Notice of
Meeting
Charleston, West Virginia
Tuesday, July 29, 2014
8:00 a.m.; Board Conference room
agenda
Charleston, West Virginia
Tuesday, July 29, 2014
8:00 a.m.; Board Conference room
agenda
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, July 29, 2014
Assistant in Cruelty Case Is Rehired ; Despite PETA Tapes, Steve Asmussen Brings Sott Blasi Back
By JOE DRAPE
Steve Asmussen, the accomplished trainer under investigation for cruelty to his horses, has rehired Scott Blasi, the assistant trainer at the center of the accusations who was caught on videotape speaking profanely and cavalierly about the stable’s injured horses.
Blasi was back at the Asmussen barn Tuesday in Saratoga Springs, N.Y. He had been fired in March within days of the release of the videotapes, which were secretly recorded in an undercover investigation by People for the Ethical Treatment of Animals
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FDA Compounding 483 Inspection Reports for 2014 Updated
Advanced Pharma Inc., Houston, TX, 483 Issued 3/17/2014 (PDF - 638KB)1AnazaoHealth Corporation, Tampa, FL, Referral Letter to FL BOP Issued 2/21/2014 (PDF - 375KB)2Central Admixture Pharmacy Services, Inc. (CAPS), Livonia, MI, 483 Issued 6/25/2014 (PDF - 928KB)3Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA, 483 Issued 6/11/2014 (PDF - 2.1MB)4Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA, 483 Issued 2/20/2014 (PDF - 1.9MB)5Downing Labs, LLC, Dallas, TX, 483 Issued 7/16/2014 (PDF - 2.1MB)6Eastern Pharmacy, Inc., Ocala, FL, 483 Issued 2/4/2014 (PDF - 516KB)7Foundation Care, LLC, Earth City, MO, Referral Letter to MO Board of Pharmacy Issued 2/26/2014 (PDF - 396KB)8Franck's Lab Inc dba Trinity Care Solutions, Ocala, FL, 483 Issued 5/23/2014 (PDF - 856KB)9Healix Infusion Therapy, Inc., Sugar Land, TX, 483 Issued 5/16/2014 (PDF - 628KB)10Hopewell Pharmacy, Hopewell, NJ, Referral Letter to NJ Board of Pharmacy Issued 2/21/2014 (PDF - 1.3MB)11Infusion Options, Inc., Brooklyn, NY, 483 Issued 4/23/2014 (PDF - 2.3MB)12John W. Hollis Inc dba John Hollis Pharmacy, Nashville, TN, 483 Issued 3/21/2014 (PDF - 1.3MB)13Kings Park Slope, Inc., Brooklyn, NY, 483 Issued 3/14/2014 (PDF - 3.2MB)14KRS Global Biotechnology, Inc., Boca Raton, FL, 483 Issued 3/17/2014 (PDF - 735KB)15Leiter's Cambrian Park Drugs, Inc., dba Leiter's Pharmacy, San Jose, CA, 483 Issued 3/6/2014 (PDF - 1.3MB)16Leiter's Compounding Pharmacy, San Jose, CA, 483 Response Dated 3/26/2014 (PDF - 3.6MB)17Lowlyn Pharmacies, Inc., d/b/a Red Cross Drug, Blanchard, OK, Referral Letter to OK Board of Pharmacy Issued 2/25/2014 (PDF - 2.4MB)18One Way Drug, LLC dba Partell Specialty Pharmacy, Las Vegas, NV, 483 Issued 5/30/2014 (PDF - 1.3MB)19Pharmakon Pharmaceuticals, Inc. Noblesville, IN, 483 Issued 3/13/2014 (PDF - 1.9MB)20Pharmakon Pharmaceuticals, Noblesville, IN, 483 Issued 4/8/2014 (PDF - 350KB)21Portage Pharmacy Inc., Portage, MI, Referral Letter to MI Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)22Premier Pharmacy Labs, Inc., Weeki Wachee, FL, 483 Issued 5/9/2014 (PDF - 2.5MB)23Region Care, Inc., Great Neck, NY, 483 Issued 3/20/2014 (PDF - 922KB)24RX South LLC DBA RX3 Pharmacy, Chester, VA, 483 Issued 2/21/2014 (PDF - 5MB)25SCA Pharmaceuticals, LLC, Little Rock, AR, 483 Issued 4/1/2014 (PDF - 1.7MB)26Stewart Compounding Pharmacy, Fayetteville, NC, 483 Issued 2/26/2014 (PDF - 1.4MB)27Unique Pharmaceuticals, Ltd. FDA Requested Recall Letter Issued 7/11/2014 (PDF - 754KB)28Unique Pharmaceuticals Ltd., Temple, TX, 483 Issued 6/20/2014 (PDF - 1MB)29Unique Pharmaceutical, Ltd., Temple, TX, Amended 483 Issued 4/4/2014 (PDF - 4.3MB)30Unique Pharmaceutical, Ltd., Temple, TX, 483 Issued 4/2/2014 (PDF - 748KB)31University Pharmacy, Inc., Salt Lake City, UT, Referral Letter to UT Board of Pharmacy Issued 2/20/2014 (PDF - 240KB)32US Compounding Inc., Conway, AR, 483 Issued 3/27/2014 (PDF - 1.1MB)33Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 6/19/2014 (PDF - 1MB)34Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 3/7/2014 (PDF - 1.2MB)35Zions RX Formulations Services LLC dba Rx Formulation Serv., Mesa, AZ, 483 Issued 1/9/2014 (PDF - 1MB)36
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Compounded Drugs of Value in Outpatient Hospice Care--A Part of LMHPCO Seminar
C 3 Compounded Drugs of Value
in Outpatient Hospice Care
John P. “Jack” McNulty, MD, FACP, FAAHPM
Founder
Palliative Care Institute of Southeast Louisiana
George B. Muller, BS in Pharm., R.Ph
Owner
Muller Compounding Consultants LLC d/b/a
Compounding Business Services
A compounded preparation is needed when
no commercially manufactured medication is
available to adequately address a patient’s
medical needs. Among the greatest therapeutic
challenges faced by both patients and caregivers
is the treatment required by individuals who
have a terminal condition. It is difficult to find
evidence-based studies on the management
of end-of-life situations because each patient’s
medical case is unique. In addition, maintaining
a controlled environment for such patients is
difficult. End-of-life care is multifaceted; it does
not lend itself to “cookbook medicine,” and
people with a terminal illness are among the
most vulnerable patients in need of effective and
compassionate care. When those patients suffer
in spite of commercially available therapies,
the innovation and experience of clinicians
and compounding pharmacists can often yield
a solution to the most challenging treatment
problems. In this presentation, we discuss some
of the most often prescribed compounds used
in outpatient hospice and palliative care to
treat common conditions (wounds, pain and
dyspnea, intractable cough, nausea and vomiting,
depression, bladder infections caused by an
indwelling catheter, rectal pain). The effectiveness
of the preparations we describe is substantiated
in the medical literature and by our personal
experience, which together encompasses nearly
100 years of clinical practice. The medications
described in this report have been shown over
time to be effective.
quoted from here
What Hospitals Need to Know about the New Drug Compounding Law
Tuesday, July 29, 20142:00-3:30 pm Eastern (90 minutes) (1:00-2:30 pm Central; 12:00-1:30 pm Mountain; 11:00 am-12:30 pm Pacific; 10:00-11:30 am Alaska; 8:00-9:30 am Hawaii)
This webinar is brought to you by the Children’s Hospital Affinity Group of the In-House Counsel and Teaching Hospitals and Academic Medical Centers Practice Groups and is co-sponsored by the Hospitals and Health Systems and Life Sciences Practice Groups.
Description
This webinar will describe the new drug compounding law passed by Congress last year, the safety issues that precipitated it, and the timeline for implementation. Hospitals often depend on customized medications, particularly for sterile injectable products and for non-sterile drugs for special populations, such as customized dosages for children, infants, neonates, and geriatric patients. Hospitals sometimes compound medications in their own pharmacies, or rely on outside sources for their compounded medications. In 2012, an outbreak of fungal meningitis and other infections among patients who received a contaminated version of a compounded steroid injection prompted Congress to clarify federal and state oversight of drug compounding.
This webinar will analyze what the changes in the Drug Quality and Security Act mean for hospitals, both for their own drug compounding and their acquisition of compounded drugs from outside pharmacies and outsourcers. Additionally, the presenters will discuss strategies that health systems can employ to ensure the safety and effectiveness of compounded drug preparations.
- Nathan A. BrownPartnerAkin Gump Strauss Hauer & Feld LLPWashington, DC
- Christopher J. Topoleski
Director of Federal Regulatory AffairsThe American Society for Health-System PharmacistsBethesda, MD
Live Show
Conducting a webinar requires the use of special software that allows the speakers and moderator to deliver an interactive presentation via the Internet. Participants will be able to download materials ahead of time and will also be able to view the speaker's PowerPoint slides during the conference, all while listening to the audio through their telephone. To test your computer's compatibility before the session, please conduct a browser test to see if Flash is installed on your computer. If it is not, please download the Flash player onto the computer on which you will be viewing the presentation.Continuing Legal Education (CLE)
CLE information will be provided to registrants at the URL where you access the materials. Find out more information on CLEs for webinars.
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