Merry Christmas to Designated Representatives & Exemptees

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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

CA Designated Representative License Application - California Board of Pharmacy

• California Designated Representative Training Courses for wholesalers, 3PL, or reverse distributors - Approved by the California State Board of Pharmacy

California Designated Representative License Applications

Updated April 5, 2018

California Board of Pharmacy - Apply for a License: "Designated Representative (Exemptee)

Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations. The Designated Representative application forms may be obtained by download only."

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California Designated Representative Training Courses for wholesalers, 3PL, or reverse distributors - 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 - 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

Keywords & Phrases:
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#approved #accepted #recognized #certified #online #web #training #certification #affidavit #course #class #program #webinar #seminar #workshop #event #elearning #certificate #provider #vendor #seller #register #registration

Full-line distributor sales topped $300 billion in 2012 - DQSA lot/item level tracking stats

Full-line distributor sales topped $300 billion in 2012, representing 91% of pharma sales - Pharmaceutical Commerce:

"The Factbook contains operational details often of high interest to vendors serving wholesalers’ infrastructure needs. One particular number to call out: two out of three HDMA members are already tracking lot-level barcodes through their systems for at least some of their products. Lot-level tracking is now the centerpiece of the Drug Quality and Security Act, which will mandate such tracking over the next four years. Data on item-level tracking (the next stage in DQSA) is occurring, but at significantly lower percentages."

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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

FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

• Purchase a California Designated Representative training course for:  
       Wholesalers | 3PL | Reverse Distributors

Updated April 19, 2022

All the links broke in the original post.

You'll be interested in:

• Human Drug Compounding - FDA.gov
• Compounding Research - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

- - -  original post follows below  - - -

The FDA just published 3 new draft guidances related to compounding. 


In a nutshell, they cover: earlier guidance prohibitions; "outsourcing facilities" (OF) voluntary registration; and how OF's should report their compounded drugs.

Category	Title	Type	Date
Procedural	Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)	Draft Guidance	12/02/13
Procedural	Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)	Draft Guidance	12/02/13
Procedural	Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)	Draft Guidance	12/02/13

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

What To Do When Your Florida CDR Quits

• Check out Florida Certified Designated Representative training for wholesalers by CDR Resource Center. Learn more today. Florida Certified Designated Representative (CDR) laws and rules examination preparation. Consulting expertise in prescription drug regulations and wholesale distribution compliance. State licensing support.
• You might also be interested in:  Florida CDR Recruitment Services Page - CDR Resource Center

What To Do When Your FL CDR Quits

Here's what the Florida Division of Drugs, Devices and Cosmetics says . . .

Customer Help:   "DIVISION OF DRUGS, DEVICES AND COSMETICS

My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do?

Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

The Department can, upon written request to appropriate personnel, provide a list of all unaffiliated CDR’s."

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

Certified Designated Representative (CDR) - FL DBPR DDC Program

Certified Designated Representative (CDR) - FL Dept of Business and Professional Regulation:  

"DIVISION OF DRUGS, DEVICES AND COSMETICS

CERTIFIED DESIGNATED REPRESENTATIVE

All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."

Return Home:  The Designated Representative and Exemptee Blog

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