News & Analysis as of

Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) DSCSA

Akin Gump Strauss Hauer & Feld LLP

In Effort to Avoid Supply Chain Disruptions, FDA Extends DSCSA Exemptions

On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading...more

Quarles & Brady LLP

FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements

Quarles & Brady LLP on

On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more

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

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...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

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

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

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

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

McGuireWoods LLP

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to...

McGuireWoods LLP on

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”. As the title suggests, the Guidance is part of FDA’s...more

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