Article 1(Purpose) #
The purpose of this Act is to contribute to the improvement of the national health by properly controlling psychotropic drugs and thereby preventing any health and sanitation dangers due to their misuse or abuse.
Article 2(Definitions) #
(1) For the purpose of this Act, the term “psychotropic drugs” means those which fall under any of the following subparagraphs, act on the human central nervous system, and the misuse or abuse of which is deemed extremely dangerous and harmful to the human body, and which are designated by the Presidential Decree: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 4631, Dec. 27, 1993; Act No. 5485, Dec. 31, 1997>
1. Drugs or substances containing drugs, which might be misused or abused, are not used for medical treatment, are unsafe, and provoke severe physical or mental dependence in case of misuse or abuse;
2. Drugs or substances containing drugs, which might be misused or abused, are used only for very limited medical treatment, and provoke severe physical or mental dependence in case of misuse or abuse;
3. Drugs or substances containing drugs, which might be misused or abused relatively less than those referred to in subparagraphs 1 and 2, are used for medical treatment, and provoke less severe physical or mental dependence in case of misuse or abuse;
4. Drugs or substances containing drugs, which might be misused or abused relatively less than those as referred to in subparagraph 3, are used for medical treatment, and provoke less physical or mental dependence in case of misuse or abuse than those referred to in subparagraph 3; and
5. Mixed substances or preparations containing those as referred to in subparagraphs 1 through 4: Provided, That those which cannot be made or prepared again into those as referred to in subparagraphs 1 through 4 by being mixed with other drugs or substances, or by which no physical or mental dependence is provoked, and which are designated by the Ordinance of the Ministry of Health and Welfare, are excluded.
(2) For the purpose of this Act, the term “psychotropic drug handlers” means those who fall under subparagraphs 1 through 6 and have obtained a license under Article 6 or designation under Article 8, and those who fall under subparagraphs 7 and 8: <Amended by Act No. 5485, Dec. 31, 1997>
1. Psychotropic drug manufacturers: those who run a business manufacturing (including preparing and subdividing; hereinafter the same shall apply) psychotropic drugs;
2. Psychotropic drug exporters and importers: those who run a business exporting and importing psychotropic drugs;
3. Psychotropic drug wholesalers: those who run a business selling psychotropic drugs to retailers, medical care businessmen and persons handling and managing or scientific researchers of psychotropic drugs;
4. Psychotropic drug precursor users: those who use psychotropic drugs as precursors in manufacturing medicines;
5. Psychotropic drug scientific researchers: those who use psychotropic drugs for scientific research;
6. Psychotropic drug managers: those who work for a medical institution and are responsible for preparation, giving and receiving, or management of psychotropic drugs delivered for administration to patients in the medical institution;
7. Psychotropic drug retailers: those who have established and registered drugstores under the Pharmaceutical Affairs Act, and run a business selling psychotropic drugs to those other than psychotropic drug handlers (excluding retailers, and medical care businessmen handling psychotropic drugs); and
8. Psychotropic drug handling medical care businessmen: doctors or dentists engaged in medical care in a medical institution, or veterinarians engaged in medical examination and treatment of animals under the Veterinarians Act, who administer psychotropic drugs, deliver psychotropic drugs for administration, or issue medical prescriptions for psychotropic drugs, for the purpose of giving medical treatment to or examining and treating human beings or animals.
Article 3(Prohibition of General Act) #
(1) No person shall hold, possess, use, manage, export, import, manufacture, sell, buy, act as an intermediate in the selling or buying, receive or give psychotropic drugs as provided for in Article 2 (1) 1, or substances containing such drugs: Provided, That this shall not apply where he obtains the approval of the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Presidential Decree. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) No person shall extract ingredients of psychotropic drugs from plants which are precursors of psychotropic drugs as provided for in Article 2 (1) 1, or export, import, sell, buy, act as an intermediate in the selling and buying, give, receive, smoke, or take in such plants, or possess such plants for the purpose of smoking or injection or making another person smoke or inject them: Provided, That this shall not apply where he obtains the approval of the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Presidential Decree. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(3) No person shall manufacture, export, import, sell, buy, act as an intermediate in the selling and buying, give, receive, possess, or hold precursors as designated by the Presidential Decree, for the purpose of manufacturing psychotropic drugs. <Newly Inserted by Act No. 4125, Apr. 1, 1989; Act No. 4631, Dec. 27, 1993>
(4) No person shall offer another person any land, facility, equipment, funds or means of transportation to commit any prohibited act under paragraphs (1) through (3). <Newly Inserted by Act No. 4125, Apr. 1, 1989>
Article 4(Prohibition of Handling) #
(1) No person other than psychotropic drug handlers under this Act shall hold, possess, use, manage, export, import, manufacture, sell, buy, act as an intermediate in the selling and buying, give, receive, prepare, administer, or deliver psychotropic drugs falling under Article 2 (1) 2 through 4, or psychotropic drugs containing substances as provided for in Article 2 (1) 2 through 4, or make out a prescription for psychotropic drugs: Provided, That this shall not apply to the following cases: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
1. Where he buys or takes over psychotropic drugs from a retailer of such drugs for a purpose other than selling pursuant to the provisions of this Act and holds them;
2. Where he receives psychotropic drugs as medicines from a medical care businessman handling psychotropic drugs pursuant to the provisions of this Act and holds and uses them;
3. Where he has the custody of or transports psychotropic drugs on behalf of a psychotropic drug handler pursuant to the provisions of this Act; and
4. Where he obtains the approval of the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Minister of Health and Welfare .
(2) No psychotropic drug handler shall handle psychotropic drugs without being subject to the provisions of this Act; Provided, That this shall not apply where he has obtained the approval of the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Presidential Decree. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 5(Restriction on Handling) #
(1) No psychotropic drug handler shall perform any act as provided for in the main sentence of Article 4 (1) for a purpose other than his business.
(2) If it is deemed necessary for the public interest under the conditions as prescribed by the Presidential Decree, the Commissioner of the Korea Food and Drug Administration may prohibit or restrict the manufacture, export, import, sale, or use of psychotropic drugs, or take other necessary measures. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 6(Permission) #
(1) Any person who desires to be a manufacturer of psychotropic drugs shall obtain permission from the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare, and any person who desires to be a precursors user, exporter, importer, or scientific researcher of psychotropic drugs, shall fall under any of the following subparagraphs, and obtain permission from the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. These provisions shall also apply where he desires to modify the permitted matters: <Amended by Act No. 4631, Dec. 27, 1993; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
1. For a precursors user of psychotropic drugs, a person who holds a license for the medicine manufacturing industry under the Pharmaceutical Affairs Act;
2. For a exporter or importer of psychotropic drugs, a person who is an importer as prescribed by the Pharmaceutical Affairs Act, and has obtained permission on items from, or made a report on items to, the Commissioner of the Korea Food and Drug Administration; and
3. For a scientific researcher of psychotropic drugs, a person who requires the use of psychotropic drugs for his scientific research.
(2) No person who is subject to a disposition of cancellation of the license for psychotropic drug handler under Article 35, and for whom two years have not elapsed thereafter, shall be granted permission referred to in paragraph (1). <Amended by Act No. 4631, Dec. 27, 1993>
Article 7(Delivery, etc. of Written Permission) #
(1) When the Commissioner of the Korea Food and Drug Administration has granted permission under Article 6, he shall record it on the list of psychotropic drug handlers and deliver written permission under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) If a person who is granted permission under Article 6, loses or damages the written permission, or its details are modified, he may have it redelivered under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
(3) No written permission shall be lent or transferred to another person.
Article 8(Designation) #
(1) Any person who desires to be a psychotropic drug wholesaler or manager shall fall under any of the following subparagraphs, and shall be designated by the Special Metropolitan City Mayor, Metropolitan City Mayor, or Do governor (hereinafter referred to as the “Mayor/Do governor”) under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. The same shall also apply when he desires to modify the designated matters: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
1. For a psychotropic drug wholesaler, a person who has established a drugstore registered under the Pharmaceutical Affairs Act, or obtained a license as a psychotropic drug wholesaler registered under the Pharmaceutical Affairs Act; and
2. For a psychotropic drug manager, a pharmacist who works for a medical institution.
(2) For a person who is subject to a disposition of cancellation of the designation as a psychotropic drug handler under Article 35, and for whom one year has not elapsed, no designation referred to in paragraph (1) shall be made. <Amended by Act No. 4631, Dec. 27, 1993>
Article 9(Delivery, etc. of Written Designation) #
(1) When the Mayor/Do governor makes a designation under Article 8, he shall record it on the list of psychotropic drug handlers, and deliver a written designation under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
(2) The provisions of Article 7 (2) and (3) shall be applicable mutatis mutandis to cases referred to in paragraph (1).
Article 10(Permission for Manufacture of Psychotropic Drugs) #
(1) If a psychotropic drug manufacturer desires to manufacture psychotropic drugs, he shall obtain permission for each item from the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. The same shall also apply when he desires to modify any permitted matter. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) In a case under paragraph (1), a person who is subject to a disposition of cancellation of item license under Article 35, and for whom one year has not elapsed thereafter, shall not obtain permission of such item.
(3) Any person who desires to obtain permission under paragraph (1) shall provide facilities conforming to the criteria for manufacturing and equipment of the item concerned as prescribed by the Presidential Decree.
(4) In a case under paragraph (1), if the item to be permitted is a new medicine under the Pharmaceutical Affairs Act, or an item designated by the Commissioner of the Korea Food and Drug Administration, the written result of tests on the safety and effectiveness, relevant literature and other necessary materials shall be submitted under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. In this case, if it is desired to manufacture any item for a clinical trial, and conduct a clinical trial for the purpose of preparing the written test result, it shall be done in conformity with such standards as determined by the Ordinance of the Ministry of Health and Welfare. <Newly Inserted by Act No. 4631, Dec. 27, 1993; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 10-2(Reexamination of New Medicine, etc.) #
(1) The items of those permitted under Article 10 (1) which fall under the former part of Article 10 (4) shall be subject to a reexamination by the Commissioner of the Korea Food and Drug Administration within three months of the expiration of four to six years after the items are permitted. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) Matters necessary for the method, procedure, time, etc. of the reexamination referred to in paragraph (1) shall be determined by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
[This Article Newly Inserted by Act No. 4631, Dec. 27, 1993]
Article 10-3(Revaluation of Items) #
(1) With respect to any item of those permitted under Article 10 (1) for which it is deemed necessary to examine the safety and effectiveness by efficacy or ingredient, the Commissioner of the Korea Food and Drug Administration may conduct a revaluation. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) Matters necessary for the method, procedure, etc. of the revaluation referred to in paragraph (1) shall be determined by the Commissioner of the Korea Food and Drug Administration. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
[This Article Newly Inserted by Act No. 4631, Dec. 27, 1993]
Article 11(Approval of Transfer of Psychotropic Drugs) #
If a manufacturer, precursors user or scientific researcher of psychotropic drugs desires to transfer psychotropic drugs (excluding preparations) to another manufacturer, precursors user, or scientific researcher of psychotropic drugs, he shall obtain the approval of the Mayor/Do governor under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
Article 12(Sale of Manufactured Psychotropic Drugs) #
No psychotropic drug manufacturer shall sell his manufactured psychotropic drugs to persons other than exporters, importers, wholesalers, retailers, and medical care businessmen handling psychotropic drugs. <Amended by Act No. 4125, Apr. 1, 1989>
Article 13(Report on Use of Psychotropic Drug Precursors) #
If a manufacturer or precursors user of psychotropic drugs uses psychotropic drugs as precursors in manufacturing psychotropic drugs or medicines, he shall report matters on the use thereof to the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 14(Obligation of Production Control and Report) #
(1) Any manufacturer or precursors user of psychotropic drugs shall observe matters as prescribed by the Ordinance of the Ministry of Health and Welfare with respect to precursors control, self-test, production control, etc. of psychotropic drugs. <Amended by Act No. 5485, Dec. 31, 1997>
(2) Psychotropic drug manufacturers shall report matters as to actual production results and sales of their manufactured psychotropic drugs to the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(3) Deleted. <by Act No. 5485, Dec. 31, 1997>
Article 15(Permission for Export and Import of Psychotropic Drugs) #
(1) If a psychotropic drug exporter or importer desires to export or import psychotropic drugs, he shall obtain permission for each item from the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) The provisions of Articles 10 (4), 10-2 and 10-3 shall apply mutatis mutandis to the items imported under paragraph (1). In this case, the term “manufacture” shall be read as the term “import”, and the term “manufacturer”, as the term “exporter and importer”. <Newly Inserted by Act No. 4631, Dec. 27, 1993>
Article 16(Sale of Exported or Imported Psychotropic Drugs and Report) #
(1) No psychotropic drug exporter or importer shall sell imported psychotropic drugs to persons other than manufacturers, precursors users, or wholesalers of psychotropic drugs: Provided, That this shall not apply where he obtains approval from the Commissioner of the Korea Food and Drug Administration in order to sell them to any scientific researcher of psychotrophic drugs or any person who has obtained approval for handling psychotrophic drugs. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) The psychotropic drug exporters and importers shall report to the Commissioner of the Korea Food and Drug Administration matters concerning the export or import of psychotropic drugs and the sale of imported psychotropic drugs under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 17(Restriction of Permission) #
If permitting the manufacture or export and import of psychotropic drugs under Articles 6, 10 and 15 is deemed to be detrimental to national health due to their possible misuse or abuse, the Commissioner of the Korea Food and Drug Administration may restrict permission to limited area or items. In this case, matters concerning such limited areas or items shall be publicly announced in advance. <Amended by Act No. 4631, Dec. 27, 1993; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 18(Restriction on Sale of Psychotropic Drug Wholesalers) #
No psychotropic drug wholesaler shall sell psychotropic drugs to any person other than scientific researchers, wholesalers, retailers, medical care businessmen and managers of psychotropic drugs: Provided, that this shall not apply where he sells them with the approval of the Mayor/Do governor. <Amended by Act No. 4125, Apr. 1, 1989>
Article 19(Keeping of Sales Books, etc. of Psychotropic Drugs) #
(1) Any psychotropic drug handler shall prepare and keep books concerning selling and giving of psychotropic drugs, enter details each time psychotropic drugs are sold or given, and obtain a seal or signature of the buyer or transferee: Provided, That the seal or signature may be omitted with respect to psychotropic drugs as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
(2) Records of books referred to in paragraph (1) shall be kept for two years from the date of preparation.
Article 20(Restriction on Sale, etc.) #
(1) Psychotropic drugs shall not be sold to a person who falls under any of the following subparagraphs: <Amended by Act No. 4631, Dec. 27, 1993>
1. A person of less than eighteen years of age;
2. A psychopath; and
3. A person who is addicted to narcotics or other drugs.
(2) If a psychotropic drug retailer sells psychotropic drugs to any person other than psychotropic drug handlers, he shall not sell them in excess of the dose as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
(3) No psychotropic drug retailer shall sell psychotropic drugs prepared for injection or those as provided for in Article 2 (1) 2, or substances containing them, to any person other than psychotropic drug handlers.
(4) No psychotropic drug handler shall sell, store or display for selling psychotropic drugs altered, decomposed, contaminated or damaged or whose useable period or availability period has expired. <Amended by Act No. 5485, Dec. 31, 1997>
Article 21(Prescription) #
(1) Medical care businessmen handling psychotropic drugs shall not administer or deliver for administration psychotropic drugs without a prescription: Provided, That this shall not apply where he enters the names and the quantity of psychotropic drugs used in a medical record, and directly administers or delivers for administration such psychotropic drugs.
(2) The prescription referred to in paragraph (1) shall be kept for two years.
Article 22(Preparation, etc. of Receipts and Supply Register of Psychotropic Drug Handlers) #
Psychotropic drug handlers shall prepare and keep for two years the receipts and supply register of psychotropic drugs under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
Article 23(Scientific Research, etc. of Psychotropic Drugs) #
(1) No person who is not a psychotropic drug scientific researcher shall use psychotropic drugs for the purpose of any scientific research.
(2) Any scientific researcher of psychotropic drugs shall prepare and keep books on the scientific research of psychotropic drugs under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare.
<Amended by Act No. 5485, Dec. 31, 1997>
(3) The books referred to in paragraph (2) shall be kept for two years. <Newly Inserted by Act No. 5485, Dec. 31, 1997>
Article 24(Report on Discontinuation of Business) #
(1) If a psychotropic drug handler (excluding retailers and medical care businessmen handling psychotropic drugs) discontinues or suspends the business of handling psychotropic drugs, or resumes such suspended business, he shall report it within twenty days after the business is discontinued, suspended, or resumed, under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
(2) Where a psychotropic drug handler falls under any of the following subparagraphs, the person listed in said subparagraphs shall report to the licensing agency under the conditions as determined by the Ordinance of the Ministry of Health and Welfare: <Newly Inserted by Act No. 5485, Dec. 31, 1997>
1. Where he dies, his successor (where it is not apparent who his successor is, an administrator of the property to be succeeded to, hereinafter the same shall apply);
2. Where he becomes an incompetent person, his guardian; and
3. Where the juristic person is dissolved, a liquidator.
(3) Where a psychotropic drug handler falls under any of subparagraphs of paragraph (2), he shall be disqualified as a psychotropic drug handler. <Newly Inserted by Act No. 5485, Dec. 31, 1997>
Article 25(Sealing) #
(1) When a psychotropic drug manufacturer, exporter, or importer manufactures or imports psychotropic drugs (excluding preparations), he shall seal vessels or packagings of such psychotropic drugs with certified sealing stamps issued by the Government, under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
(2) No psychotropic drug handler shall give or receive psychotropic drugs not sealed under paragraph (1).
(3) Deleted. <by Act No. 5485, Dec. 31, 1997>
Article 26(Matters to be Indicated on Vessels, etc.) #
Matters as prescribed by the Ordinance of the Ministry of Health and Welfare shall be indicated on vessels or packagings of or documents attached to psychotropic drugs. <Amended by Act No. 5485, Dec. 31, 1997>
Article 27(Report on Accident of Psychotropic Drugs) #
If any accident falling under any of the following subparagraphs occurs with respect to psychotropic drugs held by a psychotropic drug handler, he shall report the cause to the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor without delay under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
1. Loss caused by a disaster;
2. Loss or burglary; and
3. Degeneration, decomposition, or damage.
Article 28(Psychotropic Drugs Handling by Disqualified Person) #
If a psychotropic drug handler is disqualified due to the cancellation of permission or designation or other reasons, or he is dead, or a juristic person which is the psychotropic drug handler is dissolved, the psychotropic drug handler, inheritor, guardian, liquidator, or juristic person remaining or newly established after a merger shall transfer the psychotropic drugs held by him to another psychotropic drug handler upon approval by the Commissioner of the Korea Food and Drug Administration or Mayor/
Do governor under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 29(Advertisement) #
(1) It shall be prohibited to advertise psychotropic drugs by any means other than an advertisement in newspapers or magazines devoted professionally to articles related to medical science or pharmacy.
(2) Criteria for advertisement of psychotropic drugs shall be determined by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
Article 30 #
Deleted.<by Act No. 4631, Dec. 27, 1993>
Article 31(Treatment and Protection of Psychotropic Drug Addict) #
(1) In order to determine whether a psychotropic drug user is addicted to psychotropic drugs, or to treat and protect those who are psychotropic drug addicts, the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may establish, operate or designate a treatment and protection institution. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) The Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may have psychotropic drug users undergo a test to determine whether they are addicted to such drugs, or have a psychotropic drug addict receive treatment and protection in a treatment and protection institution as referred to in paragraph (1). In this case, the period of the test shall be not more than one month, and the treatment and protection period shall be not more than six months. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(3) If the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor desires to conduct the test or treatment and protection under paragraph (2), he shall do it through a deliberation of the treatment and protection review committee. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(4) In order to deliberate matters concerning the test and the treatment and protection as referred to in paragraph (3), the treatment and protection review committees shall be established under the Korea Food and Drug Administration, Special Metropolitan City, Metropolitan Cities, and Dos. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(5) Matters necessary for the establishment, operation and designation of treatment and protection institutions, test, treatment and protection, composition, operation, function, etc. of the treatment and protection review committees under paragraphs (1) through (4) shall be determined by the Presidential Decree.
[This Article Wholly Amended by Act No. 4125, Apr. 1, 1989]
Article 32(Report on Psychotropic Drug Addicts) #
When the head of the treatment and protection institution as provided for in Article 31 (1), or a medical care businessmen handling psychotropic drugs, finds a person who is addicted to psychotropic drugs, he shall report the address, name, age, and sex of the addict and the name of such psychotropic drugs to the Commissioner of the Korea Food and Drug Adminstration through the Mayor/Do governor. These provisions shall also apply when he treats the psychotropic drug addict or diagnoses his death. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 33(Report, Inspection and Sampling, etc.) #
(1) The Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may, if necessary, have a psychotropic drug handler make a report, or order him to present books, documents and other things concerned, and have a public official concerned enter and inspect the business place of the psychotropic drugs, and the places or facilities related to psychotropic drugs. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) The Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may, if necessary, have a public official concerned sample psychotropic drugs and medicines manufactured using them as precursors in the limit as required for a test under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(3) Any public official who conducts an inspection or sampling under paragraphs (1) and (2), shall show the interested persons a certificate indicating his authority.
Article 34(Discard Order, etc.) #
(1) The Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may order a psychotropic drug handler to discard psychotropic drugs manufactured, sold, stored, or imported in contravention of the provisions of Articles 10, 15, and 25, or inferior psychotropic drugs, etc. in such manner that any occurrence of danger and injury to the public health is prevented, or to take other necessary measures. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) If a person who receives an order issued under paragraph (1), fails to comply with it, the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may have a public official concerned discard the psychotropic drugs, or take other necessary disposition. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
Article 35(Cancellation of Permission, Designation, or Approval, and Suspension of Business) #
(1) If a psychotropic drug handler falls under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor may cancel permission (including permission on items), designation, or approval under this Act, or order the suspension of the business: Provided, That in case of psychotropic drugs which inflict or might inflict any danger and injury on the national health, if it is deemed that it is not attributable to the handler, and it is possible to attain the purpose of permission by modification of ingredients, prescription, etc. of such psychotropic drugs, he may order only such modification: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
1. Where he is sentenced to a penalty heavier than imprisonment without prison labor; and
2. Where he violates this Act or any order issued under this Act.
(2) The criteria for the administrative disposition as referred to in paragraph (1) shall be determined by the Ordinance of the Ministry of Health and Welfare. <Newly Inserted by Act No. 4631, Dec. 27, 1993; Act No. 5485, Dec. 31, 1997>
Article 35-2(Hearing) #
Where the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor intends to cancel any permission, designation or approval pursuant to the provisions of Article 35 (1), he shall hold a hearing. <Amended by Act No. 5529, Feb. 28, 1998>
[This Article Wholly Amended by Act No. 5453, Dec. 13, 1997]
Article 35-3(Disposition of Penalty) #
(1) If the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor takes a disposition of business suspension as prescribed in Article 35 against a psychotropic drug handler, he may impose on him a penalty not exceeding one hundred million won in lieu of the disposition of business suspension under the conditions as prescribed by the Presidential Decree. In this case, the imposition of the penalty shall be limited to cases in which the disposition of business suspension brings or might bring a great danger or injury to the national health, and it may not be imposed in excess of three times. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) The amount of the penalty based on the category, degree, etc. of the offense on which the penalty is imposed under paragraph (1), and other necessary matters, shall be determined by the Presidential Decree.
(3) If the penalty referred to in paragraph (1) is not paid within the time limit, the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor shall collect it according to the example of the disposition of national or local taxes in arrears. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
[This Article Newly Inserted by Act No. 4631, Dec. 27, 1993]
Article 36(Psychotropic Drug Inspectors) #
(1) In order to carry out duties of public officials concerned under Articles 31 (2) and 33 and other supervisory activities over psychotropic drugs, psychotropic drug inspectors shall be assigned to the Korea Food and Drug Administration, Special Metropolitan City, Metropolitan Cities, and Dos. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(2) The qualification and scope of duties of psychotropic drug inspectors and other necessary matters shall be as prescribed by the Presidential Decree.
[This Article Wholly Amended by Act No. 4125, Apr. 1, 1989]
Article 36-2(Honorary Advisors on Psychotropic Drugs) #
(1) Honorary advisors on psychotropic drugs may be assigned to the Korea Food and Drug Administration, Special Metropolitan City, Metropolitan Cities, and Dos and Shis/Kuns/Kus (limited to autonomous Kus) in order to prevent the misuse and abuse of psychotropic drugs and carry out information work and enlightenment, etc. thereof. <Amended by Act No. 5529, Feb. 28, 1998>
(2) The qualifications, scope of functions of honorary advisors on psychotropic drugs, and other necessary matters shall be determined by the Presidential Decree.
[This Article Newly Inserted by Act No. 5485, Dec. 31, 1997]
Article 36-3(Education of Psychotropic Drug Handlers) #
(1) Psychotropic drug handlers shall receive education on psychotropic drug control conducted by the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor. <Amended by Act No. 5529, Feb. 28, 1998>
(2) The necessary matters for the method, frequency and contents, etc. of education on psychotropic drug control referred to in paragraph (1) shall be determined by the Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Act No. 5485, Dec. 31, 1997]
Article 36-4(Collection of Materials Relevant to Psychotropic Drugs) #
The Minister of Health and Welfare and the Commissioner of the Korea Food and Drug Administration shall collect matters concerning the enforcement of this Act and other Acts and subordinate statutes relating to the psychotropic drugs, from each agency of the Government, and may demand presentation of materials on matters necessary for psychotropic drugs. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
[This Article Newly Inserted by Act No. 4631, Dec. 27, 1993]
Article 36-5(Control over Precursor Substances) #
(1) Any person who imports, exports, gives, receives, sells, or purchases the precursors as provided for in Article 3 (3) in excess of such quantity as prescribed by the Presidential Decree, shall prepare a record on the transaction, and keep it for two years, except in the following cases:
1. Where the record on the transaction is prepared and kept under the Pharmaceutical Affairs Act;
2. Where the record on the transaction is prepared and kept under the Toxic Chemicals Control Act;
3. Where any composite agent with the precursors is transacted; and
4. Where the transaction is lawful for carrying out ordinary business, and is as prescribed by the Presidential Decree.
(2) If a person who manufactures, imports, exports, or sells any substances which are precursors of psychotropic drugs (hereinafter referred to as the “precursors handler” in this Article) falls under any of the following subparagraphs, he shall report, without delay, to the Minister of Justice or the Commissioner of the Korea Food and Drug Administration: <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
1. Where the object of purchase of the precursors is obscure, and the precursors might be used for unlawful manufacture of the psychotropic drugs; and
2. Where precursors over the quantity as referred to in paragraph (1) are stolen, or their whereabouts are unknown, or when another accident occurs.
(3) Any precursors handler who has made the report to the Minister of Justice or the Commissioner of the Korea Food and Drug Administration, or any public official who has received the report under paragraph (2), shall keep such matters secret. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
(4) Matters necessary for preparing and keeping the record of transaction and making the report as referred to in paragraphs (1) and (2) shall be as prescribed by the Ordinance of the Ministry of Health and Welfare.
<Amended by Act No. 5485, Dec. 31, 1997>
[This Article Newly Inserted by Act No. 4631, Dec. 27, 1993]
Article 37 #
Deleted.<by Act No. 5485, Dec. 31, 1997>
Article 38(Fee) #
Any person who desires to obtain permission, modification of permitted matters, designation, modification of designated matters, redelivery of written permission, or designation under this Act, shall pay a fee under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 5485, Dec. 31, 1997>
Article 39(Compensation) #
Any person who reports or brings charges to a criminal investigation authority an offense on psychotropic drugs under this Act or other Acts and subordinate statutes before it is detected, or arrests the criminal, shall be paid compensation under the conditions as prescribed by the Presidential Decree.
[This Article Wholly Amended by Act No. 4125, Apr. 1, 1989]
Article 39-2(Delegation of Authority) #
The authority of the Commissioner of the Korea Food and Drug Administration or Mayor/Do governor under this Act may be delegated partially to the Commissioner of the Korea Local Food and Drug Administration, the Mayor/Do governor, or the head of the Si/Gun/Gu (limited to the autonomous Ku), under the conditions as prescribed by the Presidential Decree. <Amended by Act No. 5485, Dec. 31, 1997; Act No. 5529, Feb. 28, 1998>
[This Article Newly Inserted by Act No. 4631, Dec. 27, 1993]
Article 40(Penal Provisions) #
(1) Any person who falls under any of the following subparagraphs shall be punished by imprisonment for life or not less than five years: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
1. A person who manufactures, exports, imports, sells, buys, acts as an intermediates in the selling and buying, gives, or receives psychotropic drugs as provided for in Article 2 (1) 1, or those containing such substances, or who holds or possesses them for the purpose of manufacture, export, import, sale, purchase, mediation of sale and purchase, giving, or receiving in contravention of the provisions of Article 3 (1);
2. A person who extracts ingredients of psychotropic drugs from plants which are precursors thereof, or who exports or imports such plants or possesses them for the purpose of export or import in contravention of the provisions of Article 3 (2);
3. A person who manufacturers, exports, or imports substances which are precursors of psychotropic drugs for the purpose of manufacturing them, or who holds or possesses such materials for the purpose of manufacturing, exporting, or importing psychotropic drugs in contravention of the provisions of Article 3 (3); and
4. A person who manufactures, exports or imports psychotropic drugs as provided for in Article 2 (1) 2, or those containing such substances, or who possesses them for the purpose of manufacture, export, or import, in contravention of the provisions of Article 4 (1).
(2) Any person who has committed any act referred to in paragraph (1) habitually or for profit-making purpose shall be punished by death or imprisonment for life or not less than ten years.
(3) Any attempt to commit offenses as referred to in paragraphs (1) and (2) shall be punished.
(4) Any person who makes a preparation or plot for the purpose of committing offenses referred to in paragraphs (1) and (2) shall be punished by imprisonment for not more than ten years. <Newly Inserted by Act No. 4125, Apr. 1, 1989>
Article 41(Penal Provisions) #
(1) Any person who falls under any of the following subparagraphs shall be punished by imprisonment for not less than one year: <Amended by Act No. 4125, Apr. 1, 1989>
1. A person who holds, possesses, uses, or manages psychotropic drugs as provided for in Article 2 (1) 1, or those containing such substances in contravention of the provisions of Article 3 (1);
2. A person who sells, buys, acts as an intermediate in the selling or buying, gives, or receives plants or substances which are precursors of psychotropic drugs, or who possesses them for the purpose of selling, buying, acting as an intermediate in the selling or buying, giving or receiving them, in contravention of the provisions of Article 3 (2) and (3);
3. A person who manufactures, exports, or imports psychotropic drugs as provided for in Article 2 (1) 3, or those containing such substances, or who possesses them for the purpose of manufacture, export, or import, in contravention of the provisions of Article 4 (1);
4. A person who handles psychotropic drugs in contravention of the provisions of Article 4 (2);
5. A person who manufactures, exports or imports psychotropic drugs, or who uses them as precursors, in contravention of the provisions of Article 6 (1); and
6. A person who wholesales or manages psychotropic drugs in contravention of the provisions of Article 8 (1).
(2) Any attempt to commit an offense referred to in paragraph (1) shall be punished.
Article 42(Penal Provisions) #
(1) Any person who falls under any of the following subparagraphs, shall be punished by imprisonment for not more than ten years or a fine not exceeding one hundred million won: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
1. A person who sells, buys, acts as an intermediate in the selling and buying, gives, receives, holds, possesses, uses, manages, prepares, administers, or delivers psychotropic drugs as provided for in Article 2 (1) 2 and 3, or those containing such substances, or who issues a prescription for psychotropic drugs, in contravention of the provisions of Article 4 (1);
2. A person who manufactures, exports, or imports psychotropic drugs as provided for in Article 2 (1) 4, or those containing such substances, or who holds or possesses them for the purpose of manufacture, export, or import, in contravention of the provisions of Article 4 (1); and
3. and 4. Deleted; <by Act No. 5485, Dec. 31, 1997>
(2) Any person who sells, buys, gives, receives, prepares, administers, or delivers psychotropic drugs to or from a minor in contravention of the provisions of Article 4 (1), shall be punished by imprisonment for life or not less than five years. <Newly Inserted by Act No. 4125, Apr. 1, 1989>
(3) Any attempt to commit offenses referred to in paragraphs (1) and (2) shall be punished. <Amended by Act No. 4125, Apr. 1, 1989>
Article 43(Penal Provisions) #
(1) Any person who falls under any of the following subparagraphs shall be punished by imprisonment for not more than five years or a fine not exceeding fifty million won: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
1. A person who smokes or takes in plants which are precursors of psychotropic drugs, or who possesses them for the purpose of smoking or taking them in, or making others smoke or take them in, in contravention of the provisions of Article 3 (2);
2. A person who offers to another person a place, facility, equipment, fund or means of transportation, or the means to do any prohibited act in contravention of the provisions of Article 3 (4);
3. A person who sells, buys, acts as an intermediate in the selling and buying, gives, receives, holds, possesses, uses, manages, prepares, administers, or delivers psychotropic drugs as provided for in Article 2 (1) 4, or those containing such substances, or who issues a prescription for psychotropic drugs, in contravention of the provisions of Article 4 (1);
4. A person who violates the provisions of Article 5 (1) or 20 (1);
5. A person who conducts scientific research without obtaining permission under Article 6 (1); and
6. Deleted. <by Act No. 4631, Dec. 27, 1993>
(2) Any person who falls under any of the following subparagraphs shall be punished by imprisonment for not more than two years or a fine not exceeding twenty million won: <Newly Inserted by Act No. 4125, Apr. 1, 1989; Act No. 4631, Dec. 27, 1993; Act No. 5485, Dec. 31, 1997>
1. A person who deserts from a treatment and protection institution as provided for in Article 31 (1), or conceals such deserter without justifiable reason;
2. A person who refuses, interferes with, or evades any test or treatment and protection under Article 31 (2) without justifiable reason;
3. A person who transacts the precursors divided into small lots, with the intention to evade the obligation of record preparation as provided for in Article 36-3 (1);
4. A person who violates the provisions of Article 7 (3), 12, 16 (1), 20 (2) through (4) or 36-3 (1) through (3); and
5. A person who manufactures, exports or imports psychotropic drugs without item permission in violation of Article 10 or 15.
(3) Any attempt to commit an offense referred to in paragraph (2) 1 through 3 shall be punished. <Newly Inserted by Act No. 4125, Apr. 1, 1989; Act No. 4631, Dec. 27, 1993>
Article 44(Penal Provisions) #
Any person who falls under any of the following subparagraphs shall be punished by imprisonment for not more than one year or a fine not exceeding ten million won: <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
1. A person who violates the provisions of Article 11, 13, 18, 19 (2), 21, 23 (3), 25 (1) and (2), 28 or 29;
2. A person who fails to make a report, declaration or record under Article 14 (2), 16 (2), 24, 26, 27 or 32, or makes a false report, declaration, or record falsely;
3. A person who fails to prepare bookkeeping documents or receipts and supply ledgers under Article 19 (1), 22 or 27 (2), or prepares them falsely;
4. A person who infringes an order issued under Article 33 (1) and (2) or 34 without justifiable reason, makes a false report, or refuses, interferes with, or evades an inspection, sampling, or disposition; and
5. A person who operates a business during a business suspension period under Article 35.
Article 45(Recidivist) #
If any person habitually commits an offense under Article 41, 43 (1) 1, 2 and 6, or subparagraph 1 of Article 44, the penalty shall be aggravated up to half of that as provided for each offense. <Amended by Act No. 4125, Apr. 1, 1989>
Article 46(Concurrent Imposition of Qualification Suspension or Fine) #
(1) Any person who commits an offense under Articles 40 and 41 may be punished concurrently by suspension of qualifications for not more than ten years or a fine not exceeding one hundred million won.
(2) Any person who commits an offense under Articles 42 through 44 may be punished concurrently by suspension of qualifications for not more than seven years or a fine under the relevant Article (limited to where he is punished by imprisonment).
[This Article Wholly Amended by Act No. 5485, Dec. 31, 1997]
Article 47(Confiscation) #
(1) Psychotropic drugs, facilities, equipment, funds, means of transportation which are offered to commit an offense as provided for in this Act, or profits derived from them, shall be confiscated: Provided, That if it is impossible to confiscate them, the value of them shall be collected additionally. <Amended by Act No. 4125, Apr. 1, 1989>
(2) Psychotropic drugs confiscated under paragraph (1) shall be handed over to the Mayor/Do governor. <Amended by Act No. 4125, Apr. 1, 1989>
(3) When the Mayor/Do governor receives psychotropic drugs as referred to in paragraph (2), he shall discard them, or take necessary measures. <Amended by Act No. 4125, Apr. 1, 1989>
(4) Matters necessary for the discarding and other dispositions under paragraph (3) shall be as prescribed by the Presidential Decree.
Article 48(Joint Penal Provisions) #
If a representative of a juristic person or an agent, employee or other servant of a juristic person or individual commits an offense under this Act with respect to the business of psychotropic drugs, the juristic person or individual shall also be punished by a fine not exceeding one hundred million won, in addition to a punishment against the actor: Provided, That if it falls under offenses as provided for in Articles 43 and 44, he shall be punished by a fine as provided for with respect to each corresponding offense. <Amended by Act No. 4125, Apr. 1, 1989; Act No. 5485, Dec. 31, 1997>
Article 49(Enforcement Decree) #
Matters necessary for the enforcement of this Act shall be as prescribed by the Presidential Decree.