Biological and other specific products of Schedules C and C (1) advertised and sold as proprietary medicine, proper name of the substance should appear on label of every ampoule or container.
Specific Requirements
Biological
and other specific products of Schedules C and C (1) advertised and sold as
proprietary medicine, proper name of the substance should appear on label of
every ampoule or container. Proper name, Manufacturing Licence Number, Batch
Number, statement of potency in units, expiry date, storage requirement, etc.,
should be mentioned.
For
opthalmic solutions and suspensions, the additional requirement on lable is:
"Use within one month if opening and not for injection."
The
standard reference books are J.P, US.P, B.P, B.P.C, National Formulary of U.S.,
State Formulary of U.S.A, International Pharmacopoeia and Pharmacopoeia of
Soviet Socialist Republic.
The
label should contain -
1. Particulars specified in Schedule R,
2. Date of manufacturing,
3. Date upto which it retains its property,
4. Storage, in addition to other information.
In
addition to general information, label should depict - date of manufacture and
usage.
Drugs for export
should be labelled as per rules prevailing in country of export or importing
country. In Schedule E (1) drugs, label in red printing or printed against red
background.
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