News & Analysis as of

Manufacturers Drug Distribution

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Quarles & Brady LLP

Are You Ready for Alabama’s New Designated Representative Requirements?

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In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...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

Quarles & Brady LLP

Amidst Ongoing Manufacturer Restrictions, 340B Covered Entities and Contract Pharmacies Get Creative

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Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...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

Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now

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On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...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

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

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

Sheppard Mullin Richter & Hampton LLP

FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

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Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...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

Akerman LLP - Health Law Rx

Updated for Expanded DDC Interpretation: New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and...

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come.  When an applicant files for a change of ownership (“CHOW”) or change of location for one...more

Bricker Graydon LLP

Federal court sides with Eli Lilly challenge to HHS expansion of 340B discounts

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On March 16, 2021, the United States District Court in Indiana granted plaintiff Eli Lilly’s request for a preliminary injunction to halt implementation of a Department of Health and Human Services (HHS) rule published in...more

Foley Hoag LLP - White Collar Law &...

First Circuit's New England Compounding Center Decisions Illustrate Reach of Federal Criminal Law

In 2012, New England Compounding Center (“NECC”) shipped contaminated anti-pain medication to hospitals and clinics around the country, with devastating consequences. Patients around the country developed fungal meningitis...more

Troutman Pepper

Temporary FDA Policy for Compounding COVID-19 Drugs Poses Opportunities and Risks for Hospitals and Pharmacies

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With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more

Morgan Lewis

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

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The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

Morgan Lewis

Federal Circuit Acetris Decision Is Important for Pharmaceutical Manufacturers Planning Sales to US Government

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The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...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

Hogan Lovells

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

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On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Cooley LLP

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

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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

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

McDonnell Boehnen Hulbert & Berghoff LLP

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

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