# Ind. Code § 16-42-3-8: New drugs; time for application to take effect

> Indiana · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-8

## Section

- **Citation:** Ind. Code § 16-42-3-8
- **Heading:** New drugs; time for application to take effect
- **Jurisdiction:** Indiana
- **Kind:** Statutes
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Indiana Code / Title 16 / Article 42 / Chapter 3 / Section 16-42-3-8

## Text

Sec. 8. (a) This section does not apply under the circumstances described in section 9 of this chapter.

(b) An application provided for under section 7 of this chapter becomes effective on the one hundred eightieth day after the filing of the application. However, if the state department finds, after due notice to the applicant and giving the applicant an opportunity for a hearing that:

(1) the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling of the drug;

(2) the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drugs are inadequate to preserve the drug's identity, strength, quality, and purity; or

(3) based on a fair evaluation of all material facts, that the labeling is false or misleading in any particular;

the state department shall, before the effective date of the application, issue an order refusing to permit the application to become effective.

[Pre-1993 Recodification Citations: 16-1-30-17; 16-1-30-18 part.]

As added by P.L.2-1993, SEC.25.

## Nearby sections

- [Ind. Code § 16-42-3-1 Antibiotic drug defined](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-1.md)
- [Ind. Code § 16-42-3-2 Established name defined](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-2.md)
- [Ind. Code § 16-42-3-2.5 Duties of state veterinarian and state board of animal health](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-2.5.md)
- [Ind. Code § 16-42-3-3 Adulterated drug or device](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-3.md)
- [Ind. Code § 16-42-3-4 Misbranded drug or device](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-4.md)
- [Ind. Code § 16-42-3-5 Exemption of drugs or devices in transit for further processing, labeling, or repackaging](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-5.md)
- [Ind. Code § 16-42-3-6 Drugs dispensed on prescription](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-6.md)
- [Ind. Code § 16-42-3-7 New drugs; federal qualification; testing; application to introduce drug](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-7.md)
- [Ind. Code § 16-42-3-8 New drugs; time for application to take effect](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-8.md)
- [Ind. Code § 16-42-3-9 New drugs; exemption](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-9.md)
- [Ind. Code § 16-42-3-10 New drugs; revocation of order refusing application to take effect; revocation of approved application](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-10.md)
- [Ind. Code § 16-42-3-11 Representation of antiseptic](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-11.md)
- [Ind. Code § 16-42-3-12 Violation of chapter; offenses](https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-12.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_IN_T16_A42_C3_S16-42-3-8. Check the current official text before relying on it. Not legal advice.