Amazon to sell exclusive brand of consumer medical devices - Becker's Hospital Review

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• California Home Medical Device Retailer - HMDR Exemptee Training Certification Course  (accepted by the California Department of Public Health - Food and Drug Branch)

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Read the full article: 

Amazon to sell exclusive brand of consumer medical devices - Becker's Hospital Review

"Amazon, through a partnership with health brand consultancy Arcadia Group, will sell an exclusive new brand of consumer-focused medical devices, including blood pressure cuffs and glucose monitors" . . . 

"Arcadia Group said it had created a brand of at-home medical devices for Amazon, called Choice. It will be sold exclusively on the e-commerce giant's website."

Return Home:  The Designated Representative and Exemptee Blog

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California Home Medical Device Retailer - HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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 Publishes DSCSA-Related Guidance on Verification Systems

• California Designated Representative Training (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
• Sign-up for a course now, for:
     Wholesalers | 3PL | Reverse Distributors

Updated May 19, 2019

You might also be interested in a collection of the FDA's DSCSA-related guidances, all in one location:

Drug Supply Chain Security Act Law and Policies - FDA.gov

- - - original post follows below - - -

According to this newly published FDA guidance:

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF)

"Certain trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) are required to have verification systems in place" . . .

Background  

Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), established requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain.

FDA is issuing this guidance to describe FDA’s interpretation of the requirements of section 582 of the FD&C Act regarding verification systems. This guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products.

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - 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

California Designated Representative - Continuing Education

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy) | Buy a course now, for: wholesalers, 3PL, reverse distributors.

Updated November 7, 2022

The original link broke.

---  the original post follows below  ---

Read the full article:  California Designated Representative - Ongoing Training (on Tumblr)

"One self-assessment question is, ”Are training and experience provided to all employees to assure all personnel comply with all licensing requirements? (CCR 1780[f][4])”  This question suggests that ongoing training is expected.   

One form of training could be taking one of our courses as a form of refresher training."

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

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

Medtrade Fall 2018 - New Product Pavilion Winners

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• California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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Read the full article:   Medtrade wrap-up: Winning products, winning event and one big winner

"Medtrade attendees selected Caire’s FreeStyle Comfort portable oxygen concentrator as this year’s gold winner in the New Product Pavilion. 

Abely’s portable electric recliner, the Abelift, took home silver; and 3B Medical’s CPAP hose cleaner, the Lumin Bullet, took home bronze."

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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

Supply Chain Considerations During Hurricanes - Logistics for the Life Sciences

• California Designated Representative Training for 3PL (approved by the California State Board of Pharmacy) You can also buy a course for: wholesalers, or reverse distributors.

• Florida Certified Designated Representative - CDR Exam Prep Course

Read the full article:  Supply Chain Considerations During Hurricanes - Logistics for the Life Sciences

"As Hurricane Michael hits the Florida Panhandle, it again reminds us to assess potential locations and routes at risk, and to initiate efforts to minimize disruption."  . . . 

"In this article, Jim Monkmeyer, President of Transportation at DHL Supply Chain, comments on content from the recent Resilience 360 report, “Hurricane Peak Season: What to Expect in 2018.”"

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

California Designated Representative Training for 3PL (approved by the California State Board of Pharmacy)

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)

Return Home:  The Designated Representative and Exemptee Blog

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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

ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

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• California Designated Representative Training (approved by the California State Board of Pharmacy) - Earn a training affidavit.

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Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:

1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - Earn a training affidavit

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

Hundreds of Florida's Life Science Leaders to Convene at BioFlorida Annual Conference - BioFlorida.com

• Florida Certified Designated Representative -  CDR Exam Prep Course

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

Updated 12/10/2022

Mark your calendars!

2023 CONFERENCE DATE ANNOUNCED - BioFlorida

---  the original post follows below  ---

Read the full press release:  Hundreds of Florida's Life Science Leaders to Convene at BioFlorida Annual Conference - Annual Conference Showcases Advancements & Drives Growth of the Life Sciences Industry in Florida - BioFlorida.com

"Hundreds of Florida's executives, scientists, researchers, investors, legislators, and service providers from the biopharmaceutical, medical device, and healthIT industry will gather October 14-16 at The Westin Fort Lauderdale Beach Resort to hear from experts on recent industry trends, connect with investors and potential partners, and celebrate Florida innovation and achievements-all to continue the growth of the industry in the state."

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

AmerisourceBergen to pay $625M in drug distribution settlement - Modern Healthcare

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy)  Online courses for: wholesalers | 3PL | reverse distributors

Read the full article:  Modern Healthcare - AmerisourceBergen to pay $625M in drug distribution settlement

"In order to avoid the Food and Drug Administration's regulatory oversight, AmerisourceBergen did not register Medical Initiatives as a repackager or manufacturer with the agency, records show. Instead, the group portrayed Medical Initiatives as a state-regulated pharmacy, exploiting an exemption to the FDA registration requirement that is reserved for legitimate pharmacies, not for manufacturers or repackagers, authorities said."

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses - accepted 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