The Division proposes the rule amendment to set forth the requirements that permitted wholesale distributors 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-1.030Product Tracking and Tracing – Wholesale Distributor Requirements

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

SUMMARY: The proposed rule implements the wholesale distributor 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-1.030 Product Tracking and Tracing – Wholesale Distributor Requirements.

The following tracking and tracing requirements shall apply to wholesale distributors:

(1) PRODUCT TRACING.

(a) A wholesale distributor shall not accept ownership of a product unless the previous owner prior to, or at the time of, the transaction provides the transaction history, transaction information, and a transaction statement for the product, as applicable under this paragraph.

(b) A wholesale distributor that purchased a product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer, shall prior to, or at the time of, each transaction in which the wholesale distributor transfers ownership of a product, provide to the subsequent purchaser:

1. A transaction statement, which shall state that the wholesale distributor, or a member of the affiliate of the wholesale distributor, purchased the product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased the product directly from the manufacturer; and

2. The transaction history and transaction information.

3. If provided to a dispenser, the transaction history, transaction information, and transaction statement shall be on a single document in a paper or electronic format.

4. If provided to a wholesale distributor, the transaction history, transaction information, and transaction statement shall be through any combination of self-generated paper, electronic data, or manufacturer provided information on the product package.

5. The lot number of the product, the initial transaction date and the initial shipment date from the manufacturer are not required to be included in the transaction history and information for transactions falling under 61N-1.030(1)(b).

(c) A wholesale distributor that did not purchase a product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer, shall prior to, or at the time of, each transaction or subsequent transaction,  provide to the subsequent purchaser, a transaction statement, transaction history, and transaction information, in a paper or electronic format that complies with the requirements set forth in the departmental rules.

1. The transaction history supplied shall begin only with the wholesale distributor that purchased the product directly from the manufacturer, the exclusive distributor of the manufacturer or a repackager that purchased directly from the manufacturer.

2. The wholesale distributor that did not purchase directly from the manufacturer, the exclusive distributor of the manufacturer or a repackager that purchased directly from the manufacturer, shall inform the subsequent purchaser that the wholesale distributor received a direct purchase statement from a wholesale distributor that purchased the product directly from the manufacturer, the exclusive distributor of the manufacturer or a repackager that purchased directly from the manufacturer.

(d) A wholesale distributor shall capture the transaction information, including lot level information, transaction history, and transaction statement for each transaction described in this rule and maintain such information, history, and statement for not less than 6 years after the date of the transaction; and maintain the confidentiality of the transaction information, including any lot level information, transaction history, and transaction statement for a product and prohibit disclosure to any person other than state or federal officials, except to comply with the provisions of 61N-1.028, 61N-1.029, 61N-1.030, 61N-1.031 and 61N-1.032 F.A.C.

(2) RETURNS.

(a) Saleable Returns. Notwithstanding 61N-1.030(1)(a), F.A.C., the following shall apply:

1. Requirements. Until December 1, 2019, a wholesale distributor may accept returned product from a dispenser or repackager pursuant to the terms and conditions of any agreement between the parties, and notwithstanding 61N-1.030(1)(b), F.A.C., may distribute the returned product without providing the transaction history. For transactions subsequent to the return, the transaction history of the product shall begin with the wholesale distributor that accepted the returned product, consistent with the requirements of this rule.

2. Enhanced Requirements. Beginning December 1, 2019, a wholesale distributor may accept returned product from a dispenser or repackager only if the wholesale distributor can associate the returned product with the transaction information and transaction statement associated with that product.  For all transactions after December 1, 2019, the transaction history, as applicable, of the product shall begin with the wholesale distributor that accepted and verified the returned product.

(b) Nonsaleable Returns. A wholesale distributor may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom the product was purchased, or to a person acting on behalf of such a person, including a returns processor, without providing the information required under 61N-1.030(1)(a), F.A.C.

(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 wholesale distributor 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) TRADING PARTNER AGREEMENTS. Effective December 1, 2019, a wholesale distributor may disclose the transaction information, including lot level information, transaction history, or transaction statement of a product to the subsequent purchaser of the product, pursuant to a written agreement between such wholesale distributor and such subsequent purchaser. Nothing in this subsection shall be construed to limit the applicability of subsections 61N-1.030(1) through 61N-1.030(3), F.A.C.

(5) PRODUCT IDENTIFIER. Effective December 1, 2019, a wholesale distributor may engage in transactions involving a product only if that product is encoded with a product identifier or grandfathered as defined by 61N-1.028(7), F.A.C., and not required to be encoded with a product identifier.

(6) AUTHORIZED TRADING PARTNERS. The trading partners of a wholesale distributor may only be authorized trading partners.

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

(8) Drop Shipment.

(a) A wholesale distributor that does not physically handle or store product shall be exempt from the provisions of this rule, except the federal notification requirements adopted under 61N-1.030(7), F.A.C., provided that the manufacturer, repackager, or other wholesale distributor that distributes the product to the dispenser by means of a drop shipment for such wholesale distributor includes on the transaction information and transaction history to the dispenser, the contact information of the wholesale distributor and provides the transaction information, transaction history, and transaction statement directly to the dispenser.

(b) Drop shipment by the wholesale distributor to trading partners, other than to a dispenser, is not exempt from the provisions of this rule.

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