News & Analysis as of

DSCSA Prescription Drugs

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

Epstein Becker & Green on

The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more

Epstein Becker & Green

FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners

Epstein Becker & Green on

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more

Troutman Pepper

Navigating the Future of Pharmacy Law: Key Takeaways From the 2023 American Society of Pharmacy Law Conference

Troutman Pepper on

Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more

Jones Day

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

Jones Day on

With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

Quarles & Brady LLP

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

Quarles & Brady LLP on

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

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

Nelson Mullins Riley & Scarborough LLP

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA’s move to...

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more

Quarles & Brady LLP

More Guidance Released from FDA for Drug Supply Chain Security Act Compliance

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...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

Quarles & Brady LLP

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

Quarles & Brady LLP on

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

Quarles & Brady LLP

Final Definitions and Considerations for Trading Partners to Prepare for DSCSA Implementation

Quarles & Brady LLP on

On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more

Oberheiden P.C.

Four Things that Healthcare Providers Need to Know About FDA Counterfeiting Investigations

Oberheiden P.C. on

The U.S. Food and Drug Administration (FDA) has broad authority to evaluate and approve drugs for medical use or prescription drugs. It also has the authority to investigate fake or counterfeit medicines and substances in the...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

Hogan Lovells

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...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

Bass, Berry & Sims PLC

FDA Issues Key Guidance on the Drug Supply Chain Security Act

Bass, Berry & Sims PLC on

On June 3, the U.S. Food and Drug Administration (FDA) issued a series of four documents (two final guidance documents and two draft documents) to provide trading partners guidance on its interpretation of certain...more

King & Spalding

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

King & Spalding on

On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

Alston & Bird

Examining the Drug Supply Chain – How the Public Health Emergency Impacts DSCSA

Alston & Bird on

The Drug Supply Chain Security Act was intended to enhance the safety and security of the pharmaceutical distribution supply chain – but in a few short months, everything has changed. Our Food, Drug & Device/FDA Group...more

Foley & Lardner LLP

Blockchain: A Tool With a Future in Healthcare

Foley & Lardner LLP on

Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more

BakerHostetler

FDA Launches DSCSA Pilot Project Program, Supports Use of Blockchain Technology

BakerHostetler on

On Feb. 7, 2019, the U.S. Food and Drug Administration (FDA) published a press release and on the following day published an accompanying notice in the Federal Register announcing a Pilot Project Program Under the Drug Supply...more

Arnall Golden Gregory LLP

Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements

So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...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

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners understand their compliance obligations...more

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