News & Analysis as of

Healthcare DSCSA

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

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

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

King & Spalding

Also In The News - Health Headlines - July 2015

King & Spalding on

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more

Mintz - Health Care Viewpoints

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more

12 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide