Florida Administrative Code

The following tracking and tracing requirements shall apply to manufacturers: (1) PRODUCT TRACING. (a) A manufacturer shall, prior to or at the time of each transaction in which such manufacturer transfers ownership of a product: 1. Provide the subsequent owner with transaction h…

The following tracking and tracing requirements shall apply to wholesale distributors: (1) PRODUCT TRACING. (a) A wholesale distributor shall not accept ownership of a product unless the previous owner prior to, or at the time of, the transaction provides the transaction history,…

The following tracking and tracing requirements shall apply to dispensers: (1) PRODUCT TRACING. (a) A dispenser shall not accept ownership of a product, unless the previous owner prior to or at the time of the transaction, provides transaction history, transaction information, an…

The following tracking and tracing requirements shall apply to repackagers: (1) PRODUCT TRACING. (a) A repackager shall not accept ownership of a product unless the previous owner, prior to, or at the time of, the transaction, provides transaction history, transaction information…

A complimentary drug distributor permit is required for any person that engages in the distribution of a complimentary drug, subject to the requirements of Section 499.028, F.S. A person, prior to engaging in activity for which a complimentary drug distributor permit is required,…

A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a …

Any person who manufactures, distributes, or deals in ether in this state must possess a current valid license issued by the department, except that a manufacturer, distributor, or dealer who also purchases ether in this state shall not be required to obtain an additional permit …

A freight forwarder permit is required for any person that engages in the distribution of a prescription drug as a freight forwarder unless the person is a common carrier. A person, prior to engaging in activity for which a freight forwarder permit is required, must file an appli…

A health care clinic establishment permit is required for the purchase of a prescription drug by a place of business at one general physical location that provides health care or veterinary services, which is owned and operated by a business entity that has been issued a federal …

A medical gas manufacturer permit is required for a person or entity located in this state which engages in the manufacture of medical gases by physical air separation, chemical action, purification, or filling containers by a liquid-to-liquid, liquid-to-gas, or gas-to-gas proces…

A medical gas wholesale distributor permit is required for wholesale distribution, whether within or into this state. A person, prior to engaging in activity for which a medical gas wholesale distributor permit is required, must file with the department a completed application on…

A medical oxygen retail establishment permit is required for an entity that is located in the state and that sells or delivers medical oxygen directly to patients in this state. A person located in this state, other than a pharmacy licensed under Chapter 465, F.S., prior to engag…

A nonresident prescription drug manufacturer permit is required for any person, located outside of Florida, that is a manufacturer of a prescription drug and that engages in the distribution of such prescription drug into Florida. A person engaging in activity for which a nonresi…

A nonresident prescription drug manufacturer - virtual permit is required for any person, located outside of Florida, that is a manufacturer of a prescription drug and that engages in the distribution of such prescription drug into Florida, but does not engage in the physical pos…

An out-of-state prescription drug wholesale distributor permit is required for any person, located outside of Florida but within the United States or its territories, that engages in the wholesale distribution of prescription drugs into Florida. A person, prior to engaging in act…

An over-the-counter drug manufacturer permit is required for any person that engages in the manufacture or repackaging of an over-the-counter drug. A person located in this state, other than a pharmacy operating in compliance with pharmacy practice standards set forth in Chapter …

A prescription drug manufacturer permit is required for any person that is a manufacturer of a prescription drug and that manufactures or distributes such prescription drugs in this state. A person located in this state engaging in activity for which a prescription drug manufactu…

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…