SECTION 499.024. Drug product classification.
Latest version.
- 1The department shall adopt rules to classify drug products intended for use by humans which the United States Food and Drug Administration has not classified in the federal act or the Code of Federal Regulations.
36(1) 37Drug products must be classified as proprietary, prescription, or investigational drugs.
48(2) 49If a product is distributed without required labeling, it is misbranded while held for sale.
64(3) 65Any product that falls under the definition of drug in s. 76499.003 77may be classified under the authority of this section. This section does not subject portable emergency oxygen inhalators to classification; however, this section does not exempt any person from ss. 107499.01 108and 109499.015110. 111(4) 112Any product classified under the authority of this section reverts to the federal classification, if different, upon the federal regulation or act becoming effective.
136(5) 137The department may by rule reclassify drugs subject to this part when such classification action is necessary to protect the public health.
159(6) 160The department may adopt rules that exempt from any labeling or packaging requirements of this part drugs classified under this section if those requirements are not necessary to protect the public health.
History.-s. 9, ch. 88-159; s. 1, ch. 89-296; ss. 27, 52, ch. 92-69; s. 589, ch. 97-103; s. 42, ch. 2000-242; s. 13, ch. 2000-326; s. 61, ch. 2006-1; s. 106, ch. 2008-6; s. 19, ch. 2008-207; s. 5, ch. 2012-143; s. 37, ch. 2014-89.
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