To adopt and incorporate necessary changes to Division rules reflecting the removal of the Division’s authority to require registration and issue certificates of free sale for cosmetic products manufactured in Florida as amended by Ch.2017-051, Laws ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.016Product Registration

PURPOSE AND EFFECT: To adopt and incorporate necessary changes to Division rules reflecting the removal of the Division’s authority to require registration and issue certificates of free sale for cosmetic products manufactured in Florida as amended by Ch.2017-051, Laws of Florida (2017).

SUMMARY: Division’s authority to require registration and issue certificates of free sale for cosmetic products manufactured in Florida.

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, 499.012 FS.

LAW IMPLEMENTED: 499.002, 499.003, 499.01, 499.012, 499.015, 499.05 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, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047; [phone]; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.016 Product Registration.

(1)(a) Each drug product shall be registered with the division either as a drug or cosmetic, 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 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.

(c) The separate and distinct drug or cosmetic product for a person who performs limited manufacturing operations at an establishment such as only encapsulating, sterilizing or other processing or manipulation of the product, but not labeling, may be the product resulting from such processing and not each separate and distinct product to which the limited manufacturing operation is performed.

(d) The application forms incorporated by reference in this rule can be obtained by contacting the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, 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 http://www.flrules.org/Gateway/reference.asp?No=Ref-05666; or DBPR form number DBPR-DDC-229, “Application for Product Registration – Rx Drugs (Main & Identical),” effective May 2015, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05666; or DBPR form number DBPR-DDC-230, “Application for Product Registration – Repackaged Rx Drugs (Main & Identical),” effective May 2015, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05666; or DBPR form number DBPR-DDC-231, “Application for Product Registration – OTC Drugs (Main & Identical),” effective May 2015, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05666, 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 on the Application (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 in interstate commerce as per FDA regulations, such as:

a. Written documentation from the FDA which indicates 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. The over-the-counter monograph category to which the drug belongs; or

g. A product category identifier if the product is a cosmetic; and,

4. Pay the appropriate fee pursuant to Rule 61N-1.018, F.A.C.

(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 communications 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 U.S. National Library of Medicine;

9. Facts and Comparisons; or

10. American Drug Index.

(c) 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 DBPR form number DBPR-DDC-235, “Application for Product Registration Renewal,” effective May 2015, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05666; which is incorporated by reference herein;

2. Submit a product label or copy thereof and all labeling associated with the product if the label or labeling has changed in any respect from the initial or previous renewal registration; and,

3. Pay the appropriate fee pursuant to Rule 61N-1.018, F.A.C.

(b) Registrations issued by the department within the grace period will automatically expire 24 months after the last day of the month in which the previous registration expired.

Rulemaking Authority 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 8-2-15, ______________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Drew F. Winters, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Jonathan Zachem, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 26, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 18, 2017