marked with: general name, indication or function, specification, usage and dosage, production date, product batch number, expiration date, manufacturer, etc.. If the package size is too small, at least the general name, specification, product batch number, expiration date and other contents of the drug shall be marked
poison, hemp, essence, radioactivity, external use, over-the-counter drugs and other national regulations must be printed with the specified special logo. Chinese medicinal materials and Chinese herbal pieces shall be stipulated separately.
Chapter VI Management of drug packaging
Article 52 packaging materials and containers in direct contact with drugs must meet the pharmaceutical requirements and meet the standards to ensure human health and safety, and shall be approved by the drug regulatory department when approving drugs
drug manufacturers shall not use unapproved packaging materials and containers that directly contact drugs
for unqualified packaging materials and containers in direct contact with drugs, the drug regulatory department shall order them to stop using
Article 53 drug packaging must meet the requirements of drug quality and facilitate storage, transportation and medical use
Chinese herbal medicines must be packaged for shipment. On each package, the product name, place of origin, date and transfer out unit must be indicated, and the mark of qualified quality must be attached
Article 54 drug packages must be printed or pasted with labels and instructions in accordance with regulations
the label or instruction manual must indicate the general name, composition, specification, manufacturer, approval number, product batch number, production date, expiration date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions of the drug
the labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs must be printed with the specified marks.
the regulations on the administration of drug instructions and labels (Decree No. 24) issued by the State Food and drug administration stipulates that
Chapter III drug labels
Article 16 drug labels refer to the contents printed or pasted on drug packages, which are divided into internal labels and external labels. The inner label of drugs refers to the label of the package that directly contacts the drugs, and the outer label refers to the label of other packages other than the inner label
Article 17 the internal label of a drug shall include the general name, indications or functions, specifications, usage and dosage, production date, product batch number, expiration date, manufacturer, etc. If the package size is too small to indicate all the above contents, at least the general name, specification, product batch number, expiration date and other contents of the drug shall be marked
Article 18 the external label of a drug shall indicate the general name, ingredients, properties, indications or functions of the drug, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiration date, approval number, manufacturer, etc. If indications or functions, indications, usage and dosage, adverse reactions, contraindications and precautions cannot be fully indicated, the main contents shall be marked and the words “see the instructions for details” shall be indicated
Article 19 the label of the package used for transportation and storage shall at least indicate the general name, specification, storage, production date, product batch number, validity period, approval number and manufacturer of the drug, and may also indicate the necessary contents such as packaging quantity, transportation precautions or other marks as needed.