DIVISION OF DRUGS, DEVICES AND COSMETICS
Are there any special provisions under Chapter 499, Florida Statutes for research and development?
Yes. as follows:
- Research & Development (Pre-Clinical).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.
- Research & Development (Clinical).
- An unlicensed nonresident manufacturer may distribute (i) a prescription drug active pharmaceutical ingredient (API - not a finished dosage form), (ii) that it manufactures, (iii) to a prescription drug manufacturer permitted in this state, and (iv) in limited quantities intended for research and development and not for resale, or human use other than lawful clinical trials and biostudies authorized and regulated by federal law.
- A permit is not required to distribute limited quantities of a prescription drug that has not been repackaged from an establishment located in the United States to an establishment located in this state permitted as a prescription drug manufacturer for research and development or to a holder of a letter of exemption issued by the department for research, teaching, or testing.The prescription drug distributor must hold a valid prescription drug distribution license under the laws of the state where the transaction originates. The label must label prominently display the following statement: “Caution: Research, Teaching, or Testing Only – Not for Manufacturing, Compounding, or Resale.”
- 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