The role of the pharmacopoeia in the control of pharmaceutical preparations.

Pharmacopoeia commissions have a responsibility to protect the public in the sphere of medicines against error, ignorance or fraud. This responsibility is discharged by defining the standards with which the substance shall comply when offered for medicinal use and the methods by which compliance will be adjudged. The pharmacopoeia is one instrument among several which have been developed by society for ensuring safety in the use of medicines. Others are: -control by legislation over the training and practice of pharmacists; -limitation of the supply of certain medicines to doctors' prescriptions; -the limitation of sale to pharmacists (in most European countries) of all but a small proportion of medicines; -inspection for licensing of premises in which medicines are manufactured; -evaluation by expert committees of the formulations proposed by manufacturers and registration of such formulations for sale; -analysis of samples of medicines on the market. Many pharmacopoeias, including those having the widest territoral application, include monographs on pharmaceutical preparations. Others restrict their interest to the substances used as medicines. The arguments in support of these policies have been examined. It is claimed that the pharmacopoeia has a valid regulatory function to perform which is not incompatible with but complementary to that of the registration system.