61N-1.016. Product Registration

(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 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 department.

(c) The separate and distinct drug 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-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, 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, 499.012 FS. Law Implemented 499.01, 499.012, 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, 11-2-17.