Page 12 - Laboratory manual for students FAR222 2019 20

FAR 222 Dosage Form II Laboratory Manual

4 LABELLING OF STERILE PRODUCTS

Identification of a product is achieved by some form of labelling and the purpose is to ensure
that medicinal products are correctly described and are readily identifiable.

Proper labelling promotes safety in use. Mislabelling (or the mis-use, mis- application or mix-
up of other printed materials) is the most frequent cause of product hazard and product recall.
This is a guide to show how sterile products should be labelled to comply with the appropriate
regulations and general monographs.

LABELLING REQUIREMENTS
Found in the General Notices, the monograph on injections and sometimes in the individual
monograph. They are:

For all preparations:
a) the name of the drug or preparation, or an approved synonym
b) except in the case of a fixed recipe, the names and proportions of the medicaments
c) names and proportions of any added preservatives additional to, or alternative to any
included in the recipe
d) batch number

For injections:
a) amount of active ingredient in a suitable dose volume
b) name and proportion of any added bactericide/preservative
c) name of any added buffering or stabilising agent
d) conditions under which this product should be stored
e) date after which the preparation should not be used

The official requirements represent the minimum information needed by a pharmacist to
identify and use a preparation properly and they are not explicit enough when the product is
to be used by doctors, nurses or the lay public. It is therefore necessary for the pharmacist to
exercise their professional judgment to decide what extra information may have to be given in
a particular case. Pharmacists' professional body advises that the labels of dispensed
medicines should indicate the total quantity of the product dispensed in the container to which
the label refers.

Expiry dates:

Medicinal products, including sterile products, are labelled with a date beyond which the
product should not be used. In our practical classes, these products are given an expiry date
two years after the date of manufacture, unless some aspect of the formulation or packaging
indicates that a shorter date is more appropriate. For ophthalmic products, apart from the
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