The Drug Supply Chain Security Act (DSCSA) is rapidly approaching with implementation scheduled for November, and while most drugmakers are expected to be in compliance with the law when it takes effect, there’s still much work that needs to be done to get drug manufacturers who are not sending serialized data up to speed. Cencora’s vice president of manufacturer operations and data services Gregg Gorniak recently spoke with Regulatory Focus, highlighting how Cencora worked and continues to assist manufacturers to ensure they are prepared for DSCA implementation in November. Read the full interview here: https://ow.ly/KY9250SyP6U
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The Drug Supply Chain Security Act (DSCSA), enacted in 2013, is moving towards full implementation, achieving package-level traceability by November 27, 2024. However, the FDA has extended the compliance deadline for small dispensers to November 27, 2026, due to challenges in readiness and potential supply chain disruptions. In a new article, Frier Levitt attorneys Martha Rumore and Harini Bupathi shed light on other important deadlines for exemptions, re-opened comment periods, and more. Additionally, they discuss DSCSA requirements that pharmacists must be aware of and how to prepare. Read here: https://lnkd.in/eqDUUN7r #FrierLevitt #DSCSA #FDA #PharmacyLaw
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Product and Asset Management Director @ MENTOR Technical Group, Corp. | Asset Management, Digital Transformation, Operational Excellence, Smart Maintenance, Calibration
Among other facts: The most common CGMP citation in FY23 warning letters to drug manufacturing facilities involved quality units (21 CFR 211.22) followed closely by control and testing citations (21 CFR 211.84). In the top five citations of the year were written procedures and deviations (21 CFR 211.100), production record review, (21 CFR 211.192) and equipment cleaning and maintenance (21 CFR 211.67(b)). Find more details on FDA Citations for 2023 here: https://lnkd.in/ebSQkD-q
CDER’s Office of Compliance issued its 2023 Annual Report which highlights key initiatives and actions during the year to protect consumers and ensure the safety of our drug supply: https://lnkd.in/g_f9swua
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If you have been keeping up with the industry news, you have likely read about FDA’s firm standing on the DSCSA enforcement deadline. Patrizia Cavazzoni, Director of CDER US FDA, recently stated, “I really want to emphasize that this is not really a matter of kicking the can down the road.” She urges the industry to use the one-year stabilization period to “troubleshoot, get assistance, and secure their processes” so that all systems are ready by November 2024. Will your company be ready for the DSCSA? Do you know with whom you share information? Read more: https://lnkd.in/gseZCZ_S #Spherity #FDA #Pharma #SupplyChain #RegulatoryCompliance #DSCSA #Traceability
Cavazzoni: No more ‘kicking the can’ down the road for DSCSA compliance
raps.org
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Join us for an exclusive presentation by an FDA expert. Gain critical insights straight from the source and stay ahead in regulatory compliance. Don't miss this opportunity to learn from the best! Register for your last chance to save $200 with Early Bird: https://ow.ly/lSJz50TaVW1 View the full agenda: https://ow.ly/hFby50TaVVZ #DGEvents #FDA #riskassessment #HumanFactors
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CAPDM was among the invitees to the GIRP - European Healthcare Distribution Association 65th Annual Meeting and Conference, represented by Nancy Beshay. Attended by dozens of healthcare distribution associations in Europe and around the world, this global network explores information and shares best practices on drug shortages, regulations, supply chain security, and more. #Pharmacy #SupplyChain #GIRPAMC2024
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Associate Director, Scientific Support Services & Stability Storage at Alcami Corporation
Don't miss out on our upcoming webinar on May 22 at 11 am ET, titled "5 Essential Elements in Selecting a GMP Storage Vendor." Dive into the essentials of FDA regulations and key aspects like space qualification, environmental management, and minimizing risks. Plus, get practical advice and learn about additional offerings such as GMP cold chain logistics and aliquoting services. Sign up here➡️ https://lnkd.in/eauwmNgD #Webinar #PharmaStorage #GMP #coldchain #CDMO #AskAlcami #Alcami
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⚕️DSCSA compliance penalties are less than 12 months away. What does it mean for the pharmacy supply chain? How will you stay compliant and avoid FDA fines? Tecsys' Senior Director of Pharmacy Solutions, Valerie Bandy, highlights the 'why,' the 'what' and the 'what next' in this #DSCSACompliance webinar series: https://lnkd.in/e7fgrRZp
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This is the moment we’ve been waiting for: #FDA is ending its yearlong enforcement discretion and expects companies to be compliant. Companies can be subject to FDA enforcement actions on Nov. 28, and no one wants to become the poster child for noncompliance. Meanwhile, the FDA provided an option for those companies that will not be fully compliant in time: the waivers, exceptions, and exemptions program (#WEE). Read Carl Accettura's full article about what you can expect during the #DSCSA stabalization period. https://lnkd.in/eXKKnQtX #fdaregulation
New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability
pharmaceuticalonline.com
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Register to learn a little about DSCSA and hear guidance on readying you and your team for DSCSA compliance. If you asked, “What the heck is DSCSA?” in your head, this series is for you. Tecsys Inc. #supplychain #supplychainmanagement #consolidatedpharmacyservicecenter #cpsc #pharmacy #dscsa
⚕️DSCSA compliance penalties are less than 12 months away. What does it mean for the pharmacy supply chain? How will you stay compliant and avoid FDA fines? Tecsys' Senior Director of Pharmacy Solutions, Valerie Bandy, highlights the 'why,' the 'what' and the 'what next' in this #DSCSACompliance webinar series: https://lnkd.in/e7fgrRZp
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Mark your calendars for May 22, 11 am ET, as we dive into our webinar titled "5 Essential Elements in Selecting a GMP Storage Provider." Discover the ins and outs of FDA regulations and key aspects like space qualification, environmental management, and reducing risks. Plus, get practical advice and learn about additional offerings such as GMP cold chain logistics and aliquoting services. Sign up today➡️ https://lnkd.in/eJjUXFBf #Webinar #PharmaStorage #GMP #coldchain #CDMO #AskAlcami #Alcami
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