Florida Administrative Code

(1) The Florida Mobile Home Relocation Corporation (referred to in these rules as "Corporation") board of directors, one of whom serves as chair, shall conduct the corporation's business at meetings held as frequently as deemed necessary by the board. All such meetings shall be n…

(1) In order to receive payment from the Corporation for relocation expenses, the applicant shall submit to the Corporation, with a copy to the park owner, a Home Owner Application for Payment of Relocation Expenses, FMHRC Form 1001 (Revised 6-12-24) (https://www.flrules.org/Gate…

Rulemaking Authority 723.00611(3) FS. Law Implemented 723.061, 723.0611, 723.06116, 723.0612 FS. History-New 1-6-04, Amended 11-3-04, Repealed 10-1-08.

(1) Pursuant to Section 723.06116(1)(a)-(d), F.S., late fees will be imposed according to the following schedule: (a) 10% of total amount due for over 30 days past due; (b) 15% of total amount due for over 60 days past due; (c) 20% of total amount due for over 90 days past due; a…

(1) In order to qualify for compensation from the Corporation, the applicant must be mobile home owner as defined in Section 723.003, F.S., with title of the home in the name of the applicant and that person must have a valid rental agreement with a mobile home park on the date t…

Pursuant to Section 723.0612(12), F.S., an applicant shall have 1 year after the expiration of their notice of eviction due to change in the use of the land to apply for assistance from the Corporation. If the applicant is a participant in a legal action based on the change in th…

(1) Any applicant for payment or compensation from the Corporation who is dissatisfied with the decision of the Corporation's board of directors may file a grievance with a committee appointed to hear such grievances. The grievance committee shall be comprised of a panel of 4 mem…

(1) A word or phrase defined in the federal Food, Drug, and Cosmetic Act as defined in Section 499.002(1)(b), F.S., shall have the same meaning as in those provisions unless specifically defined otherwise in Chapter 499, F.S., or rule Chapter 61N-1, F.A.C. (2) In addition to defi…

(1) The department adopts and incorporates by reference the labeling requirements for prescription drugs and over-the-counter drugs as set forth in the federal act at 21 U.S.C. ss. 301 et seq. and in Title 21 Code of Federal Regulations Parts 1-1299 (as of 2/10/21), http://www.fl…

(1) Each compressed medical gases manufacturer or medical oxygen retailer who manufactures or refills compressed medical gases must comply with the current good manufacturing practice regulations for drug products promulgated by the FDA in 21 C.F.R. Parts 200-299 and the "Compres…

(1) Charitable Donations of Prescription Drug Samples. A physician or other authorized recipient of prescription drug samples may donate samples received according to Section 499.028, F.S., to a Restricted Prescription (Rx) Drug Distributors - Charitable Organization permittee; t…

The department adopts and incorporates by reference the labeling requirements for cosmetics as set forth in the federal act at 21 U.S.C. ss. 321, 331, and 361-363 and in Title 21 Code of Federal Regulations https://www.flrules.org/Gateway/reference.asp?No=Ref-13234 Parts 700-740 …

(1) All persons who manufacture or relabel cosmetics in Florida must follow the minimum requirements for manufacturing contained in this section to help assure product safety and quality. If a person does not engage in all phases of cosmetic manufacturing, that person need only c…

(1) The exemption from the definition of wholesale distribution in Section 499.003(48)(b)2., F.S., for "emergency medical reasons" includes: (a) Transfers of a prescription drug between health care entities or from a health care entity to a retail pharmacy to alleviate a temporar…

(1)(a) Records to document the movement of drugs, devices or cosmetics must provide a complete audit trail from a person's receipt or acquisition to sale or other disposition of the product or component. A complete audit trail includes records which document each transaction or s…

(1) Establishments in which prescription drugs are stored, manufactured, repackaged, kept, held, used, sold, stored, offered for sale, or exposed for sale, shall be secured against unauthorized entry or unauthorized access to prescription drugs when establishment personnel are no…

(1) Establishments where devices or over-the-counter drugs are manufactured, packaged, repackaged, stored, held, sold, offered for sale, exposed for sale, or kept for sale or use must do so under proper conditions of temperature as required by the manufacturer's labeling of the p…

This section addresses the application and permitting requirements of persons regulated under Part I of Chapter 499, F.S. (1) Any person that is required under Sections 499.001-.081, F.S., to have a permit shall apply to the department for the appropriate permit on forms indicate…

(1)(a) Each drug product shall be registered with the department, but shall not have duplicate registrations. Products that are both a cosmetic and a drug must be registered as a drug. (b) A formula marketed under different brand names, sizes, quantities, or distributors is not c…

(1) A written request for a certificate of free sale must be submitted to the department by the Florida permitted manufacturer of the drug indicating the name and address of the company to be designated on the free sale certificate as the distributor or manufacturer or both; the …

(1) Biennial fees for a Manufacturer or Repackager permit are as follows: Biennial Fee Prescription Drug Manufacturer (including virtual) $1,500.00 Prescription Drug Repackager $1,500.00 Device Manufacturer $1,200.00 Cosmetic Manufacturer $800.00 Over-the Counter Drug Manufacture…

(1) An inspection or investigation is a review or examination of an establishment permitted under the provisions of chapter 499, F.S., or any rule adopted thereunder, or of a non-permitted establishment for the purpose of protecting public health from misbranded or adulterated dr…

Rulemaking Authority 499.01, 499.012, 499.0122, 499.013, 499.015, 499.018, 499.028, 499.04, 499.041, 499.05, 499.06, 499.62, 499.63, 499.64, 499.66, 499.67, 499.701 FS. Law Implemented 499.01, 499.012, 499.0122, 499.013, 499.015, 499.018, 499.028, 499.04, 499.041, 499.05, 499.06,…

(1) A person must indicate in writing at the time information is submitted to the department that the information includes material which is a trade secret as defined by Section 812.081(1)(c), F.S., or other confidential material exempt from the provisions of Chapter 119, F.S., t…

(1) Any person requiring a license or permit may request an Application for Permit as a Diethyl Ether Manufacturer, Distributor, Dealer, or Purchaser DBPR-DDC Form 233, effective April 2016, which is incorporated by reference in Rule 61N-2.004, F.A.C. To renew a permit which has …

The following Restricted Prescription (Rx) Drug Distributor permits will be issued by the department: (1) Restricted Rx Drug Distributor - Charitable Organization. This permit is required for a charitable organization to authorize the possession or transfer of prescription drugs,…

(1) In addition to any other action authorized by law, the department will issue a notice of violation, warning letter, or notice of inspection results to any person that violates Chapter 499, Part I, F.S., and this rule chapter if the documented facts of the case so warrant. (2)…

(1) In lieu of the disciplinary procedures contained in ss. 499.005, 499.051, and 499.066, F.S., the offenses enumerated in this rule may be resolved by the issuance of a nondisciplinary citation. The citation will be issued using Form DBPR-DDC-250, Uniform Nondisciplinary Citati…

(1) In accordance with Section 120.695, F.S., the Department of Business and Professional Regulation (hereinafter the "Department") may issue a notice of noncompliance to a licensee, registrant or permitholder for an initial offense of a minor violation. (2) The Department design…

(1) As used in this rule chapter the terms "certificate" and "Certification Authority" are as defined by Section 668.003, F.S. (2005). The department will list on its website one or more companies authorized to serve as a Certification Authority to issue digital certificates to p…

The purpose of this section is to establish and maintain a cancer drug donation program under which unused cancer prescription drugs and cancer supplies may be donated and dispensed to eligible individuals who are diagnosed with cancer. This rule applies to the department or any …

(1) "Emergency use" means the administration of oxygen USP to an individual that is experiencing an unexpected, life-threatening, medical situation which requires immediate action. (2) "Persons authorized to receive emergency use oxygen" means: (a) A person experiencing an unexpe…

The following definitions apply to the product tracking and tracing requirements set forth in Rules 61N-1.029, 61N-1.030, 61N-1.031 and 61N-1.032, F.A.C. (1) "AFFILIATE" means a business entity that has a relationship with a second business entity if, directly or indirectly: (a) …

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…