(vi)
name and location address of manufacturer, distributor or vendor,
(vii)
storage conditions, and
(viii) the statement “Caution: For Bulk Drug Manufacturing Purposes Only”.
14.
Labelling of Parenteral preparations.
(1) The labelling of injectable drug products shall provide the health care practitioner and
other users adequate information to ensure safe and proper use of the therapeutic agent and
where all the information required may not be contained on the immediate container, they shall
be accompanied by a leaflet insert.
(2) The labelling shall state the following:-
15.
(a)
the name of the product;
(b)
percentage content of the drug in liquid preparations;
(c)
amount of active ingredients (for drug powder form);
(d)
volume of liquid to be added for reconstitution of the drug powder;
(e)
the route of administration (IM, IV, etc.);
(f)
storage conditions;
(g)
batch or lot number;
(h)
manufacture and expiry dates;
(i)
the full name and location address of the manufacturer;
(j)
preparations intended for use in dialysis, haemofiltration and irrigation shall bear
the statement “ Not intended for intravenous injection”; and
(k)
injection for veterinary use shall be so labelled, including the withdrawal period.
Declaration of non-nutritive sweeteners.
(1) The outer and inner labels of all over-the-counter human drug products containing an
approved non-nutritive sweetener as an inactive ingredient, shall bear a conspicuous
declaration as to the identity and quantity of the non-nutritive sweetener in milligram per
dosage unit and shall also bear boldly and conspicuously, any precautionary warnings for the
non-nutritive sweetener as may be prescribed by the Agency.
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