If the director finds, upon the basis of the information before him or her and after due notice and opportunity for hearing to the applicant, that the drug, subject to the application, is not safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, he or she shall, prior to such effective date, issue an order refusing to permit such application to become effective and stating the findings upon which it is based.
[ 2012 c 117 § 339; 1945 c 257 § 78; Rem. Supp. 1945 § 6163-127.]

Ask a legal question, get an answer ASAP!
Click here to chat with a lawyer about your rights.