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

• 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 August 12, 2023

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

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

FDA Summary - 2013 Compounding Pharmacy Inspections

• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

Updated Aug 28, 2020:

You might also be interested in this FDA webpage:  Human Drug Compounding - FDA.gov

or

this recent headline story:  Cardinal Health sued over alleged fraudulently obtained contracts - SeekingAlpha.com

- - -   original post follows below   - - -

Pharmacy Compounding > Summary: 2013 FDA Pharmacy Inspection Assignment:

"The agency is currently evaluating the information obtained during the inspections and where applicable, will apply its existing legal authority to protect the public health. For the firms that are operating outside the bounds of traditional pharmacy compounding and who had significant sterile production issues, FDA plans to take aggressive action, including through enforcement actions, as appropriate."

Return Home:  The Designated Representative and Exemptee Blog

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• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Round 2 Contract Suppliers Listed

• California HMDR Exemptee Training Certification Course - for home medical device retailers.

CMS Announces Round Two Contractors -- HME Business:

"Finding Contract Holders

To find Round Two contract holder, the Competitive Bidding Implementation Contractor, Palmetto GBA, has released a PDF listing all the contract holders at [. . .]

Also, CMS’s online searchable supplier directory is already showing which providers are holding competitive bidding contracts. To find the contract-holders for specific categories in specific areas, visit [. . .]  and enter the zip code in question; select up to five product categories; and then scroll down and click the green “search” button."

Resources:
Medicare.gov - Supplier Directory - Find a Supplier by Zip Code

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course - for home medical device retailers.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute