Division of Drugs, Devices and Cosmetics – Declaratory Statements

A Declaratory Statement is the sole means for obtaining a binding interpretation or opinion from the Division of Drugs, Devices and Cosmetics concerning the applicability of statutory provisions, rules or orders over which the Division has authority (Chapters 499, Florida Statutes, and Chapter 61N-1, Florida Administrative Code). A Petition for a Declaratory Statement may only be used to resolve questions or doubts as to how the statutes, rules or orders may apply to the petitioner’s particular circumstances.

Please note, the Legislature, not the Division, which is entitled to set and ultimately define the scope of practice for any profession.

With regard to any questions concerning authorization to conduct a particular activity, the Division needs to be provided specific information detailing the particular activity, the relationships between any corporate entities (contractual, parent/subsidiary/sister) that will be participating in the activity, and the roles, responsibilities, and obligations of the entities that will be participating in the activity.  Please note the Florida Legislature is the only entity authorized to set the scope of activities authorized by permits issued by the Division.  The Division is tasked with interpreting and implementing the statutory provisions in a manner consistent with the intent of the Florida Legislature.

Any Petition for Declaratory Statement that meets the requirements for Division consideration must be publicly noticed in the Florida Administrative Weekly.

Upon reaching a decision, the Division will issue an Order setting forth its findings of fact and conclusions of law.

Refer to Section 120.565, Florida Statutes, and Chapter 28-105, Florida Administrative Code, which sets out the requirements for a Petition for Declaratory Statement. Such a petition is an individual request by a substantially affected person to an agency to give its opinion as to the effect of a particular statute or rule upon the petitioner in his or her circumstances. For instance, a licensee may request for the Division to issue an opinion on whether a certain practice or procedure in which the licensee wishes to engage in is permitted within the scope of practice. The Division of Drugs, Devices and Cosmetics is limited to addressing its opinions to Chapter 499 Florida Statutes, and Florida Administrative Code 61N-1. It has no authority to render formal opinions concerning any other state statutes or federal laws and regulations.

Submit questions to:
Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047
Phone 850.717.1800
Fax to: 850.414.8240

Requests for Variances and Waivers

Requests for variances and/or waivers should be submitted for filing to the Agency Clerk’s Office. Requests must be submitted according to the guidelines outlined in Section 120.542, F.S. and Chapter 28-104, F.A.C.

Past Variance/Waivers and Declaratory Statements