Wednesday, December 11, 2024

FDA Grants Exemption to Connected Trading Partners - FDA.gov

The FDA has issued another DSCSA exemption, and posted a summary of it, on their Waivers and Exemptions Beyond the Stabilization Period webpage. 

In a nutshell, in the October 9, 2024 exemption, the exemptions apply to any partners who have completed or made documented compliance efforts but still face data exchange challenges. The FDA said it is granting additional time to avoid supply chain disruptions that may impact patients’ access to needed medications.

Go to the Waivers and Exemptions Beyond the Stabilization Period webpage:  https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

Return Home:  The Designated Representative and Exemptee Blog


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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, September 27, 2024

Training Course For Florida Prescription Drug Wholesale Distributor CDR Candidates

Training For Florida Prescription Drug Wholesale Distributor Certified Designated Representative (CDR) Candidates

All prescription drug wholesale distributors (including virtual BROKER-ONLY), and companies that are seeking to do business in or with the State of Florida, are required to have a full-time Florida licensed Certified Designated Representative (CDR). A Florida licensed Certified Designated Representative (CDR) must be employed by the Prescription Drug Wholesale Distributor at the time of new application, and during all operating hours of the facility. The State of Florida itself, administers the official proctored State exam. This training course has everything you need to train your staff to pass the official State of Florida exam.

Learn more about the course, and buy now! 
FLORIDA – Certified Designated Representative (CDR) Training Course (by CDR Resource Center)

Return Home:  The Designated Representative and Exemptee Blog

- - -


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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Monday, June 24, 2024

The FDA On DSCSA Deadlines For Small Pharmacies

The FDA is offering exemptions to the DSCSA deadlines for small dispensers (pharmacies).

This probably doesn't come as a surprise, yet this could have some ramifications for other trading partners.

Read more about:  

FDA Grants Exemptions to Small Dispensers - Waivers and Exemptions Beyond the Stabilization Period - FDA.gov

Return Home:  The Designated Representative and Exemptee Blog

- - -


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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, May 28, 2024

Bayer and 12 other major drug companies caught up in Cencora data loss - The Register

  • The top choice for CDR training! California Designated Representative Training - for wholesalers, 3PL, reverse distributors. California Pharmacy Board approved. Earns a training affidavit suitable for your Designated Representative license application. Nearly 10,000 students have taken state license-related training programs taught by SkillsPlus International Inc. ... ... ... ... ... ... #CaliforniaDesRep #CaliforniaDesignatedRepresentative | Approved | Recommended | Popular | The best choice for Designated Representative training! **Exclusive Approval**: SkillsPlus International Inc. is the **only** training provider approved by the California State Board of Pharmacy to offer these programs for wholesalers, 3PL, and reverse distributors.

According to the article:

"More than a dozen big pharmaceutical suppliers have begun notifying individuals that their data was stolen when US drug wholesaler Cencora was breached in February.

The $250-billion firm – formerly known as AmerisourceBergen – partners with some of the largest pharma dealers, including GlaxoSmithKline, Novartis, Genentech, Bayer, Regeneron and Bristol Myers Squibb."

Read the full source article: Bayer and 12 other major drug companies caught up in Cencora data loss - The Register

Monday, April 8, 2024

Medtrade 2024 Pavilion Award Winners

  • California Exemptee Certification online training program/class. State-approved by the CDPH. Respected. Reliable - Dependable - High uptime availability! The longest continuously offered online Exemptee training certification class. For home medical device retail (HMDR) Exemptee license applicants, business owners, chief executive officers, general managers and compliance officers. DME HME Exemptee Certification. 

According to the article, here are the winners:

Providers’ Choice Gold
Jover Walker Cover by Jover

Providers’ Choice Silver
Elsa by Celeritas AI (artificial intelligence tool for reimbursement)

Providers’ Choice Bronze
Tranquility® Premium OverNight™ and Premium DayTime™ Underwear by Tranquility Incontinence Products

Read the full source article:  New Product Pavilion Awards At Medtrade 2024 - Medtrade

Return Home:  The Designated Representative and Exemptee Blog


- - -

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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Thursday, January 18, 2024

California Exemptee Training Certification

Training Certification Program for California HMDR Exemptee License Applicants

California Exemptee Certification training program/course - buy/enroll now!

  • State-approved by the CDPH (California Department of Public Health - Food and Drug Branch)
  • Covers CDPH-required course content
  • Course completion certificate accepted by the CDPH for the Exemptee license application
  • Respected. Reliable - Dependable - High uptime availability! 
  • The longest continuously offered online Exemptee training certification class 
  • For home medical device retail (HMDR) Exemptee license applicants 
  • DME HME Exemptee Certification

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, October 13, 2023

DME Industry Associations - HME Business

HME Business just published a list of DME industry associations. It shows national, and state & regional associations.

View the full list of associations:  DME Industry Associations - HME Business

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Custom Search

From SkillsPlus International Inc.