DRUG FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME

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"Since December 2020, there have been reports of both distributors as well as several of their pharmacy customers receiving telephone calls and/or emails as part of a sophisticated “phishing” scam to unlawfully divert pharmaceutical goods in transit."

"RECOMMENDED ACTIONS TO PROTECT DISTRIBUTORS: RISK MITIGATION

There are several ways to validate correspondences with what appear to be legitimate distributor customers: ... "

Go to the following source document to view the complete list of recommended actions.

Source:   FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME Version 2 (Updated June 2022) - HDAPCSC (PDF)

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training 
• 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

Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

• Recommended online training courses and programs:
• California Board-approved Designated Representative training for:
      Wholesalers | 3PL | Reverse Distributors
• FDA cGMP training by SkillsPlus International Inc. 

According to the article:

"With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations."

... "she noted. “That outbound scanning is expected to increase labor by a minimum of 12 to 15% based on recent time studies. As an example, a distribution center with a 50-person night crew will need to hire six additional people just to support the outbound scanning.”"

Read the full source article:  Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

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

#CaliforniaDesignatedRepresentative #CaliforniaDesRep

The Latest Activities Related To The DSCSA - FDA Website

• California Designated Representative training courses for: 
       Wholesalers | 3PL | Reverse Distributors
• Recommended FDA CGMP online training courses and programs by SkillsPlus International Inc. 

Latest Activity - Drug Supply Chain Security Act (DSCSA)

I like how the FDA is listing and reporting activity related to the DSCSA. They're now providing links to pertinent activities in a section called "Latest Activity."

According to the referenced FDA webpage:

"The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually."

Go to:  Drug Supply Chain Security Act (DSCSA) - FDA.gov

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