The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.   The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance ...

[ Editor's Note: This article has been updated 3 March 2023 to clarify HDA's role in conducting the survey .]  The pharmaceutical industry and its trading partners have made “significant strides” in sharing transaction data with each other, which is a key element in medicine traceability mandated by the Drug Supply Chain Security Act (DSCSA). Yet there are still barriers to exchanging this data, according to a recent survey by the Healthcare Distribution Alliance (HDA...

Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes full effect this November, the US Food and Drug Administration (FDA) will begin inspecting firms to verify their compliance, asserted Howard Sklamberg, a partner at Arnold & Porter.   He outlined what FDA will be looking for in inspections at a 22 February webinar sponsored by the Food and D...

With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a guide to help drugmakers and their trading partners establish the necessary electronic systems to track their products through the supply chain.   The new chapters complement an earlier guide on understanding the compliance and baseline business requirements on trading of information, which was released in July 20...

The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA), according to a recent survey. Yet industry needs to pick up the pace if the November 2023 deadline is to be met, said an official with the Healthcare Distribution Alliance (HDA), whose group conducted the survey.   The survey found that 75% of manufacturers plan to send 100% of their DSCSA-req...

The US Food and Drug Administration (FDA) announced on Thursday that it will not take enforcement action against distributors of approved naloxone products for treating opioid overdoes under the prescription drug tracking requirements under the Drug Supply Chain Security Act (DSCSA).   The exemption would “help facilitate and expedite the distribution of naloxone to harm reduction programs on the front lines of the opioid overdose crisis, and thus directly aid in add...

Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors and third-party logistics providers (3PLs), which are set to replace the current patchwork system of state licensing standards. The standards implement aspects of the Drug Supply Chain Security Act (DSCSA) and are meant to plug holes in the country’s pharmaceutical supply chain.   The generic dru...

While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these systems go live next November, said experts who recently spoke to Regulatory Focus.   Trading partners, for example, need to start testing and piloting data exchanges now to iron out any glitches early on, and manufacturers in particular ...

The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the pharmaceutical supply chain, while the other guidance pertains to identifying trading partners that are authorized to track products though the supply chain.   The agency announced that “these documents are critical steps toward implement...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.   Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will ...

The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.   DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in ...

Pharmaceutical manufacturers are lagging behind distributors in testing electronic connections with trading partners as the November 2023 deadline for having these systems in place under the Drug Supply Chain Security Act (DSCSA) approaches, according to a recent survey by the Healthcare Distributors Alliance (HDA).   DSCSA mandates that by November 2023, prescription drug product must be electronically tracked through the supply chain to ward off counterfeiting. In ...