The Division proposes the rule amendment to set forth the requirements that dispensers 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-1.031Product Tracking and Tracing – Dispenser Requirements

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

SUMMARY: The proposed rule implements the dispenser 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-1.031 Product Tracking and Tracing – Dispenser Requirements.

The following tracking and tracing requirements shall apply to dispensers:

(1) PRODUCT TRACING.

(a) A dispenser 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;

(b) A dispenser shall, prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product, excluding dispensing to a patient or returns, provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this rule shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need; and

(c) A dispenser shall capture transaction information, including lot level information, if provided, transaction history, and transaction statements, as necessary to investigate a suspect product, and maintain such information, history, and statements for not less than 6 years after the transaction.

(2) AGREEMENTS WITH THIRD PARTIES.—A dispenser may enter into a written agreement with a third party, including an authorized wholesale distributor, under which the third party confidentially maintains the transaction information, transaction history, and transaction statements, required to be maintained under this rule, on behalf of the dispenser. If a dispenser enters into such an agreement, the dispenser shall maintain a copy of the written agreement and shall not be relieved of the obligations of a dispenser under this rule.

(3) RETURNS.

(a) Saleable Returns. A dispenser may return a product to the trading partner from which the dispenser obtained the product without providing the information required under 61N-1.031(1)(b), F.A.C.

(b) Nonsaleable Returns. A dispenser may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, to a returns processor, or to a person acting on behalf of such a person without providing the information required under 61N-1.031(1), F.A.C.

(4) REQUESTS FOR INFORMATION. Upon a request by the department, in the event of a recall or for the purpose of investigating a suspect or an illegitimate product, a dispenser shall, not later than 2 business days after receiving the request, provide the applicable transaction information, transaction statement, and transaction history that the dispenser received from the previous owner, which shall not include the lot number of the product, the initial transaction date, or the initial shipment date from the manufacturer unless such information was included in the transaction information, transaction statement, and transaction history provided by the manufacturer or the wholesale distributor to the dispenser. The dispenser may respond to the request by providing the applicable information in either paper or electronic format.

(5) PRODUCT IDENTIFIER. Effective December 1, 2020, a dispenser may engage in transactions involving a product only if the 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.

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

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

(8) EXCEPTION. Notwithstanding any other provision of law, the requirements under 61N-1.031(1) through (4), and (7), F.A.C., shall not apply to licensed health care practitioners authorized to prescribe or administer medication under Florida law or other licensed individuals under the supervision or direction of practitioners who dispense or administer products in the usual course of professional practice.

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