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Us Compounding history
Us Compounding company history timeline
During the 1980's, many licensed pharmacists, particularly those in hospitals, began to take on responsibilities of clinical patient management and the safe and appropriate use of drug products.
In the 1990’s, even with the popularity of compounding growing again only a few pharmacists can be known as a compounder or apothecary, because this technique was forgotten by most.
Convinced there was a need for a compounding pharmacy that specialized in providing quality customized medications to his customers at affordable prices, Joe started University Compounding Pharmacy in 1999.
108th Cong, 1st Sess (2003) (testimony of Sarah Sellers, PharmD, MPH, executive director, The Center For Pharmaceutical Safety).
Tightened United States Pharmacopeial Convention standards (since 2004) for sterile compounding made it difficult for hospitals to achieve all of the sterile compounding necessary for patient care.
Civen, R., Vugia, D.J., Alexander, R., Brunner, W., Sirlura, T., Parris, N.,…Rosenberg, J. (2006). Outbreak of Serratia marcescens Infections following Injection of Betamethasone Compounded at a Community Pharmacy.
Frost B, Kainer M. Eye opening: are compounded drugs causing harm? In: Society of Healthcare Epidemiology of America Annual Scientific Meeting; 2011.
Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy - United States, 2012.
In: Journal of Investigative Medicine Western Regional Meeting; 2012.
The major catalyst for change was the outbreak of fungal meningitis in 2012 at the New England Compounding Center (NECC). The outbreak crossed interstate lines, infecting a total of 793 patients nationwide and causing 64 deaths.
April 7, 2013. http://www.fda.gov/ downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ ORAElectronicReadingRoom/UCM348772.pdf.
A major foundational change was the signing of the Federal Drug Quality and Security Act in November, 2013.
503B Outsourcing Facilities came into existence in 2013 as a result of the Drug Quality and Security Act (DQSA). It created Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C), prompting extensive regulatory changes in the safe and effective compounding of drugs and medicines.
Palmer, K.L. (2014, January). FDA touts the benefits of outsourcing facility registration to state officials and hospital purchasers of compounded medications.
PEW Charitable Trust (2014, May 21). Ensuring the safety of compounded drugs: Study highlights key quality standard.
March 30, 2016. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-voluntary-recall-all-unexpired-human-and-animal-compounded-drug-products-produced.
May 6, 2016. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-pharmakon-pharmaceuticals-nationwide-voluntary-recall-purportedly-sterile-drug.
PEW Charitable Trusts (2017, December). What Are Compounded Drugs, and How Can They Be Kept Safe? Drug Quality and Security Act plays key role in important but potentially high-risk aspect of health care.
In the Spring of 2017, University Compounding Pharmacy moved into an expansive new facility that houses state-of-the-art laboratories for our sterile and non-sterile preparations.
January 4, 2018. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-update-recovery-efforts-puerto-rico-and-continued.
United States Food and Drug Administration; July 31, 2018. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-raniers-rx-laboratorys-voluntary-recall-all-sterile-compounded-drug.
115th Cong, 2nd Sess (2018) (testimony of Scott Gottlieb, (former) Commissioner of FDA).
Open Forum Infectious Diseases: In; 2018.
FDA (2018). New England Compounding Center pharmacist sentenced for role in nationwide fungal meningitis outbreak. [Press Release] Retrieved from: https://bit.ly/32ba2Wb
September 9, 2019. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-pacifico-national-incs-dba-amex-pharmacy-voluntary-recall-all-sterile-compounded-drugs.
December 19, 2019. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding.
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Us Compounding competitors
| Company name | Founded date | Revenue | Employee size | Job openings |
|---|---|---|---|---|
| Wells Pharmacy Network | 2011 | $640,000 | 1 | - |
| Wedgewood Pharmacy | 1980 | $300.0M | 286 | - |
| Dougherty's Pharmacy | 1929 | $36.1M | 15 | - |
| NuScriptRX | 2007 | $12.5M | 44 | - |
| Genoa | 1999 | $520.6M | 1,700 | - |
| Kohll's Rx | 1948 | $64.0M | 215 | - |
| Biomed Specialty Pharmacy | - | $1.3M | 15 | - |
| Cannon Pharmacy | 2002 | $2.1M | 69 | - |
| Medicine Chest Pharmacies | - | $1.9M | 5 | - |
| Pharmco International | 1997 | $700,000 | 10 | 4 |
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