50-31-313. Code imprint required on legend drugs. No legend drug in solid dosage form may be manufactured or distributed in this state unless it is clearly marked or imprinted with a code imprint identifying the drug and the manufacturer or distributor of the drug.

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Terms Used In Montana Code 50-31-313

  • 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
  • Solid dosage form: means capsules or tablets intended for oral use. See Montana Code 50-31-301
  • State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See Montana Code 1-1-201