Florida Regulations 61N-1.029: Product Tracking and Tracing – Manufacturer Requirements
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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 Fl. Admin. Code R. 61N-1.029(1)(a), in an electronic format. A manufacturer may continue to provide the transaction information, transaction history, and transaction statement required under Fl. Admin. Code R. 61N-1.029(1)(a), 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. § 360eee-1(b)(4) http://www.flrules.org/Gateway/reference.asp?No=Ref-06759, (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 5-11-16.
(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 Fl. Admin. Code R. 61N-1.029(1)(a), in an electronic format. A manufacturer may continue to provide the transaction information, transaction history, and transaction statement required under Fl. Admin. Code R. 61N-1.029(1)(a), 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. § 360eee-1(b)(4) http://www.flrules.org/Gateway/reference.asp?No=Ref-06759, (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 5-11-16.