News & Analysis as of

Supply Chain Verification Requirements

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

Hogan Lovells

FDA Extends Enforcement Discretion for Several Requirements in FSMA Regulations

Hogan Lovells on

FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more

Proskauer - Blockchain and the Law

Major Italian News Agency Uses Blockchain-Based Label to Verify the Origin of Its Articles

The leading Italian news agency, Agenzia Nazionale Stampa Associata (ANSA), which represents 24 major Italian newspapers and distributes over 3,000 news articles daily, announced in early April that it has begun using a...more

Hogan Lovells

FSMA Update: FDA Announces Continuation of Enforcement Discretion for Co-Manufacturer Supplier Verification

Hogan Lovells on

On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more

Wilson Sonsini Goodrich & Rosati

First FSVP Warning Letter Issued by the FDA

In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more

Hogan Lovells

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more

Hogan Lovells

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

Hogan Lovells on

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

Cooley LLP on

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

Pillsbury Winthrop Shaw Pittman LLP

Labeling and Pedigree Requirements of the Drug Supply Chain Security Act

Counterfeit and adulterated prescription drugs in the supply distribution chain pose a significant risk to patient safety. On November 27, 2013, President Obama enacted the Drug Supply Chain Security Act (DSCSA), which amends...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

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