Tuesday, February 25, 2014

Florida inspections reveal drug compounding health violations - South Florida Business Journal

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Violations also included improperly acting as a wholesaler.  For details, follow the link below . . .


Florida inspections reveal drug compounding health violations - South Florida Business Journal
:

"Consumers often assume drugs are manufactured with the utmost care before injecting them into their veins or dropping them into their eyes, but Florida pharmacy inspectors have found that’s not always the case.
Since October 2012, 11 South Florida pharmacies have had their licenses revoked, relinquished or permanently suspended as compounders by the state Board of Pharmacy because of violations that directly impacted product safety. "

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Monday, February 24, 2014

As Home IVs Grow, Medicare Patients Miss Out - WSJ.com


As Home IVs Grow, Medicare Patients Miss Out - WSJ.com:

"Growing numbers of patients needing intravenous medications are getting their treatments at home. But a gap in Medicare coverage is making it harder for older and sicker patients to swap hospital stays for home care.

Hundreds of new intravenous drugs and biologic products have come on the market in recent years to treat maladies such as infections, cancer and chronic diseases. Administering these medications at home generally costs $150 to $200 a day, far below the $1,500-to-$2,500-a-day cost of a typical inpatient hospital stay. Home-infusion therapy also eliminates the risk that patients will be exposed to infections caused by hospital bacteria that can invade through IV lines and catheters."

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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 11, 2014

California's E-Pedigree Law Preempted

Updated September 24, 2020

The link in the original post broke.

Here's the full text article from the California State Board of Pharmacy.  Source:  The Script (Spring 2014, page 4) - California State Board of Pharmacy: E-pedigree Pre-empted by National Tracking System Law .

"On November 27, 2013, President Obama signed Public Law
113-54, which contains provisions for a national tracking system
for prescription medication.

Included within this law are provisions that pre-empt
California’s e-pedigree requirements that were enacted originally
in 2004 and were to be in full effect by July 2017. California’s
Business and Professions Code contains provisions that
effectively preempt California’s provisions if federal legislation
in this area is enacted.

The board is required to post a message about the
inactivation of California’s e-pedigree provisions. This notice
is provided below; it also will be published in the California
Regulatory Notice Register and posted on our website. Also, this
year the board will sponsor legislation to repeal the e-pedigree
provisions that are now inactive provisions in California law.

The board thanks the many individuals including
pharmaceutical supply chain companies, computer and
technology firms, policy makers, staff of the California
delegation and the many others who worked with the board over
the last 10 years to develop e-pedigree provisions and implement
a system to strengthen the integrity of the US drug supply.

We especially thank the early adopters and those who
worked on pilot projects to ensure California’s provisions
would be implemented by the coming deadlines. It was a large
endeavor and we trust that what was learned to “get ready for
California” will be transferable to the national system that is now
under development. We are grateful to have played a role in this
important area of public safety and health.

Public Notice:

Pursuant to Business and Professions Code section 4034.1,
which provides in pertinent part that “[u]pon the effective date
of federal legislation . . . addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163(c)
– (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become
inoperative,” and which requires that within 90 days of the
enactment of such legislation the board publish a notice regarding
the invalidation of these statutes, the California State Board of
Pharmacy is hereby publishing notice that federal legislation
meeting the requirements of section 4034.1 has been enacted, and
that Business and Professions Code sections 4034, 4163, 4163.1,
4163.2, 4163.4, and 4163.5 became inoperative as of November
27, 2013."

- - -  original post follows below  - - -

California Board of Pharmacy - Information on E-Pedigree:

"Public Notice:

Pursuant to Business and Professions Code section 4034.1, which provides in pertinent part that “[u]pon the effective date of federal legislation . . . addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163(c) – (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative,” and which requires that within 90 days of the enactment of such legislation the board publish a notice regarding the invalidation of these statutes, the California State Board of Pharmacy is hereby publishing notice that federal legislation meeting the requirements of section 4034.1 has been enacted, and that Business and Professions Code sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 became inoperative as of November 27, 2013."

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Drug Wholesalers & 3PL.  If you're applying for a California Designated Representative license, you must include a training affidavit (proof of required training) in the application. Take these California Designated Representative training courses & get a training affidavit.

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Friday, February 7, 2014

U.S. PAP Device Shipments to Skyrocket -- HME Business

  • California Exemptee Certification training program/course. State-approved by the CDPH. Respected. Reliable - Dependable - High uptime availability! For home medical device retail (HMDR) Exemptee license applicants.

U.S. PAP Device Shipments to Skyrocket -- HME Business:

"U.S. shipments of auto-positive airway pressure devices will jump a considerable 70 percent over 2013 levels by 2017, according to a new report from IHS Technology.

Shipments of Auto-PAP devices in the United States will increased at a compound annual growth rate of 14.2 percent over the next four years, reaching 1,312,811 units by 2017, according to the report, Sleep Diagnostics, Sleep Therapy and Sleep Interfaces - World - 2013. Auto-PAP shipments will surpass those of continuous positive airway pressure (CPAP) machines in 2015, the report also noted."

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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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