New drugs; time for application to take effect

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.