The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals, medicines for external use, and over-the-counter medicines must bear the prescribed marks.
I. Article 14 of the Regulations for the Administration of Drug Packaging, Labeling and Instructions (Interim) stipulates that narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other drugs under special management, topical drugs, and over-the-counter drugs must be printed with a sign that complies with the regulations on their medium and large packages and labels;
the instructions must be printed with a sign that complies with the regulations; and drugs with special requirements for storage must be printed with the required signs in the Packaging, labeling in a conspicuous position and instructions.
Two, "Drug Administration Law" Article 54: "Drug packaging must be printed or labeled in accordance with the provisions of the label and instructions. Label or instructions must indicate the generic name of the drug, ingredients, specifications, manufacturer, approval number, product lot number, date of manufacture, expiration date, function, usage, dosage, contraindications, adverse reactions and precautions.
Three, "Drug Packaging, Labeling and Instruction Manual Regulations," Article IX Drug labeling is divided into the inner packaging labeling and outer packaging labeling.
1, the inner packaging label and the outer packaging labeling content shall not exceed the State Drug Administration approved drug instructions limited content; text expression should be consistent with the instructions.
2, the inner packaging label can be based on the size of its size, as far as possible, including the name of the drug, indication or function, dosage, specifications, storage, date of manufacture, production batch number, expiration date, manufacturer and other labeling content, but must be labeled with the name of the drug, specifications and production batch number.
3, in the packaging label should indicate the name of the drug, the main ingredients, properties, indications or functions, dosage, adverse reactions, contraindications, specifications, storage, date of production, production batch number, expiration date, approval number, the production company and other content.
4, large package label should indicate the name of the drug, specifications, storage, date of production, production lot number, expiration date, approval number, manufacturer and instructions for use other than the necessary content, including the number of packages, transportation precautions, or other markings.
5,) the label on the expiration date of the specific form of expression should be: valid until x years x months.
6, due to size reasons, the packaging label can not indicate all the adverse reactions, contraindications, precautions, should indicate "see instructions".
Expanded information:
Narcotic Drugs and Psychotropic Substances Control Program p>Narcotic drugs and psychotropic substances management memory mnemonic:
1, ? Narcotic drugs and psychotropic substances management mnemonic card: the municipal health administration department approved the issuance of the provincial Ministry of Health for the record, copied to the municipal pharmacy bureau, public security organs.
2,? Seal card application conditions: a diagnosis and treatment subjects, full-time pharmacy professionals and technicians, prescription-qualified practitioners, safe storage facilities and management system.
3,? Seal card validity: 3 years and 3 months.
4, special books: 5 years, after the expiration of the validity period.
5. ? Comparison of narcotic drugs and psychotropic drugs wholesalers: "narcotic and psychotropic drugs of the first category, the national batch and regional batch of two levels; the national batch of the State Drug Administration approved the qualification, purchased from the designated manufacturer; mainly supply the regional batch of the provinces for qualifying hospitals Provincial Drug Administration approved;
Regional batch of the Provincial Drug Administration approved the qualification, purchased from the national batch, purchased from the designated manufacturer needs to be approved by the Provincial Drug Administration approved; mainly For provincial qualification hospitals, for inter-provincial hospitals need to be approved by the National Drug Administration, the regional batch of transfers need to be prepared by the provincial Drug Administration."
6. Proof of mailing and transportation are issued by the provincial Drug Administration.
7, hospitals in urgent need of anesthesia essence of a rescue patient borrowing reported to the municipal Drug Administration and the Ministry of Health for the record.
8,? County-level pharmacovigilance supervise the destruction of anesthetic drugs.
9,? The second category of psychotropic drugs retail: retail chain retail second category of fine municipal drug supervisor approved, the physician's prescription is kept for 2 years, prohibited underage overdose without prescription.
10, hemp essence a transportation certificate is valid: one year.
Chinese government network - State Food and Drug Administration order