# Mont. Code Ann. § 50-31-301: 50-31-301 Definitions

> Montana · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-301

## Section

- **Citation:** Mont. Code Ann. § 50-31-301
- **Heading:** 50-31-301 Definitions
- **Jurisdiction:** Montana
- **Kind:** Statutes
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** MT Code / Title 50 / Chapter 31 / Part 3 / Section 50-31-301

## Text

50-31-301 . Definitions. As used in this part, the following definitions apply:

(1) "Antibiotic drug" means any drug intended for use by humans containing any quantity of any chemical substance that is produced by a microorganism and that has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of such a substance).

(2) "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.

(3) "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.

(4) "Established name", with respect to a drug or ingredient of the drug, means:

(a) the applicable official name designated pursuant to section 508 of the federal act (21 U.S.C. 358);

(b) if there is no official name and the drug or the ingredient is an article recognized in an official compendium, then the official title of the drug or ingredient in the compendium. If this subsection (4)(b) applies to an article recognized in the United States Pharmacopoeia, the official title used in the United States Pharmacopoeia applies.

(c) if neither subsection (4)(a) nor (4)(b) applies, then the common or usual name, if any, of the drug or of the ingredient.

(5) "Legend drug" means any drug defined by section 503(b) of the federal act (21 U.S.C. 353(b)), as amended on January 15, 1980, under which its label is required to bear the statement: "Caution: Federal law prohibits dispensing without prescription."

(6) "Manufacturer" means a person who mixed the final ingredients and prepared the final drug product.

(7) "Solid dosage form" means capsules or tablets intended for oral use.

## Nearby sections

- [Mont. Code Ann. § 50-31-301 50-31-301 Definitions](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-301.md)
- [Mont. Code Ann. § 50-31-302 50-31-302 Antiseptics considered to be germicides](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-302.md)
- [Mont. Code Ann. § 50-31-303 50-31-303 Certain drug advertisements considered false](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-303.md)
- [Mont. Code Ann. § 50-31-304 50-31-304 Certain drugs and devices exempt from labeling requirements of chapter](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-304.md)
- [Mont. Code Ann. § 50-31-305 50-31-305 When drug or device adulterated](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-305.md)
- [Mont. Code Ann. § 50-31-306 50-31-306 When drug or device misbranded](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-306.md)
- [Mont. Code Ann. § 50-31-307 50-31-307 Dispensing of prescription drugs](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-307.md)
- [Mont. Code Ann. § 50-31-308 50-31-308 Prescription drugs exempt from certain provisions of chapter](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-308.md)
- [Mont. Code Ann. § 50-31-309 50-31-309 Removal of drugs from prescription requirement](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-309.md)
- [Mont. Code Ann. § 50-31-310 50-31-310 Narcotic and marijuana laws not affected](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-310.md)
- [Mont. Code Ann. § 50-31-311 50-31-311 New drug application required](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-311.md)
- [Mont. Code Ann. § 50-31-312 50-31-312 Exemptions from new drug application requirement](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-312.md)
- [Mont. Code Ann. § 50-31-313 50-31-313 Code imprint required on legend drugs](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-313.md)
- [Mont. Code Ann. § 50-31-314 50-31-314 Exemptions from code imprint requirement](https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-314.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_MT_T50_C31_P3_S50-31-301. Check the current official text before relying on it. Not legal advice.