Article 1 These Provisions are formulated in accordance with the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs in order to strictly control narcotic drugs and psychotropic drugs in medical institutions and ensure the needs of normal medical work.
Article 2 The Ministry of Health shall be in charge of the administration of the use of narcotic drugs and psychotropic drugs of Category I in medical institutions throughout the country.
The local health administrative departments at or above the county level shall be responsible for the supervision and management of the use of narcotic drugs and psychotropic drugs of category I in medical institutions within their jurisdiction.
Chapter II Management Institutions and Personnel of Narcotic Drugs and Psychotropic Substances of Category I
Article 3 A medical institution shall establish a management institution for narcotic drugs and psychotropic drugs, in which the responsible person is responsible and the departments of medical management, pharmacy, nursing and security participate, and designate full-time personnel to be responsible for the daily management of narcotic drugs and psychotropic drugs of Category I.. ..
Article 4 Medical institutions shall incorporate the management of narcotic drugs and psychotropic drugs of category I into the annual target responsibility system assessment of their own units, establish a special inspection system for the use of narcotic drugs and psychotropic drugs of category I, organize regular inspections, keep inspection records, and promptly correct existing problems and hidden dangers.
Article 5 Medical institutions shall establish and strictly implement the systems of purchasing, acceptance, storage, custody, distribution, deployment, use, damage, destruction, loss, theft report and on-duty inspection of narcotic drugs and psychotropic drugs of category I, and formulate the responsibilities of personnel in each post. The daily work is undertaken by the pharmaceutical department.
Article 6 The management personnel of narcotic drugs and psychotropic drugs of category I in medical institutions shall master the relevant laws, regulations and provisions of narcotic drugs and psychotropic drugs, and be familiar with the use and safety management of narcotic drugs and psychotropic drugs of category I. ..
Article 7 Medical institutions shall be equipped with professional pharmaceutical technicians with strong sense of responsibility and familiar business, who shall be responsible for the procurement, storage, custody, deployment, use and management of narcotic drugs and psychotropic drugs of Category I, and the personnel shall remain relatively stable.
Article 8 Medical institutions shall regularly educate and train managers, pharmaceutical personnel and medical personnel involved in narcotic drugs and psychotropic substances of Category I in relevant laws, regulations, rules, professional knowledge and professional ethics. ..
Chapter III Procurement and Storage of Narcotic Drugs and Psychotropic Substances of Category I
Article 9 Medical institutions shall purchase narcotic drugs and psychotropic drugs of Category I according to the medical needs of their own units, and keep a reasonable inventory. The money for purchasing drugs should be paid by bank transfer.
Article 10 Narcotic drugs and psychotropic drugs of Category I shall be inspected upon arrival, and at least two people shall open the box for acceptance, and the minimum package shall be counted and accepted, and the acceptance records shall be signed by two people. The warehousing acceptance shall be recorded in a special book, including: date, voucher number, product name, dosage form, specification, unit, quantity, batch number, validity period, manufacturer, supplier, quality situation, acceptance conclusion, signature of the inspector and keeper.
Article 11 If there are any defects found in the acceptance of narcotic drugs and psychotropic drugs of Category I, they shall be counted and registered by two persons, reported to the person in charge of the medical institution for approval and stamped with the official seal, and then inquired and handled by the supplier.
Twelfth storage of narcotic drugs, psychotropic drugs of category I, the implementation of special responsibility, special warehouse (cabinet) locked. Establish special account books for narcotic drugs and psychotropic drugs of Category I entering and leaving the special warehouse (cabinet), and record the entry and exit situation one by one, including: date, voucher number, recipient department, product name, dosage form, specification, unit, quantity, batch number, expiration date, manufacturer, handler, reviewer and recipient's signature, etc., to ensure that the accounts, materials and batch numbers are consistent.
Thirteenth medical institutions to destroy expired or damaged narcotic drugs and psychotropic drugs of category I shall, under the supervision of the administrative department of health, apply to the local administrative department of health for destruction, and carry out the destruction registration.
After receiving an application from a medical institution for destroying narcotic drugs and psychotropic drugs of Category I, the administrative department of health shall be present to supervise the destruction of the medical institution within 5 days.
Chapter IV Distribution and Use of Narcotic Drugs and Psychotropic Substances of Category I
Article 14 Medical institutions may set up turnover warehouses (cabinets) for narcotic drugs and psychotropic drugs of Category I in outpatient, emergency and inpatient pharmacies according to management needs, and the inventory shall not exceed the quantity specified by the institutions. Turnover warehouse (cabinet) should be settled every day.
Fifteenth outpatient, emergency, hospitalization and other pharmacies dispensing window of narcotic drugs, psychotropic drugs of category I deployment base shall not exceed the number of the provisions of this institution.
Sixteenth outpatient pharmacies should have a fixed dispensing window, and there are obvious signs, and there are people who are responsible for the deployment of narcotic drugs and psychotropic drugs of category I.
Seventeenth medical practitioners should pass the training and examination, and obtain the qualification to prescribe narcotic drugs and psychotropic drugs of category I.
Article 18 Special prescriptions for the use of narcotic drugs and psychotropic drugs of Category I shall be issued ... The prescription format and the maximum amount of a single prescription shall be implemented in accordance with the Regulations on the Administration of Prescriptions of Narcotic Drugs and Psychotropic Drugs.
When doctors prescribe narcotic drugs and psychotropic drugs of category I, they shall record them in the medical records. Doctors are not allowed to prescribe substandard drugs for others or narcotic drugs and psychotropic drugs of Category I for themselves.
Nineteenth prescription deployment personnel and auditors should carefully check the prescriptions of narcotic drugs and psychotropic drugs of category I, and sign and register; Refusing to prescribe narcotic drugs and psychotropic drugs of category I that do not meet the requirements.
Article 20 A medical institution shall register the prescriptions of narcotic drugs and psychotropic drugs of Category I in a special volume, including the patient's (agent's) name, gender, age, identification number, medical record number, disease name, drug name, specification, quantity, prescription person, prescription number, prescription date, agent and reviewer.
The storage period of special account books shall not be less than 2 years after the expiration of the validity period of drugs.
Article 21 Medical institutions shall establish corresponding medical records for patients who use narcotic drugs and psychotropic drugs of Category I. Injectable narcotic drugs are used only in medical institutions or by medical personnel visiting patients' homes. Medical institutions should establish a follow-up or follow-up system for patients who use non-injection narcotic drugs and psychotropic drugs, and record the follow-up or follow-up in medical records. Emergency pharmacies may not prescribe non-injectable narcotic drugs and psychotropic drugs for patients outside the hospital.
Twenty-second narcotic drugs and psychotropic drugs of category I purchased by medical institutions are limited to their clinical use.
Chapter V Safety Management of Narcotic Drugs and Psychotropic Substances of Category I
Twenty-third medical institutions must be equipped with safes, doors and windows should have anti-theft facilities. Conditional medical institutions should install alarm devices for narcotic drugs and psychotropic drugs of category I.
Outpatient, emergency, inpatient and other pharmacies with turnover warehouses (cabinets) for narcotic drugs and psychotropic drugs of category I shall be equipped with safes, and the pharmacy deployment window, ward and operating room shall be equipped with necessary anti-theft facilities for storing narcotic drugs and psychotropic drugs of category I. ..
Twenty-fourth narcotic drugs, psychotropic drugs of category I in all aspects of storage should be designated person in charge, clear responsibility, shift should be recorded.
Article 25 The purchase, storage, distribution, deployment and use of narcotic drugs and psychotropic substances of Category I shall be managed and tracked according to the batch number, and can be found or recovered in time if necessary.
Article 26 Medical institutions shall uniformly number and count the prescriptions of narcotic drugs and psychotropic drugs of Category I, and establish a management system for the storage, collection, use, return and destruction of prescriptions.
Article 27 When patients use narcotic drugs and psychotropic drugs of Category I injections or patches, they shall be required to return the empty ampoules or used patches of the original batch number when they are reconstituted, and the number of recovered empty ampoules or discarded patches shall be recorded.
Twenty-eighth medical institutions in various wards, operating rooms and other allocation of narcotic drugs, psychotropic drugs of the first class injection, should recycle empty ampoules, check the batch number and quantity, and make records. The remaining narcotic drugs and psychotropic drugs of category I shall go through the formalities of returning to the warehouse.
Twenty-ninth recovered empty ampoules and discarded stickers of narcotic drugs and psychotropic drugs of Class I injections shall be counted, supervised and destroyed by special personnel and recorded.
Article 30 When a patient no longer uses narcotic drugs and psychotropic drugs of Category I, the medical institution shall require the patient to return the remaining narcotic drugs and psychotropic drugs of Category I to the medical institution free of charge, and the medical institution shall destroy them in accordance with regulations.
Thirty-first drug rehabilitation medical institutions with the Practice License of Medical Institutions approved by the relevant departments may use narcotic drugs and psychotropic drugs of Category I with drug rehabilitation indications under the guidance of medical personnel.
Thirty-second medical institutions shall immediately report to the local health administrative department, public security organs and drug supervision and administration departments when they find the following situations:
(1) Narcotic drugs and psychotropic drugs of Category I are lost, stolen or robbed in the process of storage and custody;
(two) found cheating or posing as narcotic drugs, psychotropic drugs of category I. ..
Article 33 These Provisions shall come into force as of the date of promulgation.