Sec. 10. (a) An order refusing to permit an application under section 7 or 8 of this chapter to become effective may be revoked by the state department.
(b) The state department may, after affording an opportunity for public hearing and judicial appeal, revoke an application approved under section 7 or 8 of this chapter if the state department finds any of the following:
(1) That the drug, based on evidence acquired after approval, may not be safe or effective for the intended use.
(2) That the facilities or controls used in the manufacture, processing, or labeling of the drug may present a hazard to the public health.
[Pre-1993 Recodification Citation: 16-1-30-19.]
As added by P.L.2-1993, SEC.25.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 3. Uniform Food, Drug, and Cosmetic Act: Adulteration and Misbranding of Drugs or Devices
16-42-3-1. Antibiotic Drug Defined
16-42-3-2. Established Name Defined
16-42-3-2.5. Duties of State Veterinarian and State Board of Animal Health
16-42-3-3. Adulterated Drug or Device
16-42-3-4. Misbranded Drug or Device
16-42-3-5. Exemption of Drugs or Devices in Transit for Further Processing, Labeling, or Repackaging
16-42-3-6. Drugs Dispensed on Prescription
16-42-3-7. New Drugs; Federal Qualification; Testing; Application to Introduce Drug
16-42-3-8. New Drugs; Time for Application to Take Effect
16-42-3-9. New Drugs; Exemption