By William T. Koustas –
FDA has issued a new draft guidance titled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (Draft Guidance). This Draft Guidance is the first of many to come in FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). As was apparent at the recent DSCSA public workshop (as we posted here), industry has been anxiously awaiting more information from FDA as DSCSA provisions, including provisions regarding suspect and illegitimate products, begin to take effect the first of the year.
One of the initial requirements is to notify FDA and trading partners of product that is identified as “illegitimate.” FDC Act §§ 582(b)(4), (c)(4), (d)(4), (e)(4). Under the DSCSA, if a trading partner identifies a product that is suspect, it must quarantine the product and conduct an investigation to determine whether the product is illegitimate. Id. Upon determining that the suspect product is in fact illegitimate, the product must remain quarantined, be appropriately disposed of, and a notification must be made to FDA and trading partners. Id.
The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending ways trading partners can identify and determine whether product is suspect; and (3) creating a process for trading partners to terminate illegitimate product notifications. FDC Act § 582(h)(2). The Draft Guidance addressed each of these three issues as follows:
continue to read here
FDA has issued a new draft guidance titled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (Draft Guidance). This Draft Guidance is the first of many to come in FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). As was apparent at the recent DSCSA public workshop (as we posted here), industry has been anxiously awaiting more information from FDA as DSCSA provisions, including provisions regarding suspect and illegitimate products, begin to take effect the first of the year.
One of the initial requirements is to notify FDA and trading partners of product that is identified as “illegitimate.” FDC Act §§ 582(b)(4), (c)(4), (d)(4), (e)(4). Under the DSCSA, if a trading partner identifies a product that is suspect, it must quarantine the product and conduct an investigation to determine whether the product is illegitimate. Id. Upon determining that the suspect product is in fact illegitimate, the product must remain quarantined, be appropriately disposed of, and a notification must be made to FDA and trading partners. Id.
The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending ways trading partners can identify and determine whether product is suspect; and (3) creating a process for trading partners to terminate illegitimate product notifications. FDC Act § 582(h)(2). The Draft Guidance addressed each of these three issues as follows:
continue to read here
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