The Division proposes the rule amendment to set forth the requirements that permitted repackagers 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-1.032Product Tracking and Tracing – Repackager Requirements

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

SUMMARY: The proposed rule implements the repackager 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-1.032 Product Tracking and Tracing – Repackager Requirements.

The following tracking and tracing requirements shall apply to repackagers:

(1) PRODUCT TRACING.

(a) A repackager shall not accept ownership of a product unless the previous owner, prior to, or at the time of, the transaction, provides transaction history, transaction information, and a transaction statement for the product.

(b) A repackager, prior to, or at the time of, each transaction in which the repackager transfers ownership of a product, shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product.

(c) A repackager shall capture the transaction information, including lot level information, transaction history, and transaction statement for each transaction described in 61N-1.032(1)(a) and (1)(b), F.A.C., and shall maintain such information, history, and statement for not less than 6 years after the transaction.

(2) RETURNS.

(a) Nonsaleable Product. A repackager may return a nonsaleable product to the manufacturer or repackager, or to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such manufacturer, repackager or wholesale distributor, including a returns processor, without providing the information required under 61N-1.032 (1)(b), F.A.C..

(b) Saleable or Nonsaleable Product. A repackager may return a saleable or nonsaleable product to the manufacturer, repackager, or to the wholesale distributor from whom the product was received without providing the information required under 61N-1.032(1)(b), F.A.C., on behalf of the hospital or other health care entity that took ownership of such product pursuant to the terms and conditions of any agreement between such repackager and the entity that owns the product.

(3) 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 repackager 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.

(4) PRODUCT IDENTIFIER. Beginning December 1, 2018, a repackager shall:

(a) Affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction in commerce;

(b) Maintain the product identifier information for such product for not less than 6 years after the date of the transaction;

(c) Engage in transactions involving a product only if such product is encoded with a product identifier or grandfathered as defined by 61N-1.028(7), F.A.C., and is not required to be encoded with a product identifier; and

(d) Maintain records for not less than 6 years.

A repackager is not required to affix or imprint a unique device identifier on a package that is required to have a standardized numerical identifier.

(5) AUTHORIZED TRADING PARTNERS. The trading partners of a repackager may only be authorized trading partners.

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