SC I G. Labelling

This section provides guidance on the status and interpretation of pharmacopoeial labelling sections.

1. The General Notice on Labelling distinguishes between the mandatory status of those Pharmacopoeial labelling statements that are necessary to demonstrate compliance with the monograph and the advisory status of other labelling statements included in the Pharmacopoeia.

2. This distinction, which is consistent with the approach adopted in the European Pharmacopoeia, is made in recognition of the complexity of the statutory and advisory framework within which the labelling of medicines is determined. It is hoped that by thus restricting mandatory pharmacopoeial labelling statements to those that are essential for pharmacopoeial purposes, the potential for conflict between pharmacopoeial and other statutory provisions will be minimised.

3. Within the context of any particular monograph, it should be apparent which of the labelling statements are necessary to demonstrate compliance with the monograph and are thus mandatory. As guidance, a labelling statement is considered essential for a medicinal substance

(i) where a test or assay requirement is expressed in relation to a declared value, the ‘labelled claim’ (for example, the apparent viscosity of Carmellose Sodium or the potency of Calcitonin (Salmon);

(ii) where different test requirements or limits apply to materials derived from different sources (for example, the requirements for matter insoluble in 5m ammonia depend on the botanical source of Podophyllum Resin), or intended for different purposes (for example, the sterility of Benzylpenicillin Sodium when intended for use in the manufacture of a parenteral dosage form without a further sterilisation process);

(iii) in other special circumstances.

4. Likewise a labelling statement is considered essential for a formulated preparation

(i) where a test requirement is expressed in relation to a declared value, the ‘labelled claim’;

(ii) 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 (for example, Primaquine Tablets contain Primaquine Phosphate but the content is expressed in terms of the equivalent amount of primaquine base);

(iii) where different test requirements or limits apply to the formulated preparation manufactured from different bulk drug substances (for example, Heparin Injection manufactured from Heparin Calcium or Heparin Sodium) or intended for different purposes (for example, Isosorbide Dinitrate Tablets intended to be chewed before swallowing or allowed to dissolve in the mouth);

(iv) in other special circumstances.

5. Advisory labelling statements for formulated preparations may be included either in the general monograph or in the monograph for the individual preparation, as appropriate. Such statements commonly relate to features such as the expiry date, the storage conditions, the name and amount of any excipients and the directions for making the final preparations. Additional advisory labelling statements may relate to the directions for using the preparation or the precautions relating to the handling and use of the preparation.