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Healthcare Food & Drug Regulations Drug Distribution

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

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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

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

Epstein Becker & Green

SAMHSA Final Rule Regarding OTPs Expands Access, Increases Flexibility for Patients

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more

Troutman Pepper

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

Troutman Pepper on

The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

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This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

Jones Day

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

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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

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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

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

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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

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

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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

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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

Arnall Golden Gregory LLP

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more

Jones Day

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

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The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

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