Wednesday, February 29, 2012

California Health and Safety Code Section 111656.4

California Health and Safety Code Section 111656.4 - California Attorney Resources - California Laws:

"Section 4051 of the Business and Professions Code shall
not prohibit a home medical device retail facility from selling or dispensing prescription devices if the department finds that sufficient qualified supervision is employed by the home medical device retail facility to adequately safeguard and protect the public health. Each person applying to the department for this exemption shall meet the following requirements to obtain and maintain the exemption: . . . "

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E-pedigree: California Board of Pharmacy 3/21/2012 meeting

This was just sent out from the CA Board of Pharmacy:
The Board of Pharmacy announces the scheduling of an E-pedigree meeting which will be held in conjunction with the board’s Enforcement Committee Meeting on March 21, 2012 in Burlingame, California (near the San Francisco Airport).  An agenda for the meeting will be available at least 10 days before the meeting.
E-pedigree/Enforcement Committee Meetings for the year have been scheduled, please visit our website for a complete listing of meeting dates: http://www.pharmacy.ca.gov/about/meetings.shtml
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Tuesday, February 28, 2012

What is a CA HMDR Exemptee license?

CA HMDR Licensing Program Home Page

CA HMDR Licensing Program Home Page:
"The HMDR Program is a CDPH program mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. There are three distinct licenses issued by the HMDR Program, in-state California firms, out-of-state firms, and (pharmacist) exemptees who are required employees of firms selling prescription, dangerous medical devices as described under California and Federal medical device laws. . . . Please contact the home medical device retail desk at (916) 650- 6500 should you have further questions."
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The California HMDR licensing program home page lists 3 helpful links:
1) The applications link to fill-in online Adobe Acrobat forms that can be completed, then printed and mailed for license application.
2) a link to provide direct access to an abstract of the California Sherman Food, Drug and Cosmetic Law that authorizes creation, regulation and licensing of HMDR firms and personnel, and a link to a list of frequently asked questions is provided to guide the user through common occurrences during the HMDR licensing process.

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Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants


CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
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Monday, February 27, 2012

Florida Certified Designated Representative Candidate Information Booklet (FL CDR CIB) - Feb 2012 version

- - - - -
10/06/2013 update.  CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. Here's how to find it.

Go to the home page of the Florida Department of Business & Professional Regulation:
http://www.myfloridalicense.com/dbpr/

In the search box, enter "CDR CIB"  
In the search results, click on the file ". . . /CDR.CIB.pdf" and there you have it!

For your quick reference, here's the CDR CIB:  http://www.myfloridalicense.com/dbpr/servop/testing/documents/CDR.CIB.pdf
- - - - -

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Thursday, February 23, 2012

California HMDR Exemptee License Fees

Updated May 13, 2017

Fees constantly change. The most current fee schedule can be found on the CA HMDR webpage.

- -  original post follows below  - -

Question:
How much does it cost to submit a California - Application for home medical device retailer exemptee license - new and renewal.

Answer:
It depends.
According to the application form:
  • For a new (never licensed) Exemptee application fee/license fee, it's $250. For an annual renewal, additional license, relocation, or change of ownership, it's $150. 
  • Oh, and by the way, if you're more than 30 days late, tack on an additional $10 in late fees.
Source:

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Wednesday, February 22, 2012

Dietary Supplements - Responsibilities of Retailers & Distributors

The FDA says that firms that sell dietary supplement products play an integral role in preventing tainted supplements from harming consumers and have a legal responsibility to ensure that the products they sell are not tainted. Anyone who sells or distributes these illegal products may be subject to:
  • Criminal liability – misdemeanors and felonies 
  • Seizure of your products 
  • Injunction of the responsible party or company 
  • Disgorgement of profits and restitution.
Source:
FDA - Tainted Dietary Supplements and Foods: Responsibilities of Retailers and Distributors (pdf)

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Tuesday, February 21, 2012

SkillsPlus International Inc. - Vendor Highlight

HMDR Exemptee Training Program

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee HMDR and DME Providers Certification Course,  provides information specific to the California Exemptee certification course. For those seeking two certifications, this course also meets the requirements for the Board of Pharmacy California Designated Representative.

California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by the Department of Public Health, as it meets the training requirements for this training and covers:
  • California Code of Regulations 
  • Business and Professions Code 
  • Prescription Drug Laws 
  • Controlled Substances 
  • USP Storage Conditions 
  • Health and Safety Code 
To meet this requirement, they offer a web-based, self-study class, and the final exam for this certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

To get a flavor of the web-based training, watch this snippet:



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Training program for California HMDR Exemptee license applicants
CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Monday, February 13, 2012

Change of Designated Representative-In-Charge - California

When key employees move on or are terminated, there are Designated Representative implications that you need to consider. Read on, as the consequences could invoke disciplinary action.

According to the California State Board of Pharmacy "Change of Designated Representative-In-Charge" form 17A-E1 (Rev 1/08) (pdf):
Both the designated representative-in-charge and the owner of a wholesaler, nonresident wholesaler or veterinary food-animal drug retailer are required by California law to notify the Board of Pharmacy within 30 days after the termination of the designated representative-in-charge. Failure to make this notification to the board may result in a citation and fine or other disciplinary action.

To properly notify the board of a change in designated representative-in-charge, the following items must be submitted:
  • Completed Change of Designated Representative-in-Charge form
  • $100 fee (excluding government-owned facilities)
  • Personal Background Affidavit for the NEW designated representative-in-charge only
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Tuesday, February 7, 2012

DEA raids 2 CVS pharmacies in drug abuse probe

DEA raids 2 CVS pharmacies [in FL] in drug abuse probe | Reuters:
"The Drug Enforcement Administration said on Monday it raided two CVS pharmacies over the weekend as part of an effort to curb the abuse of prescription painkillers and other potentially addictive substances.
The action, which occurred on Saturday, came one day after the agency suspended the license of drug distributor Cardinal Health Inc, prohibiting it from shipping such products from its facility in Lakeland, Florida. Cardinal immediately obtained a restraining order allowing it to continue shipments pending a hearing on February 13."
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