DIVISION OF DRUGS, DEVICES AND COSMETICS
Does my company need a permit?
DDC regulatory authority over drugs, (medical) devices and cosmetics falls into two main categories: (a) manufacturing and repackaging of drugs, medical devices and cosmetics conducted in Florida, and (b) distributing drugs, medical devices and cosmetics in and into Florida.
Activity Description |
Location |
Permit (Generally) Required under Chapter 499? |
Manufacturing a Drug, Device or Cosmetic |
In Florida |
Yes |
Repackaging a Drug, Device or Cosmetic |
In Florida |
Yes |
Distributing a Prescription Drug |
In or Into Florida |
Yes |
Distributing an Over-the-Counter Drug |
In or Into Florida |
No |
Distributing a Device |
In or Into Florida |
No |
Distributing a Cosmetic |
In or Into Florida |
No |
- What is “distributing”?
Understanding this term is critical to avoid violating Chapter 499, Florida Statutes. Florida law defines “distributing” or “distribution” to implicate both physical possession and legal title or ownership.
The term means to sell; offer to sell; give away; transfer, whether by passage of title, physical movement, or both; deliver; or offer to deliver. For example, a broker of a prescription drug wholesale transaction may require a permit under Florida law.
- What is “manufacturing”?
Includes the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device or cosmetic.
- What is “repackaging”?
Includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of a drug, device or cosmetic.
- Dispensing and Administering (Pharmacists and Medical Practitioners) – Generally Exempt
The lawful dispensing or administering of drugs to patients or ultimate consumers by a Florida-licensed pharmacist or medical practitioner operating within the scope of his or her respective professional practice typically does not require a permit issued under Chapter 499, Florida Statutes.