The Division proposes the rule amendment to clarify the application forms and requirements necessary for registration of products.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.016Product Registration

PURPOSE AND EFFECT: The Division proposes the rule amendment to clarify the application forms and requirements necessary for registration of products.

SUMMARY: The proposed amendment incorporates the application forms used to register products with the division and provides additional clarification regarding the types of documentation that applicants for product registration may provide to the division in support of the product registration.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: the economic review conducted by the agency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.05 FS.

LAW IMPLEMENTED: 499.01, 499.015, 499.04, 499.05, 559.79(2) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047, [phone]; [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.016 Product Registration.

(1)(a) No change.

(b) A formula marketed under different brand names, sizes, quantities, or distributors is not considered a separate and distinct product for registration purposes. Furthermore, the adding of color, flavor, or scents to a formula does not make a separate and distinct product for registration purposes, even for fragrance preparations where the scent is the primary product. However, the different variations must be listed with the division on the Identical Product Certification form.

(c) No change.

(d) The application forms incorporated by reference in this rule can be obtained by contacting the Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047, [phone].

(2)(a) Applicants applying for an initial product registration of a product must:

1. File with the department a completed application for the appropriate product registration using DBPR form number DBPR-DDC-228, “Application for Product Registration – Cosmetics (Main & Identical),” effective May 2015, available at https://www.flrules.org/Gateway/reference.asp?No=Ref-______ ; DOH-Form 1035, “Application for Product Registration – Drugs,” effective January 1999 or DBPR form number DBPR-DDC-229, “Application for Product Registration – Rx Drugs (Main & Identical),” effective May 2015, available at https://www.flrules.org/Gateway/reference.asp?No=Ref-______; DOH-Form 1037, “Application for Product Registration – Cosmetics,” effective January 1999 or DBPR form number DBPR-DDC-230, “Application for Product Registration – Repackaged Rx Drugs (Main & Identical),” effective May 2015, available at https://www.flrules.org/Gateway/reference.asp?No=Ref-______; or DBPR form number DBPR-DDC-231, “Application for Product Registration – OTC Drugs (Main & Identical),” effective May 2015, available at https://www.flrules.org/Gateway/reference.asp?No=Ref-______, and if applicable the Identical Product Certification, DOH-Form 1039, effective January 1993 all of which are incorporated by reference herein;

2. Submit a product label or copy thereof and all labeling associated with the main or identical product that provides information in addition to or other than what is on the product label for every product registered on the Application and listed on the Identical Product Certification form. (An English translation is required for a product manufactured for export only which has labeling in a foreign language.);

3. Submit documentation that supports the product is allowed to be distributed legal in interstate commerce as per FDA regulations, such as:

a. Written documentation from the FDA which indicates (such as approval of a drug through a new drug application – NDA, ANDA, IND, NADA, etc.; or

b. A copy of the section(s) of the Code of Federal Regulations (CFR) denoting the product’s Drug Efficacy Study Implementation (DESI) designation; or

c. A copy of the section(s) of the CFR denoting the product remains pending final DESI review; or

d. A copy and summary of material(s) and authoritative literature reviewed during the applicant’s investigation supporting that the product has not yet been reviewed in the DESI process; or

e. A copy and summary of material(s) and of authoritative literature supporting the product qualifying for grandfather status; or

f. Tthe over-the-counter monograph category to which the drug belongs,;or

g. Aa product category identifier if the product is a cosmetic); and

4. No change.

(b) Examples of material(s) and authoritative literature used as documentation to meet the requirements of subparagraph (2)(a)3. above include:

1. Sections of the United States Code (USC) or the CFR;

2. Letters, emails or other forms of commuications from the FDA;

3. Evidence that the product is currently being marketed in the United States and that the FDA has actual or constructive knowledge that the product is being marketed in the United States;

4. The Merck Manual of Diagnosis and Therapy;

5. Physicians’ Desk Reference;

6. Remington’s Pharmaceutical Science;

7. Fully cited and copied U.S. medical or pharmaceutical journal articles;

8. DailyMed published by the US National Library of Medicine;

9. Facts and Comparisons; or

10. American Drug Index.

(c)(b) An applicant must amend its product registration list for new products prior to any sales by following the procedures for an initial product registration, listing only those products to be added. Registration for these products will expire concurrently with the biennial cycle for that establishment’s other registered products. Fees will be prorated as provided for in subsection 61N-1.018(4), F.A.C.

(3) PRODUCT REGISTRATION RENEWAL.

(a) Applicants applying for renewal of a product registration must:

1. Submit the DBPR form number DBPR-DDC-235, “Application for Product Registration Renewal,” Under Chapter 499, F.S., DOH-Form 1041, effective January 1999 May 2015, available at https://www.flrules.org/Gateway/reference.asp?No=Ref-______ which is incorporated by reference herein.; The permittee should contact the department if the renewal application has not been received at least 30 days prior to the product registration’s expiration date.

2. through 3. No change.

(b) No change.

Rulemaking Authority 499.01, 499.015, 499.04, 499.05 FS. Law Implemented 499.01, 499.015, 499.04, 499.05, 559.79(2) FS. History–New 7-1-96, Formerly 10D-45.0542, Amended 1-26-99, 4-17-01, 1-1-04, Formerly 64F-12.016, Amended_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald D. Dixon, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 26, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 27, 2015