Law and Ministerial Ordinances, shall be decided by the National Board of Pharmacy.

Chapter IV. Pharmacy and Preparation

(License of Pharmacy) Article 20. Any person, before establishing a pharmacy shall be licensed by the prefectural governor under whose jurisdiction the pharmacy is located, upon payment of a fee according to the regulations as provided for by Ministerial Ordinance. The abovementioned license shall become invalid unless it is renewed annuary before December 31 upon payment of a fee fixed by the Minister of Welfare.

(Administration of Pharmacy) Article 21. A proprietor of a pharmacy, in case he is not a licensed pharmacist administering his own pharmacy, shall keep a licensed pharmacist for the administration of the pharmacy. A pharmacist who administers a pharmacy shall not concurrently engage in the administration of any other pharmacy or in any other pharmaceutical practice.

(Preparation) Article 22. No one except a licensed pharmacist shall prepare drugs for the purpose of sale or other distribution; provided that, in case a doctor, a dentist or a veterinary surgeon prepares drugs himself pursuant to his own prescription or makes a licensed pharmacist prepare his prescription, this provision shall not apply.

Article 23. A pharmacist shall not prepare drugs for the purpose of sale or other distribution at any place other than in a licensed pharmacy, except in the case as provided for otherwise by Ministerial Ordinance.

Article 24. A pharmacist shall not change or correct a prescription unless the change or correction is verified by the doctor, dentist or veterinary surgeon concerned.

Article 25. Prescriptions shall be kept on file at the pharmacy where the preparation is filled up for a period of two years from the date of preparation.

Chapter V. Drugs, Devices, Cosmetics

(Manufacture of Drugs, etc.) Article 26. Any person, before manufacturing drugs, devices or cosmetics, shall first be licensed by the Minister of Welfare for each factory or place of manufacture, upon payment of a fee according to the regulations as provided for by Ministerial Ordinance. The abovementioned license shall become invalid unless it is renewed annually before December 31 upon payment of a fee fixed by the Minister of Welfare. The manufacturer shall first obtain the approval of the Minister of Welfare for each item in order to manufacture drugs which have no standard recognized in an official compendium or to manufacture devices. The Minister of Welfare shall consider the recommendation made by the National Board of Pharmacy so far as the abovementioned approval for the manufacture of new and non-official drugs is concerned.

Article 27. The manufacturer of drugs shall keep a licensed pharmacist registered by the Minister of Welfare in each place of manufacture to supervise such manufacture;however, in case of manufacturing drugs for which it is not essentially necessary to have a full time pharmacist, he may, with the approval of the Minister of Welfare, substitute a technician other than a pharmacist. Notwithstanding the provision of the preceding paragraph, a manufacturer of biological preparations or other preparations designated by the Minister of Welfare shall keep, with the approval of the Minister of Welfare, a full time medical doctor or a full time person who has the knowledge of bacteriology in order to supervise the manufacture.

(Importer of Drugs, etc.) Article 28. The provisions of this Law regarding the manufacturers of drugs, devices or cosmetics shall apply to the importer of drugs, devices or cosmetics with necessary modifications.

(Selling of Drugs) Article 29. Any person, before engaging in selling, offering for sale, or distributing drugs, who is neither a manufacturer who whole sales his manufactured drugs, nor a proprietor of a pharmacy who sells drugs shall first obtain a license from the prefectural governor for every shop in case he keeps a shop or for every business area in the case of the periodical household distributers, upon payment of a fee according to the regulations as provided for by Ministerial Ordinance. The abovementioned license shall become invalid unless it is renewed annually before December 31 upon payment of a fee fixed by the Minister of Welfare.

(Regulations in Handling of Drugs) Article 30. For the purpose of regulating the strength, quality and purity of drugs, the Minister of Welfare shall issue the official Japanese Pharmacopoeia, the National Formulary, and any supplement to either of them, upon receipt of the original draft from the National Board of Pharmacy. Drugs recognized in the official compendium shall not be sold or distributed, manufactured, imported, stored or exhibited for the purpose of sale or other distribution, unless the strength, quality, and purity conform with the standard recognized by the official compendium.

Article 31. Non-official drugs, which shall mean drugs not included in the official Japanese Pharmacopoeia or the official National Formulary, shall not to be sold, distributed or manufactured, imported, stored or exhibited for the purpose of sale or other distribution, unless they conform to the standard approved for the drugs when approval is given for their manufacture by the Minister of Welfare as provided for in Art.26, Par.3.

Article 32. All sulfanilamide and its derivatives, penicillin or streptomycin and other antibiotic preparation, and biological preparations and other preparations designated by the Minister of Welfare shall not be sold, distributed, or manufactured, imported, stored or exhibited for the purpose of sale or other distribution, unless they conform with the standard of minimum percentage or minimum quantity for unit package or other standards designated by the Minister of Welfare. The Minister of Welfare shall be authorized, whenever he deems it necessary, to provide by Ministerial Ordinance for the matters concerning the manufacture of the drugs stated in the preceding paragraph or other necessary matters.

Article 33. The drugs designated by the Minister of Welfare shall not be sold or distributed, or stored or exhibited for the purpose of sale or other distribution, unless they have been tested and approved by the person designated by the Minister of Welfare.

(Exaggerated Advertisement, etc.) Article 34. No person shall advertise, describe or circulate false or exaggerated statements, regarding the name, method of manufacture, effect, efficacy or efficiency of any drugs, devices or cosmetics manufactured or produced under the authority of this Law. Misleading certificates or statements attributed to any doctor, of other person regarding the effect, efficacy or efficiency of drugs, devices or cosmetics shall be construed as falling under Paragraph 1 of this Article. Suggestive statements, diagrams, photographs or other ruses shall not be used in contravention of Paragraph 1 of this Article. The Statement or diagrams which suggest abortion, or obscene statements or diagrams shall not be used in connection with drugs, devices or cosmetics.

(Handling of Poison or Powerful Drugs) Article 35. On the label and labeling of a poison, its name in white on the black paper rimmed by white, and the letters of "poison" shall be demonstrated. On the label and labeling of a pawerful drug, its name in red on the white paper rimmed by red, and the letters of "powerful" shall be demonstrated.

Article 36. A manufacturer or importer of drugs shall put a poison or a powerful drug into a sealed container. A poison or a powerful drug shall be sold only in a sealed container unless it is sold by a manufacturer, an importer, or a seller of drugs who is a pharmacist himself or who employs a pharmacist.

Article 37. The manufacturer of drugs, the importer or the seller of drugs shall not sell or supply a poison or a powerful drug to a person, if the following items are not entered in the permanent record maintained by the seller:the name of a poison or a powerful drug, amount, purpose of use, date of delivery and the address, business and signature of the purchaser;provided, that poisons or powerful drugs may be sold or supplied to a pharmacist, a proprieter of pharmacy, a manufacturer or a seller of drugs, a doctor, a dentist or a veterinary surgeon, if he presents a certificate issued by the official agency concerned. The previsions of Article 35 and of this Article shall not apply to poisons or powerful drugs which are sold or distributed pursuant to the prescription of a doctor, a dentist or a veterinary surgeon. The required record in Par.1 shall be kept for two years from the date mentioned therein.

Article 38. A poison or a powerful drug shall not be delivered to any person under 14 years of age.

Article 39. A poison or a powerful drug shall be stored or exhibited, separate from other good. In the case mentioned in the preceding paragraph, the warehouse or showcase of a poison shall be looked.

(Adulterated Drug and Device) Article 40. A drug or a device which comes under any of the following items shall be deemed to be adulterated: 1. a. If whole or a part of a drug or a device consists of any filthy, putrid, or decomposed substance; b. If it has been manufactured, prepared, packed, or handled under insanitary condition whereby it may have been contaminated taminated with filth, or whereby it may have been rendered injurious to health; c. If it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; d. If it is a drug and it bears or contains, for the purpose of coloring only, a coaltar color other than one from a batch that has been certified in accordance with the regulations as provided for by Ministerial Ordinance; e. If it is a device and its use may be injurious to health; 2. If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below, the standard set forth in such compendium; 3. If it is a drug other than mentioned in the preceding item and its strength differs from, or its purity or quality falls below, that which it purports to be or is presented to possess; 4. If it is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength, or substitued wholly or partly therefore.

(Misbranded Drugs and Devices) Article 41, A drug or a device which comes under any of the following items shall be deemed to be misbranded: 1. If its labeling is false or misleading in any particular; 2. Unless a container or a package bears on its label (a) the name and place of business (in case of a juridical person, the address of its main office) of the manufacturer;and (b) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, etc.;provided that reasonable variations shall be permitted by regulations prescribed by the Ministerial Ordinance; 3. If it purports to be a drug the name of which is recognized in an official compendium and is not packed in a container, packaged and labeled as prescribed therein;provided, that the method of packing may be modified with the consent of the Minister of Welfare; 4. If it is a drug not designated solely by a name recognized in an official compendium and its label does not bear the statement as follows: a. Common or usual name of the drug, if such there be; b. In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphanetidin, amidopyrine, antipyrine, atropine, hyoscine, byoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabaine, strophanthin, strychine, thyroid, or any derivatives or preparation of any such substance, contained therein;provided that exemptions shall be established by regulations prescribed by the Ministerial Ordinance. 5. If any word, statement, or other information required by or under authority of this Law to appear on the label or labeling is not prominently placed thereon with such conspicousness (as compared with other words, statements, diagrams or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; 6. If it applies to men and contains any quantity of the narcotic or hypnotic substance such as alpha-eucaine, barbituric acid, betaeucaine, bromal, carbromal, chleral, coca, cocaine, codeine, morphine, opium paraldehyde, peyote, or sulphenmethane;or it contains any chemical derivative of, or synthetic substitute for such substance, which derivative or synthetic substitute have been, by the Minister or Welfare, designated as habit forming, and yet its label does not bear the name, quantity and percentage of such substance or derivative and in juxtaposition therewith the statement "Warning-May be habit forming" ; 7. If it consists of any quantity of sulfanilamide and its derivative, penicillin, streptomycin or any other preparation which the Minister of Welfare shall designate and its label does not bear the statement "To be used only pursuant to the prescription, or by the direction, of a doctor, dentist or a veterinary surgeon" ; 8. Unless its labeling bears the following items provided that the Minister of Welfare may issue regulations exempting any drug or device from such requirement: a. Adequate directions for use; b. Such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or method or duration of administration or application, as are necessary for the protection of public health; 9. If it has been found by the Minister of Welfare to be a drug liable to deterioration, and is not packaged and stored in such form and manner, and its label does not bear the statement of such precaution, as the Minister of Welfare shall require by regulations as necessary for the protection of the public health; 10. If it is a drug and its container is so made, formed, or filled as to be misleading;if it is an imitation of another drug;or if it is offered for sale under the name of another drug; 11. If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling thereof.

(Adulterated Cosmetics) Article 42. A cosmetic which comes under any of the following items shall be deemed to be adulterated: 1. If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such condition of use as are customary or usual; 2. If it consists, in whole or in part, of any filthy, putrid, or decomposed substance; 3. If it has been prepared, packed, or handled under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health; 4. If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; 5. If it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with the regulations as established by the Ministerial Ordinance and is other than a hair-dye.

(Misbranded Cosmetics) Article 43. A cosmetic which comes under any of the following items shall be deemed to be misbranded: 1. If its labeling is false or misleading in any particular; 2. If a container or package does not bear on its label the name and place of business (in the case of a juridical person, the place where its main office is located) of manufacturer and an accruate statement of the quantity of the contents in terms of weight, measure or numerical count, etc.;provided that exemptions shall be established by regulations prescribed by the Ministerial Ordinance; 3. If any word, statement, or other information required by or under authority of this Law to appear on the label or labeling is not prominently placed thereon with conspicuousness compared with other words, statement, diagrams or designs in the labeling and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions or purchase and use; 4. If its container is so made, formed, or filled as to be misleading.

(Prohibition) Article 44. The following acts shall hereby be prohibited: 1. Adulteration or misbranding of any drug, device or cosmetic for the purpose of sale or other distribution; 2. The manufacture or preparation of any drug, device or cosmetic that is adulterated or misbranded for the purpose of sale or other distribution; 3. The sale, offering for sale or other distribution, or the storage or exhibition for the purpose of selling, offering for sale or other distribution, of any drug, device or cosmetic that is adulterated or misbranded; 4. The using of confidential business matters by any person to his own advantage or revealing the same without reason, to those other than the authorized government or public officials, of any information acquired under authority of this Law except when relevant in any judicial proceeding under the Law; 5. The sale, offering for sale or other distribution, or the storage or exhibition for the purpose of selling, offering for sale or other distribution, of the drugs designated by the Minister of Welfare by a seller of drugs who is neither a pharmacist nor employs a pharmacist; 6. The use of words expressing "new drug" on the label, labeling, or advertisement; 7. The sale or other distribution of drugs mentioned in Items 6 and 7 of Art.41 to those other than the proprietors of pharmacy or dealers in drugs licensed under this Law and to doctors, dentists or veterinary surgeons except pursuant to the prescription or by the direction of a doctor, dentist or a veterinary surgeon;and failure to maintain written record of such sale or other distribution as provided for by Ministerial Ordinance; 8. To engage in selling, offering for sale, or distributing drugs by other means than those store-keepers and periodical household distributers provided for in Art.29.

Chapter VI. Supervision

(Test) Article 45. The Minister of Welfare or the prefectural governor, if he deems it necessary to do so, may order to a proprietor of pharmacy, and an establisher of a hospital or clinic, a manufacturer of drugs, devices or cosmetics, or to a seller or an importer thereof that their drugs, devices or cosmetics to be sold shall be tested by the person designated by the Minister of Welfare or prefectural governor.

(Cancellation of License, etc.) Article 46. The Minister of Welfare shall cancel the license of a pharmacist who falls under either one of the items of Art.4. The Minister of Welfare may cancel the license of a pharmacist and suspend his business who falls under either one of the items of Art.5. The Minister of Welfare may cancel the license or suspend the business of a manufacturer or an importer of drugs, devices or cosmetics, and the prefectural governor may cancel the license or suspend the business of a proprietor of pharmacy or seller of drugs, who has viola ed the provisions of this Law or Ministerial Ordinances under this Law. The cancellation or suspension mentioned in the preceding two paragraphs shall not be effective after a period longer than thirty days elasped unless during that period the suspension is upheld by a majority vote of the members of the executive committee of the National Board of Pharmacy assembled for a public hearing in regard to cancellation or suspension. The person whose license has been cancelled or suspended in accordance with the provisions of the preceding paragraph shall have full recourse to the court for reinstatement of this license according to the Administrative Lawsuit Special Case Law.

(Repairing, etc. of Facilities) Article 47. If the Minister of Welfare or the prefectural governor considers the facilities or premises insanitary or so unsatisfactory as to render drugs, devices or cosmetics liable to adulteration within the meaning of this Law, the Minister of Welfare or the prefectural governor may order any necessary repair or change and may limit or suspend the use of such facilities or premises.

(Disposal of Adulterated Drugs, etc.) Article 48. The Minister of Welfare or the prefectural governor may, with regard to misbranded or adulterated drugs, devices or cosmetics, make the owner or holder of the said articles abandon or dispose of them, so that these articles do not endanger the public health, or may take other necessary action.

(Inspection and Examination, etc.) Article 49. The Minister of Welfare or the prefectural governor may, when he deems it necessary to do so, demand a special report from a proprietor of pharmacy, an establisher of hospital or clinic, a manufacturer, or an importer of drugs, devices, or cosmetics, or a seller of drugs, or may direct his qualified representative to inspect pharmacy, hospital, clinic, factory, store, office, warehouse and other places used to prepare or store drugs, devices or cosmetics for the purpose of sale, or other distribution and to examine any installation, raw materials, records and other things used to prepare or store drugs, devices or cosmetics for the purpose of sale or other distribution and may direct his qualified representative to take free of charge the minimum quantity of drugs, devices, cosmetics or raw materials with doubtful quality necessary for examination purpose. The qualified representative of the Minister of Welfare or of the prefectural governor mentioned above shall take his identification certificate with him and present it on demand of the person concerned, in case where he enters the places, inspects, or takes away the materials in accordance with the provisions of the preceding paragraph.

(Inspectors of Drugs, Devices and Cosmetics) Article 50. Inspectors of drugs, devices and cosmetics shall be appointed both in the national and prefectural government in order to perform the duties concerning drugs, devices and cosmetics prescribed in the first paragraph of the preceding Article. Inspectors shall be appointed from among government and public officials by the Minister of Welfare and prefectural governor. Except the abovementioned provisions the necessary matters concerning inspectors of drugs, devices and cosmetics shall be decided by Ministerial Ordinance.

Chapter VII. Miscellaneous Provisions

(Enforcement Regulations) Article 51. The Minister of Welfare is hereby vested with the authority to establish necessary matters concerning the enforcement of this Law.

(Standard for Registration) Article 52. The Minister of Welfare may decide the standard for registration as to the equipment, facilities and qualifications of the proprietor of pharmacy, the manufacturer or seller of drugs, devices or cosmetics, as provided for in this Law on the basis of the recommendation made by the National Board of Pharmacy, whenever he deems it necessary especially from the sanitary point of view.

(Public Hearing) Article 53. The Minister of Welfare shall when he considers it necessary to do so, on his own initiative or upon an application of any interested person or agency connected with pharmaceutical affairs stating reasonable grounds therefor, hold a public hearing upon a proposal to issue, amend, or repeal any regulations under the authority of this Law.

Article 54. Under this Law, matters concerning drugs and devices which are intended for use exclusively in the diagnosis, cure, mitigation, treatment or prevention of disease in animals other than man or which are intended exclusively to affect the structure or any function of the body of animals other than man shall be under the competence of the Minister of Agriculture and Forestry.

(Exemption from Application) Article 55. The Minister of Welfare shall be authorized to exempt certain devices from the provisions of this Law by Ministerial Ordinance.

Chapter VIII Penal Provisions

Article 56. Any person who has violated the provisions of Art.22. Par.1 or 3 of Art.26 (including the case where these provisions apply with necessary modifications in Art.28), Par.1 of Art.29, Par.2 of Art.30, Art.31, Par.1 of Art.32, or Art.33 to Art.36 inclusive, Art.38, or Art.44 shall be liable to penal servitude not exceeding three years or a fine not exceeding\30,000. The penalties of the preceding paragraph may be inflicted together according to the circumstances.

Article 57. Any person who has violated the provisions of Par.3 of Art.3, Par.1 of Art.20, Arts.21, 23, 24, 25, 27 (including the case where these provisions apply with necessary modifications in Art.28), Par.1 or 3 of Art.37, or Art.39 shall be liable to penal servitude not exceeding one year or a fine not exceeding\10,000. The penalties of the preceding paragraph may be inflicted together according to circumstances.

Article 58. Any person who falls under either of the following items shall be liable to a fine not exceeding\5,000: 1. A person who has violated the order issued on the basis of the provisions of Art.45, Par.2 or 3 of Art.46, Art.47, or Art.48; 2. A person who has refused, hindered, or evaded the inspection, researching or obtaining samples free of charge by the competent officials as provided for in Par.1 of Art.49; 3. A person who has not reported or reported falsely against the demand for a report by the Minister of Welfare or the prefectural governor as provided for in Par.1 of Art.49.

Article 59. If any representative of a juridical person or a substitute or employee of a juridical person or a person within the scope of his employment violates the provisions of Arts.56, 57 and 58, not only he is punished, but also the juridical person or person may be liable to a fine according to the provisions of every Article as mentioned above.

Supplementary Provisions:

Article 60. This Law shall come into force as from the day of its promulgation.

Article 61. The following Laws and Regulations shall be abolished: The Pharmaceutical Affairs Law (Law, No.48 of 1943, hereinafter called the Former Law) The Control Law of Certain Preparations other than Medicines, etc.(Law No.232 of 1947) The Regulations governing the Organization of the Investigation Committee of Japanese Pharmacopoeia (Imperial Ordinance No.274 of 1935) The Control Regulations of Bacteriological Drugs for Prevention and Diagnosis of Disease of Domestic Animals (Ministry of Agricultural&Forestry Ordinance No.88 of 1940) The Control Regulations of Seal and Certification of Test of Medicines and Other Medical Supplies (Ministry of Welfare Ordinance No.42 of 1943) The Control Regulations of Dangerous Devices for Use of Contraception (Ministry of Home Affairs Regulations No.40 of 1930)

Article 62. The Investigation Committee of the Japanese Pharmacopoeia shall be deemed to be in existence, despite the provision of the preceding Article, until the National Board of Pharmacy is established under this Law.

Article 63. The Minister of Welfare shall perform jurisdiction of the National Board of Pharmacy under the authority of this Law, despite the provisions of this Law, until the National Board of Pharmacy is established.

Article 64. The Japan Pharmacists'Association and Prefectural Pharmacists'Association (hereinafter referred to as Pharmacists'Associations) established under the provisions of Chapter 3 of the former Law shall be dissolved;provided that they shall be deemed to exist within the purpose of liquidation. The liquidators of the Pharmacists'Associations dissolved according to the provisions of the preceding paragraph shall be elected from among the presidents, vicepresidents, managing directors or directors at the general meeting; provided that, in case the supplementary liquidators are to be elected or the liquidators are to be increased, they may be elected from among other persons. The Minister of Welfare or prefectural governor, in case he deems it necessary to do so for the public interest, may dismiss the liquidators. The liquidators shall ask for the approval of the supervising government agency for the procedure of liquidation and transaction of properties, after the decision of the general meeting. The Minister of Welfare or the prefectural governor may require the liquidators to submit a report concerning business matters of the liquidation and conditions of the properties, or have the official in charge investigate them, if he deems it necessary to do so for supervision of liquidation of the Pharmacists'Associations. In case of conducting investigations mentioned above, the official in charge shall carry a certificate with him and present it to the interested persons upon request.

Article 65. A person who has been licensed as a pharmacist in accordance with the provisions of the former Law on the date of enforcement of this Law, shall be deemed to be licensed under the provisions of this Law. A person who is deemed to be the pharmacist licensed under this Law according to the preceding Article, shall report his name, address, and registration number to the Minister of Welfare through the prefectural governor under whose jurisdiction his address is located, not later than 3 months from the date of enforcement of this Law.

Article 66. A person who has been authorized as an establisher of a pharmacy, as a manufacturer, an importer or a seller of drugs under the provisions of the Former Law, or authorized as a manufacturer of a certain preparation other than medicines under the provisions of the Control Law of the Certain Preparation other than Medicines and has been engaging in the business concerned as on the date of enforcement of this Law, may continue the business exclusively for a period of six months from the date of enforcement of this Law according to the former Law.

Article 67. The license of a pharmacist, pharmacy, manufacturer, importer or seller of drugs, which has been cancelled or suspended these business under the authority of the Former Law, before the effective date of this Law, shall not be effected by the provisions of this Law. To the cancellation or suspension as provided for in the preceding paragraph, the provisions of Paragraph 4 of Art.46 shall not apply.

Article 68. A person who has been actually engaging in manufacture of cosmetics in accordance with the provisions of the Control Law of Certain Preparations other than Medicines, etc. or who has been engaging in the manufacture of devices, or who has been engaging in the sale of a certain preparation other than medicines, as on the date of the enforcement of this Law, shall be deemed to have been licensed or approved respectively under the provisions of this Law, exclusively for the period of 6 months from the date of the enforcement of this Law.

Article 69. A person who has been authorized to manufacture sera under the provisionsof the Control Regulations of Bacteriological Drugs for the Prevention and Diagnosis of Disease of Domestic Animals, as on the date of the enforcement of this Law, shall be the same as before, exclusively for the period of 6 months from the date of the enforcement of this Law. A person who has been engaging in the sale of sera as on the date of the enforcement of this Law, shall be, deemed to be licensed under the provisions of this Law exclusively for the period of 6 months from the date of the enforcement of this Law.

Article 70. Regarding the application of Art.25, or Par.3 of Art.37, the records of prescriptions as provided for in Par.1 of Art.46 of the Enforcement Regulations of the Former Law (Ministry of Welfare Ordinance No.40 of 1943) and the documents as provided for in Par.1 of Art.107 of the same Ordinance, shall be deemed to be respectively the prescription as provided for in Art.25 and the documents as provided for in Par.1 of Art.37.

Article 71. Lables and labeling of drugs, devices or cosmetics which are printed as of the date of the enforcement of this Law may be used exclusively for the period of 6 months from the day of enforcement of this Law, in spite of the provisions of this Law.

Article 72. Penalties provided for the violation of they Former Law, Control Law of Certain Preparations other than Medicines, etc., the Control Regulations of Bacteriological Drugs for Prevention and Diagnosis of Disease of Domestic Animals, Control Regulations of Seal and Certification of Test of Medicines&Other Medical Supplies, and Control Regulations of Dangerous Devices for Contraception, before the enforcement of this Law, shall be the same as before.

Article 73. The National Pharmacist Examination shall be held as from 1949, regardless of the provisions of Article 11.

Article 74. An accredited university under the Ordinance on Universities (Imperial Ordinance No.388 of 1918) or accredited college under the Ordinance on Colleges (Imperial Ordinance No.61 of 1903) shall be considered as a university or college as provided for in the provisions of Par.1 of Art.8, for the period of existence approved in accordance with the provisions of Par.1 of Art.98 of the School Education Law (Law No.26 of 1947). A person who is a graduate of an accredited university or college as provided for in the preceding paragraph shall be considered to be the graduate of an accredited university or college as provided for in the provisions of Item 1 of Art.14.

Article 75. The 5th Amended Japanese Pharmacopoeia (Ministry for Home Affairs Ordinance No.21 of 1932) shall be considered to be the pharmacopoeia as provided for in Art.30, until the Minister of Welfare issues it in accordance with the provisions of the same Article.

Article 76. As for a person who was eligible to obtain a license as a pharmacist under the provisions of the Former Law but who failed to obtain the said license before the enforcement date of this Law for nuavoidable reasons, or a person who under the provisions of the Former Law was ineligible to obtain a license as a pharmacist, merely because he had not reached 20 years of age, but has become 20 years of age after the enforcement of this Law, Minister of Welfare may authorize him a license as a pharmacist in spite of the provisions of Par.2 of Art.3.

Minister of Welfare TAKEDA Giichi Minister of Agriculture and Forestry NAGAE Kazuo Prime Minister ASHIDA Hitoshi