reglab/statecodes huggingface dataset:
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.018 - Fees

Current through Reg. 50, No. 138; July 16, 2024
(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 Manufacturer
$800.00
Medical Gas Manufacturer
$1, 000.00
Non-resident Prescription Drug Manufacturer
							 (including virtual)
$1, 000.00
Non-resident Prescription Drug Repackager
$1, 500.00
No manufacturer shall be required to pay more than one fee
				  per establishment to obtain an additional manufacturing permit; but the
				  manufacturer must pay the highest fee applicable to the operations in each
				  establishment.
(2)
(a) Biennial fees for a Wholesale Distributor
				or Freight Forwarder permit that is issued on a Biennial basis are as follows:
Biennial Fee
Medical Gas Wholesale Distributor
$600.00
Retail Pharmacy Drug Wholesale Distributor
$100.00
Freight Forwarder
$600.00
Veterinary Prescription Drug Wholesale
							 Distributor
$1, 000.00
Limited Prescription Drug Veterinary Wholesale
							 Distributor
$1, 000.00
Prescription Drug Wholesale Distributor (including
							 Broker Only)
$1, 600.00
Out-of-State Prescription Drug Wholesale
							 Distributor
$1, 600.00
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.020 - Forms (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
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,
					 499.062,
					 499.063,
					 499.064,
					 499.066,
					 499.067
					 FS.
New 12-12-82, Formerly 10D-45.56, Amended 11-26-86, 2-4-93,
					 7-1-96, Formerly 10D-45.056, Amended 1-26-99, 1-1-04, Formerly
					 64F-12.020, Repealed
					 6-30-15.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.021 - Trade Secrets

Current through Reg. 50, No. 138; July 16, 2024
(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., the basis for the claim of trade secret and that the person does not wish
				this trade secret to be made public.
(2) Trade secret information must be
				specifically identified and noted on the documents submitted to the
				department.
(3) In the event the
				department seizes information pursuant to its inspectional authority under
				section 499.051, F.S., or rule
				61N-1.019, F.A.C., the person
				from whom the information is seized will be granted an opportunity to claim and
				designate trade secret information in accordance with this rule prior to the
				department completing enforcement action.
Rulemaking Authority
					 499.05 FS. Law Implemented
					 381.83,
					 499.051(7)
					 FS.
New 12-12-82, Formerly 10D-45.57, Amended 7-1-96, Formerly
					 10D-45.057, 64F-12.021.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.022 - Ether Applications; Licensing; Permitting; Records; Security; Distributing; Disposal

Current through Reg. 50, No. 138; July 16, 2024
(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 not expired, been revoked, suspended or otherwise terminated,
				a person must file with the department a completed "Application for Permit
				Renewal Under Chapter 499, F.S., " DBPR-DDC Form 2,
https://www.flrules.org/Gateway/reference.asp?No=Ref-13232
,
				effective October 2014, which is incorporated by reference herein.
(a) The following items must accompany the
				initial Application for Diethyl Ether Permit and renewal applications:
1. Accurate and Current Photographs - Two
				accurate and current photographs, taken within 6 months of the submission date
				of the application, of the chief executive officer or owner. The photographs
				must measure 2 inches by 2 inches and be clearly recognizable with a front
				view, full face image.
2.
				Fingerprint Cards - A complete set of fingerprints of the applicant taken by an
				authorized law enforcement officer on forms provided by the department. A new
				set of fingerprint cards is not required if the applicant is applying for a
				renewal license or permit for a license or permit held during the prior license
				or permit year which was not suspended or revoked and the chief executive
				officer has not changed.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.0245 - Notice of Non Compliance; Minor Violations

Current through Reg. 50, No. 138; July 16, 2024
(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 designates a violation of
				subsection 61N-1.012(5),
				F.A.C. - Failure to maintain a copy of the Florida Drug and Cosmetic Act,
				chapter 499, part I, F.S., and chapter 61N-1, F.A.C., Regulations for Drugs,
				Devices and Cosmetics, at the permitted establishment, as a minor violation for
				which a notice of noncompliance may be issued.
(3) The designation of a minor violation for
				purposes of section 120.695, F.S., is limited to
				only initial violations in which corrective action is commenced within 14 days
				after the licensee, registrant or permitholder's receipt of the Department's
				issuance of a notice of noncompliance. The failure of a licensee, registrant or
				permitholder to comply with the notice of noncompliance within the prescribed
				period of time shall no longer be deemed a minor violation and shall be treated
				as a disciplinary violation pursuant to section
				499.066, F.S., and/or rule
				61N-1.024, F.A.C. Violations of
				this section shall be handled in accordance with the standard disciplinary
				guidelines of the Department. Nothing provided in this section shall restrict
				the Department from seeking full administrative action in such instances where
				aggravating circumstances are present which would preclude a minor violation
				dismissal.
(4) The notice of
				noncompliance may be delivered to the licensee, registrant or permitholder's
				current mailing address by certified mail, by restricted delivery or by
				personal service. The notice of noncompliance may also be issued by an
				authorized representative of the Department.
Rulemaking Authority
					 120.695(2)(c),
					 499.05 FS. Law Implemented
					 120.695,
					 499.05,
					 499.066
					 FS.
New 11-2-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.026 - Cancer Drug Donation Program

Current through Reg. 50, No. 138; July 16, 2024
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 person who
				  donates, receives, dispenses or otherwise participates or wishes to participate
				  in the cancer drug donation program.
(1) Recipient Eligibility Requirements.
(a) A Florida resident who is diagnosed with
				cancer is eligible to receive drugs or supplies under the cancer drug donation
				program unless the person falls under paragraph
				61N-1.026(1)(b),
				F.A.C.
(b) A Florida resident is
				ineligible to participate in the cancer drug donation program if the person is
				eligible to receive cancer drugs or supplies through the Medicaid program,
				third-party insurer or any other prescription drug program funded in whole or
				in part by the Federal Government, unless these benefits have been exhausted,
				or a certain cancer drug or supply need by the patient is not covered by the
				prescription drug program as stated in section
				499.029(9),
				F.S.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.027 - Distribution of Medical Oxygen for Emergency Use

Current through Reg. 50, No. 138; July 16, 2024
(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 unexpected, life-threatening, medical situation due to oxygen deficiency and
				requiring resuscitation;
(b) A
				person exempted pursuant to section
				499.03, F.S.; and,
(c) Business establishments, universities,
				schools, and other such entities or organization conducting lawful activities
				which include frequent contact or interaction with members of the public, e.g.
				banks, hotels, restaurants, recreation camps, theme parks and resorts, and
				sports arenas. These establishments must employ an individual that has training
				on the use and administration of emergency use oxygen.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.028 - Product Tracking and Tracing - Definitions

Current through Reg. 50, No. 138; July 16, 2024
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) One business entity controls, or has the
				power to control, the other business entity, or
(b) A third party controls, or has the power
				to control, both of the business entities.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.029 - Product Tracking and Tracing - Manufacturer Requirements

Current through Reg. 50, No. 138; July 16, 2024
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 history, transaction information, and a transaction statement, in a
				single document in a paper or electronic format;
2. Capture the transaction information,
				including lot level information, transaction history, and transaction statement
				for each transaction; and,
3.
				Maintain such information, history, and statement for not less than 6 years
				after the date of the transaction.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.031 - Product Tracking and Tracing - Dispenser Requirements

Current through Reg. 50, No. 138; July 16, 2024
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, and a
				transaction statement;
(b) A
				dispenser shall, prior to, or at the time of, each transaction in which the
				dispenser transfers ownership of a product, excluding dispensing to a patient
				or returns, provide the subsequent owner with transaction history, transaction
				information, and a transaction statement for the product, except that the
				requirements of this rule shall not apply to sales by a dispenser to another
				dispenser to fulfill a specific patient need; and,
(c) A dispenser shall capture transaction
				information, including lot level information, if provided, transaction history,
				and transaction statements, as necessary to investigate a suspect product, and
				maintain such information, history, and statements for not less than 6 years
				after the transaction.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.032 - Product Tracking and Tracing - Repackager Requirements

Current through Reg. 50, No. 138; July 16, 2024
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, and a
				transaction statement for the product.
(b) A repackager, prior to, or at the time
				of, each transaction in which the repackager transfers ownership of a product,
				shall provide the subsequent owner with transaction history, transaction
				information, and a transaction statement for the product.
(c) A repackager shall capture the
				transaction information, including lot level information, transaction history,
				and transaction statement for each transaction described in paragraphs
				61N-1.032(1)(a) and
				(1)(b), F.A.C., and shall maintain such
				information, history, and statement for not less than 6 years after the
				transaction.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.001 - Application for Complimentary Drug Distributor Permit

Current through Reg. 50, No. 138; July 16, 2024
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, must file with the department a completed application on form number
				  DBPR-DDC-221, Application for Permit as a Complimentary Drug Distributor,
				  effective April 2016, adopted and incorporated herein by reference and comply
				  with all the requirements for permitting in Chapter 499, F.S., and Title 61N,
				  F.A.C. This form is available upon request from the Department of Business and
				  Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair
				  Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
https://www.flrules.org/Gateway/reference.asp?No=Ref-06903
.
Rulemaking Authority
					 499.012(3),
					 499.028(11)(a),
					 499.05 FS. Law Implemented
					 499.01,
					 499.012,
					 499.0121,
					 499.028,
					 499.04,
					 499.041,
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.002 - Application for Cosmetic Manufacturer Permit

Current through Reg. 50, No. 138; July 16, 2024
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 permit. A
				  person located in this state, prior to engaging in activity for which a
				  cosmetic manufacturer permit is required, must file with the department a
				  completed application on form number DBPR-DDC-206, Application for Permit as a
				  Cosmetic Manufacturer, effective July 2017, adopted and incorporated herein by
				  reference and comply with all the requirements for permitting in Chapter 499,
				  F.S., and Title 61N, F.A.C. This form is available upon request from the
				  Department of Business and Professional Regulation, Division of Drugs, Devices
				  and Cosmetics, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047,
				  (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-08710
.
Rulemaking Authority
					 499.012(3),
					 499.041(1)(c)
					 FS. Law Implemented 499.01,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 559.79
					 FS.
New 6-9-16, Amended
					 10-24-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.004 - Application for Diethyl Ether Manufacturer, Distributor, Dealer or Purchaser Permit

Current through Reg. 50, No. 138; July 16, 2024
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 as a purchaser
				  of ether. A person, prior to engaging in activity for which a diethyl ether
				  manufacturer, distributor, dealer, or purchaser permit is required, must file
				  with the department a completed application on form number DBPR-DDC-233,
				  Application for Permit as a Diethyl Ether Manufacturer, Distributor, Dealer or
				  Purchaser, effective April 2016, adopted and incorporated herein by reference
				  and comply with all the requirements for permitting in Chapter 499, F.S., and
				  Title 61N, F.A.C. This form is available upon request from the Department of
				  Business and Professional Regulation, Division of Drugs, Devices and Cosmetics,
				  2601 Blair Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06905
.
Rulemaking Authority
					 499.62,
					 499.63,
					 499.64,
					 499.701 FS. Law Implemented
					 499.62,
					 499.63,
					 499.64,
					 499.66,
					 499.67,
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.005 - Application for Freight Forwarder Permit

Current through Reg. 50, No. 138; July 16, 2024
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 application on
				  form number DBPR-DDC-225, Application for Permit as a Freight Forwarder,
				  effective April 2016, adopted and incorporated herein by reference and comply
				  with all the requirements for permitting in Chapter 499, F.S., and Title 61N,
				  F.A.C. This form is available upon request from the Department of Business and
				  Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair
				  Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06906
.
Rulemaking Authority
					 499.012(3),
					 499.04,
					 499.041(2)(e),
					 499.05 FS. Law Implemented
					 499.01,
					 499.012,
					 499.0121,
					 499.04,
					 499.041,
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 599.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.006 - Application for Health Care Clinic Establishment Permit

Current through Reg. 50, No. 138; July 16, 2024
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 employer tax
				  identification number. A person located in this state, prior to engaging in
				  activity for which a health care clinic establishment permit is required, must
				  file a completed application on form number DBPR-DDC-224, Application for
				  Permit as a Health Care Clinic Establishment, effective April 2016, adopted and
				  incorporated herein by reference and comply with all the requirements for
				  permitting in Chapter 499, F.S., and Title 61N, F.A.C. This form is available
				  upon request from the Department of Business and Professional Regulation,
				  Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06908
.
Rulemaking Authority
					 499.012(3),
					 499.041,
					 499.05 FS. Law Implemented
					 499.01,
					 499.012,
					 499.0121,
					 499.04,
					 499.041,
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.008 - Application for Medical Gas Manufacturer Permit

Current through Reg. 50, No. 138; July 16, 2024
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 process and
				  distributes those medical gases within this state. A person located in this
				  state, prior to engaging in activity for which a medical gas manufacturer
				  permit is required, must file with the department a completed application on
				  form number DBPR-DDC-204, Application for Permit as a Medical Gas Manufacturer,
				  effective April 2016, adopted and incorporated herein by reference and comply
				  with all the requirements for permitting in Chapter 499, F.S., and Title 61N,
				  F.A.C. This form is available upon request from the Department of Business and
				  Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair
				  Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06909
.
Rulemaking Authority
					 499.831,
					 499.834 FS. Law Implemented
					 499.005(6),
					 499.005(13),
					 499.051(1),
					 499.81,
					 499.83,
					 499.831,
					 499.832,
					 499.833,
					 499.834,
					 499.84,
					 499.85,
					 499.86,
					 499.87,
					 499.88,
					 499.89,
					 499.90,
					 499.91,
					 499.92,
					 499.93,
					 499.931,
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.009 - Application for Medical Gas Wholesale Distributor Permit

Current through Reg. 50, No. 138; July 16, 2024
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 form number
				  DBPR-DDC-217, Application for Permit as a Medical Gas Wholesale Distributor,
				  effective April 2016, adopted and incorporated herein by reference and comply
				  with all the requirements for permitting in Chapter 499, F.S., and Title 61N,
				  F.A.C. This form is available upon request from the Department of Business and
				  Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair
				  Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06910
.
Rulemaking Authority
					 499.831,
					 499.834 FS. Law Implemented
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 499.81,
					 499.83,
					 499.831,
					 499.832,
					 499.833,
					 499.834,
					 499.84,
					 499.85,
					 499.86,
					 499.87,
					 499.88,
					 499.89,
					 499.90,
					 499.91,
					 499.92,
					 499.93,
					 499.931,
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.010 - Application for Medical Oxygen Retail Establishment Permit

Current through Reg. 50, No. 138; July 16, 2024
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 engaging in
				  activity for which a medical oxygen retail establishment permit is required,
				  must file with the department a completed application on form number
				  DBPR-DDC-223, Application for Permit as a Medical Oxygen Retail Establishment,
				  effective April 2016, adopted and incorporated herein by reference and comply
				  with all the requirements for permitting in Chapter 499, F.S., and Title 61N,
				  F.A.C. This form is available upon request from the Department of Business and
				  Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair
				  Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06911
.
Rulemaking Authority
					 499.831,
					 499.834 FS. Law Implemented
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 499.81,
					 499.83,
					 499.831,
					 499.832,
					 499.833,
					 499.834,
					 499.84,
					 499.85,
					 499.86,
					 499.87,
					 499.88,
					 499.89,
					 499.90,
					 499.91,
					 499.92,
					 499.93,
					 499.931,
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.011 - Application for Nonresident Prescription Drug Manufacturer Permit

Current through Reg. 50, No. 138; July 16, 2024
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 nonresident
				  prescription drug manufacturer permit is required, must file an application on
				  form number DBPR-DDC-202, Application for Permit as a Nonresident Prescription
				  Drug Manufacturer, effective February 2017, adopted and incorporated herein by
				  reference and comply with all the requirements for permitting in Chapter 499,
				  F.S., and Rule Title 61N, F.A.C. This form is available upon request from the
				  Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-08056
.
Rulemaking Authority
					 499.01,
					 499.012,
					 499.0121,
					 499.04,
					 499.041,
					 499.05 FS. Law Implemented
					 499.01,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 499.05,
					 559.79
					 FS.
New 5-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.0111 - Application for Nonresident Prescription Drug Manufacturer - Virtual Permit

Current through Reg. 50, No. 138; July 16, 2024
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 possession
				  of any prescription drug. A person engaging in activity for which a nonresident
				  prescription drug manufacturer - virtual permit is required, must file an
				  application on form number DBPR-DDC-236, Application for Permit as a
				  Nonresident Prescription Drug Manufacturer - Virtual, effective July 2016,
				  adopted and incorporated herein by reference and comply with all the
				  requirements for permitting in Chapter 499, F.S., and Rule Title 61N, F.A.C.
				  This form is available upon request from the Division of Drugs, Devices and
				  Cosmetics at 2601 Blair Stone Road, Tallahassee, Florida 32399-1047,
				  (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07650
.
Rulemaking Authority
					 499.01,
					 499.05,
					 499.012,
					 499.0121,
					 499.04,
					 499.041 FS. Law Implemented
					 499.01,
					 499.05,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 559.79
					 FS.
New 1-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.012 - Application for Out-of-State Prescription Drug Wholesale Distributor Permit

Current through Reg. 50, No. 138; July 16, 2024
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 activity for
				  which an out-of-state prescription drug wholesale distributor permit is
				  required, must file with the department a completed application on form number
				  DBPR-DDC-214, Application for Out-of-State Prescription Drug Wholesale
				  Distributor Permit, effective March 2017, adopted and incorporated herein by
				  reference and comply with all the requirements for permitting in Chapter 499,
				  F.S., and Rule Tilte 61N, F.A.C. This form is available upon request from the
				  Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee,
				  Florida 32399, (850)717-1800, or at
https://www.flrules.org/Gateway/reference.asp?No=Ref-08481
.
Rulemaking Authority
					 499.012(3),
					 499.012(5),
					 499.04,
					 499.05,
					 499.041(2)(b)
					 FS. Law Implemented 499.005,
					 499.0051,
					 499.012,
					 499.0121,
					 499.028,
					 499.04,
					 499.041,
					 499.05,
					 499.051,
					 499.067,
					 559.79
					 FS.
New 7-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.013 - Application for Over-The-Counter Drug Manufacturer Permit

Current through Reg. 50, No. 138; July 16, 2024
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
				  465, F.S., and the rules promulgated thereunder, engaging in activity for which
				  an over-the-counter drug manufacturer permit is required, must file an
				  application on form number DBPR-DDC-205, Application for Permit as an
				  Over-The-Counter Drug Manufacturer, effective April 2016, adopted and
				  incorporated herein by reference and comply with all the requirements for
				  permitting in Chapter 499, F.S., and Title 61N, F.A.C. This form is available
				  upon request from the Department of Business and Professional Regulation,
				  Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06912
.
Rulemaking Authority
					 499.012(3),
					 499.041(1)(d)
					 FS. Law Implemented 499.01,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.014 - Application for Prescription Drug Manufacturer Permit

Current through Reg. 50, No. 138; July 16, 2024
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 manufacturer permit is
				  required, must file an application on form number DBPR-DDC-201, Application for
				  Permit as a Prescription Drug Manufacturer, effective April 2016, adopted and
				  incorporated herein by reference and comply with all the requirements for
				  permitting in Chapter 499, F.S., and Title 61N, F.A.C. This form is available
				  upon request from the Department of Business and Professional Regulation,
				  Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-06913
.
Rulemaking Authority
					 499.012(3),
					 449.041(1)(a)
					 FS. Law Implemented 499.01,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 499.005(6),
					 499.0051(13),
					 499.051(1),
					 559.79
					 FS.
New 6-9-16.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.0141 - Application for Prescription Drug Manufacturer - Virtual Permit

Current through Reg. 50, No. 138; July 16, 2024
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 prescription
				  drug. A person engaging in activity for which a prescription drug manufacturer
				  - virtual permit is required, must file an application on form number
				  DBPR-DDC-235, Application for Permit as a Prescription Drug Manufacturer -
				  Virtual, effective July 2016, adopted and incorporated herein by reference and
				  comply with all the requirements for permitting in Chapter 499, F.S., and Rule
				  Title 61N, F.A.C. This form is available upon request from the Division of
				  Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee, Florida
				  32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07651
.
Rulemaking Authority
					 499.01,
					 499.05,
					 499.012,
					 499.0121,
					 499.04,
					 499.041 FS. Law Implemented
					 499.01,
					 499.05,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 559.79
					 FS.
New 1-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.015 - Application for Prescription Drug Repackager Permit

Current through Reg. 50, No. 138; July 16, 2024
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 required, must
				  file an application on form number DBPR-DDC-203, Application for Permit as a
				  Prescription Drug Repackager, effective February 2017, adopted and incorporated
				  herein by reference and comply with all the requirements for permitting in
				  Chapter 499, F.S., and Rule Title 61N, F.A.C. This form is available upon
				  request from the Division of Drugs, Devices and Cosmetics at 2601 Blair Stone
				  Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07913
.
Rulemaking Authority
					 499.01,
					 499.012,
					 499.0121,
					 499.04,
					 499.041,
					 499.05 FS. Law Implemented
					 499.01,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 499.05,
					 559.79
					 FS.
New 5-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.0151 - Application for Nonresident Prescription Drug Repackager Permit

Current through Reg. 50, No. 138; July 16, 2024
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
				  repackager permit is required, must file an application on form number
				  DBPR-DDC-237, Application for Permit as a NonResident Prescription Drug
				  Repackager, effective July 2016, adopted and incorporated herein by reference
				  and comply with all the requirements for permitting in Chapter 499, F.S., and
				  Rule Title 61N, F.A.C. This form is available upon request from the Division of
				  Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee, Florida
				  32399-1047, (850)717-1800, or at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07653
.
Rulemaking Authority
					 499.01,
					 499.05,
					 499.012,
					 499.0121,
					 499.04,
					 499.041 FS. Law Implemented
					 499.01,
					 499.05,
					 499.012,
					 499.0121,
					 499.015,
					 499.04,
					 499.041,
					 559.79
					 FS.
New 1-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.016 - Application for Prescription Drug Wholesale Distributor Permit

Current through Reg. 50, No. 138; July 16, 2024
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 is
				  required, must file with the department a completed application on form number
				  DBPR-DDC-213, Application for a Prescription Drug Wholesale Distributor Permit,
				  effective March 2017, adopted and incorporated herein by reference and comply
				  with all the requirements for permitting in Chapter 499, F.S., and Rule Title
				  61N, F.A.C. This form is available upon request from the Division of Drugs,
				  Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee, Florida 32399,
				  (850)717-1800, or at
https://www.flrules.org/Gateway/reference.asp?No=Ref-08483
.
Rulemaking Authority
					 499.012(3),
					 499.012(5),
					 499.04,
					 499.05,
					 499.041(2)(b)
					 FS. Law Implemented 499.005,
					 499.0051,
					 499.012,
					 499.0121,
					 499.028,
					 499.04,
					 499.041,
					 499.05,
					 499.051,
					 499.067,
					 559.79
					 FS.
New 7-11-17.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.018 - Application for Restricted Prescription Drug Distributor - Blood Establishment Permit

Current through Reg. 50, No. 138; July 16, 2024
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, Florida Statutes, or
				  pursuant to an authorized practitioner's order for medical treatment or therapy
				  and engages in the wholesale distribution of a prescription drug not described
				  in section 499.003(48)(j),
				  Florida Statutes, to a healthcare entity. An applicant wishing to obtain a
				  Restricted Prescription Drug Distributor - Blood Establishment Permit as
				  required under section
				  499.01(2)(h),
				  Florida Statutes, shall submit a complete application to the department on Form
				  DBPR-DDC-234, Application for Restricted Prescription Drug Distributor - Blood
				  Establishment Permit, effective December 2017, incorporated herein by
				  reference,
http://www.flrules.org/Gateway/reference.asp?No=Ref-09236
,
				  together with the appropriate fees. A copy of Form DBPR-DDC-234, Application
				  for Restricted Prescription Drug Distributor - Blood Establishment Permit, can
				  be obtained at
https://www.myfloridalicense.com
or by contacting the Department of Business and Professional Regulation,
				  Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800.
Rulemaking Authority
					 499.01,
					 499.012,
					 499.041(4),
					 499.05 FS. Law Implemented
					 499.005(6),
					 499.0051(13),
					 499.01,
					 499.012,
					 499.0121,
					 499.041(4),
					 499.05,
					 499.051(1),
					 559.79
					 FS.
New 5-8-18.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.019 - Application for Restricted Prescription Drug Distributor - Charitable Organization Permit

Current through Reg. 50, No. 138; July 16, 2024
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 rule
				  61N-1.023(1),
				  F.A.C. An applicant wishing to obtain a Restricted Prescription Drug
				  Distributor - Charitable Organization Permit as required under section
				  499.01(2)(h),
				  Florida Statutes, shall submit a complete application to the department on Form
				  DBPR-DDC-208, Application for Restricted Prescription Drug Distributor -
				  Charitable Organization Permit, effective April 2018, incorporated herein by
				  reference,
http://www.flrules.org/Gateway/reference.asp?No=Ref-09280
,
				  together with the appropriate fees. A copy of Form DBPR-DDC-208, Application
				  for Restricted Prescription Drug Distributor - Charitable Organization Permit,
				  can be obtained at
https://www.myfloridalicense.com
or by contacting the Department of Business and Professional Regulation,
				  Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800.
Rulemaking Authority
					 499.01,
					 499.012,
					 499.05,
					 499.041 FS. Law Implemented
					 499.01,
					 499.012,
					 499.05,
					 559.79,
					 499.041
					 FS.
New 6-4-18.
Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-2 - APPLICATIONS, FORMS AND REGULATIONS › Section 61N-2.020 - Application for Restricted Prescription Drug Distributor - Destruction Permit

Current through Reg. 50, No. 138; July 16, 2024
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 warehousing
				  prescription drugs awaiting destruction, but does not include the manufacturer
				  of that drug or a permitted Restricted Prescription Drug Distributor - Reverse
				  Distributor. Applicants wishing to obtain a Restricted Prescription Drug
				  Distributor - Destruction Permit shall submit a complete application to the
				  department on form DBPR-DDC-210, Application for Restricted Prescription Drug
				  Distributor - Destruction Permit, effective April 2018, incorporated herein by
				  reference,
http://www.flrules.org/Gateway/reference.asp?No=Ref-09281
,
				  together with the appropriate fees. A copy of Form DBPR-DDC-210, Application
				  for Restricted Prescription Drug Distributor - Destruction Permit, can be
				  obtained at
https://www.myfloridalicense.com
or by contacting the Department of Business and Professional Regulation,
				  Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee,
				  Florida 32399-1047, (850)717-1800.
Rulemaking Authority
					 499.01,
					 499.012,
					 499.05,
					 499.041 FS. Law Implemented
					 499.01(2)(h),
					 499.012,
					 499.05,
					 499.041
					 FS.
New 6-4-18.