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Drug samples regulatory issues

There are two classes of color additives, those that must be certified and those that are exempt from certification. Both are strictly controlled in the United States by regulatory statutes (Food Color Additives Amendments), but an official certificate is required for each commercial batch of color of the first group, while no such certificate is necessary for the second group. For certification the manufacturer must submit a sample of the batch to the Food Drug Administration for chemical analysis. The results of the analysis are compared with the specifications for certified colors published in the Code of Federal Regulations. If the compliance is complete, a certificate is issued for that particular batch of color. [Pg.45]

See other pages where Drug samples regulatory issues is mentioned: [Pg.390]    [Pg.124]    [Pg.222]    [Pg.390]    [Pg.140]    [Pg.103]    [Pg.317]    [Pg.57]    [Pg.728]    [Pg.29]    [Pg.9]    [Pg.39]    [Pg.584]    [Pg.119]    [Pg.1]    [Pg.142]    [Pg.520]    [Pg.149]    [Pg.367]    [Pg.40]    [Pg.407]    [Pg.135]    [Pg.4]    [Pg.490]    [Pg.4]   
See also in sourсe #XX -- [ Pg.295 ]



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Drug samples

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