Florida Regulations 61N-1.032: Product Tracking and Tracing – Repackager Requirements
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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 paragraphs 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 Fl. Admin. Code R. 61N-1.032(1)(b)
(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 Fl. Admin. Code R. 61N-1.032(1)(b), 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 subsection 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. § 360eee-1(e)(4) http://www.flrules.org/Gateway/reference.asp?No=Ref-06763 (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 5-11-16.
(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 paragraphs 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 Fl. Admin. Code R. 61N-1.032(1)(b)
(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 Fl. Admin. Code R. 61N-1.032(1)(b), 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 subsection 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. § 360eee-1(e)(4) http://www.flrules.org/Gateway/reference.asp?No=Ref-06763 (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 5-11-16.