Drug Quality and Security Act

IFF Announces Clariant Has Agreed to Purchase IFF’s Cosmetic Ingredients Business Unit

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월요일, 10월 30, 2023

IFF (NYSE: IFF) today announced that Clariant—a sustainably focused specialty chemical company—has agreed to purchase IFF’s Cosmetic Ingredients business unit for $810 million.

Key Points:

IFF (NYSE: IFF) today announced that Clariant—a sustainably focused specialty chemical company—has agreed to purchase IFF’s Cosmetic Ingredients business unit for $810 million.
Reporting through IFF’s Scent division, IFF’s Cosmetic Ingredients business unit develops, manufactures and markets innovative ingredients for the cosmetic and personal care industry, including active ingredients, functional ingredients and delivery systems, primarily through the Lucas Meyer Cosmetics brand.
“Aligned with our best-owner mindset, the proposed sale of our Cosmetic Ingredients business to Clariant will allow us to focus on our core businesses, maximizing growth and returns.
We are convinced that Clariant is the best owner for the Cosmetic Ingredients business and with an ability to invest, will offer the business and our colleagues a bright future.”
IFF’s Cosmetic Ingredients business unit includes the Lucas Meyers Cosmetics and IBR brands and operates six research and development and/or production sites globally.

Anebulo Pharmaceuticals Announces New CEO

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금요일, 10월 6, 2023

Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) ("Anebulo"), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication ("ACI"), today announced that Richie Cunningham has been appointed as Anebulo’s Chief Executive Officer, replacing Simon Allen.

Key Points:

Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) ("Anebulo"), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication ("ACI"), today announced that Richie Cunningham has been appointed as Anebulo’s Chief Executive Officer, replacing Simon Allen.
His leadership and expertise in the biopharmaceutical industry will be valuable as Anebulo prepares for phase 3 development of ANEB-001," said Joseph F. Lawler, Founder and Chairman.
Most recently, Mr. Cunningham served as CEO at Tyme where he led the company through a merger with Syros Pharmaceuticals.
Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse disorder.

RedSail Technologies and LSPedia Announce Full Platform Integration with OneScan Pharmacy Pro - A Seamless Fusion of Pharmacy Management and DSCSA Compliance at Special Pricing

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화요일, 9월 26, 2023

Regulatory compliance, EPCIS, Partnership, Pharmacy, Food, NABP, ASN, Drug Quality and Security Act, SOP, Procrastination, DSCSA, Pinnacle, Health, FDA, Dark Enlightenment, Medical device

For that reason, we've selected LSPedia, who has proven to be the industry's DSCSA leader in quality, performance, and expertise.

Key Points:

For that reason, we've selected LSPedia, who has proven to be the industry's DSCSA leader in quality, performance, and expertise.
We have earned and continue to earn trust from pharmacies, and integrating OneScan Pharmacy Pro upholds and improves on that standard."
On the flip side, RedSail pharmacies using NRx or PrimeCare can also leverage OneScan Pharmacy Pro to meet their DSCSA solution needs, without direct software integration.
With OneScan Pharmacy Pro's integration in PioneerRx, pharmacies are equipped with a tried-and-tested, robust mechanism to navigate DSCSA compliance.

FDA Rejects Bulk Compounding For Ephedrine Sulfate

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월요일, 8월 28, 2023

FDA, Pharmaceutical, Health, Other Health, Nexus, Medication, Drug Quality and Security Act, Security, Congress, Ephedrine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Federal, Register, Food, Syringe, Pharmaceutical industry

Nexus Pharmaceuticals LLC announced that the U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register that ephedrine sulfate should not be bulked by compounding facilities.

Key Points:

Nexus Pharmaceuticals LLC announced that the U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register that ephedrine sulfate should not be bulked by compounding facilities.
Bulking is the practice of an outsourcing facility to “compound a drug using a bulk drug substance.”1 The FDA explained that bulk compounding is allowed only where there is a drug shortage or “the bulk drug substance appears on a list” set by the FDA called “the 503B Bulks List.”2 Section 503B refers to the portion of the Drug Quality and Security Act setting forth requirements when certain compounded products may be allowed.
On August 21, 2023, the FDA published its conclusion as to ephedrine sulfate that the FDA “now decided not to place [it] on the 503B Bulks List.”3 The FDA confirmed that companies including Nexus with its EMERPHED® product already have FDA-approved products available for both the vial and syringe presentations of ephedrine sulfate, including “as a 5 mL single dose, prefilled syringe that contains 25 mg/5 mL (5 mg/mL) ephedrine sulfate, preservative-free, for intravenous administration, and as a 10 mL single dose, prefilled syringe that contains 50 mg/10 mL (5 mg/mL) ephedrine sulfate, preservative-free, for intravenous administration.”4
In its notice this week, the FDA also confirmed that “the products available as prefilled syringes are premixed formulations and do not require dilution prior to administration for their labeled indications.”5 The FDA concluded that “there is no clinical need for outsourcing facilities to compound using the bulk substance[] ephedrine sulfate” and “therefore we are not including these bulk drug substances on the 503B Bulks List.”6
“We are pleased that the FDA properly decided bulk compounding for ephedrine sulfate is not authorized,” said Chief Executive Officer and President, Usman Ahmed.
EMERPHED® was the first 10 mL ephedrine sulfate prefilled syringe approved by the FDA.

Inmar Intelligence Extends Exclusive Contract for DSCSA Compliance with MMCAP Infuse

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수요일, 8월 16, 2023

Partnership, Pharmacy, USP, MMCAP, Drug Quality and Security Act, Trust, Patient, DSCSA, SVP, Medical device

This contract extension solidifies Inmar's position as the sole vendor for MMCAP Infuse members in this category.

Key Points:

This contract extension solidifies Inmar's position as the sole vendor for MMCAP Infuse members in this category.
With this new agreement, all 13,000 MMCAP Infuse members will have access to Inmar's state-of-the-art DSCSA Compliance solution, enabling healthcare institutions to efficiently track products, streamline operations and ensure adherence to DSCSA regulatory requirements.
"Inmar Intelligence is pleased to continue our partnership with MMCAP Infuse, providing its members with exclusive access to RxTransparent, our DSCSA Compliance solution," said David Schweihs, SVP, Healthcare Solutions at Inmar Intelligence.
In addition to RxTransparent, MMCAP Infuse has an existing contract with Inmar for Rx Returns, MEDidentify, and USP solutions.

TraceLink Collaborates with GS1 US to Author GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3 to Support EPCIS Data Exchange

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목요일, 8월 17, 2023

EPCIS, Communication, GS1, Partnership, XML, Organization, Dangerous Drugs (Supply to Addicts) Regulations 1968, Drug Quality and Security Act, Documentation, Patient safety, DSCSA, FDA, GS1 US, Cryptocurrency, Medical device

BOSTON, Aug. 17, 2023 /PRNewswire/ -- TraceLink Inc., the leading digital network platform company enabling end-to-end product orchestration by connecting more than 290,000 healthcare and life sciences entities through its B2N Integrate-Once™ network, is proud to announce its continuing support of Drug Supply Chain Security Act (DSCSA) 2023 readiness through its partnership with GS1 in the authoring of the GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3. An early adopter of GS1 standards, TraceLink has now exchanged over one million DSCSA-compliance EPCIS transactions between trading partners on the TraceLink network, with over 1,075 companies now being EPCIS-enabled for DSCSA compliance data exchange in preparation for November 2023 deadlines.

Key Points:

An early adopter of GS1 standards, TraceLink has now exchanged over one million DSCSA-compliance EPCIS transactions between trading partners on the TraceLink network, with over 1,075 companies now being EPCIS-enabled for DSCSA compliance data exchange in preparation for November 2023 deadlines.
The latest implementation documents, published by GS1 US on May 26th, 2023, serve as an EPCIS serialized data exchange implementation blueprint for companies across the US pharmaceutical and healthcare supply chain.
The expanded documentation provides detailed descriptions of end-to-end trading partner event choreographies for serialized item traceability use cases under DSCSA.
GS1 is a global, non-profit organization dedicated to the design and implementation of global standards for efficient business communication.

TraceLink Collaborates with GS1 US to Author GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3 to Support EPCIS Data Exchange

Retrieved on:

목요일, 8월 17, 2023

BOSTON, Aug. 16, 2023 /PRNewswire/ -- TraceLink Inc., the leading digital network platform company enabling end-to-end product orchestration by connecting more than 290,000 healthcare and life sciences entities through its B2N Integrate-Once™ network, is proud to announce its continuing support of Drug Supply Chain Security Act (DSCSA) 2023 readiness through its partnership with GS1 in the authoring of the GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3. An early adopter of GS1 standards, TraceLink has now exchanged over one million DSCSA-compliance EPCIS transactions between trading partners on the TraceLink network, with over 1,075 companies now being EPCIS-enabled for DSCSA compliance data exchange in preparation for November 2023 deadlines.

Key Points:

An early adopter of GS1 standards, TraceLink has now exchanged over one million DSCSA-compliance EPCIS transactions between trading partners on the TraceLink network, with over 1,075 companies now being EPCIS-enabled for DSCSA compliance data exchange in preparation for November 2023 deadlines.
"Given the sense of urgency for November 2023, we want to jumpstart EPCIS implementations..." said Elizabeth Waldorf.
The latest implementation documents, published by GS1 US on May 26th, 2023, serve as an EPCIS serialized data exchange implementation blueprint for companies across the US pharmaceutical and healthcare supply chain.
The expanded documentation provides detailed descriptions of end-to-end trading partner event choreographies for serialized item traceability use cases under DSCSA.

IFF Completes Divestiture of Flavor Specialty Ingredients Business

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수요일, 8월 2, 2023

IFF (NYSE:IFF) today announced that it successfully completed the previously announced divestiture of its Flavor Specialty Ingredients (FSI) business to Exponent, a leading UK-based private equity firm, on August 1, 2023.

Key Points:

IFF (NYSE:IFF) today announced that it successfully completed the previously announced divestiture of its Flavor Specialty Ingredients (FSI) business to Exponent, a leading UK-based private equity firm, on August 1, 2023.
“The sale of our FSI business unit is another step in our journey to continuously maximize value,” said Frank Clyburn, IFF CEO.
“Portfolio optimization is a central part of our ongoing strategy to improve growth and returns.
This focus allows us to concentrate on our most attractive businesses and strengthen our capital structure by reducing outstanding debt.

TraceLink Accelerates DSCSA 2023 Customer Readiness, Supply Chain Digitalization, and Drug Shortage Predictability in Second Quarter of 2023

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목요일, 7월 27, 2023

EPCIS, Pharmacy, Intelligence, MINT, Drug Quality and Security Act, Patient, DSCSA, Satellite navigation device, Nursing, Medical device

BOSTON, July 27, 2023 /PRNewswire/ -- TraceLink Inc., the leading digital network platform company enabling end-to-end product orchestration by connecting more than 290,000 healthcare and life sciences entities through its B2N Integrate-Once™ network, today announced significant business growth and rapidly accelerating network adoption. With the looming Drug Supply Chain Security Act (DSCSA) compliance deadline on November 27, 2023, pharmaceutical supply chain companies continue to expand digital network connections on the TraceLink network to improve supply chain performance and leverage the extensive serialization and track-and-trace network foundation to tackle the ongoing challenges of drug shortages.

Key Points:

With the looming Drug Supply Chain Security Act (DSCSA) compliance deadline on November 27, 2023, pharmaceutical supply chain companies continue to expand digital network connections on the TraceLink network to improve supply chain performance and leverage the extensive serialization and track-and-trace network foundation to tackle the ongoing challenges of drug shortages.
Key highlights of the quarter include:
43 new customer accounts and 90 new customer projects initiated for DSCSA compliance.
Launched the Multienterprise Information Network Tower (MINT) solution to power end-to-end, real-time supply chain visibility and multienterprise process collaboration.
The TraceLink conference focused on DSCSA 2023 readiness plans, emerging opportunities to address drug shortages by leveraging AI with supply chain data, and building a foundation for supply chain digitalization to drive better end-to-end visibility, collaboration, and intelligence.

TraceLink Accelerates DSCSA 2023 Customer Readiness, Supply Chain Digitalization, and Drug Shortage Predictability in Second Quarter of 2023

Retrieved on:

목요일, 7월 27, 2023

EPCIS, Pharmacy, Intelligence, MINT, Drug Quality and Security Act, Patient, DSCSA, Satellite navigation device, Nursing, Medical device

BOSTON, July 27, 2023 /PRNewswire/ -- TraceLink Inc., the leading digital network platform company enabling end-to-end product orchestration by connecting more than 290,000 healthcare and life sciences entities through its B2N Integrate-Once™ network, today announced significant business growth and rapidly accelerating network adoption. With the looming Drug Supply Chain Security Act (DSCSA) compliance deadline on November 27, 2023, pharmaceutical supply chain companies continue to expand digital network connections on the TraceLink network to improve supply chain performance and leverage the extensive serialization and track-and-trace network foundation to tackle the ongoing challenges of drug shortages.

Key Points:

With the looming Drug Supply Chain Security Act (DSCSA) compliance deadline on November 27, 2023, pharmaceutical supply chain companies continue to expand digital network connections on the TraceLink network to improve supply chain performance and leverage the extensive serialization and track-and-trace network foundation to tackle the ongoing challenges of drug shortages.
Key highlights of the quarter include:
43 new customer accounts and 90 new customer projects initiated for DSCSA compliance.
Launched the Multienterprise Information Network Tower (MINT) solution to power end-to-end, real-time supply chain visibility and multienterprise process collaboration.
The TraceLink conference focused on DSCSA 2023 readiness plans, emerging opportunities to address drug shortages by leveraging AI with supply chain data, and building a foundation for supply chain digitalization to drive better end-to-end visibility, collaboration, and intelligence.