Montana Code 50-31-314. Exemptions from code imprint requirement
Current as of: 2023 | Check for updates
|
Other versions
50-31-314. Exemptions from code imprint requirement. The board of pharmacy may grant exemptions from the requirements of 50-31-313 and 50-31-315 upon a showing by a drug manufacturer or distributor that size, physical characteristics, or other compelling reasons render application of a code imprint on a legend drug subject to the provisions of 50-31-313 impractical or impossible. Any exemption granted must be included in the list required by 50-31-315 and must describe the physical characteristics and type of drug covered by the exemption.
Terms Used In Montana Code 50-31-314
- Code imprint: means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, marks or monograms unique to the manufacturer or distributor of the drug, or both. See Montana Code 50-31-301
- Distributor: means a person who distributes for resale a drug in solid dosage form under the person's own label whether or not the person is the manufacturer of the drug. See Montana Code 50-31-301
- Legend drug: means any drug defined by section 503(b) of the federal act (21 U. See Montana Code 50-31-301
- Manufacturer: means a person who mixed the final ingredients and prepared the final drug product. See Montana Code 50-31-301