Drugs, Devices, and Cosmetics License Requirements

How does Florida regulate and authorize licenses?   

Under the Florida Statutes, a “license” to regulate professions and occupations means any permit, registration, certificate, or license issued by the Department of Business and Professional Regulation (the “DBPR”). An occupational license is a privilege accorded by the state or its subdivisions to conduct a business at a particular location and is not a property right protected by substantive due process; the denial of such license does not prevent the business owner from pursuing a lawful occupation but merely stops the business from operating at a particular location. Ammons v. Okeechobee County, 710 So. 2d 641 (Fla. 4th DCA 1998).  

On July 1, 2021, the Florida Legislature passed Section 163.211 into law, which prevents any county, municipality, or other political subdivision of Florida from implementing additional licensing requirements for most occupations. Therefore, a prospective applicant only needs to satisfy state statutory requirements. 

Need help receiving, renewing, or defending your license? Schedule your consultation today with a top administrative law and licensing attorney.  

How does the licensing process work in Florida?  

A prospective licensee must apply through the DBPR, which must review the application and have the discretion to reject or accept applications for new licenses and license renewals as long as the discretionary review is reasonable. See KJS v. Department of Children and Family Services, 974 So. 2d 1106 (Fla. 1st DCA 2007).  

On the other hand, licensees seeking renewal must file for renewal before their license expires, or they will not be allowed to engage in their occupation until the DBPR grants a separate, new license. See Legal Environmental Assistance Foundation, Inc. v. Board of County Com’rs of Brevard County, Fla., 61 F.3d 25 (11th Cir. 1995).  

When the DBPR receives a license application, the agency has 90 days to examine the application, timely notify the applicant of any errors or omissions, request additional information, and, ultimately, issue a notice of intent to either grant or deny the license. The DBPR may not deny renewal without a full, open, and fair hearing for license renewals. See Wilson v. Pest Control Commission of Fla., 199 So. 2d 777 (Fla. 4th DCA 1967).  

Which laws and regulations apply to Florida’s drugs, devices, and cosmetics licenses?  

The  Florida Drug and Cosmetic Act (Chapter 499, Florida Statutes) is the primary statute governing these licenses. This Act outlines the requirements for obtaining and maintaining a license and the enforcement provisions for violations of the Act. Federal regulations also apply to drugs, devices, and cosmetics, including the Federal Food, Drug, and Cosmetic Act (FD&C Act) and rules enforced by the US Food and Drug Administration (FDA). 

The DBPR, through its Division of Drugs, Devices, and Cosmetics, administers the licensing and enforcement of Chapter 499. The Division is responsible for issuing permits, conducting inspections, and enforcing the provisions of the Act. In addition, the Division collaborates with federal agencies such as the FDA to ensure compliance with state and federal regulations. 

What are Florida’s application and retention requirements for drugs, devices, and cosmetics licenses? 

Application Requirements:

To obtain a drugs, devices, and cosmetics license in Florida, applicants must submit a completed application to the Division, along with the required fees and supporting documentation. The specific application requirements vary depending on the type of license sought, such as a manufacturer, distributor, or prescription drug repackager license. Some common conditions include proof of insurance, financial statements, and a description of the applicant’s business activities. 

Retention Requirements:

In addition to the application requirements, licensees must adhere to various retention requirements to maintain their license. These retention requirements include regular inspections, compliance with the Florida Administrative Code (FAC), and adherence to the FD&C Act. Licensees must also comply with the recordkeeping, labeling, and reporting requirements outlined in Chapter 499, FS, and Chapter 61N-1, FAC. 

Failure to comply with these requirements may result in disciplinary action by the Division, including fines, suspension, or revocation of the license. Moreover, licensees must renew their licenses periodically by submitting a renewal application, paying the renewal fee, and providing any required documentation to demonstrate ongoing compliance with the relevant laws and regulations. 

To determine whether you meet the drug, device, and cosmetics license requirements, please contact our office to set up your initial consultation. 

Can the DBPR’s license decision be appealed?  

Yes, an adverse license decision made by the DBPR is appealable. The authority for appealing such decisions comes from the Florida Administrative Procedure Act (APA), Chapter 120 of the Florida Statutes. Specifically, the right to appeal derives from Florida Statutes §120.569 and §120.57. The APA establishes the framework for challenging agency actions, such as licensing decisions, through administrative hearings and judicial review.  

If an applicant or licensee receives an adverse decision from the DBPR, they may request an administrative hearing to challenge it. The request for a hearing must be submitted within the timeframe specified in the agency’s notice, which is generally 15 days from the date of the notice, as provided in Section 120.569(2)(a), Florida Statutes. 

The administrative hearing process commences with submitting a petition for a hearing to the agency. The petition must comply with the requirements outlined in Rule 28-106.201, Florida Administrative Code. If the petitioner qualifies for an administrative hearing, the case is referred to the Division of Administrative Hearings (DOAH) and assigned to an administrative law judge (ALJ). 

The ALJ conducts the hearing, like a trial, with both parties presenting evidence and testimony. After the hearing, the ALJ issues a recommended order, which includes findings of fact, conclusions of law, and a recommendation for a final decision. The DBPR then reviews the recommended order and issues a final order, either adopting, modifying, or rejecting the ALJ’s recommendations. 

Suppose the petitioner is unsatisfied with the DBPR’s final order. In that case, they can seek judicial review by filing a notice of appeal with the appropriate District Court of Appeal, as provided in Section 120.68, Florida Statutes. The court reviews the case to determine if the agency’s decision follows from competent, substantial evidence and complies with the law. 

Have more questions about a professional licensing-related situation?  

Crucially, this overview of drugs, devices, and cosmetics licenses does not begin to cover all the laws implicated by this issue or the factors that may compel the application of such laws. Every case is unique, and the laws can produce different outcomes depending on the individual circumstances. 

Jimerson Birr attorneys guide our clients to help make informed decisions while ensuring their rights are respected and protected. Our lawyers are highly trained and experienced in the nuances of the law, so they can accurately interpret statutes and case law and holistically prepare individuals or companies for their legal endeavors. Through this intense personal investment and advocacy, our lawyers will help resolve the issue’s complicated legal problems efficiently and effectively. 

Having a Jimerson Birr attorney on your side means securing a team of seasoned, multi-dimensional, cross-functional legal professionals. Whether it is a transaction, an operational issue, a regulatory challenge, or a contested legal predicament that may require court intervention, we remain a tireless advocate every step of the way. Being a value-added law firm means putting the client at the forefront of everything we do. We use our experience to help our clients navigate even the most complex problems and come out the other side triumphant. 

If you want to understand your case, the merits of your claim or defense, potential monetary awards, or the amount of exposure you face, you should speak with a qualified Jimerson Birr lawyer. Our experienced team of attorneys is here to help. Call Jimerson Birr at (904) 389-0050 or use the contact form to set up a consultation.