Monday, August 5, 2019

Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace

Read the full article:  Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace.com


According to Dirk Rodgers:

"Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets?  Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost."

His analysis of the situation is a worthy read.

You might also be interested in his book, "The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances 2nd Edition:"




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California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.
California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

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 1, 2019

Suspicious Phone Calls To Board Licensees

Updated March 14, 2026

You might also be interested in: 

Alert: Beware of Scam Letters and/or Phone Calls (PDF): 
https://www.pharmacy.ca.gov/licensees/letter_phone_scam.pdf

- - -  original post follows below  - - -

IMPORTANT: Suspicious Phone Calls to Licensees - An alert from the California State Board of Pharmacy

The Board emailed this alert:

"The California State Board of Pharmacy has learned that several licensees recently have received phone calls from scam artists claiming to be board inspectors or DEA agents calling about investigation matters.

At least one caller impersonating a board inspector gave a fake name, “Peter Williams.” It is unclear what kind of information the callers are seeking.

If you have questions or doubts about a caller claiming to work for the Board of Pharmacy, please contact the board at (916) 518-3100. Remember that board inspectors will NEVER request any form of payment by telephone."

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California Designated Representative Training Programs. Largest selection of Board-approved Designated Representative online courses. 3 distinct classes for: wholesalers; 3PL; reverse distributors. Earns a training affidavit accepted by the Board.
California Designated Representative Training Programs. Largest selection of Board-approved Designated Representative online courses. 3 distinct classes for: wholesalers; 3PL; reverse distributors. Earns a training affidavit accepted by the Board.

- - - 


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):

Saturday, July 27, 2019

Wholesaler Dangerous Drugs & Dangerous Devices Self-Assessment Forms

Go to the webpage:
Wholesaler Dangerous Drugs & Dangerous Devices Self-Assessment Forms - California State Board of Pharmacy

According to the Board:

"The assessment shall be performed before July 1 of every odd-numbered year. The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff. 
The board is in the process of updating the Self-Assessment forms through a formal rulemaking.  The updates include references to statutory and regulatory changes that occurred between 2014 and 2016.  The last time the forms were formally updated was 2014. 
Current regulation requires a pharmacy or wholesaler to complete the 2014 version of the Self-Assessment form.  Please be advised, however, the board will accept completion of either the 2014 version OR the 2016 version.  The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it."

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California Designated Representative Training Program for Wholesalers. Board-approved. Earns a training affidavit accepted by the Board.
California Designated Representative Training Program for Wholesalers. Board-approved. Earns a training affidavit accepted by the Board.

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, July 26, 2019

California Designated Representative Forms

California State Board of Pharmacy - Designated Representative Personal License Application Forms

Get your California Designated Representative personal license application forms here:
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California Designated Representative training programs. 3 Board-approved courses for: wholesaler, 3PL, reverse distributor. Earns a training affidavit.
California Designated Representative training programs. 3 Board-approved courses for: wholesaler, 3PL, reverse distributor. Earns a training affidavit.

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):

Tuesday, July 23, 2019

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

Read the full text of the Op-Ed:  Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

From the Op-Ed:
"As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.  ... 
Importation laws undermine the country’s progress in building a modern technology infrastructure to track and trace prescription drugs. Making exceptions to the in-progress track-and-trace system would ignore the many instances of drug diversion and counterfeiting that led to the creation and passage of the law in 2013."

The Op-Ed covers the following areas:
  • State drug importation laws undermine the process that keeps our supply chain safe
  • Why the U.S. is building a track-and-trace system 
  • How track-and-trace works 
  • Importation undermines the track-and-trace system
  • Importation enables counterfeits 
  • Forgetting the lessons 
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California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.

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):

Drug Return Company Ordered to Pay $94 Million in Restitution and $15 Million in Fines for Refund Scheme - FrierLevitt.com


Read the full article:  Drug Return Company Ordered to Pay $94 Million in Restitution and $15 Million in Fines for Refund Scheme - FrierLevitt.com

"Earlier this month, a Pennsylvania federal judge ordered Devos Ltd., a drug return company, to pay over $94 million in restitution and $15 million in fines for failing to channel refunds back to customers and keeping the money for itself. Devos, which does business as Guaranteed Returns" ...

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The only Board-approved California Designated Representative online training course approved for reverse distributors. Earns a training affidavit accepted by the California State Board of Pharmacy.
The only Board-approved California Designated Representative online training course approved for reverse distributors. Earns a training affidavit accepted by the California State Board of Pharmacy.

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):

Tuesday, July 9, 2019

California Designated Representatives Can Renew Licenses By Credit Card

The California State Board of Pharmacy recently included this item in a July 1, 2019 Board of Pharmacy Update:

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California Designated Representative Training Course For Wholesalers. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Course For Wholesalers. Earns a training affidavit accepted by the California State Board of Pharmacy.



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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