On May 24, 2012, the United States Senate passed Senate Bill 3187, also known as the “Food and Drug Administration Safety and Innovation Act.” While SB 3187 has been on the life sciences industry’s radar because of its Prescription Drug User Fee Act (PDUFA) reauthorization provisions, there are other sections of the bill that would certainly pique the interest of drug manufacturers and wholesale distributors. In addition to the well-known PDUFA provisions, SB 3187 would also amend 21 U.S.C. 351 by adding track-and-trace requirements for drug manufacturers and wholesale distributors. This section of SB 3187, also known as the “Securing Pharmaceutical Integrity Act of 2012,” was not included in the House of Representatives’ version of PDUFA that passed quickly last month.
Among other things, the Securing Pharmaceutical Integrity Act of 2012 (Act) would require manufacturers to do the following:
- Apply RxTEC (a data carrier that includes the standardized numerical identifier, lot number, and the expiration date of a product) to the individual saleable units and homogeneous case of all products intended to be introduced into interstate commerce;
- Maintain change of ownership and transaction information, including RxTEC data, for each individual saleable unit of product and homogenous case introduced in interstate commerce;
- Maintain change of ownership and transaction related to a product where the change of ownership has occurred between non-affiliated entities, or when a product is returned from the immediate previous source; and
- Provide specific change of ownership and transaction information to the immediate subsequent recipient of such product, including the proprietary or established name of the product, the National Drug Code number of the product, container size, number of containers, the lot number or numbers of the product, and a signed statement that the company did not knowingly and intentionally adulterate or counterfeit such product.
Additionally, the Act would require wholesale distributors to:
- Only receive products encoded with RxTEC from a licensed or registered manufacturer, wholesaler, or repackager;
- Maintain change of ownership and transaction information where a change of ownership has occurred between non-affiliated entities, including RxTEC data by lot, the business name and address of the immediate previous source and the immediate subsequent recipient of the product, the proprietary or established name of the product, the National Drug Code number of the product, container size, number of containers, the lot number or numbers of the product, and the date of the transaction;
- Provide specific change of ownership and transaction information to the immediate subsequent recipient of such product, including the proprietary or established name of the product, the National Drug Code number of the product, container size, number of containers, the lot number or numbers of the product, and a signed statement that the wholesaler received the product from a registered or licensed manufacturer or repackager; and
- Receive a signed statement from the immediate subsequent recipient of the product stating that the trading partner did not knowingly and intentionally adulterate or counterfeit such product.
Further, manufacturers and wholesalers would be required to “utilize RxTEC data at the lot level, as part of ongoing activities to significantly minimize or prevent the incidences of a suspect product in the pharmaceutical distribution supply chain.”
The Act would require manufacturers and wholesalers to begin complying with these provisions no later than 4½ and 6½ years, respectively, after the date of its enactment. The Act would take effect on January 1, 2022, “or on the date on which Congress enacts a law providing for express preemption of any State law regulating the distribution of drugs, whichever is later.”
Currently, various members of the House and the Senate are meeting to reconcile the differences between their respective versions of PDUFA. Please check back here for updates.
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