Glossary / Regulatory / Category 1, Category 2, and Category 3

Category 1, Category 2, and Category 3

Interim FDA classifications for nominated bulk drug substances. Category 1 substances may be used in compounding while under evaluation; Category 2 substances have identified safety concerns and may not; Category 3 covers substances nominated without adequate supporting information. Removal from Category 2 is not an approval.

Interim FDA classifications for nominated bulk drug substances. Category 1 substances may be used in compounding while under evaluation; Category 2 substances have identified safety concerns and may not; Category 3 covers substances nominated without adequate supporting information. Removal from Category 2 is not an approval.

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