News & Analysis as of

Supply Chain Wholesale

Faegre Drinker Biddle & Reath LLP

FDA Issues Final Guidance on Supply Chain Verification Systems

In December 2023, the Food and Drug Administration (FDA) issued a final guidance, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,” explaining the agency’s interpretation of the...more

Hogan Lovells

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

Hogan Lovells on

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

Quarles & Brady LLP on

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

BakerHostetler

FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

BakerHostetler on

On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more

Paul Hastings LLP

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

Paul Hastings LLP on

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

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

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

McDermott Will & Emery

FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics...

McDermott Will & Emery on

The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more

Holland & Knight LLP

Proposed FDA Rules Could Be Game Changers for the Pharmaceutical Supply Chain

Holland & Knight LLP on

New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more

Cozen O'Connor

FTC Seeks Information to Study Causes and Impacts of Supply-Chain Disruptions

Cozen O'Connor on

The Federal Trade Commission (“FTC”) issued orders under Section 6(b) of the FTC Act to nine large retailers, wholesalers, and consumer good suppliers requiring them to provide information for a study examining recent...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

Saul Ewing LLP

From Business Viability and Cashflow Analysis to First Payment Rights — Restructuring and Bankruptcy Considerations for the Food,...

Saul Ewing LLP on

Host Kermit Nash, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with Barry Chatz, a partner in the Firm’s Bankruptcy and Restructuring Practice, on a variety of financial...more

Akin Gump Strauss Hauer & Feld LLP

Election 2020: What Would a Biden Win Mean for the U.S. Electric Power Sector?

Part One - As the 2020 election nears, the Democratic campaign has begun to talk policy specifics regarding energy and climate change. Although the Trump administration undertook to dismantle many Obama-era policies and...more

Proskauer - Minding Your Business

Price Gouging Laws and the Dormant Commerce Clause?

During the pandemic, businesses are asking about their potential price gouging liability in states that they do not sell into directly but where their products might end up. At least one federal circuit court addressed this...more

Dorsey & Whitney LLP

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

Dorsey & Whitney LLP on

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

Foley & Lardner LLP on

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?

Hogan Lovells on

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

McGuireWoods LLP on

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

Oklahoma Supreme Court Strikes Down New Distribution Statute as Unconstitutional

McDermott Will & Emery on

In a win for alcohol beverage suppliers, on Wednesday the Oklahoma Supreme Court issued an opinion in The Institute For Responsible Alcohol Policy v. State ex rel. Alcohol Beverage Laws Enforcement Comm’n. In a 5-4 ruling,...more

BCLP

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

BCLP on

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

Holland & Knight LLP on

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

Hogan Lovells

UK: FCA General Insurance and Protection Sector Views 2017

Hogan Lovells on

The FCA has outlined the current trends, risks and its overall assessment of the General Insurance sector in its 2017 Sector Views, published last week.  ...more

Cooley LLP

Blog: Compliance Date for Drug Supply Chain’s Security Act’s Serialization and Verification Requirements Quickly Approaching

Cooley LLP on

Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable...more

Mintz - Health Care Viewpoints

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more

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