FDA releases guidance on pharmaceutical supply chain security

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The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S.

So far this year, the agency has released more than a dozen guidance documents related to the development of new drugs, the use of pharmacogenomic data in drug submissions, quality considerations for cannabis-derived compounds and clinical trials for drug and biologics.

Here, we summarize the guidance on suspicious and illegitimate products, clarifying the interpretation of terms such as counterfeit, diverted, stolen, fraudulent transaction and unfit for distribution, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). Read more

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What to consider before renewing your serialization contract

As we kickstart the last quarter of 2021, the federal deadline for full interoperability in pharmaceutical serialization, as dictated by the DSCSA (Drug Supply Chain Security Act), will soon reach its two-year countdown on November 27. Since November 2018, all manufacturers, including virtual manufacturers and brand owners, have been required to serialize products at the lowest salable unit. Products that do not contain a unique serial number on the packaging, along with other required information (GTIN, serial, lot and expiry date), are not authorized to be sold or purchased. As stated in the guidelines, “Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.”

Technical challenges coupled with a global pandemic have hindered the roadmap towards serialization compliance. Pressured by the supply chain amidst the COVID-19 outbreak, the FDA announced an enforcement discretion on verifying s…

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Ensuring accuracy and compliance during repackaging

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The accuracy of serialization data and compliance by trading partners provides the foundation for compliance with the Drug Supply Chain Security Act (DSCSA). During the pharmaceutical packaging process, however, there may be unplanned events that jeopardize the integrity of the data, reduce productivity and increase operational costs.

Equipment jams, power failures, product damage during handling and operator errors will happen. Additionally, a product that is processed without incident may need to be removed from a pallet for periodic QA sampling. All of these events impact the many serialization-related requirements with which pharmaceutical manufacturers, repackagers and Contract Manufacturing Organizations (CMOs) must now adhere.

Factors that necessitate that packaging be reworked, and like many choices in life, you can either do it the hard (costly) way or the easy …

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FDA shares guidance to protect the pharma supply chain

FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final while another two are draft guidance. 

“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain,” said Donald D. Ashley, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research, in a statement. 

The FDA introduced the Drug Supply Chain Security Act (DSCSA) requirements to identify and weed out illegitimate products. 

The recent documents include recommendations for complying with DSCSA requirements and how to provide enhanced drug distribution security at the package level to comply with requirements that go into effect in November 2023. After that da…

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