Regulations on the Control of Narcotic Drugs and Psychotropic Drugs (Revised in 2016)

Order of the State Council of the People's Republic of China No.666

February 6, 2016

(Promulgated by the Order of the State Council No.442 on August 3, 2005; revised for the first time according to Decision of the State Council on Revising Some Administrative Regulations on December 7, 2013; and revised for the second time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016)

Chapter I General Provisions

Article 1 With a view to strengthening control on narcotic drugs and psychotropic drugs, ensuring the lawful, safe and reasonable use of narcotic drugs and psychotropic drugs, and preventing them from flowing into illegal channels, the present Regulation is formulated in accordance with the provisions of the Drug Administration Law and other relevant laws.

Article 2 The present Regulation shall be applicable to the plant of anesthetic raw herbs and the experiment and research, production, management, use, storage, and transportation of narcotic drugs and psychotropic drugs, and other activities, and the supervision and administration thereof.
The import and export of narcotic drugs and psychotropic drugs shall be handled in accordance with the provisions of relevant laws.

Article 3 The narcotic drugs and the psychotropic drugs as mentioned in the present Regulation shall refer to the drugs and other substances listed into the Catalog of Narcotic Drugs and the Catalog of Psychotropic Drugs (hereinafter called Catalogs). Psychotropic drugs shall be classified into psychotropic drugs of category I and psychotropic drugs of category II.
The Catalogs shall be formulated, adjusted and publicized by the department of drug supervision and administration of the State Council together with the public security department of the State Council and the competent department of health of the State Council.
In case there occurs any misuse of any drug or any other substance that is listed for sale but has not been listed in the Catalogs or of the psychotropic drugs of category II, which has resulted in or may result in serious social harmfulness, the department of drug supervision and administration of the State Council shall, together with the public security department of the State Council and the competent department of health of the State Council, list the drug or the substance into the Catalogs or adjust the psychotropic drugs of category II into the psychotropic drugs of category I.

Article 4 The state shall make control on anesthetic raw herbs and narcotic drugs and psychotropic drugs. Unless otherwise specified by the present Regulation, no entity or individual may plant any anesthetic raw herbs, or carry out experiment and research, production, management, use, storage, or transportation of narcotic drugs and psychotropic drugs and other activities.

Article 5 The department of drug supervision and administration of the State Council shall be responsible for the supervision and administration of narcotic drugs and psychotropic drugs nationwide, and shall, together with the competent department of agriculture of the State Council, conduct supervision and administration on anesthetic raw herbs. The department of public security of the State Council shall be responsible for making investigation into acts which result in the flowing of anesthetic raw herbs and narcotic drugs and psychotropic drugs into illegal channels. Other competent departments of the State Council shall be responsible for the work in relation to the administration of narcotic drugs and psychotropic drugs within their own scope of functions.
The departments of drug supervision and administration of the people's governments at provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the supervision and administration of narcotic drugs and psychotropic drugs within their own administrative regions. The local public security organs at or above the county level shall be responsible for making investigation into acts which result in the flowing of narcotic drugs and psychotropic drugs into illegal channels within their own administrative regions. Other relevant competent departments of the local people's governments at or above the county level shall be responsible for the work relating to the administration of narcotic drugs and psychotropic drugs within their own scope of functions.

Article 6 Any enterprise undertaking the production and management of narcotic drugs and psychotropic drugs and any entity using these drugs may take part in the industry association according to law. The industry association shall strengthen self-disciplinary management on the industry.

Chapter II Planting, Experiment and Research and Production

Article 7 The state shall, according to the needs for medical treatment, national reserve and the materials needed for enterprise production, determine the demand of narcotic drugs and psychotropic drugs, and control the total amount of the planting of anesthetic raw herbs and the production of narcotic drugs and psychotropic drugs.
The department of drug supervision and administration of the State Council shall formulate annul production plan according to the demand of narcotic drugs and psychotropic drugs.
The department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council shall, according to the annual production plan for narcotic drugs, make an annual plan for planting anesthetic raw herbs.

Article 8 Any enterprise undertaking the plant of anesthetic raw herbs shall, according to the annual planting plan, plant the anesthetic raw herbs.
The enterprises undertaking the plant of anesthetic raw herbs shall report the planting conditions periodically to the department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council.

Article 9 The enterprises undertaking the plant of anesthetic raw herbs shall be determined by the department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council together, no other entity or individual shall plant anesthetic raw herbs.

Article 10 The following conditions shall be met for carrying out the experiment and research on narcotic drugs and psychotropic drugs, with the approval of the department of drug supervision and administration of the State Council:
1. The purpose is for medical treatment, scientific research or teaching;
2. The entity has measures and management system for ensuring the safety of narcotic drugs and psychotropic drugs needed for the experiment; and
3. The entities or its personnel have no acts in violation of the provisions of any anti-drug law or administrative regulation within 2 years.

Article 11 The entities undertaking the experiments and research of narcotic drugs and psychotropic drugs shall, when applying for the certificate documents of approval for the relevant drugs, handle it according to the provisions of the Pharmaceutical Administration Law; if there is necessity to transfer the research results, they shall be subject to the approval of the department of drug supervision and administration of the State Council.

Article 12 In case any drug research entity produces any controlled drugs as prescribed in the present Regulation during the process of making experiment and research on ordinary drugs, it shall stop the activity of experiment and research immediately, and report to the department of drug supervision and administration of the State Council. The department of drug supervision and administration of the State Council shall, according to the reality, make decision on whether to approve it to continue the experiment and research in a timely manner.

Article 13 The clinical trials on narcotic drugs and the psychotropic drugs of category I shall not target on healthy people.

Article 14 The state shall implement the system of designated production on narcotic drugs and psychotropic drugs.
The department of drug supervision and administration of the State Council shall, according to the demand of narcotic drugs and psychotropic drugs, determine the quantity and overall arrangement of the designated production enterprises of narcotic drugs and psychotropic drugs, and make adjustment and publicity on the quantity and layout according to annual demand.

Article 15 The designated production enterprises of narcotic drugs and psychotropic drugs shall have the following conditions:
1. Having drug production license;
2. Having documents of approval for the experiment and research of narcotic drugs and psychotropic drugs;
3. Having production facilities, storage conditions and the corresponding safeguard management establishments for narcotic drugs and psychotropic drugs complying with the requirements;
4. Having the ability to conduct work safety management on enterprises through network and to report production information to the department of drug supervision and administration;
5. Having the management system for ensuring the safety production of narcotic drugs and psychotropic drugs;
6. Having the management level and business scale meeting the requirement for safety production of narcotic drugs and psychotropic drugs;
7. The personnel in the departments of production management and quality control over narcotic drugs and psychotropic drugs shall be familiar with the laws and administrative regulations on the control of narcotic drugs and psychotropic drugs and the relevant anti-drug laws and administrative regulations;
8. Having no acts of production and sale of bogus drugs, low quality drugs or in violation of the relevant anti-drug laws and administrative regulations; and
9. Complying with the requirements for the quantity and overall arrangement of the designated production enterprises of narcotic drugs and psychotropic drugs as publicized by the department of drug supervision and administration of the State Council.

Article 16 To engage in the production of narcotic drugs or psychotropic drugs, it is required to obtain the approval of the drug administration of the people's government of the province, autonomous region and municipality directly under central government at its locality.

Article 17 Any designated production enterprise shall, when producing narcotic drugs and psychotropic drugs, obtain the number of documents of approval for drugs according to the provisions of the Pharmaceutical Administration Law.
The department of drug supervision and administration of the State Council shall organize experts in the aspects of medical science, pharmacy, social science and ethics, as well as anti-drugs, and etc. to form an expert team, which shall make appraisal on the social harmfulness of narcotic drugs and psychotropic drugs coming into the market for the first time and the possibility for their being misused, and propose suggestions on whether to approve it or not.
No enterprise that has not obtained the number of documents of approval for drugs may produce narcotic drugs and psychotropic drugs.

Article 18 In case of occurrence of any serious critical incident, which results in the incapability of any designated production enterprise to carry out ordinary production or the failure to ensure the supply of narcotic drugs and psychotropic drugs, the department of drug supervision and administration of the State Council shall determine another pharmaceutical production enterprise to produce narcotic drugs and psychotropic drugs.
After the end of the serious critical incident, the department of drug supervision and administration of the State Council shall determine in time that the enterprises as prescribed in the preceding paragraph shall stop production of narcotic drugs and psychotropic drugs.

Article 19 A designated enterprise shall arrange the production strictly in accordance with the annual production plan for narcotic drugs and psychotropic drugs, and report the production conditions to the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality as prescribed.

Article 20 A designated production enterprise shall, according to the provisions of the present Regulation, sell narcotic drugs and psychotropic drugs to the enterprises that have the business qualification of narcotic drugs and psychotropic drugs or to other entities approved by the present Regulation.

Article 21 The labels of narcotic drugs and psychotropic drugs shall be printed with the marks as prescribed by the department of drug supervision and administration of the State Council.

Chapter III Management

Article 22 The state shall apply designated management system to narcotic drugs and psychotropic drugs.
The department of drug supervision and administration of the State Council shall, according to the demand of narcotic drugs and the psychotropic drugs of category I, determine the overall arrangement of the designated wholesales enterprises of narcotic drugs and the psychotropic drugs in category I, and make adjustment and publicity on the overall arrangement according to the annual demand.
No pharmaceutical management enterprise may deal in anesthetic raw herbs and raw material medicine of psychotropic drugs of category I. But the small package of the said drugs for the use of medical treatment, scientific research and teaching may be dealt in by wholesales pharmaceutical enterprises as prescribed by the department of drug supervision and administration of the State Council.

Article 23 The designated wholesales enterprise of narcotic drugs and psychotropic drugs shall not only have the conditions for establishing pharmaceutical management enterprises as prescribed in Article 15 of the Pharmaceutical Administration Law, but also shall have the following conditions:
1. Having the conditions for storage of narcotic drugs and pharmaceutical drugs as prescribed in the present Regulation;
2. Having the ability to implement safety management on enterprises and to report management information to the department of drug supervision and administration through networks;
3. The entity and its staff members have no acts in violation of the relevant anti-drug laws and administrative regulations within 2 years; and
4. Complying with the overall arrangement of the designated wholesales enterprises as promulgated by the department of drug supervision and administration of the State Council.
The designated wholesales enterprises of narcotic drugs and the psychotropic drugs of category I shall also have the ability to ensure the supply of narcotic drugs and the psychotropic drugs of category I as needed for the medical institutions within their own responsibility areas, and shall have the management system for ensuring the safety operation of narcotic drugs and the psychotropic drugs of category I.

Article 24 Any enterprise that undertakes the wholesales business of narcotic drugs and the psychotropic drugs of category I across any province, autonomous region, or municipality directly under the Central Government (hereinafter referred to as the national wholesales enterprise) shall be subject to the approval of the department of drug supervision and administration of the State Council; any enterprise undertaking the wholesales business of narcotic drugs and the psychotropic drugs of category I within its own province, autonomous region or municipality directly under the Central Government (hereinafter referred to as the regional wholesales enterprise) shall be subject to the approval of the department of drug supervision and administration department of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality. Any enterprise specially undertaking the wholesales business of the psychotropic drugs of category II shall be subject to the approval of the department of drug supervision and administration department of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality.
National wholesales enterprises and regional wholesales enterprises may undertake the wholesales business of psychotropic drugs of category II.

Article 25 A national wholesales enterprise may sell narcotic drugs and the psychotropic drugs of category I to regional wholesales enterprises or to the medical institutions that have obtained the qualification for using narcotic drugs and the psychotropic drugs of category I or other entities approved according to the provisions of the present Regulation.
A national wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution that has obtained the qualification on using narcotic drugs and the psychotropic drugs of category I, be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at the place where the medical institution is located.
The department of drug supervision and administration of the State Council shall, when approving national wholesales enterprises, clarify the areas in which they shall undertake liabilities for drug supply.

Article 26 A regional wholesales enterprise may sell narcotic drugs and the psychotropic drugs of category I to the medical institutions that have obtained the qualification on using narcotic drugs and the psychotropic drugs of category I within the administrative region of its own province, autonomous region, and municipality directly under the Central Government; where there is necessity to sell the said drugs to the medical institutions that have obtained the qualification on using narcotic drugs and the psychotropic drugs of category I within the administrative region of any neighboring province, autonomous region, and municipality directly under the Central Government due to the reason of special geographical locations, it shall be subject to the approval of the administrative department of drug supervision of the people's government of provinces, autonomous regions or municipalities directly under the Central Government of the place where the enterprise is located. The administrative department of drug supervision responsible for examination and approval shall report the examination and approval status to the administrative department of drug supervision of the people's government of provinces, autonomous regions or municipalities directly under the Central Government of the place where the medical institution is located within five days of approval.
The department of drug supervision and administration of the people's government of any province, autonomous region, and municipality directly under the Central Government shall, when approving any regional wholesales enterprise, clarify the region where it shall undertake liabilities for drug supply. Where there is necessity to adjust narcotic drugs and the psychotropic drugs of category I between regional wholesales enterprises due to emergency medical treatment and difficulties in transportation and other special circumstances, the adjustment information shall be reported to the department of drug supervision and administration of the people's government at the province, autonomous region and municipality directly under the Central Government at the place where the enterprises are located for archival filing within 2 days after the adjustment.

Article 27 A national wholesales enterprise shall purchase narcotic drugs and the psychotropic drugs of category I from designated production enterprises.
A regional wholesales enterprise may purchase narcotic drugs and the psychotropic drugs of category I from national wholesales enterprises or may purchase narcotic drugs and the psychotropic drugs of category I from designated production enterprises upon the approval of the department of drug supervision and administration of the people's government of the province, autonomous region, and municipality directly under the Central Government at its locality.

Article 28 Any national wholesales enterprises or regional wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution, send the drug to the medical institution. No medical institution shall pick up the goods by itself.

Article 29 The designated wholesales enterprises of psychotropic drugs of category II may sell psychotropic drugs of category II to medical institutions, designated wholesales enterprises and the retailing pharmaceutical enterprises as prescribed in Article 31 of the present Regulation and other entities as approved by the provisions of the present Regulation.

Article 30 No narcotic drugs and the psychotropic drugs of category I may be retailed.
Trading of narcotic drugs and psychotropic drugs in cash shall be prohibited, but excluding the narcotic drugs and the psychotropic drugs lawfully purchased by individuals.

Article 31 Any pharmaceutical retail chain enterprise that applies unified purchase of goods, unified distribution and unified management may, upon the approval of the department of drug supervision and administration at the level of the city divided into districts at its locality, undertake the retail business of psychotropic drugs of category II.

Article 32 The retail enterprises of psychotropic drugs of category II shall, upon the strength of the prescriptions issued by the practicing physician, sell the psychotropic drugs of category II according to the prescribed dosage, and keep the prescriptions for two years for reference; no one may sell the psychotropic drugs of category II in excess of the dosage or without prescriptions; no one may sell the psychotropic drugs of category II to minors.

Article 33 Government pricing shall be applied to narcotic drugs and psychotropic drugs, and on the basis of making factory price and wholesales price, a nationally unified retail price shall be implemented step by step. The concrete measures shall be formulated by the competent department of price of the State Council.

Chapter IV Using

Article 34 Where any pharmaceutical production enterprise needs to produce ordinary pharmaceuticals with narcotic drugs and the psychotropic drugs of category I as raw materials, it shall submit an annual demand plan to the department of drug supervision and administration of the people's government of the province, autonomous region, and municipality directly under the Central Government at its locality. After the said department has collected the annual demand plans and reported them to the department of drug supervision and administration of the State Council for approval, the said enterprise may purchase them from the designated production enterprises.
Where any pharmaceutical production enterprise needs to produce any ordinary pharmaceuticals with the psychotropic drugs of category II as raw materials, it shall report the annual demand plan to the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality, and purchase them from the designated wholesales enterprises or designated production enterprises.

Article 35 In case such non-pharmaceutical production enterprises as food, food additives, cosmetic, oil paint and etc. need to use caffeine as raw materials, they shall be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality, and purchase it from the designated wholesales enterprises or designated production enterprises.
In case any scientific research or teaching entity needs to use narcotic drugs and psychotropic drugs to carry out experiments and teaching activities, it shall be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality, and purchase them from the designated wholesales enterprises or designated production enterprises.
Where there is necessity to use standard articles and comparison articles of narcotic drugs and psychotropic drugs, it shall be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality and purchase them form the entities approved by the department of drug supervision and administration of the State Council.

Article 36 In case any medical institution needs to use narcotic drugs and the psychotropic drugs of category I, it shall be subject to the approval of the competent department of health of the people's government at the level of the city divided into districts at its locality, and obtain the seal card for purchasing narcotic drugs and the psychotropic drugs of category I (hereinafter referred to as the seal card). Then the medical institution shall purchase narcotic drugs and the psychotropic drugs of category I from the designated wholesales enterprises within the administrative region of its own province, autonomous region, and municipality directly under the Central Government upon the strength of the seal card.
The competent department of health of the people's government at the city divided into districts shall, when issuing seal card to medical institutions, send a copy of the information of the medical institutions that have obtained the seal cards to the department of drug supervision and administration of the city divided into districts at its locality, and report it to the competent department of health of the people's government at the province, autonomous region, and municipality directly under the Central Government for archival filing. The said department shall circulate a report on the name list of the medical institutions that have obtained the seal cards to the designated wholesales enterprises within its own administrative region.

Article 37 A medical institution shall have the following conditions when obtaining a seal card:
1. Having full-time management personnel of narcotic drugs and the psychotropic drugs of category I;
2. Having practicing physicians that have obtained the qualification on prescribing narcotic drugs and the psychotropic drugs of category I; and
3. Having establishments and management systems that can ensure the safety storage of narcotic drugs and the psychotropic drugs of category I.

Article 38 A medical institution shall, according to the provisions of the competent department of health of the State Council, hold training and examination for the practicing physicians of its own entity on their using of narcotic drugs and psychotropic drugs, and grant the qualification on prescribing narcotic drugs and the psychotropic drugs of category I to those who have passed the examination. No practicing physician may issue prescriptions on narcotic drugs and the psychotropic drugs of category I until he/she has obtained the qualification on prescribing narcotic drugs and the psychotropic drugs of category I, but no one may issue such prescriptions for himself/herself. A medical institution shall have the name list of the practicing physicians that have the qualification on prescriptions of narcotic drugs and the psychotropic drugs of category I and the alteration situations submitted periodically to the competent department of health of the people's government at the city divided into districts at its locality, and send a copy to the department of drug supervision and administration at the same level. A physician shall, according to the guiding principle for clinical application formulated by the competent department of health of the State Council, use narcotic drugs and psychotropic drugs.

Article 39 Any practicing physician that has the qualification on prescribing narcotic drugs and the psychotropic drugs of category I shall, according to the guiding principles of clinical application, satisfy the patients' reasonable demand for drug use, if they really need to use narcotic drugs and the psychotropic drugs of category I. In case any patient suffering from the pain of cancer or any other patient of critically ill who is treated at a medical institution cannot get narcotic drugs and the psychotropic drugs of category I, the patient or his/her relatives may file an application to the practicing physician. If the practicing physician who has the qualification on prescribing narcotic drugs and the psychotropic drugs of category I believes the request is reasonable, he/she shall provide narcotic drugs and the psychotropic drugs of category I for the patient in a timely manner.

Article 40 A practicing physician shall issue narcotic drugs and psychotropic drugs by using special prescriptions, and the maximum dosage of a single prescription shall comply with the provisions of the competent department of health of the State Council.
Any pharmacist or checker of prescriptions on narcotic drugs and the psychotropic drugs of category I shall check them carefully, sign his/her name and make registration on them; for those not complying with the provisions of the present Regulation, the pharmacist or checker shall refuse to dispense.
The format of the special prescriptions on narcotic drugs and psychotropic drugs shall be prescribed by the competent department of health of the State Council.

Article 41 A medical institution shall make special book registration on the prescriptions on narcotic drugs and psychotropic drugs, and strengthen administration on them. The prescriptions on narcotic drugs shall be kept for at least three years, and the prescriptions on psychotropic drugs shall be kept for at least two years.

Article 42 In case any medical institution needs narcotic drugs and the psychotropic drugs of category I for rescuing patients in emergency, but the medical institution is unable to provide such drugs, it may borrow them from other medical institutions or designated wholesales enterprises for emergency use. After the end of the rescue work, it shall report the borrowing information in a timely manner to the department of drug supervision and administration of the city divided into districts at its locality and the competent department of health for archival filing.

Article 43 For any narcotic drug or psychotropic drug which is needed for clinical use but with no supply in the market, if any medical institution which holds the license of preparations of medical institution and the seal card needs to prepare the preparations, it shall be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality. The preparations of narcotic drugs and psychotropic drugs prepared by any medical institution may only be used in its own medical institution, and shall not be sold to others.

Article 44 Where due to the need of curing diseases, an individual may carry narcotic drugs and the psychotropic drugs of category I within the maximum dosage of a single prescription upon the strength of the medical certificate and his/her identity certificate. If anyone carries any narcotic drug or the psychotropic drug of category I to enter or exit the territory, the customs house shall grant discharge in light of the principle of self-use and reasonableness.
In case any physician carries small amount of narcotic drugs and psychotropic drugs to enter or exit the territory for medical treatment, he/she shall hold the certificate for carrying narcotic drugs and psychotropic drugs issued by the department of drug supervision and administration of the people's government at or above the provincial level. The customs house shall grant discharge on the basis of the certificate for carrying narcotic drugs and psychotropic drugs.

Article 45 In case any medical institution or detoxification institution for drug dependency carry out treatment of narcotic drug addiction, it may use Methadone or other narcotic drugs or psychotropic drugs for treatment of narcotic drug addiction as determined by the state. The concrete measures shall be formulated by the department of drug supervision and administration of the State Council, the public security department of the State Council and the competent department of health of the State Council.

Chapter V Storage

Article 46 Any enterprise undertaking the plant of anesthetic raw herbs, any designated production enterprise, national wholesales enterprise and regional wholesales enterprise, or the narcotic drug storage entity established by the state shall set up special warehouses for storage of narcotic drugs and the psychotropic drugs of category I. The warehouses shall comply with the following requirements:
1. Being installed with special security door with double key and two persons in charge;
2. Having corresponding fireproof facilities; and
3. Having monitoring facilities and alarm device, the alarm device shall be interconnected with the alarm system of public security organs.
The drug storage place established by a national wholesales enterprise upon the approval of the department of drug supervision and administration of the State Council shall comply with the provisions of the preceding paragraph.
The designated narcotic drug production enterprises shall keep the anesthetic raw herbs and the preparations separately.

Article 47 Entities using narcotic drugs and the psychotropic drugs of category I shall set up special warehouses or special cabinets to store narcotic drugs and the psychotropic drugs of category I. The special warehouses shall set up security facilities and install alarm device; the special cabinets shall use safes. The management of double key with two persons in charge shall be applied to the special warehouses and the special cabinets.

Article 48 Any enterprise undertaking the plant of anesthetic raw herbs, any designated production enterprise, national wholesales enterprise and regional wholesales enterprise, or the narcotic drug storage entity established by the state, as well as the entity using narcotic drugs and the psychotropic drugs of category I shall staff special personnel being responsible for the management work, and establish special account books for storage of narcotic drugs and the psychotropic drugs of category I. The in-warehouse of drugs shall be checked and accepted by two persons and the out-warehouse of drugs shall be rechecked by two persons, and the drug shall comply with the account book. The time limit for keeping the special account books shall be no less than five years from the expiry of the period of validity of the drugs.

Article 49 The enterprises undertaking the management of psychotropic drugs of category II shall set up special independent warehouse or special cabinet in the drug warehouse to store the psychotropic drugs of category II, and establish special account books under the charge of special person, The time limit for keeping the special account books shall be no less than five years from the day when the valid date of the drug expires.

Chapter VI Transportation

Article 50 Anyone consigning, undertaking the transport or transporting by itself any narcotic drug or psychotropic drug shall take safeguard measures to prevent the narcotic drug or psychotropic drug from being stolen, robbed of or lost in the process of transportation.

Article 51 Where containers or railway luggage vans shall be used for the transportation of narcotic drugs and the psychotropic drugs of category I by railway, the concrete measures shall be formulated by the department of drug supervision and administration of the State Council together with the competent department of railways of the State Council.
Where there is no railway line, and there is necessity to transport narcotic drugs and the psychotropic drugs of category I through highway or water way, the escorting shall be made by special personnel.

Article 52 Any entity that consigns or transports by itself narcotic drugs and the psychotropic drugs of category I shall apply for obtaining transportation certificate to the local drug administration at the level of the city divided into districts. The valid period of the transportation certificate shall be one year.
The transportation certificate shall be kept by special person, and shall not be altered, transferred, or lent.

Article 53 Any consignor shall, when handling formalities for transportation of narcotic drugs and the psychotropic drugs of category I, deliver the duplicate of the transportation certificate to the carrier, who shall check and keep the duplicate of the transportation certificate and inspect the package of the goods. If there is no transportation certificate or the package of the goods does not comply with the requirements, the carrier shall not undertake the consignment.
A carrier shall carry the duplicate of the transportation certificate during consignment for checking.

Article 54 In case of posting narcotic drugs and psychotropic drugs, the sender shall submit the certificate of granting the mailing issued by the local drug administration at the level of the city divided into districts. The postal office shall check and keep the certificate of granting the mailing; if there is no certificate of granting the mailing, the postal office shall not accept and mail the said drugs.
The competent department of postal service of a province, autonomous region, or municipality directly under the Central Government shall designate postal offices that comply with the safeguard conditions to be responsible for accepting and mailing narcotic drugs and psychotropic drugs. A postal office shall, when accepting and mailing narcotic drugs and psychotropic drugs, check them according to law.
The concrete measures for the administration of mailing of narcotic drugs and psychotropic drugs shall be formulated by the department of drug supervision and administration of the State Council together with the competent department of postal service of the State Council.

Article 55 In case narcotic drugs or the psychotropic drugs of category I are transported between designated production enterprises and national wholesales enterprises and regional wholesales enterprises, the consigner shall report the relevant information on the transportation before the consignment to the department of drug supervision and administration of the people's government of the province, autonomous region, and municipality directly under the Central Government at its locality. For the transportation across provinces, autonomous regions, and municipalities directly under the Central Government, the department of drug supervision and administration that has received the information shall circulate a report to the department of drug supervision and administration at the corresponding level at the place where the consignee is located. In case the transportation is made within the administrative region of its own province, autonomous region or municipality directly under the Central Government, the department of drug supervision and administration that has received the information shall circulate a report to the department of drug supervision and administration at the level of the city divided into districts where the consignee is located.

Chapter VII Procedures for Examination and Approval and the Supervision and Administration

Article 56 An applicant shall, when filing an application for matters subject to examination and approval as prescribed in the present Regulation, submit the relevant materials proving that it complies with the conditions as prescribed by the present Regulation. The department of examination and approval shall make a decision on whether to grant approval or not within 40 days from the day of receiving the application. If a decision on approval is made, the certificate documents of license shall be issued or the licensing matters shall be noted in the relevant certificate documents of license. If a decision on not granting approval is made, the reasons shall be explained in writing.
When determining designated production enterprises and designated wholesales enterprises, the department of examination and approval shall, according to the requirements for the overall arrangement, determine designated production enterprises and designated wholesales enterprises through fair competition from the enterprises complying with the conditions after examination, and publicize them. Other enterprises that comply with the conditions may raise a demur to the department of examination and approval within 10 days from the day of publicity. The department of examination and approval shall make examination on the demur within 20 days from the day of receiving the demur, and make a decision on whether to make adjustment or not.

Article 57 The department of drug supervision and administration shall, according to the prescribed power of functions, make supervision and inspection on the plant of anesthetic raw herbs and the experiment and research, production, management, use, storage, and transportation of narcotic drugs and psychotropic drugs.

Article 58 The department of drug supervision and administration of the people's government at or above the provincial level shall establish monitoring information network according to the reality, and make real-time monitoring on the production, purchase, sale, inventory, the amount of usage and flow of narcotic drugs and psychotropic drugs of designated production enterprises, designated wholesales enterprises and the entities using them, and share the information with the public security organs at the corresponding level.

Article 59 The designated production enterprises, designated wholesales enterprises and the entities using narcotic drugs and psychotropic drugs, which have not connected with the monitoring information network shall, through electronic information, fax, written forms, and other ways, report monthly the production, purchase, sale, inventory, the amount of usage and flow of narcotic drugs and psychotropic drugs of their own entities to the department of drug supervision and administration and the public security organ at the level of the city divided into districts at their localities; a medical institution shall also report to the competent department of health of the people's government at the level of the city divided into districts at its locality.
The department of drug supervision and administration at the level of any city divided into districts shall report the relevant information on narcotic drugs and psychotropic drugs of their own regions to the upper level department of drug supervision and administration every three months.

Article 60 For any kind of narcotic drugs and psychotropic drugs having been misused or having resulted in serious social harmfulness, the department of drug supervision and administration of the State Council shall take such measures within a certain time limit as suspending their production, management, use or restricting the scope for their use and their usage, and etc.. For any narcotic drug or psychotropic drug which is no longer used as pharmaceutical, the department of drug supervision and administration of the State Council shall revoke its number of document of approval and the standard for the drug, and publicize it.
In case any department of drug supervision and administration or competent department of health discovers there is any hidden safety trouble in the administration of narcotic drugs and the psychotropic drugs of any production and management enterprises and the entities using them, it shall order them to eliminate the trouble immediately or within a prescribed time limit; if there is any evidence proving that these drugs may enter into illegal channels, it shall take seizure and distraint and other mandatory administrative measures in a timely manner, and make administrative disposal decision within 7 days, and circulate a report to the public security organ at the corresponding level.
In case any department of drug supervision and administration discovers that any medical institution that has obtained the seal card fails to purchase narcotic drugs and the psychotropic drugs of category I as required, it shall circulate a report to the competent department of health at the corresponding level in a timely manner. The competent department of health that receives the report shall make investigation and handling at once. The department of drug supervision and administration may order the designated wholesale enterprises to suspend selling narcotic drugs and the psychotropic drugs of category I to the medical institution, if necessary.

Article 61 The production and management entities and the entities using narcotic drugs and psychotropic drugs shall make registration on overdue and damaged narcotic drugs and psychotropic drugs and apply for destroying them to the department of drug supervision and administration at the level of the counties where they are located. The department of drug supervision and administration shall be present and supervise the destruction of drugs within 5 days from the day of receiving the application. A medical institution shall, for the overdue and damaged narcotic drugs and psychotropic drugs kept in its own entity, file an application with the competent department of health in light of the procedures prescribed in the present Article, and the competent department of health shall be responsible for supervising the destruction of the drugs.
The narcotic drugs and the psychotropic drugs captured according to law shall, apart from being used for scientific research upon the approval of the department of drug supervision and administration of the State Council or the public security department of the State Council, be destroyed in light of the relevant provisions of the state.

Article 62 The competent department of health of the people's government at or above the county level shall make supervision and inspection on practicing physicians for their prescribing narcotic drugs and psychotropic drugs.

Article 63 The department of drug supervision and administration, the competent department of health and the public security organ shall circulate a report mutually on the name lists of the production and management entities and entities using narcotic drugs and psychotropic drugs and other management information.
The department of drug supervision and administration at all levels shall circulate a report on the plant of anesthetic raw herbs and the matters of examination and approval and revocation in the management of experiment and research, production, management, using, storage and transportation of narcotic drugs and psychotropic drugs to the public security organ at the corresponding level.
The management entities or entities using narcotic drugs and psychotropic drugs shall report the archival filing matters submitted to the departments of drug supervision and administration at all levels to the public security organs at the corresponding level at the same time.

Article 64 In case of occurrence of such circumstances as any narcotic drug or psychotropic drug being stolen, robbed of, lost or flowing into illegal channels, the entity occurring such cases shall take necessary control measures at once, and report to the public security organ and the department of drug supervision and administration at the level of the county where it is located. A medical institution shall also report to its competent department in charge in case of occurrence of the said circumstances.
The public security organ shall, when receiving any report or complaint, or when there is any evidence proving that any narcotic drug or psychotropic drug may flow into illegal channels, carry out investigation in time, and take necessary measures to control the relevant entities.
The department of drug supervision and administration and the competent department of health and other relevant departments shall cooperate with the public security organs to carry out work.

Chapter VIII Legal Liabilities

Article 65 In case the department of drug supervision and administration or the competent department of health violates the provisions of the present Regulation, and has any of the following circumstances, its upper level administrative department or supervision department shall order it to correct; if the circumstance is serious, the person-in-charge who is directly responsible and other personnel directly liable shall be given administrative punishment according to law; if a crime is constituted, the criminal liabilities shall be investigated for:
1. Granting administrative license to applicants who do not comply with the conditions or making decision on granting administrative license exceeding legal power;
2. Failing to be present and supervise the destruction of overdue or damaged narcotic drugs and psychotropic drugs;
3. Failing to perform the function of supervision and inspection, failing to discover any illegal act that should be discovered, or failing to make investigation into and punishment in time on illegal acts it discovers, or failing to conduct supervision and inspection in light of the procedures as prescribed by the present Regulation; or
4. Other acts of derelict of duty or neglecting duty in violation of the provisions of the present Regulation.

Article 66 In case any enterprise undertaking the plant of anesthetic raw herbs violates the provisions of the present Regulation, and has any of the following circumstances, the department of drug supervision and administration shall order it to correct within a prescribed time limit, and give it warnings; if it fails to correct within the time limit, it shall be given a fine ranging from CNY50,000 to CNY100,000; if the circumstance is serious, its qualification on planting shall be canceled:
1. Failing to plant according to the annual planting plan for anesthetic raw herbs;
2. Failing to report the information on the planting as required; or
3. Failing to store narcotic drugs as required.

Article 67 In case any designated production enterprise violates the provisions of the present Regulation and has any of the following circumstances, the department of drug supervision and administration shall order it to correct within a prescribed time limit, and give it warnings, as well as confiscate the illegal gains and the illegally sold drugs; if it fails to correct within the time limit, it shall be ordered to stop production and be imposed upon a fine ranging from CNY50,000 to CNY100,000; if the circumstance is serious, its qualification on designated production shall be canceled:
1. Failing to arrange production in light of the annual production plan for narcotic drugs and psychotropic drugs;
2. Failing to report the production conditions to the department of drug supervision and administration as required;
3. Failing to store narcotic drugs and psychotropic drugs as required or failing to establish and keep special account books as required;
4. Failing to sell narcotic drugs and psychotropic drugs as required; or
5. Failing to destroy narcotic drugs and psychotropic drugs as required.

Article 68 In case any designated wholesales enterprise sells narcotic drugs and psychotropic drugs in violation of the present Regulations, or manages anesthetic raw herbs and the raw material medicine of psychotropic drugs of category I in violation of the provisions of the present Regulation, the department of drug supervision and administration shall order it to correct within a prescribed time limit, give it warnings, and confiscate the illegal gains and the drugs illegally sold; if it fails to correct within the time limit, it shall be ordered to stop business operation, and be given a fine of 2 times up to 5 times of the value of drugs illegally sold; if the circumstance is serious, it shall be revoked of the qualification on designated wholesale.

Article 69 In case any designated wholesales enterprise violates the provisions of the present Regulation, and has any of the following circumstances, the department of drug supervision and administration shall order it to correct within a prescribed time limit, and give it warnings; if it fails to correct within the time limit, it shall be ordered to stop business operation, and be given a fine ranging from CNY20,000 to CNY50,000; if the circumstance is serious, its qualification on designated wholesale shall be canceled:
1. Failing to purchase narcotic drugs and the psychotropic drugs of category I as required;
2. Failing to ensure the supply of narcotic drugs and the psychotropic drugs of category I within its own responsibility region of drug supply;
3. Failing to perform the obligations on delivery of goods to medical institutions;
4. Failing to report the purchase, sale, amount of inventory, and flow of narcotic drugs and psychotropic drugs as required;
5. Failing to store narcotic drugs and psychotropic drugs as required or failing to establish and keep special account books as required;
6. Failing to destroy narcotic drugs and psychotropic drugs as required; or
7. Adjusting narcotic drugs and the psychotropic drugs of category I between regional wholesales enterprises in violation of the present Regulation, or failing to put on archives as required due to special circumstances after adjusting narcotic drugs and the psychotropic drugs of category I.

Article 70 In case any retail enterprise of psychotropic drugs of category II stores, sells or destroys the psychotropic drugs of category II in violation of the provisions of the present Regulation, the department of drug supervision and administration shall order it to correct within a prescribed time limit, give it warnings, and confiscate the illegal gains and the illegally sold drugs; if it fails to correct within the time limit, it shall be ordered to stop business operation, be imposed upon a fine ranging from CNY5,000 to CNY20,000; if the circumstance is serious, its qualification on the retail of psychotropic drugs of category II shall be canceled.

Article 71 In case any entity as prescribed in Article 34 or 35 of the present Regulation purchases narcotic drugs and psychotropic drugs in violation of the present Regulation, the department of drug supervision and administration shall confiscate the illegally purchased narcotic drugs and psychotropic drugs, order it to correct within a prescribed time limit and give it warnings; if it fails to correct within the time limit, it shall be ordered to stop business operation or the relevant activities, and be given a fine ranging from CNY20,000 to CNY50,000.

Article 72 In case any medical institution that has obtained the seal card has any of the following circumstances, the competent department of health of the people's government at the level of cities divided into districts shall order it to correct within a prescribed time limit, and give it warnings; if it fails to correct within the time limit, it shall be given a fine ranging from CNY5,000 to CNY10,000; if the circumstance is serious, it shall be revoked of the seal card; the person-in-charge who is directly responsible and other personnel directly liable shall be given punishments of degradation, removal from post or dismissal according to law:
1. Failing to purchase or store narcotic drugs and the psychotropic drugs of category I as required;
2. Failing to keep the special prescriptions on narcotic drugs and psychotropic drugs as required, or failing to make registration on the prescriptions as required;
3. Failing to report the purchase, inventory, and the amount of usage of narcotic drugs and psychotropic drugs as required;
4. Failing to put on archives the narcotic drugs and the psychotropic drugs of category I after emergency borrowing of them; or
5. Failing to destroy narcotic drugs and psychotropic drugs as required.

Article 73 In case any practicing physician who has the qualification on prescribing narcotic drugs and the psychotropic drugs of category I prescribes narcotic drugs and the psychotropic drugs of category I in violation of the present Regulation, or uses narcotic drugs and the psychotropic drugs of category I without following the guidelines for clinical application, the medical institution where he works shall cancel its qualification on prescribing narcotic drugs and the psychotropic drugs of category I; if this leads to serious results, the original certificate issuing department shall revoke his/her practicing certificate. If any practicing physician fails to use psychotropic drugs of category II in light of the guidelines for clinical application or fails to prescribe psychotropic drugs of category II by using special prescriptions, which results in serious consequences, the original certificate issuing department shall revoke his/her practicing certificate.
In case any practicing physician without the qualification on prescribing narcotic drugs and the psychotropic drugs of category I issues prescriptions of narcotic drugs and the psychotropic drugs of category I without permission, the competent department of health of the people's government at or above the county level shall give him/her warnings, and suspend his practicing activities; if it results in serious consequences, he/she shall be revoked of the practicing certificate; if a crime is committed, he/she shall be subject to criminal liabilities according to law.
In case any pharmacist or checker fails to check the prescriptions on narcotic drugs and the psychotropic drugs of category I in violation of the present Regulation, which results in serious consequences, the original certificate issuing department shall revoke his/her practicing certificate.

Article 74 In case anyone transports narcotic drugs and psychotropic drugs in violation of the present Regulation, the department of drug supervision and administration and the department of transportation administration shall, according to their respective functions, order it/him to correct, give it/him warnings, and impose upon it/him a fine ranging from CNY20,000 to CNY50,000.
In case any postal office that accepts and mails narcotic drugs and psychotropic drugs fails to go through formalities for mailing in accordance with the provisions of the present Regulation, the competent department of postal service shall order it to correct and give it warnings; if it results in the loss of any mail of narcotic drugs and psychotropic drugs, it shall be punished according to the provisions of postal laws and administrative regulations.

Article 75 In case any entity obtains the qualification on the experiment and research, production, management and use of narcotic drugs and psychotropic drugs by providing false materials, disguising the relevant information or taking other fraudulent means, the original department of examination and approval shall revoke the qualification it has obtained, and it shall not file an application for the relevant narcotic drugs and psychotropic drugs within 5 years; if the circumstance is serious, it shall be imposed upon a fine ranging from CNY10,000 to CNY30,000. If it has any pharmaceutical production license, pharmaceutical management license or practicing license of medical institution, its certificate documents of license shall be revoked according to law.

Article 76 In case any pharmaceutical research entity produces narcotic drugs and psychotropic drugs controlled under the present Regulation during the process of experiment and research and development of ordinary pharmaceuticals, but fails to make report in light of the provisions of the present Regulation, the department of drug supervision and administration shall order it to correct, give it warnings, and confiscate the illegal drugs; if it refuses to correct, it shall be ordered to stop experiment and research and development activities.

Article 77 In case any clinical trial institution of medicine makes experiments on healthy people for the clinical trial of narcotic drugs and the psychotropic drugs of category I, the department of drug supervision and administration shall order it to stop the illegal acts, and give it warnings; if the circumstance is serious, its qualification of a clinical trial institution of medicine shall be canceled; if a crime is constituted, it shall be subject to criminal liabilities according to law. If it results in the damage of the object of trial, the clinical trial institution of medicine shall assume the liabilities for treatment and compensation according to law.

Article 78 In case any designated production enterprise, designated wholesales enterprise or the retail enterprise of psychotropic drugs of category II produces and sells bogus and low quality narcotic drugs and psychotropic drugs, the department of drug supervision and administration shall cancel its qualification on designated production, qualification on designated wholesale or the qualification on retail of psychotropic drugs of category II, and give it punishment according to the relevant provisions of the Pharmaceutical Administration Law.

Article 79 In case any designated production enterprise, designated wholesales enterprise or any other entity conducts trading of narcotic drugs and psychotropic drugs in cash, the department of drug supervision and administration shall order it to correct, give it warnings, confiscate the illegally transacted drugs, and impose upon it a fine ranging from CNY50,000 to CNY100,000.

Article 80 In case any entity that has occurred such cases as its narcotic drugs and psychotropic drugs being stolen, robbed or lost fails to take necessary control measures in violation of the provisions of the present Regulation or fails to make report in light of the present Regulation, the department of drug supervision and administration and the competent department of health shall, according to their respective functions, order it to correct and give it warnings; if the circumstance is serious, it shall be given a fine ranging from CNY10,000 to CNY100,000; if it has any superior department in charge, its competent superior department shall give the person-in-charge who is directly responsible and other personnel directly liable such punishments as degradation or removal from posts.

Article 81 In case any entity that has obtained the qualification on the plant of anesthetic raw herbs and the experiment and research, production, management, use and transportation, and etc. of narcotic drugs and psychotropic drugs profiteers, transfers, leases, lends or alters its certificate documents of license of narcotic drugs and psychotropic drugs, the original department of examination and approval shall revoke its corresponding certificate documents of license, and confiscate its illegal gains; if the circumstance is serious, it shall be imposed upon a fine of two times up to five times of the illegal gains; if there is no illegal gains, it shall be imposed upon a fine ranging from CNY20,000 to CNY50,000; if a crime is constituted, it shall be subject to criminal liabilities according to law.

Article 82 In case anyone violates the provisions of the present Regulation and causes narcotic drugs and psychotropic drugs flow into illegal channels, which results in harmfulness, if a crime is constituted, he/it shall be subject to criminal liabilities; if the circumstance is not serious enough to constitute a crime, the public security organ at or above the county level shall impose upon it/him a fine ranging from CNY50,000 to CNY100,000; and the illegal gains shall be confiscated, if any; if the circumstance is serious, it/he shall be imposed upon a fine of 2 times up to 5 times of the illegal gains; and the original certificate issuing department shall revoke its certificate documents of license for the production, management and use of drugs.
In case the department of drug supervision and administration or the competent department of health discovers any of the circumstances as prescribed in the preceding paragraph, it shall circulate a report immediately to the public security organ at the corresponding level at its locality, and transfer the case and the relevant materials to the public security organ in accordance with the relevant state provisions.

Article 83 The administrative punishments made by the department of drug supervision and administration as prescribed in this Chapter shall be determined by the department of drug supervision and administration at or above the county level in light of the division of functions as prescribed by the department of drug supervision and administration of the State Council.

Chapter IX Supplementary Provisions

Article 84 The experiment and research as mentioned in the present Regulation shall refer to the clinical pharmaceutical research for the purpose of medical treatment, scientific research or teaching.
Where any family planning technical service institution which may carry out clinical medical services relating to family planning upon approval needs to use narcotic drugs and psychotropic drugs, it shall follow the provisions of the present Regulation on the use of narcotic drugs and psychotropic drugs by the relevant medical institutions.

Article 85 The opium poppy shell in the Catalog of Narcotic Drugs may only be used for the production of traditional Chinese medicines prepared in ready-to-use forms and the medical prescriptions. The concrete measures for the administration shall be formulated by the department of drug supervision and administration of the State Council separately.

Article 86 The provisions on the administration of the relevant narcotic drugs of the present Regulation shall be abided by for the purchase, storage and use of anesthetic raw herbs in the production of compound preparations which contain narcotic drugs.

Article 87 The concrete measures for the administration of supplying and using narcotic drugs and psychotropic drugs by medical institutions in army troops shall be formulated by the department of drug supervision and administration of the State Council together with the general logistics department of the People's Liberation Army according to the present Regulation.

Article 88 The concrete measures for the administration of narcotic drugs and psychotropic drugs for animal use shall be formulated by the competent department of veterinarian administration of the State Council together with the competent department of drug supervision and administration of the State Council according to the present Regulation.

Article 89 The present Regulation shall be implemented as of November 1st, 2005. The Administrative Measures for the Control of Narcotic Drugs as promulgated by the State Council on November 28, 1987 and the Administrative Measures for the Control of Psychotropic Drugs as promulgated by the State Council on December 27, 1988 shall be repealed simultaneously.