Form DBPR-DDC-231 "Application for Product Registration - Otc Drugs (Main & Identical)" - Florida

What Is Form DBPR-DDC-231?

This is a legal form that was released by the Florida Department of Business & Professional Regulation - a government authority operating within Florida. As of today, no separate filing guidelines for the form are provided by the issuing department.

Form Details:

  • Released on August 1, 2015;
  • The latest edition provided by the Florida Department of Business & Professional Regulation;
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  • Fill out the form in our online filing application.

Download a printable version of Form DBPR-DDC-231 by clicking the link below or browse more documents and templates provided by the Florida Department of Business & Professional Regulation.

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Download Form DBPR-DDC-231 "Application for Product Registration - Otc Drugs (Main & Identical)" - Florida

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State of Florida
Department of Business and Professional Regulation
Division of Drugs, Devices, and Cosmetics
Application for Product Registration – OTC Drugs (Main & Identical)
Form No.: DBPR-DDC-231
APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your
application to ensure faster processing.
APPLICATION
APPLICATION REQUIREMENTS
The biennial registration fee is $30 per MAIN product, $15 per IDENTICAL product.
The registration fee for an amendment to an existing product registration that expires
Application
in less than 12 months is $15 PER PRODUCT.
for Product
Make cashier’s check, corporate or business check, or money order payable to the
Registration
Florida Department of Business and Professional Regulation.
Sign and date the Affidavit section of the application.
Submit the completed application with enclosures to:
Department of Business and Professional Regulation
2601 Blair Stone Road
Tallahassee, FL 32399-1047
General Application Instructions
1.
You are ONLY REQUIRED to register products that are physically manufactured, packaged, repackaged, labeled or
relabeled IN FLORIDA. If your products ARE NOT physically manufactured, packaged, repackaged, labeled or
relabeled IN FLORIDA you DO NOT have to register them.
2.
For each FDA-approved drug, please provide the FDA approval letter or other evidence, such as a printout from
the FDA website (http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm) reflecting the FDA approval
to market the drug in the United States.
3.
If you are relying on an OTC monograph as the basis for your being able to market the drug in the United States,
YOU MUST provide the citation to the specific OTC monograph from the Code of Federal Regulations; failure to
provide citation to the OTC monograph will result in denial of the application.
4.
For each drug that is not approved by the FDA, e.g. drugs that are the subject of pending Drug Efficacy Study
Implementation (DESI) proceeding(s), drugs that are marketed pursuant to the grandfather provisions under the
federal Food, Drug and Cosmetic Act, etc., YOU MUST provide documentation that the product is currently able to
be distributed into interstate commerce as per the FDA regulations as described in Rule 61N-1.016(2), F.A.C.;
failure to provide the requested documentation may result in denial of the application.
5.
If you are manufacturing and/or distributing a drug in bulk package, except tablets, capsules, or other dosage unit
forms, intended for processing, repackaging, or use in the manufacture of another drug, you may be exempt from
the labeling requirements. [Please see 21 CFR 201.122].
6.
If you are manufacturing and/or shipping bulk drug product which product is to be processed, labeled, or
repacked at an establishment other than the establishment where the drug was originally processed or packed,
you may be exempt from the labeling requirements. [Please see 21 CFR 201.150]. If you believe you are exempt,
please provide copies of the quality agreements between the manufacturing establishments.
7.
PLEASE DO NOT attempt to register a product if it is pending FDA review and approval; submitting such a product
slows down the division’s review process.
8.
Section 499.015(1)(b), F.S., states: “The department may not register any product that does not comply with the
Federal Food, Drug, and Cosmetic Act, as amended, or Title 21 C.F.R. Registration of a product by the department
does not mean that the product does in fact comply with all provisions of the Federal Food, Drug, and Cosmetic
Act, as amended.”
DBPR-DDC- 231 - Application for Product Registration – OTC Drugs (Main & Identical)
Incorporated by rule(s): 61N-1.016, F.A.C.
Eff. Date August 2015
Page 1 of 8
State of Florida
Department of Business and Professional Regulation
Division of Drugs, Devices, and Cosmetics
Application for Product Registration – OTC Drugs (Main & Identical)
Form No.: DBPR-DDC-231
APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your
application to ensure faster processing.
APPLICATION
APPLICATION REQUIREMENTS
The biennial registration fee is $30 per MAIN product, $15 per IDENTICAL product.
The registration fee for an amendment to an existing product registration that expires
Application
in less than 12 months is $15 PER PRODUCT.
for Product
Make cashier’s check, corporate or business check, or money order payable to the
Registration
Florida Department of Business and Professional Regulation.
Sign and date the Affidavit section of the application.
Submit the completed application with enclosures to:
Department of Business and Professional Regulation
2601 Blair Stone Road
Tallahassee, FL 32399-1047
General Application Instructions
1.
You are ONLY REQUIRED to register products that are physically manufactured, packaged, repackaged, labeled or
relabeled IN FLORIDA. If your products ARE NOT physically manufactured, packaged, repackaged, labeled or
relabeled IN FLORIDA you DO NOT have to register them.
2.
For each FDA-approved drug, please provide the FDA approval letter or other evidence, such as a printout from
the FDA website (http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm) reflecting the FDA approval
to market the drug in the United States.
3.
If you are relying on an OTC monograph as the basis for your being able to market the drug in the United States,
YOU MUST provide the citation to the specific OTC monograph from the Code of Federal Regulations; failure to
provide citation to the OTC monograph will result in denial of the application.
4.
For each drug that is not approved by the FDA, e.g. drugs that are the subject of pending Drug Efficacy Study
Implementation (DESI) proceeding(s), drugs that are marketed pursuant to the grandfather provisions under the
federal Food, Drug and Cosmetic Act, etc., YOU MUST provide documentation that the product is currently able to
be distributed into interstate commerce as per the FDA regulations as described in Rule 61N-1.016(2), F.A.C.;
failure to provide the requested documentation may result in denial of the application.
5.
If you are manufacturing and/or distributing a drug in bulk package, except tablets, capsules, or other dosage unit
forms, intended for processing, repackaging, or use in the manufacture of another drug, you may be exempt from
the labeling requirements. [Please see 21 CFR 201.122].
6.
If you are manufacturing and/or shipping bulk drug product which product is to be processed, labeled, or
repacked at an establishment other than the establishment where the drug was originally processed or packed,
you may be exempt from the labeling requirements. [Please see 21 CFR 201.150]. If you believe you are exempt,
please provide copies of the quality agreements between the manufacturing establishments.
7.
PLEASE DO NOT attempt to register a product if it is pending FDA review and approval; submitting such a product
slows down the division’s review process.
8.
Section 499.015(1)(b), F.S., states: “The department may not register any product that does not comply with the
Federal Food, Drug, and Cosmetic Act, as amended, or Title 21 C.F.R. Registration of a product by the department
does not mean that the product does in fact comply with all provisions of the Federal Food, Drug, and Cosmetic
Act, as amended.”
DBPR-DDC- 231 - Application for Product Registration – OTC Drugs (Main & Identical)
Incorporated by rule(s): 61N-1.016, F.A.C.
Eff. Date August 2015
Page 1 of 8
Section
Specific Application Instructions
New vs. Amended Application: If the establishment does not have drug products registered with
the department, it is a NEW application. If the establishment has drug products registered with
the department and this is a new product to add to the existing registration, it is an AMENDED
application.
I
Product Registration Permit Number: Record the current DBPR issued permit number for drugs
registered with the department. Leave blank if this is a new application.
Florida Over-the-counter Drug Manufacturer Permit Number: Please list the current DBPR issued
permit for the drug establishment.
Provide the requested information pertaining to the establishment’s name, address, etc.
Telephone, email, and fax contact information is used to quickly resolve questions with
II
applications. If such information is not provided, questions regarding applications will be mailed to
the application contact’s mailing address and may take longer to resolve.
Provide the requested information pertaining to the establishment’s name, ownership, registered
III
agent, and operating hours.
This section is divided into two parts (A) main OTC drug products and (B) identical OTC drug
products. List each product separately, providing the requested information for each product.
Product Name: The name must be recorded as it will appear on the product label.
Manufacturer: If the establishment registering the product is not the preparer or producer of the
product, provide the name of the preparer or producer along with the city and state where the
product was manufactured.
IV
Labeling: Please provide the product labeling for all products. If the lot # and expiration date are
on the immediate container at the time of manufacturing, the labeling provided for review by the
Department must include a visual representation of the final labeling which accurately represents
the placement of the lot# and expiration date. IF THE PRODUCT LABELS AND LABELING
HAVE BEEN APPROVED BY THE FDA, PLEASE SUBMIT THE SAME LABELS AND LABELING
FOR REVIEW. PLEASE ENSURE THAT THE LABELING IS OF SUFFICIENT SIZE THAT IT
CAN BE READ, EVEN IF THIS MEANS THE LABELING PROVIDED IS LARGER THAN THE
ACTUAL LABELING INCLUDED WITH THE PRODUCT.
This section is the section where you calculate your product registration fee. The section also
V
serves as a final checklist of items that will assist the applicant with completing the application
correctly.
An authorized representative of applicant must sign and date this form. The authorized
representative should be an owner, officer or employee with authority to bind the establishment to
VI
the representations made on the registration application.
Include the representative’s title
(president, owner/operator, facility manager, etc.).
DBPR-DDC- 231 - Application for Product Registration – OTC Drugs (Main & Identical)
Incorporated by rule(s): 61N-1.016, F.A.C.
Eff. Date August 2015
Page 2 of 8
State of Florida
Department of Business and Professional Regulation
Division of Drugs, Devices, and Cosmetics
Application for Product Registration – OTC Drugs (Main & Identical)
Form No.: DBPR-DDC-231
If you have any questions or need assistance in completing this application, please contact the
Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, at
850.717.1800. For additional information see the Instructions at the beginning of this application.
Section I – Application Type
CHECK ONE OF THE APPLICATION TYPES
New Application (Does not hold current product registration number) [3308/1022]
Amended Application. (Adding new products to existing product registration) [3308/3020]
Product Registration Permit Number: _______________________
Florida Over-the-Counter Drug Manufacturer Permit Number: _______________________
Section II – Applicant Information
APPLICANT’S NAME (Name in which registration will be issued):
Name:
FEID No.:
PHYSICAL ADDRESS OF ESTABLISHMENT
Street Address:
City:
State:
Zip Code (+4 optional):
County (if Florida address):
Country:
E-Mail Address:
Phone Number:
Fax Number:
MAILING ADDRESS (If different from physical address)
Street Address:
City:
State:
Zip Code (+4 optional):
E-Mail Address:
Phone Number:
Fax Number:
APPLICATION CONTACT (Name of the person the department should contact if there are questions
regarding this application.)
Last/Surname:
First:
Middle:
Suffix:
Address
City:
State:
Zip Code (+4 optional):
Telephone Number:
Fax Number:
E-Mail Address:
DBPR-DDC- 231 - Application for Product Registration – OTC Drugs (Main & Identical)
Incorporated by rule(s): 61N-1.016, F.A.C.
Eff. Date August 2015
Page 3 of 8
Section III – Applicants NOT already permitted under Chapter 499, F.S. must provide the following:
CORPORATE NAME (If different from applicant name)
Name:
FEID No.
TYPE OF OWNERSHIP
Publicly Held Corporation
Closely Held Corporation
Limited Liability Company
Not-for-Profit Corporation
Sole Proprietorship
Government
Partnership – Including Limited
Professional Corporation
Professional Limited
Liability Partnership and Limited
Liability Company
Partnership
Other:__________________
If you checked ANY “Type of Ownership” OTHER THAN “Sole Proprietorship” please list the State of
Incorporation or State of Organization.
State:
If you checked ANY “Type of Ownership” OTHER THAN “Sole Proprietorship” please list name and
address of the applicant’s Registered Agent for service of process in Florida.
Name:
Address:
City:
State:
Zip Code
OPERATING HOURS
Mon
:
am/pm to
:
am/pm
Fri
:
am/pm to
:
am/pm
Tue
:
am/pm to
:
am/pm
Sat
:
am/pm to
:
am/pm
Wed
:
am/pm to
:
am/pm
Sun
:
am/pm to
:
am/pm
Thu
:
am/pm to
:
am/pm
DBPR-DDC- 231 - Application for Product Registration – OTC Drugs (Main & Identical)
Incorporated by rule(s): 61N-1.016, F.A.C.
Eff. Date August 2015
Page 4 of 8
Section IV
A. Main OTC Products
Main OTC Drug Products
Drug information (Name should be the same as it
Manufacturer (if different from applicant):
appears on the label):
Name, City and State
1.
Name:
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
2.
Name:
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
Name:
3.
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
Name:
4.
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
5.
Name:
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
6.
Name:
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
7.
Name:
FDA Establishment no: _________________________
Name:
Strength:
Dosage Form:
Bulk?
Yes
No
NDC#
n/a
Citation to OTC
________________________________
Monograph:
________________________________
YOU MUST ATTACH PRODUCT LABELING FOR EACH PRODUCT YOU ARE SEEKING TO
REGISTER. LABELING INCLUDES ALL LABELS AND OTHER WRITTEN, PRINTED OR GRAPHIC
MATERIAL ON OR ACCOMPANYING THE PRODUCT.
DBPR-DDC- 231 - Application for Product Registration – OTC Drugs (Main & Identical)
Incorporated by rule(s): 61N-1.016, F.A.C.
Eff. Date August 2015
Page 5 of 8
Page of 8