DIVISION OF DRUGS, DEVICES AND COSMETICS
Are there any special provisions under Chapter 499, Florida Statutes for research and development?
Yes. See FAQ #8.b., and as follows:
- Pre-Clinical Research & Development. A permit is not required for the manufacture and distribution of products that (i) are the subject of an FDA-approved investigational program, and (ii) are not for clinical research or investigation (for actual use in or on humans or animals). The department recommends ensuring that the products are labeled accordingly to avoid confusion.
- Exemption Letters. The department may issue exemption letters to qualified persons who use prescription drugs for lawful research, teaching, or testing, and not for resale.
- Restricted Prescription Drug Distributor – Institutional Research Permit