(2) The destruction of other expired and damaged drugs under special management shall apply to the hospital pharmaceutical affairs management committee and be carried out under its supervision, and the destruction shall be registered. The waste after the use of radioactive drugs must be properly disposed of according to the relevant provisions of the state.
(3) The reported loss (referring to the use of the remaining drugs after ampoule) shall be destroyed by the doctors and nurses in the department and signed by two people on the back of the prescription. The drug dealer should check the authenticity of his signature.
1. Destruction method of unqualified drugs
1. Generally, remove the packing box, peel off the tablets or capsules and destroy them. If it's an injection, pour out the potion and destroy it.
2. Conventional drugs shall be destroyed by the enterprise itself, and controlled drugs (poison, hemp, sperm, release and termination of pregnancy) shall be reported to the local county-level drug regulatory department for approval, and the county-level drug regulatory department shall supervise the destruction, and the relevant procedures shall be complete, with records of nonconforming products reporting and destruction.
Two. Destruction process of unqualified drugs
1, destroy the declaration
After the approval of the financial department, the unqualified drugs that have been confirmed to be expired and the damaged drugs and their packages that have been reported to be damaged shall be cleaned up regularly and destroyed centrally. Before centralized destruction, the quality control department shall supervise the warehouse management department to fill in the Declaration Form for Drug Destruction and attach the List of Abandoned Drugs. After the approval of the general manager, the two forms shall be reported to the Food and Drug Administration and the Tax Bureau. Without approval, it shall not be destroyed by itself.
2. Failure cycle
In order to clean up the warehouse in time, so as not to cause waste accumulation and occupy the site, waste drugs are destroyed at least once a year. During this period, when the Food and Drug Administration has a unified action requirement, it will implement it according to the unified deployment.
3. Destroy monitoring
Before the drugs are destroyed, they should be counted under the supervision of the quality control department to prevent the loss of unqualified drugs from causing adverse consequences such as safety accidents; Under the guidance and supervision of the Food and Drug Administration, the destruction treatment must consider preventing environmental pollution, and stay away from urban areas and densely populated areas, as well as the upper reaches of wind and water; Take effective measures such as mashing, burning and deep burial for destruction. The quality control department monitors the whole process from delivery to destruction.
4. Destroy records
In the process of destroying the above-mentioned waste drugs, the quality control department should supervise all links to accurately record and sign. The original documents reviewed and submitted for approval shall be submitted to the financial department for review; The Quality Control Department is responsible for filing the documents and materials according to the whole process within three days after the incident, and the retention period is not less than three years.
3. Production and operation enterprises and users shall take measures against expired and damaged narcotic drugs and psychotropic drugs.
1. Production and business enterprises shall register and apply to the local county-level drug supervision and administration department for destruction. The drug supervision and administration department at the county level shall be present to supervise the destruction within 5 days from the date of receiving the application.
2. Medical institutions shall register the expired and damaged narcotic drugs and psychotropic drugs stored in their own units, and apply to the competent health department, which shall be responsible for supervising the destruction.
3. Narcotic drugs and psychotropic drugs collected according to law shall be destroyed in accordance with the relevant provisions of the state, except those approved for scientific research by the drug supervision and administration department of the State Council or the public security department of the State Council. (Narcotic drugs and psychotropic drugs collected by health administrative law enforcement according to law shall be registered by health supervision institutions, and an application shall be submitted to the competent health department, which shall be responsible for supervising the destruction. )
4. Medical institutions that fail to destroy narcotic drugs and psychotropic drugs in accordance with regulations may be given administrative punishment according to Article 72 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs.
legal ground
Regulations on the Implementation of Drug Administration Law of People's Republic of China (PRC) (revised on 20 19).
Article 40 The drug supervision and administration department of the State Council shall re-evaluate the drugs that have been approved for production and sale, and according to the re-evaluation results, it may take measures such as ordering to modify the drug instructions, suspending production, sale and use, etc. For drugs that cause serious adverse reactions or endanger human health for other reasons, the approval certificate of the drug shall be revoked.
Regulations on the Administration of Narcotic Drugs and Psychotropic Substances (revised 20 16)
Article 61 An enterprise that produces, deals in and uses narcotic drugs and psychotropic drugs shall register expired and damaged narcotic drugs and psychotropic drugs and apply to the drug supervision and administration department at the county level for destruction. The pharmaceutical supervisory and administrative department shall be present to supervise the destruction within five days from the date of receiving the application. Medical institutions shall apply to the competent health department in accordance with the procedures stipulated in this article for expired and damaged narcotic drugs and psychotropic drugs stored in their own units, and the competent health department shall be responsible for supervising the destruction. Narcotic drugs and psychotropic drugs collected according to law shall be destroyed in accordance with the relevant provisions of the state, except those approved for scientific research by the drug supervision and administration department of the State Council or the public security department of the State Council.