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

Return Home:  The Designated Representative and Exemptee Blog

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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

FRAUD ALERT: Scammers Diverting Drug Shipments from Distributors, Pharmacies

• Board-approved California Designated Representative online training courses for: 
      Wholesalers | 3PL | Reverse Distributors

Here is the full text of an email alert sent by the California State Board of Pharmacy:

"Pharmacies, hospitals, and distributors are being warned about scammers using sophisticated techniques to obtain account numbers and other sensitive information and unlawfully divert quantities of pharmaceutical goods in transit. In some cases, scammers pretended to represent the state’s board of pharmacy or employees for a particular distributor or pharmacy.

The callers requested and obtained each pharmacy’s DEA number and account purchasing information for their principal distributor. The scammers then called each distributor – pretending to be the pharmacy – and ordered between $100,000 and $300,000 worth of products. Common products ordered included a variety of HIV medications (Descovy, Triumeq, Odefsey) and Xarelto, Otezla, and Eliquis.

Once the products were delivered, the scammers called the pharmacy – pretending to be the distributor – and advised the pharmacy the order was made in error. The scammers then arranged for a courier to pick up the diverted product.

The Healthcare Distribution Alliance Pharmaceutical Cargo Security Coalition (HDAPCSC) has released a report about this problem: “Fraud Alert: Distributor/Customer Product Ordering Scheme,” Version 2 (Updated June 2022). The report discusses methods being used to divert drug shipments and tips for protecting distributors and pharmacies.

The California State Board of Pharmacy urges drug distributors and pharmacists to read the report and learn how to spot fraudulent activity and prevent drug diversion."

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Source: 

FRAUD ALERT: Scammers Diverting Drug Shipments from Distributors, Pharmacies (an email alert sent by the California State Board of Pharmacy on June 24, 2022)

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

New NCPA Report Highlights How Drug Wholesalers, Independent Drugstores Profit From Generic Price - PRNewswire

Read the full article: New NCPA Report Highlights How Drug Wholesalers, Independent Drugstores Profit From Generic Price... -- WASHINGTON, Sept. 28, 2015 /PRNewswire-USNewswire/ --:

"NCPA's report outlines several reasons for generic drug price increases within the supply chain and offers new insights into both wholesalers and pharmacies:"

'via Blog this'

. . .  specifically, the article calls out:

• Drug Wholesalers, and
• Independent Drugstores and the "Gray Market."

Note:  in this article, NCPA means the National Center for Policy Analysis

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

New Cardinal and McKesson Customer Deals Show A Changing Generic Channel - Drug Channels

• Popular California Designated Representative online training programs/courses for wholesalers, 3PL, and reverse distributors. Board-approved. Offered by SkillsPlus International Inc.

Read the full article: Drug Channels: New Cardinal and McKesson Customer Deals Show A Changing Generic Channel:

"These latest deals show how generic purchasing consortia are accelerating business alignment between pharmacies and their wholesaler suppliers.

The deals also signal further generic purchasing consolidation. For both brand-name and generic drug manufacturers, a robust channel strategy function is more important than ever."

'via Blog this'

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Return Home:  The Designated Representative and Exemptee Blog

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

Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession

New Poll Finds Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession | Business Wire:

"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."

Return Home:  The Designated Representative and Exemptee Blog

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

Drug Channels: 12 Fastest-Growing, Private Specialty Pharmacies

Drug Channels: Say Hello to the 12 Fastest-Growing, Private Specialty Pharmacies:

"The 2013 Inc. 500 list, which is based on 2012 revenues, includes 12 specialty pharmacies. The pharmacies and their key stats are listed below, along with recent specialty forecasts. Diplomat Pharmacy again topped the specialty pharmacy list, with revenues of $1.1 billion, up 42% vs. 2011. The other 11 pharmacies had total revenues of $1.3 billion.

Pay attention: these companies are the vanguard of tomorrow’s pharmacy industry."

Return Home:  The Designated Representative and Exemptee Blog

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

FDA - 2013 Pharmacy Inspections - Form 483 Observations

The FDA is posting their observations, via Form 483, of pharmacies that they've inspected re: compounding.

ORA FOIA Electronic Reading Room > 2013 Pharmacy Inspections:

"2013 Pharmacy Inspections"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog

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