The Florida Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics (“DDC”) cannot and does not give legal advice or advisory opinions.  Nothing on this site constitutes legal advice, and the department strongly recommends relying only on the advice of a private attorney.

DDC permitting requirements as regards drugs, (medical) devices and cosmetics fall 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.
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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 a “drug”, “device”, or “cosmetic”?

Refer to Section 499.003, Florida Statutes.

Please note that “drug” specifically includes active pharmaceutical ingredient (API). Also, “devices” that contain “drugs” are classified as drugs if any of the principal intended purposes is achieved through chemical action.

  • 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. The term excludes, however, certain administrative activities.

Possibly.  Florida law contains no exemption for “combination products” containing prescription drugs.  As such, medical convenience kits that contain prescription drugs are generally regulated as prescription drugs. For a definition of Combination Products check out:

http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm118332.htm

Unless you are the “manufacturer” of all the prescription drugs contained in the combination product, a (Nonresident) Prescription Drug Manufacturer permit may not provide appropriate licensure under Chapter 499, Florida Statutes.

Possibly.  Corporate offices, sales centers, call centers, etc. sometimes engage in activity constituting a sale, or an offer to sell or to deliver.  See the definition of “distributing”, above.

Possibly. A permit issued under Chapter 499, Florida Statutes is only valid for the establishment for which the permit was originally issued. Changing establishments requires a new permit application – before the move. An “establishment” is a place of business at one general physical location that may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit, floor, or building must be identified in the most recent permit application.

Possibly.  Permits issued under Chapter 499, Florida Statutes are specific to the original holder, and may not be bought, sold, traded, leased or otherwise transferred.  Further, an application for a new permit is required when a majority of the ownership or controlling interest of a permitted establishment is transferred or assigned or when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the establishment will rest with the lessee.

The application for the new permit must be made before the date of the sale, transfer, assignment, or lease.

Common types of ownership changes:

Transaction Description New Permit

(Generally) Required?

Change of ownership of the establishment (often in the form of an asset sale). Yes
Change of ownership of the permittee (often in the form of a stock sale) Yes
Merger or acquisition where permittee DOES NOT survive the transaction Yes
Merger or acquisition where permittee survives the transaction, and controlling interest in the permittee has not changed Usually No
Change of ownership of the permittee’s parent entity Usually No
Change of ownership of the permittee’s “grandparent” entity Almost Never

Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

All API’s are “drugs” under Chapter 499, Florida Statutes, and an API is a “prescription drug” if substantially all finished dosage forms in which it may be lawfully dispensed or administered in this state are also prescription drugs. As such, manufacturing or repackaging an API in Florida requires a permit. Distributing an API in or into Florida may require a permit – regardless of where the API is manufactured or by whom.

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.

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

Probably not.  Florida executive agencies such as the department cannot give waivers or variances of statutory requirements.  The department may, however, provide such a variance or waiver with respect to the administrative rules promulgated under Chapter 499, Florida Statutes.

Need Help?

All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.

Drew Winters, Division Director

Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047

Telephone: 850.717.1800