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FDA Extends DSCSA Compliance: New Deadlines for Drug Supply Chain Partners

In a recent announcement, the FDA issued updates on exemptions from the Drug Supply Chain Security Act (DSCSA) final implementation deadline, extending compliance timelines for specific partners within the pharmaceutical industry.   This decision acknowledges the difficulties faced by some manufacturers and distributors in meeting the stringent traceability requirements, despite the Act being in place for over a decade.   The FDA aims to minimize potential disruptions in the pharmaceutical supply chain to ensure critical medications remain accessible to patients. Background of the DSCSA The DSCSA, enacted in November 2013, was established to enhance drug traceability within the U.S. pharmaceutical supply chain.   By mandating unit-level serialization and visibility from manufacturers to dispensers, the DSCSA addresses issues of counterfeiting, contamination, and drug shortages.   Under this law, each pharmaceutical product moving through the supply chain must be traceable back to
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The True Cost of Driver Detention: Financial Losses and Safety Concerns in Trucking

The report quantifies the direct and indirect losses stemming from detention times, totaling billions in lost productivity and additional costs.   Fleets are charging detention fees, yet fewer than half are paid, indicating a widespread acceptance of unpaid wait times.   Additionally, the report uncovers that detained trucks are driven faster post-detention, and drivers are also speeding on routes known for detainment. Financial Impacts of Driver Detention ATRI's research reveals staggering numbers: the for-hire trucking sector alone lost over 135 million hours to detention in 2023, translating to $3.6 billion in direct expenses.   Not only does this amount to unpaid labor for drivers, but it also incurs operational costs for fleets, particularly when unplanned delays push delivery schedules or require last-minute rerouting.   Although 94.5% of fleets impose detention fees, fewer than half of these invoices are paid, which poses a severe cash flow problem and leaves carriers co
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Raising Awareness Mile by Mile: Road Scholar Highlights Trucks Dedicated to Cancer and Epilepsy Causes This November

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November is dedicated to increasing awareness for Lung Cancer, Epilepsy, and Pancreatic Cancer—three critical causes that Road Scholar Transport proudly highlights with dedicated awareness trucks.   These 53’ trailers aren’t just about logistics; they’re powerful symbols for advocacy and education across communities nationwide. Lung Cancer: A Preventable Tragedy Lung cancer, the second most prevalent cancer in the U.S., will impact an estimated 234,580 new diagnoses this year, with approximately 125,070 lives lost.   Road Scholar's lung cancer awareness truck, inspired by the Lung Cancer Alliance, features advocates and survivors who are testaments to the importance of early diagnosis and support networks. The idea to create an awareness truck for Lung Cancer Alliance got started when Linda Sacco, a volunteer at the organization, and her husband, ran into Road Scholar’s former President Jim Barrett at an antique car show.   Linda’s husband was a former driver for Road Sc
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Ensuring Safe Transport: The Importance of Due Diligence When Selecting Carriers

Selecting the right carrier is critical for shippers and manufacturers aiming to protect their goods, reputation, and bottom line.   This process involves conducting due diligence, a systematic evaluation to ensure a carrier meets safety, compliance, and reliability standards.   By thoroughly researching carriers’ safety records, financial stability, regulatory compliance, and service quality, companies can minimize risks associated with transport. What is Due Diligence? In logistics, due diligence refers to assessing a carrier’s qualifications and operational practices to confirm they align with specific needs and safety standards.   It’s an ongoing effort to verify that chosen carriers are capable, reputable, and compliant.   Proper due diligence might include reviewing safety and inspection records, financial stability, insurance coverage, and customer reviews, alongside verifying compliance with regulations, especially for hazardous or temperature-sensitive shipments. Key
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Understanding the Latest FDA Regulations for Pharmaceutical Transportation

The FDA’s latest regulations for pharmaceutical transportation play a critical role in ensuring the safety and integrity of sensitive medical products throughout the supply chain.   These regulations emphasize stringent guidelines on Good Distribution Practices (GDP), temperature control, packaging, documentation, and risk management to protect pharmaceuticals from contamination, degradation, and theft. Key Components of the Regulations: Good Distribution Practices (GDP): The cornerstone of pharmaceutical logistics, GDP ensures that products are handled and stored appropriately during transit.   Compliance with GDP mitigates risks like contamination or degradation, requiring facilities and carriers to follow strict handling, storage, and cleanliness protocols. Temperature Control: Maintaining precise temperature conditions is vital for many pharmaceuticals, such as vaccines, biologics, and insulin, which are particularly suscepti
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From Economy to Lawsuit Reform: ATRI's Top Trucking Issues of 2024

The 2024 ATRI Top Industry Issues Report highlights significant challenges facing the trucking industry, with the state of the economy and truck parking topping the list of concerns.   The economic downturn, freight recession, and rising operating costs have placed intense pressure on carriers, while a shortage of parking spaces continues to affect drivers’ safety and efficiency.   Other major concerns include lawsuit abuse reform, insurance costs, and driver compensation.   The push for battery-electric vehicles also ranked as a top issue, reflecting the industry's focus on transitioning to zero-emission fleets. The Economy and Its Impact on Trucking The No. 1 concern in the report is the state of the economy, which continues to exert significant pressure on the trucking industry.   With costs of operations reaching an all-time high and freight demand remaining weak, carriers are feeling the squeeze.   The industry has been in a nearly two-year freight recession, with a separa
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Preparing for Protect-from-Freeze Shipping Season: Why It’s Crucial to Safeguard Your Freight

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Protect from freeze season, which most identify as the end of October through April, is here.   Industries reliant on temperature-sensitive products must prioritize protect-from-freeze shipping to prevent costly damages.   This season is particularly crucial for sectors such as pharmaceuticals, food and beverage, and chemicals, where exposure to freezing temperatures can compromise product integrity. 1. Pharmaceuticals Medications, vaccines, and biologics are particularly vulnerable to temperature fluctuations.   Freezing can destroy the molecular structure of vaccines, alter the composition of liquid medications, and degrade the efficacy of biologic treatments.   For example, insulin and other injectable drugs must be kept within a strict temperature range to remain effective. Freezing temperatures can cause these products to crystallize or lose potency, leading to ineffective treatments and potential health risks for patients. 2. Food and Beverage Frozen food is common,
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