In other words, do you call more than one compounding pharmacy to see who can make the compound the cheapest? Why wouldn't you especially if the stories are true about adding APIs to jack up the prices? Why wouldn't you when you learn that if the same compound is sold for office use to your doctor it is way cheaper than if it is sold directly to you? Why wouldn't you if you are having to pay for it yourself rather than your insurance paying for it? What are the potential consequences to consumers and to compounders if we openly make price a factor and tell consumers to shop around for who can make the cheapest version of the compound? Will the compounders who do the proper procedures, test, etc. and have the lowest profit margins be driven out of the market by those who don't use proper procedures, don't test, don't follow the regulations etc.? Isn't that happening right now? Many advertise their price on the Internet so consumers can easily price shop now. If we openly say price is a factor and that is okay, would it cause price wars that result in a level playing field? Do a search on the Internet to see how many compounding pharmacies you can find that will make whatever compound you want? Do a search to see how many advertise their price? As consumers we may not know however we aren't comparing apples to apples. We may not know that one company follows the rules and regulations and test and one doesn't and that is why the price is different. And maybe consumers don't care too much about whether rules and regulations are followed anymore. Maybe they don't care where the API/bulk powders come from (because my guess is you can make a cheaper compounded drug if you buy from less reputable sources of powders). Maybe all consumers care about in 2015 is if the compounded drug works for them or at least they believe that it does and that the price is the lowest possible.
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, January 29, 2015
Observation and Question of the Day January 29, 2015 I hear from some readers that price or cost of compounded drugs does matter to them and how much compounders are pocketing as profit doesn't matter. They prefer a cheaper made compounded drug to a more expensive commercially available drug. While price is not suppose to be factor, it clearly has become a factor. So how many consumers of compounded drugs price shop their compounds?
EMA Touts Big Year for Veterinary Products By Michael Mezher - Published 27 January 2015
EMA Touts Big Year for Veterinary ProductsBy Michael Mezher - Published 27 January 2015
The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year.
- See more at: http://www.raps.org/focus-online/news.aspx#sthash.0y58pURt.dpufHow to Effectively Respond to FDA 483s
How to Effectively Respond to FDA 483s
In 2014, FDA conducted 527 medical device compliance inspections in the United States, almost half of which resulted in the issuance of an FDA Form 483.
State prisons submit execution secrecy rule
State prisons submit execution secrecy rule
It shields certain companies, primarily "compounding pharmacies," and individuals involved in the execution process from public disclosure. The secrecy ...
Wednesday, January 28, 2015
Oklahoma Board of Pharmacy New Rules Approved on January 14, 2015 and submitted to the legislature for approval
The following rules were approved by the Board on 01/14/2015 and
have been submitted to the legislature for approval:
Chapter 1. Administrative Operations
[posted 01/26/15]
Chapter 10. Pharmacists; and Interns, Preceptors and Training Areas
[posted 01/26/15]
Chapter 12. Unused Prescription Drug Program for Oklahoma's
Medically Indigent
[posted 01/26/15]
Chapter 13. Emergency / Disaster Prescription Drug Rules
[posted 01/26/15]
Chapter 15. Pharmacies
[posted 01/26/15]
Chapter 20. Manufacturers, Repackagers, Outsourcing Facilities,
Medical Gas Suppliers and Distributors
[posted 01/26/15]
Chapter 25. Rules Affecting Various Registrants
[posted 01/26/15]
California Board of Pharmacy Agenda and Materials for Meeting January 27-28, 2015
January 27-28, 2015
Webcast | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 | Agenda | Meeting Materials |
List of FDA 483 Issued and Released for Compounding Pharmacies in 2014
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 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 10/10/2014 (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, 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 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)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)Medi-Fare Drug and Home Health Center, Inc., Blacksburg, SC, 483 Issued 9/12/2014 (PDF - 371KB)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)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 2/26/2014 (PDF - 1.4MB)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)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 Formulation Serv., Mesa, AZ, 483 Issued 1/9/2014 (PDF - 1MB)
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