Sepecial drugs, API manufacturer, high quality suppliers

Sepecial drugs, API manufacturer, high quality suppliers

Specialty medicine refers to the medicine mainly used for the treatment of a certain disease.

Sepecial drugs are high-cost prescription medications used to treat complex, chronic conditions like cancer, rheumatoid arthritis, and multiple sclerosis.

Sepecial drugs sometimes require special handling and administration (typically injection or infusion), and patients using a specialty drug may need careful oversight from a health care provider who can watch for side effects and ensure that the medication is working as intended.

Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other drugs under special control shall be strictly implemented in the process of administration and use of the relevant state regulations.

Special drug management system:

purpose

Drugs under special control shall be implemented in strict accordance with the relevant state regulations.

Duties and responsibilities

The Purchasing department is responsible for the purchase of drugs, the quality management department is responsible for the acceptance and maintenance of drugs, and the storage and transportation department is responsible for the storage of special drugs.

Job content

4.1 Toxic Drugs

4.1.1 The distribution of toxic drugs must be carried out in accordance with the provisions of the National Measures for the Administration of Toxic Drugs for Medical Use, and the supply and management should be done well.

4.1.2 Toxic drugs shall be checked by two persons and checked by two persons. Those that fail to pass the inspection shall not be put into storage and sold.

4.1.3 During the acceptance of toxic drugs, in addition to the acceptance items of ordinary drugs, the special marks printed on the inner and outer packages must be checked, and the Arrival Acceptance Record Sheet shall be separately archived and kept for more than one year and not less than three years after the validity of the drug.

4.1.4 Toxic drugs shall be managed by counters, double and double locks. It should be a custodian with strong sense of responsibility, serious and responsible work and skilled business.

4.1.5 Toxic drugs should adhere to the daily dynamic collision, monthly inventory, account and goods compliance rate of 100%. Find the problem immediately report level by level, and timely investigation.

4.1.6 Toxic drugs must be shipped out of the warehouse with legal and valid exit certificates, without which they shall not be shipped out of the warehouse, and sales and exit review records shall be made.

4.1.7 Toxic drugs must be packed in a single package and shall not be mixed with ordinary drugs.

4.1.8 The reported damage and destruction of toxic drugs shall be carried out according to the Management System for Narcotic Drugs and Class I Psychotropic Drugs.

4.2 Class II psychotropic drugs

4.2.1 The purchase of Class II psychotropic drugs must be made by a legal manufacturer or an entity that has been approved by the Municipal drug regulatory department to handle Class II psychotropic drugs.

4.2.2 Class II psychotropic drugs can be supplied to legal medical institutions.

4.2.3 Distribution units selling Class II psychotropic drugs must check the business scope of the purchasing units, and enterprises without Class II psychotropic drugs shall not supply them.

4.2.4 Acceptance procedures and items of Class II psychotropic drugs are the same as those of ordinary drugs. The Arrival Acceptance Record Sheet shall be separately archived and kept for one year beyond the validity of the drug, but not less than three years.

4.2.5 Type II spirits shall be stored in designated areas with obvious signs.

4.2.6 Class II psychotropic drugs must be taken out of the warehouse with legal and valid exit certificates, without which they shall not be taken out of the warehouse, and sales and exit review records shall be established.

Administrative examination and approval

On January 6, 2022, the comprehensive bureau of state food and drug administration issued by the state food and drug administration of the special drugs and drug administration for examination and approval on enabling countries with the seal of notice (drug safety harness tube [2022] no. 2), according to the needs of special drug administrative examination and approval work, from the date of release, enable the "special seal for national drug supervision and administration of special drug approval", The former "Special Seal of the National Medical Products Administration for Examination and Approval of Import and Export of Special Drugs" shall be abolished at the same time.

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