The Board just held their June 24, 2013 e-Pedigree meeting. Still a lot of ground to cover, and "time is running out," as Dirk Rodgers reports in his excellent analysis.
Hey California Board of Pharmacy: Your Time Is Running Out!:
" . . . disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action. It was almost as if the Board members and staff had made no progress . . . "
You might also be interested in:
e-Pedigree Committee Meeting Materials (6/24/2013 meeting) - PDF
Webcast Archive (CA Dept of Consumer Affairs) - some Board of Pharmacy meeting videos get posted here after some delay
Return Home: The Designated Representative and Exemptee Blog
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute
CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute
SkillsPlus Intl Info Blog
Wednesday, June 26, 2013
Saturday, June 22, 2013
The Exemptee Institute
Home - Exemptee Institute of SkillsPlus Intl Inc:
"Since 2002, SkillsPlus Intl Inc. has offered an approved California Department of Public Health Home Medical Device Retailer (CDPH HMDR) training certification course. Establishing our Exemptee Institute is our commitment to offer the highest quality Exemptee training certification course available on the market."
Return Home: The Designated Representative and Exemptee Blog
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):Friday, June 21, 2013
Lawsuit Against CMS To Stop July Competitive Bidding Expansion
- California Exemptee Certification for home medical device retail HMDR Exemptee license applicants:
California Exemptee Certification
" . . . filed a lawsuit against Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), asking her to stop the July 1 expansion of competitive bidding because of “licensing irregularities.”
“Today’s lawsuit zeroes in on a critical flaw in the bidding program—the failure to ensure that all bidders had satisfied state and local licensing requirements before accepting the bids and awarding contracts,” stated Tyler Wilson, president of AAHomecare, in a press release."
Return Home: The Designated Representative and Exemptee Blog
- - -
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):Wednesday, June 19, 2013
CA HMDR Licensing - Info - Forms - FAQs
HMDR Licensing Program Home Page:
"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws."
Return Home: The Designated Representative and Exemptee Blog
"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws."
Return Home: The Designated Representative and Exemptee Blog
- - -
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):Draft Compounding Pharmacy Bill by the House
A nice article with the latest details . . .
FDA Law Blog: Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013:
"This bill does not define a “compounding pharmacy” or create a “compounding manufacturer” category, unlike the pending Senate Health, Education, Labor and Pensions Committee (“HELP”) legislation (S. 959)."
Return Home: The Designated Representative and Exemptee Blog
FDA Law Blog: Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013:
"This bill does not define a “compounding pharmacy” or create a “compounding manufacturer” category, unlike the pending Senate Health, Education, Labor and Pensions Committee (“HELP”) legislation (S. 959)."
Return Home: The Designated Representative and Exemptee Blog
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):
at
4:27 AM
Labels:
bill,
cgmp,
compounding,
congress,
draft,
drug,
fda,
gmp,
HELP,
House,
legislation,
manufacturer,
pharmacy,
Senate
Monday, June 17, 2013
FDA - Hurricane Checklist - Medical Devices
- Buy now! California HMDR Exemptee License Training Certification
- California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.
Public Health Focus > Hurricane Safety Checklist:
"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.
In general, FDA encourages consumers to: . . . " (follow the link above to the FDA's checklist)
More specifically for medical devices:
Medical Devices
- If you have a "life-supporting" or "life-sustaining" device that depends on electricity, you should contact your healthcare provider for information on how to maintain function in the event of a loss of power.
- Keep your device and supplies clean and dry. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
- For more information, see FDA Offers Tips about Medical Devices and Hurricane Disasters15 (en EspaƱol16).
Return Home: The Designated Representative and Exemptee Blog
--------------------
- - -
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):Saturday, June 1, 2013
"Stop This Train Wreck" - Instead, support HR 1717 (to replace CMS competitive bidding)
‘There’s No More Room for Apathy’ -- HME Business:
"Providers must refuse to give in to “apathy” and must form a dedicated and united front in support of gaining as many co-sponsors as possible for H.R. 1717, the bill that would replace competitive bidding with the market pricing program, said Tom Ryan, CEO of New York provider Homecare Concepts. Ryan made an impassioned call to action for providers to support the bill while speaking to attendees of the American Association for Homecare’s Washington Legislative Conference."
Return Home: The Designated Representative and Exemptee Blog
"Providers must refuse to give in to “apathy” and must form a dedicated and united front in support of gaining as many co-sponsors as possible for H.R. 1717, the bill that would replace competitive bidding with the market pricing program, said Tom Ryan, CEO of New York provider Homecare Concepts. Ryan made an impassioned call to action for providers to support the bill while speaking to attendees of the American Association for Homecare’s Washington Legislative Conference."
Return Home: The Designated Representative and Exemptee Blog
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):
Subscribe to:
Posts (Atom)
Custom Search