News & Analysis as of

Food and Drug Administration (FDA) Wholesale

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

WilmerHale on

Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more

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

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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

FDA Announces Draft Guidance on Outsourcing Facility Sales

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The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...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27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more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

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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

McGuireWoods LLP

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

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The U.S. Food and Drug Administration (FDA) is accepting comment until June 6, 2022, on its proposed rule, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers....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

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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

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

Cozen O'Connor

1st Amendment Win For Credit Card Surcharges| Texas Sues Over Electricity Bills | Dodgy COVID Fees

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2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more

ArentFox Schiff

FDA issues guidance for industry on wholesale distributor verification requirement for saleable returned drug product

ArentFox Schiff on

FDA issued a Compliance Policy delaying enforcement of the DSCSA’s saleable returns verification requirement by one year. So now, instead of wholesale distributors having to comply by November 27, 2019, FDA will exercise...more

McGuireWoods LLP

Cost Control — Understanding State Wholesale Drug Importation Programs

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While a number of state initiatives have sought to control prescription drug costs — such as through regulation of pharmacy benefit manager practices, anti-price gouging, price transparency, and rate-setting review — the use...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

Kelley Drye & Warren LLP

Louisiana Adopts Price Reporting Law

Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...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

Pillsbury Winthrop Shaw Pittman LLP

Labeling and Pedigree Requirements of the Drug Supply Chain Security Act

Counterfeit and adulterated prescription drugs in the supply distribution chain pose a significant risk to patient safety. On November 27, 2013, President Obama enacted the Drug Supply Chain Security Act (DSCSA), which amends...more

Hinshaw & Culbertson LLP

Health Law Alert: Pharmacies and Prescription Drug Dispensers...Are You Ready for The March 1, 2016 DSCSA Compliance Deadline?

In order to improve drug security throughout the supply chain, and to facilitate drug recalls and to address drug importation, diversion, and counterfeiting, Congress passed the Drug Supply Chain Security Act (the "DSCSA")....more

McCarter & English, LLP

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

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Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

Mintz - Health Care Viewpoints

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

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