The Department of Business and Professional Regulation (DBPR) is the agency charged with licensing and regulating businesses and professionals in the State of Florida including those in the drugs, devices and cosmetics industries.
The attorneys at Gaitan Law Group work with pharmaceutical, biotechnology, medical device, and cosmetic companies to ensure compliance with the laws of the State of Florida (DBPR), as well as federal regulations as enforced by the U.S. Food and Drug Administration (FDA).
The DBPR’s Division of Drugs, Devices and Cosmetics (DDC) oversees the activities of companies manufacturing and/or distributing products within the State of Florida. DDC permitting requirements for drugs, medical devices and cosmetics are generally classified into two main categories:
(a) manufacturing and repackaging of drugs, medical devices and cosmetics in Florida; and
(b) distributing drugs, medical devices and cosmetics in and into Florida.
The chart below summarizes the permitting requirements for drugs, medical device and cosmetic companies, under the laws enforced by the DBPR:
|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|
OPENING A NEW MANUFACTURING, REPACKAGING OR DISTRIBUTION FACILITY IN FLORIDA
If you are opening a new facility in Florida that will be engaged in any of the following activities, you are required to acquire a permit from the DBPR prior to becoming operational:
- Manufacturing a drug, medical device or cosmetic;
- Repackaging a drug, medical device or cosmetic; and/or
- Distributing prescription drug.
Our attorneys have years of experience counseling clients through the permitting process. We work with our clients to prepare them for the pre-permit inspection to avoid unnecessary delays or tolling of the 90 day statutory review period. Our attorneys are specialized in the area of drug, device and cosmetic regulations, and possess an acute understanding of Good Manufacturing Practices (GMP), Quality Standards (QS), and related manufacturing controls which allows them to guide clients in developing comprehensive written Standard Operating Procedures (SOP). Once an inspection is scheduled, we often attend the inspection and work with the inspectors to mitigate and resolve any deficiencies on the spot in order to ensure that the permit is immediately issued. Our goal is to allow our clients to become operational and profitable as soon as possible.
Under Florida Statute, drug, medical device or cosmetic facilities found to be operating without a permit may be fined $1,000 – $3,000 per violation (that is, $1,000 – $3,000 per day you are operating without a permit). The DBPR is aggressive at bringing action against companies that are operating without a permit. Our attorneys are often called on to respond to notices of violation and administrative complaints, working with clients to develop an adequate Corrective and Preventive Action plan (CAPA), negotiate the exuberant penalties imposed by the state, settle cases or file for an administrative hearing before the DOAH.
For assistance in understanding if your company must be permitted, or to speak with an attorney about getting your company permitted, contact us at 786.440.8115.
To speak with an experienced attorney regarding a licensing or administrative matter involving the DBPR, e-mail Gaitan Law Group at [email protected] or call us at 786.440.8115. We offer flexible fee arrangements.