§201.10. Drugs; statement of ingredients. — Inbound Citations
21 C.F.R. § 201.10
Statutory Authority
Cited by 7 regulations in release Current.
Citations to 21 C.F.R. § 201.10 as a whole
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(b) Such statement of identity shall be in terms of the established name of the drug. In the case of a prescription drug that is a mixture and that has no established name, the requirement for statement of identity shall be deemed to be satisfied by a listing of the quantitative ingredient information as prescribed by § 201.10.
Citations to §201.10(a)
Citations to §201.10(d)(2)
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(a) The amount (percentage) of alcohol present in a product shall be stated in terms of percent volume of absolute alcohol at 60 °F (15.56 °C) in accordance with § 201.10(d)(2) of this chapter.