Pharmaceutical Manufacturing Handbook: Production and

8. A description of the scientifi c training and the appropriate experience considered
by the proponent to qualify a researcher as an adequate expert to
investigate the medication
9. The names and “ curricula vitae ” of all researchers
10. An investigation layout planned for test accomplishment in humans
Solicitations for release of new medications are generally very extensive,
sometimes thousands of pages. The information has to be enough to justify the
affi rmations contained in the label of the proposed medication with respect to
effectiveness, dosage, and safety. The exact composition of the content on the
medication label is usually decided by consensus between the proponent and the
FDA.
The requisites for solicitation of new medications, whether by prescription or not,
are identical. The instructions contained in the medication labels for use without
prescription should demonstrate that the medication can be used safely without
medical supervision.
Once the medications are perfected, the publicity related to them has to be routinely
presented to the FDA.
The rules of 1985 also changed the requisites regarding addendums that are
necessary when alterations are proposed in the medication or in its labeling, for
example.
In regulations promulgated by the FDA on February 12, 1972, a clinic should be
called upon regarding the effectiveness of a medication. After that the information
may be included in the label or in the drug informative leafl et with eligible sentence
and defi ned by dark lines that contour it [43] .
Other dispositions contained in the alterations to the 1962 law are as follows:
1.
2.
3.
4.
5.
6.
REGULATORY ASPECTS 187
Immediate registration with the FDA before starting the production, repacking,
or relabeling of medications and later annual registration, with inspections
to be made at least once every two years.
Supportive inspections in the factory, particularly where prescription medications
are produced.
The procedures used by the manufacturers should be in conformity with the
good manufacturing practices, which permits the government to better inspect
of all the operations.
The common name should be presented on the label.
The publicity of a prescription medication should present a brief summary
mentioning the secondary effects, the contraindications, and the medication
effectiveness.
All antibiotics are subject for certifi cation procedures.
3.2.5.4 Labeling Requisites
According to a 1962 law, the main requisites for labeling are as described below.
The labeling of over - the - counter medications is regulated by the Food, Drug and
Cosmetic Act, which states: