Showing posts with label meeting. Show all posts
Showing posts with label meeting. Show all posts

Wednesday, June 26, 2013

Tuesday, April 30, 2013

e-Pedigree Updates - CA Rx Board - Enforcement Comm Mtg 3/14/13

  • If you need a California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application. Board-approved California Designated Representative courses: - Wholesaler Training Course - 3PL Training Course - Reverse Distributor Training Course    ---  NEARLY 10,000 STUDENTS HAVE TAKEN OUR STATE LICENSE-RELATED TRAINING COURSES  ---

Updated December 5, 2025

The meeting minutes link in the original post has been updated.

---  the original post follows below  ---

More e-Pedigree conversations, taking place at CA Board of Pharmacy meetings.

[The video link has been removed]

Here's a video from the Enforcement Committee Meeting of March 14, 2013 that covers the following agenda items (Tip: e-Pedigree discussion starts at the 2 hr & 9 min mark):

Discussion on the Implementation of California’s Electronic Pedigree - Requirements for Prescription Medication
  • A. Update on the Status of Proposed Regulations to Implement Serialized Numeric Identifiers, Grandfathering and Manufacturer Reporting of How the 50 Percent Threshold of Serialized Products on January 1, 2015 Has Been Determined (Proposals to Add Title 16, California Code of Regulations, Sections 1747 and 1747.1)
  • B. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E-Pedigree Implementation Schedule
  • C. Discussion Concerning Elements for Possible Regulation Requirements to Permit Inference as Provided by California Business and Professions Code Section 4163
  • D. Discussion on the Certification Process to Comply with California’s E-Pedigree Law
  • E. Discussion on the Use of Drop Shipments in an E-Pedigree System
  • F. General Discussion/Questions and Answers
Additional information:
Meeting minutes

Return Home:  The Designated Representative and Exemptee Blog


- - -

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):

Monday, June 4, 2012

CA Board of Pharmacy - June 12, 2012 Mtg - e-Pedigree Agenda Item

Updated May 2, 2022

Minutes of this meeting:
Minutes - Enforcement Committee and E‐Pedigree Public Meeting - June 12, 2012

- - - - -

Here's the e-Pedigree agenda item.

California Board of Pharmacy - Enforcement Committee and E‐Pedigree Public Meetings - June 12, 2012 Agenda

II. Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication

a. Discussion about the Presence of Counterfeit Avastin and Altuzan in California Physician Offices and Clinics
b. Dysfunction In California’s Supply of Prescription Medication Discovered During Board of Pharmacy Investigations
c. Board of Pharmacy’s Letters to Federal Representatives and Senators on Elements Needed in any Proposal for Federal Legislation
d. Colloquy from Senators Enzi and Harkin in Support of Retaining Protections in California Law in Future Federal Requirements for Tracking Prescription Medications Through Pharmaceutical Supply Chain
e. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Robert Celeste, Director, Healthcare, GS1 US 2. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
f. General Discussion
g. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
h. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to Section 4163.2 of the Business and Professions Code
i. Discussion concerning Elements for Inference as Provided by California Business and Professions Code Section 4163.3
j. Closing Comments

Return Home:  The Designated Representative and Exemptee Blog

- - -

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):

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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California Designated Representative Training Courses - Accepted by the California Board of Pharmacy - Earn a training affidavit to include in your license application


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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):


Friday, September 9, 2011

CA e-Pedigree - Board of Pharmacy Mtg Update - Sept 7, 2011

Updated 12/6/2011:

The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

Return Home:  The Designated Representative and Exemptee Blog

- - -

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):

Friday, September 2, 2011

CA e-Pedigree - Nice Analysis

Big Sur Coast in Central California looking so...Image via Wikipedia
Updated May 26, 2022:
California Board of Pharmacy Re-awaken:  'via Blog this'

If you're following the evolution of California e-Pedigree, then you'll want to read this analysis by Dirk Rodgers.

The key takeaway for me is, Board of Pharmacy guidance is needed before folks can plan and act:
". . . the Board needs to provide some guidance on, but there are some other very important questions that need to be answered before companies are likely to fully invest in pedigree solutions.  Here I’m referring to both solution providers and companies within the supply chain."

Return Home:  The Designated Representative and Exemptee Blog

- - -

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):

Thursday, August 18, 2011

e-Pedigree Requirements - CA Board of Pharmacy

According to a recent CA Board of Pharmacy email notification:

The Board of Pharmacy announces it has consolidated its September
Enforcement Committee Meeting into a Board Meeting, and will hold this
meeting on September 7, 2011 in Los Angeles.  An agenda will be released
before the end of August. 
The principal discussion item at this meeting will be California’s e-pedigree
requirements
The location of the meeting is:
Health Services Department Auditorium
313 North Figueroa Street
Los Angeles, CA 90012
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