Monday, October 18, 2021

Recommended - The Best Choice For Exemptee Training

Recommended - The Top Choice For Exemptee Training!

California’s Home Medical Device Retail (HMDR) laws require that companies carrying items needing a prescription have "Exemptees" (or pharmacists) responsible for the distribution of these items. In order for a company to be compliant with the regulations, the Exemptee(s) must complete training recognized by the California Department of Public Health (CDPH), Food and Drug Branch. Specifically, the Exemptee license applicant must provide proof of required training with their license application.

Recommended - The Top Choice For Exemptee Training!
The Top Choice For Exemptee Training!
This California Exemptee online training certification course covers all required course topics specified by the California Exemptee license application form. Successful course completion earns a course completion certificate to include in your Exemptee license application (accepted by the CDPH).

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):
#2024 #2025

Thursday, September 30, 2021

California Designated Representative - Disciplinary Actions

California State Board of Pharmacy - Disciplinary Actions

If you:

  • are a California Designated Representative applicant or licensee, or 
  • manage a wholesale or 3PL facility, 

- then your professional status and public reputation rest upon legal and regulatory compliance.

When facilities and/or licensees break applicable laws and regulations, the Board takes enforcement action. Typically, the Board files accusations, and then follows that with disciplinary action.

When disciplinary action occurs, people (including the public and consumers) can learn about it through a couple of ways:

  • They can view lists of licensees reported on the Board's Disciplinary Actions webpage, or
  • They can read the details of each case, naming the licensee, the cause for discipline, and the resulting Board action, as reported in the Board's newsletter, The Script. In each issue of The Script, in a section labeled "Disciplinary Actions," individual cases are hyperlinked and can open up a detailed legal document for the case.

Resources:


Register now! Enroll now to take a Board-approved California Designated Representative online training course for:  Wholesalers | 3PL | Reverse Distributors. Image of the Golden Gate Bridge.
Register now! Enroll now to take a Board-approved California Designated Representative online training course for:  Wholesalers | 3PL | Reverse Distributors.

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, July 26, 2021

California Designated Representative 3PL Training Course

California Designated Representative Third-Party Logistics (3PL) Training Course

The Designated Representative-3PL protects the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business. 

California Designated Representative Third-Party Logistics (3PL) Training Course. Image of a lighthouse on the California coast.
Purchase now to take this California
Designated Representative 3PL
training course
.

3PL Course Topics

Importantly, this course covers all topics specified on the California Designated Representative license application form, and focuses on knowledge and understanding of:

  • California and federal laws regarding the distribution of: dangerous drugs and dangerous devices, and controlled substances
  • quality control systems
  • United States Pharmacopoeia standards or federal Food and Drug Administration standards relating to the safe storage, handling and transport of dangerous drugs and dangerous devices

Course Details

  • Students may complete the course from a personal computer, laptop, iPad, and may complete the course from multiple devices at work or at home. In other words, study wherever you like.
  • Students are prompted to resume where they left-off from the last training session.
  • Quizzes started and not yet finished can be saved to the next sign-in session. In addition, there are no extra fees to retake the quizzes.
  • Course takes approximately 7-8 hours depending on the speed the student responds to quiz questions.
  • Course fee: $525. Purchase now to take this California Designated Representative 3PL training course.
  • Above all, if you have questions, please e-mail us for the fastest response at jennifer.payne@skillsplusinc.com

Benefits of Our California Designated Representative 3PL Course

  • Online internet-based e-learning, to fit your schedule, 365 x 24 x 7. Come and go as needed. What is e-learning? Therefore, our courses are convenient and flexible.
  • We’ve added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. Similarly, this makes our courses more accessible.
  • Nearly 10,000 students have taken our state license-related courses. In other words, our courses are very popular!
  • We have offered a California Designated Representative training course continuously since 2002. Therefore, we have a long record of experience.

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, July 19, 2021

New DSCSA Related Guidance Docs

According to this FDA In Brief quote by Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research:

"Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on."

Read more and see the links to the four (4) newly added guidance documents: 
FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain - 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):

Wednesday, July 14, 2021

Wholesaler Self-Assessments Due Before July 1

Self-Assessment Forms

California State Board of Pharmacy

Has your facility completed a self-assessment form? 

PICs are required to complete a self-assessment before July 1 of each odd-numbered year. 

View the current self-assessment forms and updated self-assessment draft forms. Although licensees are required to complete currently adopted self-assessment forms, either the current or draft forms are acceptable.

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, July 6, 2021

FDA Issues Safety Communication About Philips Recall - Sleep Review

According to the article:

"The US Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021."

Read the full source article:  FDA Issues Safety Communication About Philips Recall - Sleep Review

Related news:


- - -

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, May 24, 2021

California Designated Representative License Training - For Wholesalers

California Designated Representative Wholesaler License - Online Training Course

  • If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.
  • State-approved by the California State Board of Pharmacy
  • Online training classroom available 24 x 7. Come and go as needed.
  • More than 7,000 students have taken our state license-related courses
  • Offered continuously since 2002

Recommended Training Provided By SkillsPlus Intl Inc.

California Designated Representative Wholesaler License - Online Training Course
Buy Now! California Designated Representative Wholesaler Training Course

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, May 17, 2021

Growing Power Outages Pose Grave Threat To People Who Need Medical Equipment To Live - NPR. org

We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students.

Growing Power Outages Pose Grave Threat To People Who Need Medical Equipment To Live

According to the article:

"Over the past several decades, Americans have increasingly benefited from in-home technology, which can extend lifespans and enable more people to stay in their own homes. But the expanding array of such devices — including home oxygen machines, medication nebulizers, home dialysis, infusion pumps, and electric wheelchairs — all depend on a reliable power supply."

" . . . a study published earlier this year in the journal Epidemiology which found that rentals of oxygen equipment had nearly tripled from 2008 to 2018, based on data from more than 243,000 Kaiser Permanente patients."

Read the full source article:  Growing Power Outages Pose Grave Threat To People Who Need Medical Equipment To Live - NPR.org

Return Home:  The Designated Representative and Exemptee Blog

California Exemptee Training - Purchase now to take this online training class, California HMDR Exemptee Training Certification Course. For home medical device retailers. We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students.
California Exemptee Training - Purchase now to take this online training class, California HMDR Exemptee Training Certification Course. For home medical device retailers. We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students.


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, April 19, 2021

Exemptee Training | Designated Representative Training

Purchase now to take one of these online training courses: 
     California HMDR Exemptee 
     California Designated Representative:
         Wholesaler | 3PL | Reverse Distributor
     Florida CDR training & examination preparation

California HMDR Exemptee Training Certification Course

  • State approved by the California Department of Public Health - Food and Drug Branch
  • For home medical device retailers (HMDR)
  • We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. 

California Designated Representative Training Courses

  • State approved by the California State Board of Pharmacy
  • For wholesalers, 3PL, reverse distributors

Florida Certified Designated Representative (CDR) Training & Exam Preparation

  • Training, courses, examination preparation, consulting, and more!

Return Home:  The Designated Representative and Exemptee Blog

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HMDR Exemptee Training | Designated Representative Training
HMDR Exemptee Training | Designated Representative Training


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):

Saturday, April 10, 2021

AHRQ: Studies Fail to Show Long-Term Benefit for CPAP - MedPage Today

According to this article, AHRQ: Studies Fail to Show Long-Term Benefit for CPAP -  Sleep apnea specialists dumbfounded at critique of "gold standard" treatment:

"The big fear that I have, and many of my colleagues have, is that the way this report is worded could easily be misinterpreted as saying that prescribing CPAP doesn't improve these (long-term) outcomes, so we shouldn't be paying for it," said David Rapoport, MD, who directs the sleep medicine research program at the Icahn School of Medicine at Mount Sinai in New York City.

He said CPAP is widely recognized as the most effective treatment for improving OSA symptoms, such as snoring and daytime sleepiness.

"Nothing else even comes close," he said. "CPAP s really a remarkable treatment for addressing the breathing disorder associated with obstructive sleep apnea. But it has to be used, and compliance remains a big issue."

Read the full source article:  AHRQ: Studies Fail to Show Long-Term Benefit for CPAP - MedPage Today

Additional resources cited in the article:

Return Home:  The Designated Representative and Exemptee Blog

- - - - - 

California HMDR Exemptee license online training certification course for home medical device retailers. Image of hands typing on a laptop computer.
Buy now! California HMDR Exemptee license online training certification course for home medical device retailers.


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, April 1, 2021

3PL - California Designated Representative Training Course - for third-party logistics providers

California Designated Representative-3PL

According to the California Board of Pharmacy, "To be licensed as a Designated Representative - 3PL in California, you must satisfy the requirements under Business and Professions Code section 4053.1. Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager."

California Designated Representative-3PL Training Course

If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet.

  • Earn a training affidavit (accepted by the Board) by taking any one of our California Designated Representative courses for:  3PL | Wholesalers | Reverse Distributors
  • Approved by the California State Board of Pharmacy
  • Online training classroom available 24 x 7
  • Nearly 10,000 students have taken our state license-related courses

------

3PL - California Designated Representative Training Course - for third-party logistics providers. Image of a glowing blue laptop in the darkness.
3PL - California Designated Representative Training Course - for third-party logistics providers


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):

Wednesday, January 27, 2021

California Exemptee License Training Certification Class -- An online training course for HMDR

An online training program for home medical device retailer Exemptee license applicants and their managers - California Exemptee License Training Certification Course

California home medical device retail laws require companies carrying items needing a prescription to have Exemptees (or pharmacists) responsible for the distribution of these items. In order to comply with the regulations, a company's Exemptee(s) must complete training approved and accepted by the California Department of Public Health (CDPH) - Food and Drug Branch.

This Exemptee course is provided by SkillsPlus International Inc. and is recognized by the CDPH. Successful course completion earns a course completion certificate suitable for your Exemptee license application submission.

About Our California HMDR Exemptee Training Course

  • Learn more & buy now | California Exemptee Training
  • $525 per student. No extra fees to retake any of the quizzes.
  • Recognized by the CDPH.  By the way, the Exemptee license application asks, "Have you completed training program(s) that address the following: (Attach copy of completed training certificate) …"
  • This course covers all topics specified in the license application.
  • The online classroom is open 24 x 7 for your convenience. Come and go as needed. It's reliable with high uptime availability.
  • We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. 
  • Highly recommended, offered continuously since 2002.

Questions?

Give us a call:  (415) 948-5220

People Also Ask

Question: Where can I find the California HMDR Exemptee license application form?
Answer: You can find and download the form from the California Home Medical Device Retail Program website

Return Home:  The Designated Representative and Exemptee Blog

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Home medical device retail (HMDR) Exemptee license training course | Learn more, and buy


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, January 11, 2021

LAWBOOK FOR PHARMACY - California State Board of Pharmacy

It's that time of year again.

Here's the updated California Pharmacy Law Book for the current year.

Lawbook for Pharmacy - a free publication from the California State Board of Pharmacy (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Online Training Courses. For: 3PL, wholesalers, reverse distributors. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
California Designated Representative Online Training Courses. For: 3PL, wholesalers, reverse distributors. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.  


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):

Saturday, January 9, 2021

HME Providers See Spike In Demand For Home Oxygen Therapy

According to the article:

"As COVID-19 cases spike across the country, HME providers are seeing a spike in demand for home oxygen therapy, so much so that they’re worrying about their supply of concentrators."

 "“We’re really struggling with the volume because of the delays in shipping from manufacturers,” said Irene Magee, vice president and director of Green Island, N.Y.-based Northeast Home Medical Equipment.  

Providers are also juggling a wide range of patient therapy needs for a disease with a lot of unknowns. Some patients only need oxygen for a day or two, while others are longer term or have higher-flow needs." 

Read the full source article:  PROVIDERS BATTLE SURGE, WORRY ABOUT INVENTORY - HME NEWS

Return Home:  The Designated Representative and Exemptee Blog

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California Exemptee License Training - online training certification course for home medical device retailers applying for an HMDR Exemptee license. State approved.
California Exemptee License Training - online training certification course for home medical device retailers applying for an HMDR Exemptee license. State approved. 

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):

Wednesday, January 6, 2021

California - Statutory Changes in Pharmacy Law

Updated April 7, 2022

The PDF for 2021 is no longer available.

You can download the pharmacy law changes for the current year from this Board webpage:
---  the original post follows below  ---

Statutory Changes in Pharmacy Law - Published by the California State Board of Pharmacy

Unless otherwise noted, the provisions take effect January 1, 2021

View the 31 page source document, "Pharmacy Law Changes for 2021 (PDF)," on this Board webpage:  

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):
     Florida:

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

     California (earn a training completion certificate):

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