Showing posts with label implementation. Show all posts
Showing posts with label implementation. Show all posts

Friday, June 9, 2023

DSCSA Readiness - A Long Way To Go

Updated July 31, 2026

Companies Are Not Ready

The end to end pharmaceutical supply chain still isn't ready for DSCSA implementation.

Some articles are warning that the November 2023 date will be a challenge:

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Tuesday, September 30, 2014

Will The FDA Delay The DSCSA? - Rx Trace

Read the full article:  Will The FDA Delay The DSCSA? - Rx Trace:

"More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27" . . .

'via Blog this'

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Wednesday, June 26, 2013

Tuesday, May 28, 2013

Dirk Rodgers on Pedigree Law (Federal & CA) & Funding

Updated July 10, 2026

The post didn't age well.

Instead, you might 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  ---

The California Pedigree Law implementation date is fast approaching . . .

Would A U.S. Federal Pedigree Law Require A New UFA?:

"NOTE: We are just about 1-1/2 years away from January 1, 2015, the first date that manufacturers must serialize some of their drugs and start drug pedigrees. From this point on, time is going to go by pretty fast for companies who are not yet ready."

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Sunday, March 11, 2012

E-Pedigree Agenda Item - CA Pharmacy Board Meeting 3-21-2012

Updated 4/19/2012 with the following:

The CA Board of Pharmacy just emailed this out:

"On behalf of the Board of Pharmacy, the Department of Consumer Affairs today added to its website the webcast of its March 21, 2012 Enforcement Committee/e-Pedigree Meeting.  At this meeting, presentations were made by FDA and multiple supply chain members.  . . .

To view the webcast of the March 21, 2012 meeting go to:
http://www.dca.ca.gov/publications/multimedia/pharm_20120321.wmv  "


Note:  I hope you've got patience with the wmv download.  I didn't have 2 hours worth of patience to wait for the download.

- - - - original post follows - - - -

According to this California Board of Pharmacy NOTICE OF MEETING AND AGENDA - Enforcement Committee and E‐Pedigree Public Meeting - March 21, 2012:

Here's what's listed under this agenda item, Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication:

a. Discussion about the Presence of Counterfeit Avastin in California Physician Offices
b. Presentation and Discussion of a Proposal for Federal Legislation by the Pharmaceutical Distribution Security Alliance
c. Presentation by Connie T. Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Center for Drug Evaluation and Research, US Food and Drug Administration
d. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Kimberly Fleming, Senior Manager, Product Security, EMD Serono, Inc, 2. Robert Celeste, Director, Healthcare, GS1 US 3. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
e. General Discussion
f. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
f. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to section 4163.2 of the Business and Professions

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