BFAD Guidelines on Labeling of Drug Products

• LABEL refers to the means of display of written, printed or graphic matter upon the immediate container, or attached to or accompanying any pharmaceutical specialties.
• LABELING refers to all labels and other written, printed or graphic matter upon any article or any of its container or wrappers or accompanying such articles.
• INNER LABEL refers to the label on or affixed to an immediate container of a drug.
• OUTER LABEL refers to the label on or affixed to the outside package of a drug.
• PACKAGING MATERIAL refers to all items used or attached to bind, enclose or contain the drug or preparation in the final form for market presentation of the product.
• PRINCIPAL DISPLAY LABEL (40%) refers to the part of the label that is most likely to be displayed, presented, shown or examined under customary conditions of display for retail sale.
• PRESCRIPTION DRUGS are drug preparations that are dispensed only upon presentation of a valid prescription.
• OVER-THE-COUNTER DRUGS are drug preparations that are dispensed without a prescription and are used for self medication.
• The Rx symbol shall be prominently placed on the principal display panel of the label.
• The symbol shall be on contrasting color to the background to which it appears, with no particular color required and shall not be less than 1/5 of the shorter dimension of the label.
• For products individually packed in foil or similar wrapper, the symbol shall appear on the foil and outer container from which they are removed from dispensing.
• Prescription requirement caution must appear on the inner and outer retail container as follows: “Caution: Food, Drug and Cosmetic Act prohibits dispensing without prescription”.
• The brand name or generic name must appear on the principal display panel of the label.
• For products requiring reconstitution or dilution prior to administration, the final form of the product for administration shall be the pharmaceutical form to be used as part of the name of the drug product.
• When the mode of administration is part of the product name, the nomenclature may be as follows: cefuroxime injection - ready to use, Ceftriaxone for injection - to be diluted.
• The generic name must be written in full and not to be abbreviated.
• The dosage and mode of administration section of a package insert states the dosage in terms appropriate to the dosage form and includes the time interval of administration between doses or may be expressed as frequency of doses.
• The information for the patient section of a package insert includes all information which may assist the prescriber and dispenser in instructing the patients for the proper, safe and effective use of the product.
• The formulation of a package insert consists of the generic name and other scientifically recognized terms in English referring to the active ingredient and the amount expressed per dosage unit.
• The manufacturer and distributor section of a package insert states the business names and addresses of the manufacturer and distributor.
• The pharmacology section of a package insert consists of a brief pharmacologic profile of the drug based on the animal and human studies.
• The contraindications section of a package insert includes situations in which the drug should not be used because it is known that the risk involved clearly outweighs any potential benefits.
• The warnings section of a package insert highlights the possible occurrence of serious potential hazards with the use of the drug and provides information about its limitation of use.
• A package insert includes a description of the chemical and physical properties of the active substances relevant to the formulations of the product and its pharmacologic actions.
• The indications section of a package insert refers only to the BFAD approved clinical use of the product based on substantial evidence of the efficacy and safety of the drug in the given dosage form.
• Excipients which are found to be liable to affect physiological functions shall be declared on the formulation with the warning thereof.
• The precautions section of a package insert describes instances in which the use of the drug should be closely supervised to avoid undesired side effects.
• The storage condition section of a package insert includes special handling instructions and storage conditions which have a bearing on the stability of the preparation.
• A package insert is a part of drug labelling intended to provide authoritative and objective guides to the medical professional who have the capacity by training and authorized by law to interpret the information, in order to prescribe, dispense and administer the drug safely.
• The pharmacology section of a package insert includes a discussion of the human pharmacokinetic data relevant to the effective clinical use and toxic effects of the drug.
• The name of the drug should be printed most prominently as the title in a package insert.
• For OTC drugs, a package insert must also be included and must be designed and worded within the understanding of the self-medicating user.
• A package insert shall contain information applying only to the product and its active substance/s.
• The availability section of a package insert covers the dosage forms, including administration accessories and diluents.
• A package insert shall consist of factual and scientific information stated explicitly without subjectivity, devoid of promotional implications or use of comparisons.
• The brand name or generic name of the product shall be printed on the tin foil for every two pieces of the dosage form.
• The pharmacologic category should be printed on the principal display panel.
• The product’s indication should concisely state whether it is for treatment, prevention, diagnosis of a clearly recognizable disease or a significant manifestation of disease or symptomatic relief associated with a disease, condition or a syndrome.
• Active ingredient should be stated in its approved common name ( generic name / international non proprietary name).
• The amount of active ingredient shall be expressed in metric system or units pf potency where applicable.