Each municipality, Shenfu Demonstration Zone market Supervision Administration, Health Commission, drug regulatory departments of each district administrative committee of the provincial Free Trade Zone, provincial Food and Drug Administration, provincial medical institutions:
The Notice of the National Health Commission of the State Drug Administration on Strengthening the Administration of Tramadol Compound preparations and other drugs (the State Drug Administration (2023) No. 22) is hereby forwarded to you, and the following requirements are put forward, please fully implement them:
First, the city, Shenfu-demonstration zone market supervision Bureau, the provincial free trade zone drug supervision department, the provincial food and drug administration should focus on tramadol compound preparations, etazocine, piropanil and hydrocodone base compound oral solid preparations (each dose unit contains hydrocodone base does not exceed 5 mg，It does not include other narcotic drugs, psychotropic drugs or drug precursor chemicals) and other varieties newly included in the administration of psychotropic drugs in Category II，Before July 1, the registration of the original inventory of the above-mentioned drugs in the drug trading enterprises that do not have the qualification for dealing in Category II psychotropic drugs within the jurisdiction shall be completed，Register and summarize the Remaining Inventory List of Newly Included Anesthetic Drugs (see Annex for details)，File together with the purchase invoice and the shipping order (copy)。
2. Drug regulatory departments at all levels shall urge drug distributors that do not have the qualification for dealing in Category II psychotropic drugs to set up special counters or warehouses to store the remaining relevant drugs and manage and sell them in accordance with the relevant provisions on psychotropic drugs，Timely report and approve sales numbers after sale;In daily supervision, it is necessary to check whether the quantity of the remaining drugs purchased and sold is consistent with the reported quantity，Whether there is any underreporting or underreporting of inventory。
Third, drug regulatory departments at all levels should strengthen supervision, urge drug distribution enterprises to implement the main responsibility, pay attention to the recent procurement of enterprises, and strictly prevent drug wholesale enterprises, retail chain headquarters and retail pharmacies from buying the above drugs abnormally, failing to manage and sell them in accordance with regulations and leading to the occurrence of illegal channels。
Iv. Medical institutions at all levels shall purchase, administer and use Tramadol compound preparations, etazocine and pirampanil, esketamine hydrochloride nasal spray in strict accordance with the Drug Administration Law, the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances and other laws and regulations。Health departments at all levels should effectively strengthen the supervision of all aspects of the management of the use of narcotic drugs in medical institutions under their jurisdiction, and strictly prevent the abuse of related drugs or their flow into illegal channels。
Annex: List of the remaining inventory of drugs newly included in the list of anesthetic drugs by the drug distributor
Liaoning Provincial Drug Administration Liaoning Provincial Health Commission
2023年6月15日
