Friday, October 19, 2018

Medtrade Fall 2018 - New Product Pavilion Winners

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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)
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):
     Florida:

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

     California (earn a training completion certificate):

Thursday, October 11, 2018

Supply Chain Considerations During Hurricanes - Logistics for the Life Sciences

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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):
     Florida:

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

     California (earn a training completion certificate):
California Designated Representative Training for 3PL (approved by the California State Board of Pharmacy)
California Designated Representative Training for 3PL (approved by the California State Board of Pharmacy)

Tuesday, October 9, 2018

FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org

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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)
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):
     Florida:

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

     California (earn a training completion certificate):

Friday, October 5, 2018

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

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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)
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):
     Florida:

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

     California (earn a training completion certificate):

Thursday, October 4, 2018

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

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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

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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):

Tuesday, October 2, 2018

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

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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
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):
     Florida:

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

     California (earn a training completion certificate):

Thursday, September 6, 2018

Designated Representative Training Courses - A collection of links

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A Useful Link Collection - Designated Representative Training Courses

Every once in awhile, it's helpful to put related links together in a collection.  I've put this collection together for Designated Representative license applicants.


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, August 3, 2018

US subpoenas AmerisourceBergen over opioid products - CNBC

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Read the full article:  US subpoenas AmerisourceBergen over opioid products - CNBC (click this link)

"AmerisourceBergen, which is among the defendants, is one of the largest drug distributors in the country. AmerisourceBergen and rivals Cardinal Health and McKesson control 85 percent of the U.S. prescription drug market.  The subpoena came from the U.S. Attorneys Office for the Southern District of Florida."

This topic is related to the opioid epidemic and reporting suspicious orders of controlled substances.

Return Home:  The Designated Representative and Exemptee Blog

California Designated Representative training courses accepted by the California State Board of Pharmacy. For wholesalers, 3PL, and reverse distributors.  Earn a training affidavit.

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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):

Tuesday, July 24, 2018

Building a New Drug Wholesaler Compensation Model: What Happens as Brand Inflation Slows? - Drug Channels

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Read the full article:  Building a New Drug Wholesaler Compensation Model: What Happens as Brand Inflation Slows? - Drug Channels

" . . . what this could mean for the Big Three drug wholesalers --- AmerisourceBergen, Cardinal Health, and McKesson. I explain some of the problems that arise when wholesalers are compensated based on a brand-name drug’s list price. I then suggest an alternative approach that would reshape wholesalers’ economics. It appears that even the wholesalers’ trade association supports some sort of new model."


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):

Saturday, July 21, 2018

Wholesalers, are you ready for an inspection? - California State Board of Pharmacy

Wholesalers, are you ready for an inspection? - A newsletter article by the California State Board of Pharmacy (The Script - July 2018 Page 12 - click this link)

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy - Learn more and buy!

"Be prepared. Whether the Board is conducting an inspection related to a complaint or a request is made for a routine inspection, having important records readily retrievable will help expedite the process. The Board recommends wholesalers' Designated Representatives and Designated Representatives-In-Charge become aware of the location of the following records. Maintaining these records in a centralized area may help when a board inspector arrives at your front door."


California Designated Representative Training Courses
Here's a list of the major categories of records:

  • Policies and Procedures
  • Records
  • Controlled Substances
  • Training Records
  • Licenses and Registrations
  • Miscellaneous Reports

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):

Friday, June 29, 2018

Most Medicare Claims for Replacement PAP Device Supplies Didn't Comply With Medicare Requirements - OIG

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California HMDR Exemptee Training Certification:

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Read the full June 2018 report:

Most Medicare Claims for Replacement Positive Airway Pressure Device Supplies Did Not Comply With Medicare Requirements - DHS OIG (PDF - click this link)

"Most Medicare claims that DME suppliers submitted for replacement PAP device supplies did not comply with Medicare requirements. Of the 110 claims in our sample, 24 complied with Medicare requirements; however, 86 claims with payments totaling $13,414 did not. On the basis of our sample results, we estimated that Medicare made overpayments of almost $631.3 million for replacement PAP device supply claims that did not meet Medicare requirements."

The CMS expressed interest in educating health care providers on avoiding Medicare billing errors.

Return Home:  The Designated Representative and Exemptee Blog


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Training for HMDR Exemptee license applicants - Earn a course completion certificate - Accepted by the California Dept of Public Health (CDPH)


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, June 12, 2018

AAH reports drop in suppliers ... | HME News

California HMDR Exemptee Training
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California HMDR Exemptee Training Certification:

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Read the full article:   In brief: AAH reports drop in suppliers, Trustees report shaky finances | HME News:

"The states with the biggest reductions in the number of unique traditional DME suppliers from November 2010 to January 2018 are Florida (52%), California (45%), Illinois (42%) and Texas (39%)."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

Saturday, May 26, 2018

Get ready for summer and have fun! - Complete California Designated Representative training first!

Get California Designated Representative training done before summer arrives!

Earn a training affidavit  -  Training programs for California Designated Representative license applicants

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

Schools out for summer, and it's time to have fun.  Be sure to have a fantastic summer, by getting your California Designated Representative training out of the way now.

Take one of our many popular California Designated Representative training programs for:
  • Wholesalers
  • Third-Party Logistics Providers (3PLs)
  • Reverse Distributors
Learn more and buy one of our Designated Representative training courses:  http://www.dreprof.com/


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):

Sunday, May 13, 2018

FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) - FDA Law Blog

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Read the entire article:   FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) - FDA Law Blog:

"Pursuant to Section 582, trading partners in the pharmaceutical distribution supply chain must implement over a period of time certain tracking, tracing, and product identification requirements."

'via Blog this'

View the referenced guidance document:
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry - FDA (PDF)


Return Home:  The Designated Representative and Exemptee Blog

Earn a training affidavit  -  Training programs for California Designated Representative license applicants

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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):

Thursday, April 19, 2018

New HMDR Application Forms Take Effect July 2018

New California Home Medical Device Retailer (HMDR) Applications Forms - Effective July 2018 (click this link)

  • Facility application forms
  • Exemptee application form
If you're looking to submit a facility or Exemptee license application, be sure you're choosing the correct form.  The HMDR home page (at the time of writing) posts the soon to expire "outgoing" forms, and the soon to become effective "incoming" application forms.

CA HMDR Exemptee Training
If you have questions about which version to submit, you might want to reach out to the HMDR office.  For example, if you look at the new Exemptee application, it states, "If you have any questions, please contact the Home Medical Device Retailer Exemptee Licensing Desk at (916) 341-7354, (800) 495-3232."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

Monday, April 16, 2018

Amazon shelves plans to sell, distribute drugs to hospitals: CNBC

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Read the full article: Amazon shelves plans to sell, distribute drugs to hospitals: CNBC

"Amazon.com Inc has shelved plans to sell and distribute pharmaceutical products to hospitals, CNBC reported on Monday, citing sources familiar with the matter."


Return Home:  The Designated Representative and Exemptee Blog

Training programs and courses for California Designated Representative license applicants  -  Earn a training affidavit - For wholesalers, or reverse distributors, or third party logistics providers (3PL)
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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):

Thursday, April 5, 2018

New Products Wow at Medtrade Spring | HomeCare Magazine

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California HMDR Exemptee Training Certification Course:

Accepted by California Department of Public Health (Food and Drug Branch).  Earn a training completion certificate.
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Updated October 19, 2018

    • Caire’s FreeStyle Comfort portable oxygen concentrator as this year’s gold winner 
    • Abely’s portable electric recliner, the Abelift, took home silver; and 
    • 3B Medical’s CPAP hose cleaner, the Lumin Bullet, took home bronze
- -   original post follows below  - -

View the list of winners:   New Products Wow at Medtrade Spring | HomeCare Magazine:

"Medtrade Spring 2018 attendees voted on their favorite new products in the long-running New Product Pavilion Providers’ Choice Awards, sponsored by HomeCare Magazine. Top vote getters at the Spring version of the nation’s premiere HME-focused trade show were:"

'via Blog this'


Training certification course for California HMDR Exemptee license applicants  -  Earn a course completion certificate - for home medical device retailers

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

McKesson accused of skimming profit, harming patients - Modern Healthcare

Read the complete article:  McKesson accused of skimming profit, harming patients - Modern Healthcare:

"Allegedly, an Omni employee saw McKesson employees pool overfill from the FDA-approved packages of the cancer drugs in a non-sterile environment and facility in Frisco, Texas. The products were then placed into pre-filled syringes that were re-labeled—in some instances with fake product codes and expiration dates, according to the lawsuit. "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative Reverse Distributors  -  Earn a training affidavit  -  CA Board of Pharmacy approved



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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):

Thursday, March 22, 2018

How To Change Address or Name - California Board of Pharmacy

California Board of Pharmacy - Change Address or Name

We often are asked how to submit an address change or name change to the California Board of Pharmacy.

Here's how to do it.  Go to the California Board of Pharmacy website, and follow the "Change of Address and/or Name" link on their home page (refer to the following image).


Return Home:  The Designated Representative and Exemptee Blog

Training programs for California Designated Representative license applicants  -  Earn a training affidavit


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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):

Monday, March 12, 2018

Designated Representative-Reverse Distributor License - California State Board of Pharmacy

Updated April 4, 2018

California Designated Representative Training Course for Reverse Distributors (click this link)

  • SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

  • Successful course completion earns a training affidavit
  • Buy Now! - $625 per student

- -  original post follows below  - -

View the Board's webpage:  Designated Representative Reverse Distributor License - California State Board of Pharmacy:

"Designated Representative-Reverse Distributor License

To be licensed as a Designated Representative-Reverse Distributor in California, you must satisfy the requirements under Business and Professions Code section 4053.2. A designated representative-reverse distributor license is responsible for supervision over a licensed wholesaler that ONLY acts as a reverse distributor pursuant to Business and Professions Code section 4022.6.

Applications and Instructions
Designated Representative - Reverse Distributor (PDF)"

You might also be interested in:

Training program for California Designated Representative Reverse Distributor license applicants

About - California Designated Representative Reverse Distributor Training


'via Blog this'

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Training programs for California Designated Representative license applicants  -  Earn a training affidavit


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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):

Friday, March 2, 2018

Wholesalers Must Report Suspicious Orders to Board

Wholesalers Must Report Suspicious Orders to Board

According to the Board (as published in the March 2018 issue of The Script):
"The new law requires wholesalers reporting suspicious orders to provide the board with a copy of the information provided to the U.S. Drug Enforcement Administration. The information may be emailed to the board at wholesalesuspiciousorders@dca.ca.gov.  
Suspicious orders include – but are not limited to – orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency."

Section 4169.1 is added to the Business and Professions Code, to read:
  • A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
Return Home:  The Designated Representative and Exemptee Blog

Training programs for California Designated Representative license applicants  -  Earn a training affidavit

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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):

Friday, February 23, 2018

Application For Designated Representative License

California Designated Representative license applicants - Free Tips

Important Tip: Follow All Instructions About Your Name

The license application forms for California Designated Representative candidates can be tricky when it comes to filling out the form fields with your name.

Here's the main point, whichever form you're completing, read all the instructions that are related to your name. Failure to do so, can result in common errors that could delay the processing of your license application.

Here's a small sampling of name-related instructions to pay attention to:
  • Full Name: Must be EXACTLY THE SAME as the name on your state issued driver’s license or state issued identification card (Jr., II, etc., must be included). It also must be EXACTLY THE SAME as the name on your application.
  • If you have a hyphenated name, two last names, or two first names, you need to list your name on each of the following documents to match that of your state issued identification, such as the Designated Representative Application, or Request for Live Scan form, or fingerprint cards
  • Have you ever used a different name? List each prior name on the application under Previous Names. Did you have a maiden name, married name, former name, AKA?  Have you ever used Jr., Sr., II, etc., with your name?  If you do not list all of your previous names, the Board might not be able to locate, match, or verify your documents.
  • Live Scan Service:  You're reminded that your legal name must be on file with the Board. If your name has changed you are required to notify the Board within 30 days of the change.
If you're still confused, the Board maintains a Contact Us webpage.


Return Home:  The Designated Representative and Exemptee Blog

Training programs for California Designated Representative license applicants - Earn a training affidavit


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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):

Tuesday, February 6, 2018

A Lesson from McKesson: How Specialty Pharmacy Growth Is Hurting Wholesalers - Drug Channels

Read Adam Fein's full article:  Drug Channels: A Lesson from McKesson: How Specialty Pharmacy Growth Is Hurting Wholesalers:

"Wholesalers have been trying to alter their conventional pricing and contracting approaches to address these pressures, though it’s not clear how successful these efforts have been. The specialty boom may prove to be a mixed blessing for wholesalers."

'via Blog this'

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Training programs for California Designated Representative (for wholesalers or 3PL) license applicants - Earn a training affidavit


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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):

Monday, January 29, 2018

California HMDR Laws for 2018

California HMDR Laws for 2018

New CA Home Medical Device Retailer (HMDR) Law - Effective Jan 1, 2018

Read the full Bill:   Bill Text - AB-1387 Home medical device retail facility business: licensing: inspections.:

"AB 1387, Arambula. Home medical device retail facility business: licensing: inspections.

The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.

This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually."

'via Blog this'

Source: The legislation above is referenced on the CA HMDR Program website

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Training program and certification for California Home Medical Device Retailers (HMDR) Exemptee license applicants - Earn a completion certificate


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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

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