Showing posts with label deadlines. Show all posts
Showing posts with label deadlines. Show all posts

Monday, June 24, 2024

The FDA On DSCSA Deadlines For Small Pharmacies

The FDA is offering exemptions to the DSCSA deadlines for small dispensers (pharmacies).

This probably doesn't come as a surprise, yet this could have some ramifications for other trading partners.

Read more about:  

FDA Grants Exemptions to Small Dispensers - Waivers and Exemptions Beyond the Stabilization Period - FDA.gov

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Thursday, October 19, 2017

Cutting Through the DSCSA Confusion | Healthcare Packaging

The FDA guidance, deadlines, and the role(s) your company play(s), all contribute to the confusion.

Read the full summary:  Cutting Through the DSCSA Confusion | Healthcare Packaging:

"At a Global Track & Trace event held last week in New Jersey, Gordon Glass, Vice President Consulting, Excellis Health Solutions, updated attendees with key insights and important lenses through which to view and interpret the likely-to-be-postponed regulations."

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Monday, July 11, 2016

The Race for Track & Trace: Are 3PLs ready for serialization?

Read the full article: The Race for Track & Trace: Are 3PLs ready for serialization?:

. . ."Phase II, which goes into effect beginning in November 2017, requires item-level serialization and poses a real challenge for 3PLs.

Brian Daleiden, vice president of industry marketing at TraceLink, a cloud-based track-and-trace network, warned that many 3PLs are only starting to realize the potential issues and complications they face. “If you’re a pharmaceutical company supplying products covered under DSCSA, working with 3PLs, and you are not today having any active conversations about what your plans and expectations are, you are creating serious risk for your ability to supply products and meet the serialization deadlines,” he said. “Not to say compliance cannot be reached, but you should be having the conversation today.”"

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
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Tuesday, November 18, 2014

Expert cautions: DSCSA deadlines may cause drug shortages - in-Pharma Technologist

Updated August 18, 2026

The original link broke.  You might also like:

Drug Supply Chain Security Act (DSCSA) - FDA.gov:
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

---  the original post follows below  ---

Read the full article: Expert cautions: DSCSA deadlines may cause drug shortages - in-Pharma Technologist:

"Supply chain consultant Dirk Rodgers wrote recently that wholesale distributors are having issues getting in touch with suppliers in order to meet one of the first deadlines of the DSCSA, which, after Jan. 1, 2015, requires all drugs transported through the supply chain to be accompanied by transaction information, transaction history and transaction statements.

“The real problem is that, despite many attempts by wholesale distributors to contact their suppliers to find out their ability to provide that information on that date, no response has been received from a significant percentage of those suppliers,” Rodgers says. "

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):
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