DIVISION OF DRUGS, DEVICES AND COSMETICS
Are there any exceptions to the licensing requirements under Chapter 499, Florida Statutes?
Here are some exceptions:
- Intracompany Transfers to Florida-Located Prescription Drug Wholesale Distributor Permittees. An out-of-state prescription drug wholesale distributor permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesale distributor, in its state of residence, to a licensed prescription drug wholesale distributor in this state, if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name.
- Research & Development.
- 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.”
- API Distributions to Florida Prescription Drug Manufacturers for Production. A permit is not required to distribute an API from an establishment located in the U.S. to an establishment located in this state permitted as a prescription drug manufacturer for use by the recipient in preparing, deriving, processing, producing, or fabricating a prescription drug finished dosage form at the establishment in this state where the product is received under an approved and otherwise valid New Drug Approval Application (NDA), Abbreviated New Drug Application (ANDA), New Animal Drug Application (NADA), or Therapeutic Biologic Application (also “Biologics License Application” or BLA), provided that the application, active pharmaceutical ingredient, or finished dosage form has not been withdrawn or removed from the market in this country for public health reasons. The API distributor must hold a valid prescription drug distribution license under the laws of the state where the transaction originates.
- Health Care Entity Own-Use Repackaging. A Restricted Prescription Drug Distributor – Health Care Entity permit holder does not require a separate prescription drug repackager permit to repackage prescription drugs in this state for its own use or for distribution to hospitals or other health care entities in the state under common control for those entities’ own use. The permit holder must (a) notify the department in writing of its intention to engage in repackaging 30 days before beginning repackaging operations, (b) adhere to current state and federal good manufacturing practices, and (c) label the prescription drugs in accordance with state and federal laws and rules.
- Pharmacies and Healthcare Practitioners. Florida-licensed pharmacies operating in compliance with pharmacy practice standards defined in Chapter 465, Florida Statutes and rules adopted under that chapter are not “manufacturers” under Chapter 499, Florida Statutes and are therefore exempt from drug manufacturer permitting requirements. Lawful prescription drug dispensing and administration activities are likewise not “distribution” transactions subject to prescription drug distributor permitting requirements under Chapter 499, Florida Statutes.