Misbranded drugs and devices: Contents of label on package.
1. Except as provided in subsections 2 and 3, a drug or device shall be deemed to be misbranded if in package form unless it bears a label containing:
(a) The name and place of business of the manufacturer, packer or distributor; and
(b) An accurate statement of the quantity of the contents in terms of weight, measure or numerical count.
2. The label affixed to a container which contains a prescription drug intended for use by a human being shall include:
(a) The name and place of business of the manufacturer; and
(b) If different, the name and place of business of the packer or distributor,
Êof the drug in its final dosage form.
3. A label affixed to a container by a pharmacist is not required to include the name and place of business of the manufacturer, packer or distributor.
4. Under paragraph (b) of subsection 1, reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Commissioner.
Last modified: February 26, 2006