Fla. Admin. Code Ann. R. 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 paragraph 61N-1.030(1)(b), F.A.C.

(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 rules 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 paragraph 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 paragraph 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 paragraph 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 subsection 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) http://www.flrules.org/Gateway/reference.asp?No=Ref-06761 (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 subsection 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.

Notes

Fla. Admin. Code Ann. R. 61N-1.030

Rulemaking Authority 499.0121, 499.05 FS. Law Implemented 499.002, 499.0121, 499.05, 499.052 FS.

Adopted by Florida Register Volume 42, Number 081, April 26, 2016 effective 5/11/2016.

New 5-11-16.