On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law. It required that each new owner of a prescription drug receives an “ownership history” containing information on all of the item’s previous owners all of the way back to the item’s manufacturer. Key points of the law are:
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Storing the Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) information for 6 years (12 years for suspect product). [Title II Section 582 (d)(1)(A)(iii) & (d)(1)(D)(4)(iv)]
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Having a way for dispensers to reply to an FDA information request within 2 business days. [Title II Section 582 (d)(1)(D)]
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Having a means for storing “lot level” information (NDC number, lot number, expiration date and serial number) as defined by Tittle II.[Title II Section 582 (d)(1)(A)(iii)]
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Verifying the T2 (EPCIS) information for completeness and against what was actually received [Title II Section 582 (d)(1)]
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Item quarantine processing and documentation [Title II Section 582 (d)(1)(D)(4)(A)]
The regulations, in part, require dispensers to have developed protocols to identify suspect and illegitimate products by January 1, 2015.
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The law defines a suspect / illegitimate product as one for which there is reason to believe it:
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Is potentially counterfeit, diverted, or stolen;
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Is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
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Is potentially the subject of a fraudulent transaction; or
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Appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
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The DSCSA requires trading partners (which includes dispensers), upon determining that a product in their possession is a suspect product, to quarantine the product while they promptly conduct an investigation to determine whether the product is an illegitimate product.
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The law also requires trading partners, upon determining that a product in their possession or control is illegitimate, to notify FDA and all immediate trading partners (that they have reason to believe may have received the illegitimate product) within 24 hours after making the determination. Read more about it at FDA.gov.