(decree number. The State Council Decree No.442nd)
Chapter IV Utilization
Article 34 Where a pharmaceutical production enterprise needs to produce ordinary drugs from narcotic drugs and psychotropic drugs of Category I, it shall submit an annual demand plan to the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and submit an annual demand plan to the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located. The people's governments of autonomous regions and municipalities directly under the Central Government shall, after summarizing, report to the drug supervision and administration department of the State Council for approval and purchase from designated production enterprises.
Where a pharmaceutical production enterprise needs to produce ordinary drugs with psychotropic drugs of Category II as raw materials, it shall declare the annual demand plan to the pharmaceutical supervisory and administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government and purchase from the designated wholesale enterprise or designated production enterprise.
Article 35 Non-pharmaceutical production enterprises such as food, food additives, cosmetics and coatings that need to use caffeine as raw materials shall obtain the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located, and purchase them from designated wholesale enterprises or designated production enterprises.
If scientific research and teaching units need to use narcotic drugs and psychotropic drugs for experiments and teaching activities, they shall purchase them from designated wholesale enterprises or designated production enterprises with the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located.
Where it is necessary to use the standard and reference substances of narcotic drugs and psychotropic drugs, it shall be approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government and purchased from units approved by the pharmaceutical supervisory and administrative departments of the State Council.
Article 36 Where a medical institution needs to use narcotic drugs and psychotropic substances of Category I, it shall obtain a signature card for the purchase and use of narcotic drugs and psychotropic substances of Category I (hereinafter referred to as the signature card) with the approval of the competent health department of the municipal people's government where the district is located. Medical institutions shall purchase narcotic drugs and psychotropic drugs of Category I from designated wholesale enterprises within the administrative areas of provinces, autonomous regions and municipalities directly under the Central Government with their signature cards.
When the health administrative department of the municipal people's government with districts issues the seal cards of medical institutions, it shall send a copy of the medical institutions that have obtained the seal cards to the municipal drug supervision and administration department with districts where they are located, and report them to the health administrative department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government for the record. The competent health authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall notify the designated wholesale enterprises within their respective administrative areas of the list of medical institutions that have obtained signature cards.
Article 37 A medical institution shall meet the following conditions for obtaining a seal card:
(1) Having full-time managers of narcotic drugs and psychotropic drugs of Category I;
(2) A medical practitioner who is qualified to prescribe narcotic drugs and psychotropic drugs of Category I;
(3) Having facilities and management systems to ensure the safe storage of narcotic drugs and psychotropic substances of Category I. ..
Thirty-eighth medical institutions shall, in accordance with the provisions of the competent department of health in the State Council, train and assess the knowledge of the use of narcotic drugs and psychotropic drugs for medical practitioners in their own units. Those who pass the examination shall be granted the qualification of prescription of narcotic drugs and psychotropic drugs of category I. Only after obtaining the qualification of prescription of narcotic drugs and psychotropic drugs of category I can medical practitioners prescribe narcotic drugs and psychotropic drugs of category I in this medical institution, but they shall not prescribe such prescriptions for themselves.
Medical institutions shall regularly submit the list of medical practitioners who are qualified to prescribe narcotic drugs and psychotropic drugs of category I and their changes to the health authorities of the municipal people's government with districts where they are located, and send a copy to the pharmaceutical supervisory and administrative department at the same level.
Medical personnel shall use narcotic drugs and psychotropic drugs in accordance with the guiding principles for clinical application formulated by the health administrative department of the State Council.
Article 39 A medical practitioner who is qualified to prescribe narcotic drugs and psychotropic drugs of category I shall meet the rational drug use needs of patients who really need to use narcotic drugs and psychotropic drugs of category I in accordance with the guiding principles of clinical application ... When cancer pain patients and other critically ill patients who are in medical institutions cannot obtain narcotic drugs or psychotropic drugs of category I, patients or their relatives may apply to medical practitioners. A medical practitioner with the qualification to prescribe narcotic drugs and psychotropic drugs of category I shall provide them to patients in time if he thinks that the narcotic drugs or psychotropic drugs of category I are reasonable.
Fortieth medical practitioners should use special prescriptions to prescribe narcotic drugs and psychotropic drugs, and the maximum dosage of a single prescription should comply with the provisions of the competent health department of the State Council.
The prescriptions of narcotic drugs and psychotropic drugs of category I shall be carefully checked by the allocator and the checker, and signed and registered; For those who do not conform to the provisions of these regulations, prescription allocators and auditors shall refuse to issue drugs.
The format of special prescriptions for narcotic drugs and psychotropic drugs shall be stipulated by the competent health department of the State Council.
Article 41 Medical institutions should register the prescriptions of narcotic drugs and psychotropic drugs in special books and strengthen management. Prescriptions for narcotic drugs shall be kept for at least 3 years and prescriptions for psychotropic drugs for at least 2 years.
Article 42 When a medical institution rescues a patient in urgent need of narcotic drugs and psychotropic drugs of Category I, it may urgently borrow them from other medical institutions or designated wholesale enterprises. After the rescue work, it shall timely report the borrowing situation to the municipal drug supervision and administration department and the competent health department where the district is located for the record.
Article 43 For narcotic drugs and psychotropic drugs that are not available in the market for clinical needs, if a medical institution with a Preparation License and a Medical Institution Seal Card needs to prepare preparations, it shall obtain approval from the pharmaceutical supervisory and administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government. Narcotic drugs and psychotropic drugs prepared by medical institutions can only be used in their own medical institutions and may not be sold abroad.
Article 44 For the purpose of treating diseases, an individual can carry narcotic drugs and psychotropic drugs of Category I within the maximum dose of a single prescription with the medical diagnosis certificate and personal identification certificate issued by a medical institution; Those who bring narcotic drugs and psychotropic substances of category I into or out of the country shall be released by the customs in accordance with the principle of reasonable use.
Medical personnel carrying a small amount of narcotic drugs and psychotropic drugs into or out of the country for medical needs shall hold a certificate of carrying narcotic drugs and psychotropic drugs issued by the pharmaceutical supervisory and administrative department of the people's government at or above the provincial level. The customs shall release narcotic drugs and psychotropic drugs on the strength of their carrying certificates.
Article 45 Medical institutions and drug rehabilitation institutions may use methadone or other narcotic drugs and psychotropic drugs designated by the state for drug rehabilitation. The specific management measures shall be formulated by the drug supervision and administration department of the State Council, the public security department of the State Council and the health administrative department of the State Council.