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Compounding News

January 17, 2017
January 17, 2017
At the end of 2016, FDA issued final guidance that will require pharmacists to obtain a valid “patient-specific prescription” for each drug...
APhA opposes final guidance in joint comments
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November 07, 2016
November 07, 2016
Compounding is an important part of pharmacy practice as it permits patients with unique medical needs to have access to vital medications.  APhA...
Association submits recommendations on insanitary conditions at compounding facilities and on compounded drug products that are essentially copies of a commercially available drug product
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May 03, 2016
May 03, 2016
Rep. Buddy Carter (R-GA), BSPharm, on April 28 delivered an impassioned speech on the House floor in protest of recent FDA draft guidance on...
Agency’s draft guidance would prohibit most office-use compounding
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November 01, 2015
October 28, 2015
USP is urging pharmacist stakeholders to review proposed revisions to one of its national standards for compounded preparations.
 The chapter,...
Revisions to USP <797> under way
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September 29, 2015
September 29, 2015
The U.S. Pharmacopeial Convention (USP) is urging pharmacist stakeholders to review proposed revisions to General Chapter <797> Pharmaceutical...
Revisions to USP <797> under way
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September 01, 2015
August 28, 2015
The pharmacy compounding industry was changed forever after the 2012 fungal meningitis outbreak attributed to the New England Compounding Center. In...
Determining the benefits of registering as an outsourcing facility under the 2013 compounding law
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April 01, 2015
March 31, 2015
FDA’s newly configured, 14-member Pharmacy Compounding Advisory Committee (PCAC) convened on February 23–24 at FDA headquarters in suburban...
PCAC added 25 drugs to agency’s do-not-compound list; deemed two bulk drug substances unfit for agency’s bulk list
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February 19, 2015
February 19, 2015
FDA continues to issue guidance on how to enforce the Drug Quality and Security Act after the compounding law was enacted in late 2013. The agency...
Guidance pertains to 2013 compounding law’s 503A and 503B, along with a draft memorandum of understanding
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November 01, 2014
October 31, 2014
At the height of the nation’s recent debate over compounding, Cheri Garvin, BSPharm, President and CEO of The Compounding Center in Leesburg, VA,...
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September 01, 2014
August 25, 2014
Pharmacists who compound preparations within the Commonwealth of Massachusetts and those who ship compounded preparations into the state from...
New regulations take effect in December
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