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
Thursday, November 27, 2014
Wednesday, November 26, 2014
Question of the Day November 26, 2014 Who is the largest and most powerful human compounding pharmacy? Who is the largest and most powerful animal compounding pharmacy? Are they owned by pharmacist or corporations/companies? How long before the biggest and most powerful compounders buy out or force the shut down or bankruptcy of the smaller less powerful compounding pharmacies? Have the buy outs already in process?
Patient Sues Hospital and Pharmacy for Allegedly Giving Contaminated Medications POSTED ON NOVEMBER 25, 2014
Belleville, IL - A Belleville (IL) hospital, along with a local pharmacy, is being sued by a patient for allegedly giving him contaminated medication following a heart surgery, causing her to contract an infection. Melissa Owens has filed a 3-count complaint against defendants Dr. John D. Sadoff, St. Elizabeth’s Hospital, and New England Compounding Pharmacy Incorporated on 27th October in the Saint Clair County Court.
The complaint says Owens underwent an open heart surgery at defendant St. Elizabeth’s Hospital on 27th August, 2012. The coronary bypass surgery was performed by Sadoff. Subsequent to the heart operation, Owens developed a very severe infection, the suit says. On 26th October, 2012, she came to know that her infection was a result of taking contaminated drugs produced by the New England Compounding Pharmacy, according to the complaint. The plaintiff says the medications weren’t sterile.
Updated 2014 FDA Pharmacy Inspections and Related Records Released as of November 26, 2014
2014 Pharmacy Inspections and Related Records
Advanced Pharma Inc., Houston, TX, 483 Issued 3/17/2014 (PDF - 638KB)Alexander Infusion, LLC dba Avanti Health Care Services, New Hyde Park, NY, 483 Issued 7/9/2014 (PDF - 1.4MB)- ALK-Abello, Inc., Port Washington, NY, 483 Issued 02/25/14 (PDF - 1.3MB)
AnazaoHealth Corporation, Tampa, FL, Referral Letter to FL BOP Issued 2/21/2014 (PDF - 375KB)Browns Compounding Center, Inc., Englewood, CO, 483 Issued 8/11/2014 (PDF - 580KB)- California Pharmacy and Compounding Center, Newport Beach, CA, 483 Issued 8/25/2014 (PDF - 2.8MB)
Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA, 483 Issued 8/8/2014 (PDF - 1.5MB)Central Admixture Pharmacy Services, Inc. (CAPS), Livonia, MI, 483 Issued 6/25/2014 (PDF - 928KB)Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA, 483 Issued 6/11/2014 (PDF - 2.1MB)Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA, 483 Issued 2/20/2014 (PDF - 1.9MB)- Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL, 483 Issued 8/12/2014 (PDF - 1.4MB)
Custom Compounding Centers, LLC, Los Alamitos, CA, 483 Issued 8/28/2014 (PDF - 457KB)Custom RX LLC, dba Custom RX Compounding Pharmacy, Richfield, MN, 483 Issued 8/28/2014 (PDF - 775KB)DNA Pharmacy Services Inc dba Palm Beach Compounding, Jupiter, FL, 483 Issued 8/13/2014 (PDF - 251KB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc.), Dallas, TX, 483 Response Dated 8/20/2014 (PDF - 4.2MB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc.), Dallas, TX, 483 Response Dated 8/6/2014 (PDF - 4MB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc), Dallas, TX, FDA Requested Recall Letter Issued 9/9/2014 (PDF - 941KB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc), Dallas, TX, 483 Issued 7/16/2014 (PDF - 2.1MB)Eastern Pharmacy, Inc., Ocala, FL, 483 Issued 2/4/2014 (PDF - 516KB)Edge Pharmacy Services, LLC, Colchester, VT, 483 Issued 8/20/2014 (PDF - 923KB)Foundation Care, LLC, Earth City, MO, Referral Letter to MO Board of Pharmacy Issued 2/26/2014 (PDF - 396KB)Franck's Lab Inc dba Trinity Care Solutions, Ocala, FL, 483 Issued 5/23/2014 (PDF - 856KB)Healix Infusion Therapy, Inc., Sugar Land, TX, 483 Issued 5/16/2014 (PDF - 628KB)Health Dimensions, Inc., Farmington Hills, MI, 483 Response Dated 8/29/2014 (PDF - 1.5MB)Health Dimensions Inc., Farmington Hills, MI, 483 Issued 8/8/2014 (PDF - 613KB)HHCS Pharmacy, Inc. dba Freedom Pharmacy, Orlando, FL, 483 Issued 7/28/2014 (PDF - 1.7MB)Hopewell Pharmacy, Hopewell, NJ, Referral Letter to NJ Board of Pharmacy Issued 2/21/2014 (PDF - 1.3MB)Infusion Options, Inc., Brooklyn, NY, 483 Issued 4/23/2014 (PDF - 2.3MB)I.V. Specialty Ltd., Austin, TX, 483 Issued 7/22/2014 (PDF - 1019KB)Johnson Memorial Cancer Center, Enfield CT, 483 Issued 8/5/2014 (PDF - 916KB)John W. Hollis Inc dba John Hollis Pharmacy, Nashville, TN, 483 Issued 3/21/2014 (PDF - 1.3MB)- Jubilant HollisterStier, LLC, Spokane, WA, 483 Issued 4/15/14 (PDF - 18MB)
Kings Park Slope, Inc., Brooklyn, NY, 483 Issued 3/14/2014 (PDF - 3.2MB)KRS Global Biotechnology, Inc., Boca Raton, FL, 483 Issued 3/17/2014 (PDF - 735KB)LeeSar, Inc., Fort Myers, FL, 483 Issued 8/8/2014 (PDF - 541KB)Leiter's Cambrian Park Drugs, Inc., dba Leiter's Pharmacy, San Jose, CA, 483 Issued 3/6/2014 (PDF - 1.3MB)Leiter's Compounding Pharmacy, San Jose, CA, 483 Response Dated 3/26/2014 (PDF - 3.6MB)Lowlyn Pharmacies, Inc., d/b/a Red Cross Drug, Blanchard, OK, Referral Letter to OK Board of Pharmacy Issued 2/25/2014 (PDF - 2.4MB)Martin Avenue Pharmacy, Inc., Naperville, IL, 483 Issued 7/21/2014 (PDF - 1.8MB)Medi-Fare Drug and Home Health Center, Inc., Blacksburg, SC, 483 Issued 9/12/2014 (PDF - 371KB)Nebraska Methodist Hospital, Omaha, NE, 483 Issued 7/14/2014 (PDF - 772KB)Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN, 483 Issued 8/21/2014 (PDF - 422KB)One Way Drug, LLC dba Partell Specialty Pharmacy, Las Vegas, NV, 483 Issued 5/30/2014 (PDF - 1.3MB)Oregon Compounding Centers, Inc., dba Creative Compounds, Wilsonville, OR, Amended 483 Issued 9/12/2014 (PDF - 1.9MB)Oregon Compounding Centers, Inc., dba Creative Compounds, Wilsonville, OR, 483 Issued 8/28/2014 (PDF - 1.7MB)People’s Pharmacy, Inc. #2, Austin, TX, 483 Issued 7/28/2014 (PDF - 560KB)Perry Drug Inc., Overland Park, KS, 483 Issued 9/9/2014 (PDF - 821KB)Pharmakon Pharmaceuticals, Inc. Noblesville, IN, 483 Issued 3/13/2014 (PDF - 1.9MB)Pharmakon Pharmaceuticals, Noblesville, IN, 483 Issued 4/8/2014 (PDF - 350KB)Portage Pharmacy Inc., Portage, MI, Referral Letter to MI Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)Premier Pharmacy Labs, Inc., Weeki Wachee, FL, 483 Issued 5/9/2014 (PDF - 2.5MB)Region Care, Inc., Great Neck, NY, 483 Issued 3/20/2014 (PDF - 922KB)RX South LLC DBA RX3 Pharmacy, Chester, VA, 483 Issued 2/21/2014 (PDF - 5MB)SCA Pharmaceuticals, LLC, Little Rock, AR, 483 Issued 4/1/2014 (PDF - 1.7MB)Sina LLC, dba OncoMed (Onco 360), Great Neck, NY, 483 Issued 8/22/2014 (PDF - 936KB)South Coast Specialty Compounding, Inc. (Park Pharmacy and Compounding), Irvine, CA, 483 Issued 7/2/2014 (PDF - 708KB)SSM Health Care St. Louis dba SSM St. Clare Health Center, Fenton, MO, 483 Issued 8/14/2014 (PDF - 711KB)Stewart Compounding Pharmacy, Fayetteville, NC, 483 Issued 2/26/2014 (PDF - 1.4MB)Transdermal Therapeutics, Inc., Birmingham, AL, 483 Response Dated 10/14/2014 (PDF - 952KB)Transdermal Therapeutics, Inc, Birmingham, AL, 483 Issued 6/27/2014 (PDF - 413KB)UCSF Home Therapy Services, San Francisco, CA, 483 Issued 9/12/2014 (PDF - 893KB)Unique Pharmaceuticals, Ltd. FDA Requested Recall Letter Issued 7/11/2014 (PDF - 754KB)Unique Pharmaceuticals Ltd., Temple, TX, 483 Issued 6/20/2014 (PDF - 1MB)Unique Pharmaceutical, Ltd., Temple, TX, Amended 483 Issued 4/4/2014 (PDF - 4.3MB)Unique Pharmaceutical, Ltd., Temple, TX, 483 Issued 4/2/2014 (PDF - 748KB)University Pharmacy, Inc., Salt Lake City, UT, Referral Letter to UT Board of Pharmacy Issued 2/20/2014 (PDF - 240KB)US Compounding Inc., Conway, AR, 483 Issued 3/27/2014 (PDF - 1.1MB)Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 6/19/2014 (PDF - 1MB)Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 3/7/2014 (PDF - 1.2MB)Wickliffe Pharmaceutical, Inc., Lexington, KY, 483 Issued 5/22/2014 (PDF - 206KB)Zions RX Formulations Services LLC dba Rx Formulation Serv., Mesa, AZ, 483 Issued 1/9/2014 (PDF - 1MB)
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