Labelling

Labelling
The labelling requirements of the Pharmacopoeia are not comprehensive and laws governing the statements to be declared on labels of official articles should also be met. In the United Kingdom the provisions of regulations issued in accordance with the Medicines Act 1968, together with those of regulations for the labelling of hazardous materials, should be met.
Only those statements in monographs given under the heading Labelling that are necessary to demonstrate compliance or otherwise with the monograph are mandatory. Any other statements are included as recommendations.
Such matters as the exact form of wording to be used and whether a particular item of information should appear on the primary label and additionally, or alternatively, on the package or exceptionally in a leaflet are, in general, outside the scope of the Pharmacopoeia. When the term 'label' is used in Labelling statements of the Pharmacopoeia, decisions as to where the particular statement should appear should therefore be made in accordance with relevant legislation.
The label of every official article states (i) the name at the head of the monograph and (ii) a reference consisting of either figures or letters, or a combination of figures and letters, by which the history of the article may be traced.
The label of every official formulated preparation other than those of fixed strength also states the content of the active ingredient or ingredients expressed in the terms required by the monograph. Where the content of active ingredient is required to be expressed in terms other than the weight of the official medicinal substance used in making the formulation, this is specifically stated under the heading Labelling. Thus, where no specific requirement is included under the heading Labelling, it is implied that the content of active ingredient is expressed in terms of the weight of the official medicinal substance used in making the formulation. For example, for Ampicillin Injection, which contains Ampicillin Sodium but for which the content is expressed in terms of the equivalent amount of ampicillin, a specific requirement to this effect is included under the heading Labelling. For Amitriptyline Tablets which contain Amitriptyline Hydrochloride and for which the result of the assay is expressed in terms of amitriptyline hydrochloride no specific statement is included under the heading Labelling; these Tablets are thus labelled with the nominal weight of Amitriptyline Hydrochloride.
These requirements do not necessarily apply to the labelling of articles supplied in compliance with a prescription.