: The Division proposes the rule amendment to set forth the requirements that permitted manufacturers must follow for tracking and tracing certain prescription drug products through the distribution supply chain.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.029Product Tracking and Tracing – Manufacturer Requirements

PURPOSE AND EFFECT: The Division proposes the rule amendment to set forth the requirements that permitted manufacturers must follow for tracking and tracing certain prescription drug products through the distribution supply chain.

SUMMARY: The proposed rule implements the manufacturer requirements of the federal tracking and tracing law.

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: 499.0121, 499.05 FS.

LAW IMPLEMENTED: 499.002, 499.0121, 499.05, 499.052 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 North Monroe Street Suite 26A, Tallahassee, Florida 32399-1047, [phone], [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.029 Product Tracking and Tracing – Manufacturer Requirements.

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.

(b) Requests For Information. Upon a request by the department, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, a manufacturer shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request, provide the applicable transaction information, transaction history, and transaction statement for the product.

(c) Electronic Format. Effective December 1, 2017, a manufacturer shall provide the transaction information, transaction history, and transaction statement required under 61N-1.029(1)(a), F.A.C., in an electronic format.  A manufacturer may continue to provide the transaction information, transaction history, and transaction statement required under 61N-1.029(1)(a), F.A.C., in a paper format to a licensed health care practitioner authorized to prescribe medication under Florida law or other licensed individual under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice.

(d) Product Identifier. Effective December 1, 2017, a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Such manufacturer shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction.  A package that is required to have a standardized numerical identifier is not required to have a unique device identifier.

(2) AUTHORIZED TRADING PARTNERS. The trading partners of a manufacturer may only be authorized trading partners.

(3) VERIFICATION. The department adopts and incorporates by reference the manufacturer verification requirements as set forth in the federal act at 21 U.S.C. s. 360eee-1(b)(4) (as of 12/1/15).  A manufacturer must establish, maintain, and adhere to written policies and procedures setting forth the manner in which the manufacturer will meet the federal verification requirements as adopted by the department.

Rulemaking Authority 499.0121, 499.05 FS. Law Implemented 499.002, 499.0121, 499.05, 499.052 FS. History–New ________.

 

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

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 9, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 30, 2015