Florida Administrative Code

A prescription drug manufacturer - virtual permit is required for any person, located in Florida, that is a manufacturer of a prescription drug and that manufactures and distributes such prescription drug in or into Florida, but does not engage in the physical possession of any p…

A prescription drug repackager permit is required for any person, located in Florida, that is a repackager of a prescription drug and that distributes such prescription drug in or within Florida. A person engaging in activity for which a prescription drug repackager permit is req…

A nonresident prescription drug repackager permit is required for any person, located outside of Florida, that is a repackager of a prescription drug and that distributes such prescription drug into Florida. A person engaging in activity for which a nonresident prescription drug …

A prescription drug wholesale distributor permit is required for any person, located inside of Florida, that engages in the wholesale distribution of prescription drugs in Florida. A person, prior to engaging in activity for which a prescription drug wholesale distributor permit …

A Restricted Prescription Drug Distributor - Blood Establishment Permit is required for any establishment located in this state that collects blood and blood components only from volunteer donors as defined in Section 381.06014, F.S., or pursuant to an authorized practitioner's o…

A Restricted Prescription Drug Distributor - Charitable Organization Permit is required for a charitable organization to authorize the possession or transfer of prescription drugs, including prescription drug samples, as set forth in subsection 61N-1.023(1), F.A.C. An applicant w…

A Restricted Prescription Drug Distributor - Destruction Permit is required for a person to take possession in Florida of a prescription drug for the purpose of arranging for its destruction, including persons transporting prescription drugs to a destruction facility or warehousi…

A Restricted Prescription Drug Distributor - Government Programs Permit is required for a state or local government agency, or any entity eligible to purchase prescription drugs at public health services prices to distribute its prescription drugs to a contract provider or its su…

A Restricted Prescription Drug Distributor - Health Care Entity Permit is required for a hospital or health care entity for the limited purpose of transferring prescription drugs among hospitals or other health care entities that are either: (1) under common control; or (2) membe…

A Restricted Prescription Drug Distributor - Institutional Research Permit is required for a licensed pharmacy of a university to transfer prescription drugs to practitioner or non-practitioner researchers for university sponsored research conducted in accordance with Section 100…

A Restricted Prescription Drug Distributor - Reverse Distributor Permit is required for any person located in this state who engages in the handling, processing and removal of expired or otherwise adulterated or unsuitable prescription drugs on behalf of licensed pharmacies, prac…

A Retail Pharmacy Drug Wholesale Distributor Permit is required for any retail pharmacy as defined in Section 499.003(46), F.S., that is engaged in wholesale distribution of prescription drugs within this state under the conditions enumerated in Section 499.01(2)(g), F.S. An appl…

A Third Party Logistics Provider permit is required for any person that contracts with a prescription drug wholesale distributor or prescription drug manufacturer to provide warehousing, distribution, or other logistics services on behalf of a manufacturer, wholesale distributor,…

A Veterinary Prescription Drug Retail Establishment Permit is required for any person that sells veterinary prescription drugs to the public pursuant to the requirements of Sections 499.01(2)(k)1.-7., F.S., but does not include a pharmacy licensed under Chapter 465, F.S. Applican…

A Veterinary Prescription Drug Wholesale Distributor Permit is required for any person that engages in the distribution of veterinary prescription drugs in or into this state, except that a veterinary prescription drug wholesale distributor that also distributes prescription drug…

A current permitholder wishing to change their mailing address shall submit a complete application to the department on Form DBPR-DDC-238, Application for Change of Mailing Address, effective January 2018, incorporated herein by reference, http://www.flrules.org/Gateway/reference…

A current permitholder wishing to change their name shall submit a complete application to the department on Form DBPR-DDC-110, Application for Name Change, effective January 2018, incorporated herein by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-09237. A copy…

A current permit holder wishing to change their physical location shall submit a complete application to the department on Form DBPR-DDC-109, Application for Change of Physical Location, effective January 2018, incorporated herein by reference, http://www.flrules.org/Gateway/refe…

A current product registration holder wishing to obtain a Certificate of Free Sale for their product shall submit a complete application to the department on Form DBPR-DDC-239, Application for Certificate of Free Sale, effective January 2018, incorporated herein by reference, htt…

Certification as a Designated Representative is required for any natural person who is designated by a prescription drug wholesale distributor or out-of-state prescription drug wholesale distributor to act as their designated representative pursuant to Section 499.012(15), F.S. A…

When an establishment that requires a permit pursuant to this part submits an application for a change of ownership or controlling interest with the required fees, the establishment may also submit a request for a temporary permit granting the establishment authority to operate n…

When an establishment that requires a permit pursuant to this part submits an application for a change of physical location with the required fees, the establishment may also submit a request for a temporary permit granting the establishment authority to operate no more than 90 c…

Rulemaking Authority 20.25 FS. Law Implemented 120.53 FS. History-New 3-8-82, Formerly 16-7.01, 16-7.02, 16-7.002, Repealed 2-16-12.

Rulemaking Authority 403.061(28) FS. Law Implemented 403.0615 FS. History-New 5-29-78, Formerly 17-1.126, Amended 6-1-84, Formerly 17-104.040, Amended 11-28-96, Repealed 2-23-12.

(1) In responding to short-term emergencies, the Department may use monies from the Water Quality Assurance Trust Fund for, among other things, the following purposes: (a) Contracting with independent contractors for the assessment and taking of remedial action to alleviate a sho…

Rulemaking Authority 120.53, 403.061 FS. Law Implemented 120.53 FS. History-New 6-30-86, Formerly 17-109.010, Repealed 1-11-11.

Rulemaking Authority 120.53(5), 403.061 FS. Law Implemented 120.53 FS. History-New 6-30-86, Formerly 17-109.020, Repealed 1-11-11.

Rulemaking Authority 120.53(5), 403.061 FS. Law Implemented 120.53 FS. History-New 6-30-86, Formerly 17-109.030, Repealed 1-11-11.

Rulemaking Authority 120.53(5), 403.061 FS. Law Implemented 120.53 FS. History-New 6-30-86, Formerly 17-109.040, Repealed 1-11-11.

In assessing damages for aquatic animals killed, the value of the aquatic animals is to be determined by adding the replacement, recreational and commercial values if these are listed separately in accordance with the following table of values: (1) Marine Species. COMMON NAME SCI…

The values for the threatened and endangered fish species, as listed in Rules 39-27.003 and 39-27.004, F.A.C., shall be assessed at a minimum value of $10,000.00 per fish for endangered species and at a minimum value of $5,000.00 per fish for threatened species. Rulemaking Author…

Rulemaking Authority 403.061, 403.141 FS. Law Implemented 403.061, 403.141, 403.161 FS. History-New 2-16-93, Formerly 1711.003, Repealed 2-16-12.

(1) Notice. (a) In addition to complying with the notice provisions of Rule Chapter 28-103 of the Uniform Rules of Procedure, notice of the Department's intent to adopt, amend, or repeal a rule shall be given in accordance with any applicable federal regulations, and a copy of th…

(1) Although a person seeking a variance under Section 120.542F.S., must comply with Rule Chapter 28-104, F.A.C., a person seeking a variance under Section 373.414(17) or 403.201, F.S., must demonstrate that any hardship asserted as a basis of the need for a variance is peculiar …

Requests for formal determinations of the landward extent of wetlands and surface waters shall be governed by Rule 62-343.040, F.A.C. Rulemaking Authority 120.54(5), 373.026, 373.043, 373.044, 373.421 FS. Law Implemented 120.60, 373.026, 373.117, 373.421 FS. History-New 7-1-98.

(1) Service. Service of any document shall be deemed complete upon being properly addressed, stamped, and deposited in the United States Mail, or upon receipt of the complete document by the clerk of the Department or any other party to whom a document is sent by facsimile transm…

(1) In addition to the requirements for the processing of applications under subsections 28-107.002(2), 62-4.055(1), 62-312.006(5), paragraph 62-343.090(2)(f), and Rules 62-343.040, and 62-620.510, F.A.C., govern the processing of applications by the Department, providing that an…

Rulemaking Authority 380.051 FS. Law Implemented 380.051 FS. History-New 9-21-87, Formerly 17-112.030, Amended 11-13-96, Repealed 3-8-12.

This rule chapter lists the delegation agreements which have been entered into by the Department with another state agency, political subdivision or water management district, and which delegate any of the Department's duties and responsibilities under Chapters 253, 373, 376 and …

The Secretary, as head of the Department, has delegated authority as follows: (1) To the Assistant Secretary of the Department to act on behalf of the Secretary in all matters during the absence of the Secretary, including the signing of contracts, and in the absence of both the …

Rulemaking Authority 110.503(2) FS. Law Implemented 110.503 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.501, 110.503 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.502, 110.503 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.502, 110.503 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.503, 110.505 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.502, 110.503 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.503 FS. History-New 8-28-95, Repealed 2-21-12.

Rulemaking Authority 110.503(2) FS. Law Implemented 110.503, 110.504 FS. History-New 8-28-95, Repealed 2-21-12.

As used in this chapter the following terms shall have the following meanings. These definitions are substantially equivalent to those set forth for these terms in 42 USC §9601 (1986). (1) "Facility" means (a) any building, structure, installation, equipment, pipe or pipeline (in…

(1) Any owner or operator of a facility who has knowledge of any release of a hazardous substance from a facility in a quantity equal to or exceeding the reportable quantity in any 24-hour period shall notify the Department by calling the State Warning Point Number, (850)488-1320…