Training Affidavit For California Designated Representatives

Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

Looking for a California Designated Representative training program?

YOU NEED A TRAINING AFFIDAVIT – If you need a training affidavit as proof of completing a training program, as part of your California Designated Representative or  CA Designated Representative-3PL license application, then keep reading.

WE CAN HELP YOU
Buy one of our courses:  Designated Representative Training Programs by SkillsPlus Intl Inc.  –  These online self-study courses are $525 per student, and they are approved by the California Board of Pharmacy. Learn more about our CA Designated Representative training programs. When you’ve successfully completed a program, simply request your copies of completed training affidavits.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Home Medical Device Retail Exemptee Online Training Certificate – HMDR

The Home Medical Device Retailer Exemptee License Application requires proof of HMDR Exemptee training program completion.

SkillsPlus International Inc. offers an Exemptee training program (that covers topics specified by the California Dept of Public Health – Food and Drug Branch). Upon successful completion of this training course, the student will receive a certificate of completion, that is acceptable to the CDPH FDB.

Learn more about Exemptee training by SkillsPlus Intl Inc.
Buy and register now! – SkillsPlus Intl Inc. Exemptee Training Course

HMDR Exemptee Training

 


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Wholesaler Application Instructions – CA Board of Pharmacy

Drug capsules orbiting the earth

“A wholesaler permit is required before any firm or organization who sells for resale or negotiates for distribution, may distribute, broker or transact the sale or return of dangerous drugs or dangerous devices in California. Wholesalers sell and distribute dangerous drugs and dangerous devices (also called “legend” items or prescription-required drugs and devices) to other business entities who are authorized by law to purchase the items or sell to licensed health care providers who are authorized by law to possess the dangerous drugs and dangerous devices.”

View the complete set of instructions: Source: California Board of Pharmacy – Wholesaler Application Instructions

Drug wholesaler applicants will also need to have a Designated Representative.
SkillsPlus Intl Inc. offers an online training course designed for Designated Representative applicants.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Exemptee Training

Law books, scale, and gavelAccording to the Home Medical Device Retailer Licensing Program:

“This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.”

HMDR Exemptee applicants must provide proof of training (concerning applicable laws and regulations) in their application submission.

If you are seeking exemptee training, go to:
Exemptee Training offered by SkillsPlus Intl Inc.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Florida Certified Designated Representative (CDR) Application Available Online

Vitamin bottles and pillsHere’s how to find the FL CDR application form online.

Go to the following webpage:
Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics – Certified Designated Representative

Then scroll down to the bottom of the page, and click on:
Apply Using A Printable Application

If you need help, the page states:
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.

You might also be interested in:


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Florida Certified Designated Representative (CDR) Required For Wholesale Distributors

Law books, gavel, scaleThe Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics answers the question, “Does my company need a permit?”  Their answer includes a helpful chart, definitions, and a link to relevant Florida statutes

Prescription drug wholesalers need to have a Florida Certified Designated Representative (CDR):

“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”).”

Source: Certified Designated Representative – Florida Department of Business & Professional Regulation

Buy Now!
FL Certified Designated Representative (CDR) online exam prep course by SkillsPlus Intl Inc. – Lots of practice exams – Practice makes perfect! – Available around-the-clock 24 x 7


Go to DREprof.com: The Designated Representative and Exemptee Training Website

New CA Licenses Required For Third-Party Logistics Providers (3PLs)

Wood gavel on stack of red law booksThis announcement was just sent by the California Board of Pharmacy:

“Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy.

Formerly, these entities were licensed as wholesalers or nonresident wholesalers by the Board of Pharmacy, but with passage of federal legislation in November 2013 and Assembly Bill 2605 (Bonilla) in 2014, entities that were previously licensed by the board as wholesalers need to obtain a different license as a third-party logistics provider as well as designate a responsible manager and secure licensure of specialized employees who will serve as designated representatives – 3PLs.

Wholesalers that operate as 3PLs need to work with the board to achieve compliance and become properly licensed.

To view the legislation, go to: http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml

For a 3PL application, go to: http://www.pharmacy.ca.gov/applicants/index.shtml

For more information, call the Board of Pharmacy at: (916) 574-7900.”

You might also be interested in:

Link to AB-2605 Pharmacy: third-party logistics providers.(2013-2014)


Go to DREprof.com: The Designated Representative and Exemptee Training Website

 

California HMDR Exemptee – Minimum Qualifications

Woman pondering a question

Many California Home Medical Device Retailer (HMDR) Exemptee applicants have questions about the minimum qualifications for Exemptee eligibility.

If you navigate to, and open up the HMDR Exemptee Application (PDF), here’s what you’ll see:

Minimum qualifications:

  • Education: High school diploma GED or equivalent. Attach copies of any applicable certifications or licenses that you may hold.
  • On-the-Job Training: Attach copies of current employer’s training records listing job-specific training provided and dates completed.
  • Work Experience: One or more years paid experience, attach dates, name(s) of employer(s), and addresses. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent.
  • Training Programs: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.”

Source (as of the date of this blog post):
State of California – Health and Human Services Agency – California Department of Public Health Food and Drug Branch – Application For Home Medical Device Retailer Exemptee License – New and Renewal (Form CDPH 8695 (09/09))


Go to DREprof.com: The Designated Representative and Exemptee Training Website

 

Wishful Thinking?! Both Work Experience AND Training Are Required

eLearning - Online TrainingThis topic is coming up a lot lately. There appears to be confusion about whether work experience satisfies the training program requirement, or vice versa.

In a nutshell, if you are applying for a California Designated Representative or Exemptee License, you’ll have to meet both the work experience requirement, and the training program requirement (i.e., completing a training program that addresses key subjects/topics).

Work experience does not substitute for the training program, and the training program does not substitute for work experience.

References:

  1. Application For Home Medical Device Retailer Exemptee License – New And Renewal (CDPH Food & Drug Branch) – PDF  
  2. Designated Representative Requirements And Application (CA State Board of Pharmacy) – PDF

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Apply for a Designated Representative License – CA Board of Pharmacy

Follow the link below to find and download the application form that you need, including Designated Representative, and Wholesaler applications:

“Apply for a License – Please select the license type you wish to apply for to download the application and instructions.” – via CA Board of Pharmacy – Apply for a License.


 

Go to DREprof.com: The Designated Representative and Exemptee Training Website

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