Wednesday, October 1, 2014

Ohio Lethal Injections Need Drugmaker Protection, Says AG

  1. Ohio Lethal Injections Need Drugmaker Protection, Says AG

    time.com/.../ohio-lethal-injection-secrecy-law-drugs/?...
    Time
    12 hours ago - Like most states, the Ohio Department of Rehabilitation and Correction is attempting to acquire drugs from compounding pharmacies, which are not regulated by  ...

5 Things You Need to Know About Where Rx Drugs Come ..

  1. 5 Things You Need to Know About Where Rx Drugs Come ...  

    www.thenationworld.com/5-things-need-know-rx-drugs-come.html
    7 hours ago - Compounding pharmacies are legal, but are not FDA-regulated. Unlike traditional pharmacies, which dispense drugs manufactured by drug companies,  ...

EmlemHealth Announces Changes with list of excluded compounded drugs and their commercially available, FDA-Approved alternatives


  1. Change to Compounded Drug Coverage - EmblemHealth  

    www.emblemhealth.com/.../Change-to-Compounded-Dru...

    EmblemHealth
    9 hours ago - Click on the link below to see a list of the most frequently prescribed excluded compounded drugs and their commercially available, FDA-approved alternatives.

Updated list of FDA 483s issued in 2014 (10/1/2014)

Updated List of FDA 483s issued in 2013 as of those released and posted by FDA as of October 1, 2014

Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN, FDA 483 Issued 8/21/2014 (PDF - 422KB)

Health Dimensions Inc., Farmington Hills, MI, 483 Issued 8/8/2014 (PDF - 613KB)

DNA Pharmacy Services Inc dba Palm Beach Compounding, Jupiter, FL, 483 Issued 8/13/2014 (PDF - 251KB)

Browns Compounding Center, Inc., Englewood, CO, FDA 483 Issued 8/11/2014 (PDF - 580KB)

Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL, FDA 483 Issued 8/12/2014 (PDF - 1.4MB)

More Kudos for Oklahoma State Board of Pharmacy Regarding Recent Disciplinary Action Against Compounding Pharmacies and Pharmacists

Quantum Medical, Inc, #3-4367 – Case No. 1285: Admitted
to guilt on 28 counts including failing to meet United States
Pharmacopeia (USP) Compounding Standards and Board rules
for sterile compounding; failing to establish and maintain effective
controls against diversion; failing to supervise employees
as they relate to the practice of pharmacy; allowing someone
other than a pharmacist to unlock the pharmacy area; allowing
prescription medications to be left outside the prescription
area when the pharmacist is not in attendance; failing to have
an area designated for the preparation of sterile therapeutic
preparations; failing to have a sink with hot and cold running
water that is convenient to the compounding area; allowing a
person to have access to the parenteral pharmacy in the absence
of an Oklahoma-registered pharmacist; failing to have a documented,
ongoing quality assurance program; failing to ensure
that all compounders who compound pharmaceuticals meet
all requirements for training, testing, and education; failing
to have available for inspection completed documentation of
pharmacist-supervised training and testing in product preparation
of pharmacy technicians participating in the preparation
of compounded products; preparing an inordinate amount of
products in anticipation of a prescription prior to receiving a
valid prescription; failing to properly label and store hazardous
drugs; failing to require that all staff wear personnel protective
equipment (PPE) while working with hazardous drugs;
failing to make the required facility improvements within the
time required; failing to require a technician to have received a
pharmacy technician permit before performing any of the duties
of pharmacy technicians; failing to document training of a currently
permitted technician within 10 days of hire; and placing
drugs with a home care agency, pursuant to agreement, that are 
not allowed by Board rules. Parenteral (sterile compounding)
permit is suspended. Must provide sterile and nonsterile
compounding policies and procedures manual to Board for
approval prior to being allowed to compound. $7,500 fine.

James Casebeer, DPh, #10740 – Case No. 1286: Admitted to
guilt on 32 counts including failing to meet USP Compounding
Standards and Board rules for sterile compounding; failing
to establish and maintain effective controls against diversion;
failing to supervise employees as they relate to the practice of
pharmacy; allowing someone other than a pharmacist to unlock
the pharmacy area; allowing prescription medications to be
left outside the prescription area when the pharmacist is not in
attendance; allowing a person to have access to the parenteral
pharmacy in the absence of an Oklahoma-registered pharmacist;
failing to have a documented, ongoing quality assurance
program; failing to have available for inspection completed
documentation of pharmacist-supervised training and testing
in product preparation of pharmacy technicians participating
in the preparation of compounded products; preparing an inordinate
amount of products in anticipation of a prescription
prior to receiving a valid prescription; failing to properly label
and store hazardous drugs; failing to require that all staff wear
PPE while working with hazardous drugs; failing to make the
required facility improvements within the time required; failing
to document training of a currently permitted technician
within 10 days of hire; and placing drugs with a home care
agency, pursuant to agreement, that are not allowed by Board
rules. Placed on probation for five years until June 12, 2019.
$5,000 fine. Must successfully complete both sterile and
nonsterile compounding education approved by the Board,
and show that his resumed compounding would not put
the public at risk before doing either sterile or nonsterile
compounding. Shall attend a one-day (eight-hour) law
seminar in addition to the required 15 hours of continuing
education (CE) during the calendar years of 2014 and 2015.
All CE required for license renewal shall be live during the
five years of probation.

South Dakota Board of Pharmacy October 2014 Newsletter

Oklahoma Board of Pharmacy October 2014 Newsletter--Major Disciplinary Action Against Compounders

NABP Newsletter October 2014

New Jersey Board of Pharmacy October 2014 Newsletter with Details of New Compounding State Laws

Arizona Board of Pharmacy October 2014 Newsletter--including disciplinary action

Louisiana Board of Pharmacy October 2014 Newsletter--important law changes federal and state

Montana Board of Pharmacy October 2014 Newsletter

Kudos to Oklahoma Board of Pharmacy for Disciplinary Action against OK Compounding --6535 counts--admitted guilt to one count--3 years probation; $520,200 fine!!! No business allowed for 5 days

OK Compounding, LLC, #2-6161 – Case No. 1268: Admitted
to guilt on one count and neither admits nor denies guilt on the
remaining 6,535 counts including, but not limited to, employee
training, record keeping, proper billing for services, properly
licensed staff, unlicensed interstate sales, failing to perform
and document an adequate final check of preparations prior to
their release from the pharmacy, and failing to have available
written policies and procedures for all steps in the compounding
of preparations. Placed on probation for three years until
April 16, 2017. $520,200 fine. Must cease business operations
and fill no prescriptions for five full days between
June 12, 2014 and July 21, 2014.

Nevada Board of Pharmacy October 2014 Newsletter

Pine Pharmacy invests $1M to fill drug distribution void Oct 1, 2014, 10:37am EDT

http://www.bizjournals.com/buffalo/news/2014/10/01/pine-pharmacy-invests-1m-to-fill-drug-distribution.html

BREAKING NEWS!! Coverage revised for compound drugs prescribed for Medicare-eligible IHCP members Effective November 1, 2014, the Indiana Health Coverage Programs (IHCP) is revising its coverage policy for extemporaneously compounded drug products prescribed for IHCP members who are also eligible for Medicare Part D coverage. Compounded drug products containing a Medicare Part D-covered drug product will not be covered by the IHCP for dually eligible members. This change applies to dates of service on or after November 1, 2014.

more information found here

APOTECA To Engage In A Unique Enterprise Solution For IV Automation At The Ohio State University - Dayton ...

IV Logics is excited to announce that the APOTECA™ integrated Enterprise IVCompounding Solution will be incorporated into The Ohio State University's ..

Top FiercePharma Stories

Key Quote to Note: The logic then was, as it has remained, that the subtle dangers of defective drugs can often be lethal, and that such dangers will almost invariably be inscrutable to the untutored eye of the consumer or patient.

quoted from article posted earlier this week:

http://digitalcommons.pace.edu/cgi/viewcontent.cgi?article=1253&context=plr

Must Read and Take Note: The misbranding prohibition has sharp teeth. Introducing or delivering a misbranded drug or device is not an intent crime but instead a strict liability misdemeanor, which becomes a felony when there is intent to defraud or mislead.7

Open Payments website reveals $3.5 billion paid to docs, hospitals By Jaimy Lee Posted: September 30, 2014 - 8:00 pm ET Tags: Compensation, Devicemakers, Healthcare Reform, Hospitals, Pharmaceuticals, Physicians, Robert Wah

http://www.modernhealthcare.com/article/20140930/NEWS/309309990&utm_source=AltURL&utm_medium=email&utm_campaign=am&AllowView=VXQ0UnpwZTVBL2VlL1IzSkUvSHRlRU9nakV3ZEErOWQ=?mh

Minnesota Board of Pharmacy October 1, 2014 Newsletter--Check out board action against compounding pharmacy for veterinary compounds not being patient-specific

Louisiana Board of Pharmacy October 1, 2014 Newsletter-Coverage of Federal and State Law Changes

Arizona Board of Pharmacy October 1, 2014 Newsletter