LABELLING

LABELLING
In general, labelling of medicines is subject to supranational and national regulation and to international agreements. The statements under the heading Labelling therefore are not comprehensive and, moreover, for the purposes of the Pharmacopoeia only those statements that are necessary to demonstrate compliance or non-compliance with the monograph are mandatory. Any other labelling statements are included as recommendations. When the term "label" is used in the Pharmacopoeia, the labelling statements may appear on the container, the package or a leaflet accompanying the package, as decided by the competent authority.
WARNINGS
Materials described in monographs and reagents specified for use in the Pharmacopoeia may be injurious to health unless adequate precautions are taken. The principles of good quality control laboratory practice and the provisions of any appropriate regulations are to be observed at all times. Attention is drawn to particular hazards in certain monographs by means of a warning statement; absence of such a statement is not to be taken to mean that no hazard exists.
IMPURITIES
A list of all known and potential impurities that have been shown to be controlled by the tests in a monograph may be given for information. The list may be divided into two sublists entitled "Qualified impurities" and "Other detectable impurities". Qualified impurities are those previously accepted by the competent authority as being qualified; impurities deemed qualified by other means (for example, impurities which occur as natural metabolites) may also be included. Other detectable impurities are those potential impurities that have not been detected in any samples of the substance during elaboration of the monograph or that occur in amounts below 0.1 per cent, but that have been shown to be limited by the tests.
FUNCTIONALITY-RELATED CHARACTERISTICS
A list of functionality-related characteristics that are not the subject of official requirements but which are nevertheless important for the use of a substance may be appended to a monograph, for information (see also above 1.1. General statements).