Misbranded drugs and devices: Designation of drug by name not in compendium.
1. A drug or device shall be deemed to be misbranded if it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:
(a) The common or usual name of the drug, if such there be; and
(b) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromide, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances contained therein.
2. To the extent that compliance with the requirements of paragraph (b) of subsection 1 is impracticable, exemptions shall be established by regulations promulgated by the Commissioner.
Last modified: February 26, 2006