Thursday, November 10, 2022

California Exemptee Certification - SkillsPlus International Inc.

SkillsPlus International Inc. HMDR Exemptee Training

California requires home medical device retailers (HMDR) & durable medical equipment (DME) providers to retain an on-site Exemptee (who must be physically present during all hours of operation) to conduct their business. 

California Exemptee Certification

This course is approved & recommended by the California Department of Public Health (CDPH), as it meets their training certification requirements. 

If you are applying for a California HMDR Exemptee license, then you'll need to include proof of required training in your license application (a course completion certificate, or a transcript).

SkillsPlus International Inc. offers a state-approved training course for HMDR Exemptee license applicants. Successful course completion earns a course completion certificate (accepted by the California Department of Public Health - Food and Drug Branch), that serves as proof of required training. Include the course completion certificate in your license application submission.

  • Learn more, buy now! California Exemptee Training Certification Program.
    • $525 per student. 
    • no extra fees to retake quizzes.  
    • online training certification
    • available 24 x 7 - come and go as you like
    • covers required topics specified in the California HMDR Exemptee license application. Each topic has a topic exam.
    • earns a course completion certificate accepted by the CDPH. 
    • nearly 10,000 students have taken our state license-related training courses
California Exemptee Certification 2022 | This course is approved & recommended by the California Department of Public Health (CDPH), as it meets their training certification requirements. Image of hands typing on a keyboard.

Approved training program for California HMDR Exemptee license applicants and their supervisors/managers - offered by SkillsPlus International Inc.

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Friday, November 4, 2022

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition - FDA.gov

According to the FDA:

"The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose. The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.

Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established ... "

Source: 

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication - FDA.gov

Alcohol Deaths Take Lives of Working-Age Americans

I'm surprised at the research findings.

"Alcohol consumption is a leading preventable cause of death in the US, and death rates from fully alcohol-attributable causes (eg, alcoholic liver disease) have increased in the past decade, including among adults aged 20 to 64 years."

"The findings of this cross-sectional study suggest that an estimated 1 in 8 total deaths among US adults aged 20 to 64 years were attributable to excessive alcohol use, including 1 in 5 deaths among adults aged 20 to 49 years. The number of premature deaths could be reduced with increased implementation of evidenced-based, population-level alcohol policies, such as increasing alcohol taxes or regulating alcohol outlet density."

Source:
Estimated Deaths Attributable to Excessive Alcohol Use Among US Adults Aged 20 to 64 Years, 2015 to 2019 - JAMA Netw Open. 2022;5(11):e2239485. doi:10.1001/jamanetworkopen.2022.39485

Saturday, October 15, 2022

Your Favorite Cereal May No Longer Be 'Healthy' Under New FDA Guidance - Food and Wine

According to the article:

"The FDA has proposed a change to the definition of "healthy," and breakfast cereal brands, in particular, could suffer.  ...

"Under the proposed definition," the FDA wrote, "more foods that are part of a healthy dietary pattern and recommended by the Dietary Guidelines would be eligible to use the claim on their labeling, including nuts and seeds, higher fat fish (such as salmon), certain oils and water."

However, as the FDA admits, the changes could also force some foods to drop their healthy claims — and one example the agency has tossed around multiple times is breakfast cereal, in large part due to the proposed definition's increased emphasis on added sugars."

Read the full source article: Your Favorite Cereal May No Longer Be 'Healthy' Under New FDA Guidance - Food and Wine

Additional Reading: FDA NEWS RELEASE - FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease - FDA.gov

Wednesday, August 24, 2022

The Best California Designated Representative Training

All three (3) of our California Designated Representative online training programs are approved by the California State Board of Pharmacy.

Our California Designated Representative online training courses are popular.
Nearly 10,000 students have taken our state license-related training programs since 2002.

Learn more and sign-up for a course:

    If you're applying for a California Designated Representative license, then you'll need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any one of our California Designated Representative training courses.
      Each course covers the required topics specified by its respective Designated Representative license application form.

        All three (3) of our California Designated Representative online training programs are approved by the California State Board of Pharmacy. Our California Designated Representative online training courses are popular. More than 7,000 students have taken our state license-related training programs since 2002.
        SkillsPlus International Inc. offers the largest selection of California State Board of Pharmacy-approved training programs for California Designated Representative license applicants.

        #CaliforniaDesignatedRepresentative
        #CaliforniaDesRep

        Friday, August 19, 2022

        U.S. approves sale of over-the-counter hearing aids - Reuters

        According to the article:

        "The Food and Drug Administration on Tuesday approved the sale of over-the-counter hearing aids, allowing millions of Americans to buy hearing aids without seeing an audiologist and potentially saving individuals thousands of dollars.

        The rules, which take effect in mid-October, apply to hearing aids for people with mild to moderate hearing loss. The aids will be available directly from stores or online without medical exams, a prescription or audiologist fitting adjustment."

        Read the full source article: U.S. approves sale of over-the-counter hearing aids - Reuters

        Go to the FDA NEWS RELEASE - FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans - More Affordable Hearing Aids Could Be in Stores as Soon as Mid-October


        Tuesday, July 26, 2022

        California HMDR Exemptee Online Training Certification Class

        California HMDR Exemptee online training certification course

        California HMDR Exemptee Online Training Certification Class - for home medical device retailers​
        - for home medical device retailers​

        Buy Exemptee training now!

        If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate accepted by the California Department of Public Health - include it in your license application.

        • $525 per student. 
        • Earns a course completion certificate accepted by the California Department of Public Health. Covers required topics specified in the Exemptee license application form
        • Learn more and buy - no extra fees to retake quizzes

        Nearly 10,000 students have taken our state license-related training programs.

        Contact us:  (415) 948-5220

        - - -


        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 5, 2022

        Do Not Use Baby Neck Floats Due to the Risk of Death or Injury - FDA.gov

        According to the safety communication:

        "The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury."

        Read the full safety communication:  Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication - FDA.gov

        Wednesday, June 29, 2022

        SkillsPlus International Inc. - The leader in compliance training

        Image of the SkillsPlus International Inc. logo

        SkillsPlus International Inc.

        The leader in compliance training

        Specializing in:
        • FDA cGMP online training programs and courses
        • California Designated Representative training courses for license applicants
        • California HMDR Exemptee training certification for license applicants

        Mailing Address

        SkillsPlus International Inc.
        1183 University Drive Ste 105-251
        Burlington, NC
        27215
        USA

        Friday, June 24, 2022

        FDA Denies Authorization to Market JUUL Products - FDA.gov

        According to the news release:

        "Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action." 

        Read the full news release: FDA Denies Authorization to Market JUUL Products - FDA.gov

        Thursday, June 23, 2022

        Vitamins, Supplements a Waste of Money for Most, Task Force Says - WebMD

        According to the article:

        "If you're healthy and not pregnant, you probably don't need vitamins or supplements, an expert panel has concluded."

        "The task force’s guidance does not apply to children, to people with a known nutritional deficiency, or those who are hospitalized."

        "Cameron emphasized the task force’s recommendations do not apply to pregnant people or people trying to get pregnant."

        Continue reading the source article for additional recommendations and details.

        Read the full source article:  Vitamins, Supplements a Waste of Money for Most, Task Force Says - WebMD


        Wednesday, June 15, 2022

        A new technology offers treatment for HIV infection through a single injection - World Pharma News

        According to the article:

        "Currently, the researchers explain, there is no genetic treatment for AIDS, so the research opportunities are vast. Dr. Barzel concludes: "We developed an innovative treatment that may defeat the virus with a onetime injection, with the potential of bringing about tremendous improvement in the patients' condition. When the engineered B cells encounter the virus, the virus stimulates and encourages them to divide, so we are utilizing the very cause of the disease to combat it. Furthermore, if the virus changes, the B cells will also change accordingly in order to combat it, so we have created the first medication ever that can evolve in the body and defeat viruses in the 'arms race'.

        Based on this study we can expect that over the coming years we will be able to produce in this way a medication for AIDS, for additional infectious diseases and for certain types of cancer caused by a virus, such as cervical cancer, head and neck cancer and more."

        Read the full source article: A new technology offers treatment for HIV infection through a single injection - World Pharma News

        Friday, May 27, 2022

        FDA reveals dire 'unsanitary' conditions at baby formula plant linked to shortages, including broken equipment - Business Insider

        According to the article:

        "A baby food plant linked to product recalls and formula shortages across the US had a leaky roof, broken equipment, condensation, and unsanitary surfaces, according to the Food and Drug Administration. 

        FDA commissioner Robert Califf said conditions at Abbott Nutrition's plant in Sturgis, Michigan, were "egregiously unsanitary" and allowed bacteria to spread." 

        Read the full source article: FDA reveals dire 'unsanitary' conditions at baby formula plant linked to shortages, including broken equipment - Business Insider

        Definitions:

        • Egregious: shocking, outstandingly bad

        Wednesday, May 25, 2022

        The Best California Designated Representative Training

        Popular online training programs taught by SkillsPlus International Inc.

        Board-Approved California Designated Representative Training Programs

        • The largest collection of approved online training courses for California Designated Representative license applicants and their managers
        • Successful course completion earns a training affidavit (accepted by the California State Board of Pharmacy) to include in your Designated Representative license application.
        • Highly recommended training, more than 7,000 students have taken our state license-related training classes
        • SkillsPlus International Inc. specializes in professional training courses!
          We only do one thing, and we do it well!

        - - -

        The largest collection of approved online training courses for California Designated Representative license applicants and their managers
        Learn More | Buy Now | California Designated Representative Training 
             for: Wholesalers | 3PL | Reverse Distributors

        Friday, May 20, 2022

        CMS Unveils More User-Friendly Medicare Website - CMS.gov

         According to the press release:

        "New Medicare.gov will incorporate public feedback and make it easier to compare, choose, and understand Medicare coverage.

        Today, the Centers for Medicare & Medicaid Services (CMS) unveiled several updates to the Medicare.gov website that make it easier, for millions of people who use it, to navigate and access information to compare and select health and drug coverage and find providers. The updated website, based on consumer feedback, prominently features timely initiatives and messages on the homepage and highlights key tasks and information most frequently sought by people with Medicare, people nearing Medicare eligibility, and their families."

        Read the full press release:  CMS Unveils More User-Friendly Medicare Website - CMS.gov

        Friday, April 29, 2022

        The FDA Proposes Rules To Ban Menthol In Cigarettes, And More!

        According to the FDA news release:

        "Today, the U.S. Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in  cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit." 

        Read the full FDA news release: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death - FDA.gov

        Monday, April 25, 2022

        California Exemptee Certification - SkillsPlus Intl Inc.

        This training program is designed for California HMDR Exemptee license applicants and their managers. For home medical device retailers.

        The Best Choice For California Exemptee Training Certification


        This course is accepted by the California Department of Public Health, as it meets their training certification requirements for Exemptee license applicants.  California requires home medical device retailers (HMDR) & durable medical equipment (DME) providers to retain an on-site Exemptee (who must be physically present during all hours of operation) to conduct their business.  
        California HMDR Exemptee Training Certification Course - State-approved by the CDPH. Earns a course completion certification to include in your Exemptee license application | Learn more & buy.
        Buy Exemptee Training Now!


        If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate accepted by the CDPH - include it in your license application.

        About The California HMDR Exemptee Course


        This course is recommended by the California Department of Public Health (CDPH) as it meets their training requirements, and covers:
        • State and Federal laws relating to the distribution of dangerous drugs and dangerous devices
        • State and Federal laws relating to the distribution of controlled substances
        • Knowledge and understanding of quality control systems
        • The United States Pharmacopoeia standards relating to the safe storage and handling of drugs
        • The safe storage and handling of home medical devices
        • Prescription terminology, abbreviations, and format
                To meet CDPH requirements, we offer a web-based, self-study class, and the final exams for this certification. The class is fast, to the point, and has helped thousands of California Exemptee license applicants get licensed.

                Keywords and Phrases:
                #HMDR #Exemptee #California #HMDR #CDPH #HME #DME #HMDRexemptee #Exemptee #approved #accepted #certified #online #web #training #eLearning #certificate #certification #program #course #class #webinar #seminar  2024 2025 2026 #workshop #event #provider #vendor #seller #registration #purchase #buy C

                Saturday, April 9, 2022

                Should You Worry About Vision Loss from Viagra? - The People's Pharmacy

                According to the article:

                "The likelihood of serious vision loss from Viagra is low, but a recent study confirms it is real. Report ANY changes in eyesight promptly!

                Drugs for erectile dysfunction have become very popular. They include avanafil (Stendra), tadalafil (Cialis), vardenafil (Levitra) and the original, sildenafil (Viagra). Such drugs are referred to as phosphodiesterase 5 inhibitors, abbreviated PDE5Is. Most men are interested in the benefits of such medications. The risks, on the other hand, get much less attention. A study published in JAMA Ophthalmology, April 7, 2022 reveals an often overlooked complication of PDE5Is: vision loss from Viagra and similar ED drugs."

                Read the full source article: Should You Worry About Vision Loss from Viagra? - The People's Pharmacy

                References:  Risk of Ocular Adverse Events Associated With Use of Phosphodiesterase 5 Inhibitors in Men in the US - JAMA Network


                Friday, March 11, 2022

                California Designated Representative Training Courses

                SkillsPlus International Inc. is the ONLY training provider approved by the California State Board of Pharmacy to offer California Designated Representative training programs for wholesalers, 3PL, and reverse distributors.

                Learn more & sign-up for a Board-approved California Designated Representative course: 

                California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

                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 by taking any of our California Designated Representative training courses.

                These SkillsPlus International Inc. online training courses are designed for California Designated Representative license applicants and their managers. We make the messy regulatory requirements simple and easy to understand!

                These courses cover all the topics specified on their respective California Designated Representative license application form.

                Nearly 10,000 Students Trained!

                Courses taught by SkillsPlus International Inc. are popular, and highly recommended.

                • No need to schedule your training. Buy the course. Start when you’re ready! Therefore, buy now and start studying!
                • Online internet-based e-learning. Available 365 x 24 x 7. Come and go as needed. In other words, 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. Therefore, our courses are more accessible.
                • Nearly 10,000 students have taken our state license-related courses. In other words, our courses are very popular!
                • Offered continuously since 2002. Therefore, we have a long record of experience.

                Buy Now! California Designated Representative: 

                • (415) 948-5220
                Keywords & Phrases:
                #CaliforniaDesignatedRepresentative | #CaliforniaDesRep
                #approved #accepted #certified #online #provider #vendor #seller #training #course #class #affidavit #certificate #certification #webinar #seminar #workshop 

                Thursday, February 17, 2022

                The FDA’s Cigarette Health Warning Rule Is Postponed to April 2023

                U.S. Graphic Health Warnings Postponed Again


                According to the article:

                Source: FDA.gov
                "The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

                The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022."

                Read the full source article:  U.S. Graphic Health Warnings Postponed Again - Tobacco Reporter

                Learn more at: Cigarette Labeling and Health Warning Requirements - FDA.gov

                Keywords & Phrases:
                #FDA #CGMP #GMP


                Wednesday, February 9, 2022

                Yes, Mark Cuban did start a real online drugstore - ABC10

                Mark Cuban Cost Plus Drug Company is a real wholesale drug distributor that works with an accredited pharmacy.

                According to the article:

                "Mark Cuban’s online drugstore, Mark Cuban Cost Plus Drug Company, is a legitimate online store to buy medication. It’s registered as a “wholesale drug distributor” instead of a “pharmacy” because Mark Cuban’s store does not fill prescriptions itself — it works with a partner pharmacy to dispense medication."

                "TruePill, Mark Cuban Cost Plus Drug Company’s pharmaceutical partner, is an accredited digital pharmacy with the National Association of Boards of Pharmacy (NABP) and its accreditation was confirmed through email by an NABP spokesperson."

                Read the full source article:  Yes, Mark Cuban did start a real online drugstore - ABC10.com

                Monday, January 31, 2022

                California Exemptee Training

                California Exemptee Certification 2022 by SkillsPlus International Inc.

                • $525 per student. Covers required topics specified in the Exemptee license application form.
                • Earns a course completion certificate accepted by the California Department of Public Health, to include in your California HMDR Exemptee license application.

                California Exemptee Certification 2022 by SkillsPlus International Inc. - Image of the San Francisco Golden Gate bridge.
                California Exemptee Certification 2022 by SkillsPlus International Inc.
                Learn more and purchase this course
                .

                Keywords & Phrases:

                #HMDR #HME #DME #Exemptee #HMDRexemptee 

                The best choice, the best place, the top choice, for Exemptee training. Popular | Recommended

                Friday, January 7, 2022

                Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

                According to the FDA:

                "Consumers need to beware of products to lighten or whiten their complexion. These products, which include both injectable skin whitening and skin bleaching products, are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants.

                Injectable skin whitening products are marketed for injection into a vein or muscle or under the skin. They are sold online and in some retail outlets and health spas. They often promise to lighten the skin, correct uneven skin tone, and reduce blemishes. Some products even claim to treat conditions such as liver disorders and Parkinson’s disease.

                Although the average consumer might not assume so, these products are unapproved new drugs whose sales are not condoned by the U.S. Food and Drug Administration (FDA). The FDA has not approved any injectable drugs for skin whitening or lightening."

                Source:  Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

                Saturday, January 1, 2022

                California Designated Representative Training Courses

                Start off the year with a bang!  Enroll now in any one of our Board-approved California Designated Representative training courses to earn a training affidavit for your license application:

                California Designated Representative Training Courses

                Don't get caught snoozing in the new year! 

                Nearly 10,000 Students Have Taken Our Courses!


                Reasons why our online training programs are so popular and highly recommended:
                • These online training courses are designed for California Designated Representative license applicants and their managers. We make the messy regulatory requirements simple and easy to understand!
                • Earn a Board-accepted training affidavit, for your license application, by taking any one of our courses.
                • No need to schedule your training. Buy the course. Start when you’re ready! Therefore, buy now and start studying!
                • Online internet-based e-learning, easily accessed to make it possible & convenient for you to study from your home or office, in other words, study in any location!
                • Our courses involve more than just reading slides.
                • Available 365 x 24 x 7. Come and go as needed. In other words, our courses are convenient and flexible.
                • Composed of a series of self-study pre-recorded presentations that cover essential and required topics (as specified on their respective California Designated Representative license application form).
                • Designed with a follow-up quiz after each course section. When you finish, you will request your completion documents, specifically, your training affidavit.
                • 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. Therefore, our courses are more accessible.
                • Offered continuously since 2002. Therefore, we have a long record of experience.
                Updated For 2022 Pharmacy Law Changes | California Designated Representative Training Courses. Image of pill capsules on a pink background.
                California Designated Representative Training Courses

                - - -

                #CaliforniaDesRep #CaliforniaDesignatedRepresentative
                third-party logistics providers

                From SkillsPlus International Inc.