The Law of Compounding Medications And Drugs

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

Monday, February 23, 2015

FDA 2014 Pharmacy Inspections and Related Records Released as of February 20, 2015

  • Absolute Pharmacy, LLC, Lutz, FL 483 Issued 11/19/2014 (PDF - 1.4MB)
  • 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)
  • Ambient Healthcare of Central Florida Inc, Ocala, FL, 483 Issued 9/15/2014 (PDF - 637KB)
  • American Specialty Pharmacy, Plano, TX 483 Issued 12/19/2014 (PDF - 1.3MB)
  • AnazaoHealth Corporation, Tampa, FL, Referral Letter to FL BOP Issued 2/21/2014 (PDF - 375KB)
  • BioScrip Pharmacy (NY), Inc., Lake Success, NY, 483 Issued 9/19/2014 (PDF - 1.9MB)
  • Browns Compounding Center, Inc., Englewood, CO, 483 Issued 8/11/2014 (PDF - 580KB)
  • California Pharmacy and Compounding Center, Newport Beach, CA 483 Issued 10/17/2014 (PDF - 544KB)
  • 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)
  • Civic Center Pharmacy, Scottsdale, AZ 483 Issued 10/9/2014 (PDF - 495KB)
  • Coastal Meds, LLC., Biloxi, MS 483 Issued 11/10/2014 (PDF - 691KB)
  • Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL, 483 Issued 8/12/2014 (PDF - 1.4MB)
  • Coram Healthcare Corp. of Indiana, Crown Point, IN, 483 Issued 12/16/2014 (PDF - 1.1MB)
  • Custom Compounding Centers, LLC, Los Alamitos, CA, 483 Response Dated 10/17/2014 (PDF - 637KB)
  • Custom Compounding Centers, LLC, Los Alamitos, CA, 483 Response Dated 10/9/2014 (PDF - 225KB)
  • Custom Compounding Centers, LLC, Los Alamitos, CA, 483 Response Dated 9/18/2014 (PDF - 844KB)
  • 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)
  • Diversified Pharmacy Inc dba University Compounding Pharmacy, Troy, MI 483 Issued 11/13/2014 (PDF - 869KB)
  • 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)
  • Exela Pharma Sciences, LLC, Lenoir, NC, 483 Issued 11/21/2014 (PDF - 406KB)
  • 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)
  • Green Hills Health and Wellness Pharmacy Inc, Nashville, TN, 483 Issued 10/22/2014 (PDF - 727KB)
  • 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)
  • Hieber’s Pharmacy, Pittsburgh, PA 483 Issued 9/18/2014 (PDF - 540KB)
  • 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)
  • Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA, Amended 483 Issued 12/10/2014 (PDF - 976KB)
  • Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA, 483 Issued 12/05/2014 (PDF - 911KB)
  • Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy, Fort Myers, FL, 483 Issued 12/22/2014 (PDF - 1.6MB)
  • 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 12/2/2014 (PDF - 1.2MB)
  • 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)
  • Leiter’s Compounding, San Jose, CA Amended 483 Issued 10/8/2014 (PDF - 1.2MB)
  • Leiter’s Compounding, San Jose, CA 483 Issued 10/7/2014 (PDF - 818KB)
  • 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)
  • Marlborough Hospital, Marlborough, MD, 483 Issued 9/17/2014 (PDF - 472KB)
  • Martin Avenue Pharmacy, Inc., Naperville, IL, 483 Issued 7/21/2014 (PDF - 1.8MB)
  • McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 483 Issued 12/31/2014 (PDF - 475KB)
  • Medi-Fare Drug and Home Health Center, Inc., Blacksburg, SC, 483 Issued 9/12/2014 (PDF - 371KB)
  • Medi-Home Infusion Pharmacy, Irmo, SC 483 Issued 9/17/2014 (PDF - 643KB)
  • Medistat RX L.L.C., Foley, AL 483 Issued 9/18/2014 (PDF - 798KB)
  • National Prescription Services Inc. dba HRI Pharmacy, Warrenville, IL, 483 Issued 11/24/2014 (PDF - 444KB)
  • 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)
  • Northern New England Compounding Pharmacy, LLC, Littleton, NH, 483 Issued 9/30/2014 (PDF - 455KB)
  • One Way Drug, LLC dba Partell Specialty Pharmacy, Las Vegas, NV, 483 Issued 5/30/2014 (PDF - 1.3MB)
  • OPS International Incorporated dba Olympia Pharmacy, Orlando, FL 483 Issued 12/4/2014 (PDF - 1.3MB)
  • Oregon Compounding Centers, Inc. d/b/a Creative Compounds, Wilsonville, OR 483 Response Dated 10/1/2014 (PDF - 5MB)
  • 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)
  • PharmaLogic CSP, Inc., Bridgeport, WV, 483 Issued 12/12/2014 (PDF - 600KB)
  • 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)
  • Right Value Drug Stores, Inc., Hurst, TX 483 Issued 12/12/2014 (PDF - 1.7MB)
  • 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 10/10/2014 (PDF - 1.5MB)
  • Stewart Compounding Pharmacy, Fayetteville, NC, 483 Issued 2/26/2014 (PDF - 1.4MB)
  • Summerton Drug Compounding and Dispensary, Summerton, SC 483 Issued 10/17/2014 (PDF - 493KB)
  • Total Pharmacy Services, Inc., Houma, LA 483 Issued 9/30/2014 (PDF - 514KB)
  • 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)
  • Triangle Compounding, Cary, NC, 483 Issued 9/22/2014 (PDF - 1MB)
  • 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)
  • Vann Healthcare Services Inc, Glasgow, KY, 483 Issued 9/24/2014 (PDF - 681KB)
  • Walgreens Infusion Services, Houston, TX 483 Issued 11/25/2014 (PDF - 1.1MB)
  • Wellness Pharmacy, Inc., Birmingham, AL, 483 Response Dated 10/20/2014 (PDF - 2.2MB)
  • Wellness Pharmacy, Inc., Birmingham, AL, 483 Issued 9/30/2014 (PDF - 251KB)
  • 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 Formulations Serv., Mesa, AZ 483 Issued 12/2/2014 (PDF - 526KB)
  • Zions RX Formulations Services LLC dba Rx Formulation Serv., Mesa, AZ, 483 Issued 1/9/2014 (PDF - 1MB)

- February 23, 2015
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This blog is not affiliated with any company nor does it or has it ever represented any particular company's views. The opinions expressed in this blog are those solely of the author unless indicated otherwise.Nothing contained on this Blog shall constitute legal advice nor be construed as a representation to be reasonably relied upon. This blog site is published by and reflects the personal views of the Author. No representation is made about the accuracy of the information, which solely constitutes the Author’s personal view on these issues. The information contained in this blog site is provided only as general information and personal opinions, and blog topics may or may not be updated after being initially posted. To make informed legal decisions, you should always consult with your own lawyer for your personal legal needs.

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