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Wholesale Manufacturers

Foley & Lardner LLP

US District Court in Puerto Rico Rejects Distributor’s Efforts to Hold Wholesalers Liable for a Terminated Agreement Under Puerto...

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Share on Twitter Print Share by Email Share Back to top In Meta Med, LLC, et al., v. Insulet Corporation, et al., Lyvette Mercado Velez, a dietitian, entered into a distribution agreement with Insulet Corporation, a medical...more

Bass, Berry & Sims PLC

Alaska Board of Pharmacy Issues Notice Altering the Notification of Facility Changes

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On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...more

Hogan Lovells

U.S.: FDA enforcement of certain DSCSA requirements delayed until November 2024

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The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that provides a one-year reprieve from certain...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Quarles & Brady LLP

New Alabama Law Imposes Designated Representative Registration Requirements for Wholesalers and Manufacturers

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Beginning on January 1, 2024, pursuant to recently passed Alabama House Bill 79 individuals serving as the designated representative for an Alabama-licensed facility will be required to hold an Alabama designated...more

Pillsbury Winthrop Shaw Pittman LLP

Effective January 1, 2023, Numerous States Begin to Impose Notification Requirements and Prohibitions on Products Containing...

Multiple states have enacted laws that impose prohibitions or notification obligations on the commercial distribution of PFAS-containing products, with requirements under the laws of three states (California, Maine and New...more

Paul Hastings LLP

Clock is Ticking: 1-Year until DSCSA’s Enhanced Drug Distribution Security Requirements Take Effect

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Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...more

Faegre Drinker Biddle & Reath LLP

The Race Toward Full DSCSA Implementation

In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more

Quarles & Brady LLP

Puerto Rico Implements Licensure Requirement for Non-Resident Wholesalers & Manufacturers

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While the vast majority of states require non-resident wholesale distributors and manufacturers that ship prescription drugs into their states to obtain a non-resident license, Puerto Rico had been one of the few that did not...more

Morgan Lewis - As Prescribed

One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers

The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more

Morgan Lewis - As Prescribed

Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA

Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more

Skadden, Arps, Slate, Meagher & Flom LLP

Third Circuit Demands Rigorous Analysis of the Predominance Requirement for Class Certification in Pharmaceutical Antitrust Case

On April 22, 2020, the Third Circuit Court of Appeals vacated and remanded an order certifying a class of direct purchaser plaintiffs in In re: Lamictal Direct Purchaser Antitrust Litigation, holding that the district court...more

Dorsey & Whitney LLP

California’s Sweeping Price-Gouging Statute Presents Unique Risks to Manufacturers, Wholesalers, Distributors and Retailers of...

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Unchartered Waters - State price-gouging laws have come into focus in recent weeks as all 50 states have declared an emergency in the wake of the COVID-19 crisis. There is a relatively underdeveloped body of...more

Foley & Lardner LLP

Implications for the Fashion, Apparel & Beauty Industries Due to the Coronavirus

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Like other industries, the fashion, apparel & beauty businesses have been, and continue to be hit hard by the COVID-19 pandemic. The $400 billion dollar American fashion industry employs over four million people, excluding...more

Hogan Lovells

COVID-19: Actions taken by EU competition authorities - will the HCC's approach go viral?

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Within the first week of the confinement measures in Europe, the Hellenic Competition Commission (HCC) was one of the first EU competition authorities to announce a more lenient approach towards certain vertical agreements,...more

McGuireWoods LLP

Don’t Overlook EU, UK Antitrust Issues With Vertical Arrangements During the COVID-19 Pandemic

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During the current COVID-19 pandemic, antitrust/competition law in the EU and UK has focused primarily on competitor cooperation and price increases of certain products, such as face masks, hand sanitizer, paracetamol,...more

McDermott Will & Emery

THE LATEST: California Jury Rejects Robinson-Patman Act Claim Against 5-hour Energy Maker

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Family-owned wholesalers brought a Robinson-Patman claim against the maker of 5-hour Energy alleging discounts given to Costco amounted to illegal price discrimination. A jury in California rejected the claim after a...more

ArentFox Schiff

5-Hour Energy Drink Maker Allowed to Charge Higher Prices to Costco’s Competitors

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Last week, a California federal jury concluded that the maker of 5-Hour Energy Drink did not violate federal antitrust law by selling the energy shots to Costco for less than the price charged to its family-owned rivals....more

BCLP

Price Discrimination Update: Living Essentials Jury Verdict

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On October 21, 2019, a jury empaneled by the United States District Court for the Central District of California found that the makers of 5-Hour Energy “shots” did not violate the Robinson-Patman Act (“RPA”) by providing more...more

Seyfarth Shaw LLP

California Adopts Major Changes to Warranty Reimbursement Requirements Effective January 1, 2020

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On October 12, 2019, California governor Gavin Newsom signed into law Assembly Bill 179 (A.B. 179), a bill that will make significant changes to the warranty reimbursement provisions of the California Vehicle Code effective...more

Lewitt Hackman

Franchisor 101: No Need for Good Cause

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A Wisconsin federal judge granted summary judgment in favor of a food service and cleaning equipment maker (“Stoelting”), ruling that minimum purchase requirements under two dealer agreements were not a franchise fee under...more

BCLP

Missouri Alcohol Retailers no longer Tongue-Tied by Tied-House Restrictions on Advertising

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Missouri tied-house law, which restricts dealings between suppliers, wholesalers and retailers, is currently in flux following a recent ruling by the US District Court for the Western District, which held that several of...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

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Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Blank Rome LLP

2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better

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Although several bills were introduced in Congress and President Trump has complained that drug prices are way too high, during 2017, the federal government did not pass any law nor implement any policy requiring drug...more

Arnall Golden Gregory LLP

Drug Pricing Continues to be a Hot Topic for State Legislatures

Due to the recent significant increases in certain drug prices that have led to allegations of “price gouging” and antitrust violations, several state legislatures have enacted new laws aimed at controlling prescription drug...more

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