FDA Issues Warning Letter To McKesson For DSCSA Violations

• California Designated Representative Training Course for Wholesalers (approved by the California State Board of Pharmacy) - earns a Board-acceptable training affidavit
• Buy a course now for: wholesalers | 3PL | reverse distributors

Updated June 20, 2025

The original link to the article broke.

---  the original post follows below  ---

Read the full article:  First Warning Letter Issued Under DSCSA - FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping - Healthcare Packaging

"According to the letter to McKesson, “The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.”  . . . 

The letter highlights two other examples in which the firm did not demonstrate proper quarantining of suspect product or provide records to show that requirements were met in identifying illegitimate product or subsequent requirements."

Read the FDA warning letter:  McKesson Corporation Headquarters 2/7/19 - FDA Warning Letter

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers, 3PL, reverse distributors

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 Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org

• California Designated Representative Training for Wholesalers (approved by the California State Board of Pharmacy). Or buy a course for: 3PL | Reverse Distributors.

• FDA QSR and cGMP Training Courses

Read the full news article:   FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org

"“Transaction data for prescription drug purchases from the firm show that lot/batch numbers are not captured/retained; as such the firm does not have sufficient processes in place to determine and notify, within 24 hours, all the immediate trading partners that the firm had reason to believe may have received illegitimate product,” the 483 says."

Read the FDA Form 483:   McKesson Corporation, San Francisco, CA. Form 483 issued 07/03/2018 (PDF)

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy)

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."

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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

McKesson pays $18 million to settle CDC shipping allegations | Modern Healthcare

Read the full article: McKesson pays $18 million to settle CDC shipping allegations | Modern Healthcare:

"McKesson contracted with the CDC for its Vaccines for Children program, which provides federally purchased vaccines to children age 18 and younger. McKesson distributed the vaccines from manufacturers to healthcare providers. According to the government contract, the shipping of vaccines requires temperature monitors in each box, and those monitors must be programmed to detect if the air temperature falls below 2 degrees Celsius or rises above 8 degrees Celsius. The Department of Justice alleged McKesson did not set the temperature monitors to the proper range, yet still submitted claims for services. "

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Related articles

• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  Florida Certified Designated Representative (CDR) Exam Prep
• 
  About The HMDR Licensing Program

Drug Wholesaler, McKesson, to Pay States $151 Million to Settle Drug Pricing Allegations

• California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc., Board-approved training programs 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 September 30, 2020

The original link broke.  You might still be interested in:

MCKESSON TO PAY $151M TO SETTLE DRUG-PRICING SUIT - HealthLeaders

- - -  the original post follows below  - - -

McKesson to Pay States $151 Million to Settle Drug Pricing Allegations:

"McKesson Corp. (MCK) has agreed to pay California and 29 other states a total of $151 million to settle allegations that it inflated prescription drug prices, causing states' Medicaid programs to overpay pharmacy reimbursements by millions of dollars, according to the California Department of Justice.

The payment is in addition to an April settlement that had McKesson paying more than $190 million to the federal government to resolve similar claims."

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• California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc., Board-approved training programs 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