BCSCP - HISTORY OF COMPOUNDING
QUESTIONS & ANSWERS(RATED A+)
What happened during the roman empire - ANSWERExtemperoaneous compounding
dominated the practice of pharmacy
What changed in pharmacy in the post WWII era (1945-1970s) - ANSWERindustrial
pharmaceutical manufacturing boomed
Since the 1970s, the ____ has been concerned about patient injury and death as a
result of contaminated or incorrectly prepared CSPs - ANSWERFDA
What changed in the 1980-1990s era - ANSWERExtemporaneous compounding was
revitalized...
However, there were many incidents resulting in injury or death secondary to
contaminated eye drops, cardioplegia, parenteral nutrition, or other CSPs
The _________ and ____________ recognized USP797 in 2012... and in 2015 required
all hospitals to be compliant - ANSWERCenter for Disease Control and Prevention
(CDC) and Ceneters for Medicare and Medicaid Services (CMS)
In November 2014, the ___________________________ was enacted by congress.
Title I of this is the Compounding Quality Act which solidifies traditional pharmacy
compounding through 503A pharmacies regulated by the state boards of pharmacy and
503B outsourcing facilities regulated by the FDA - ANSWERDrug Quality and Security
Act (DQSA)
In 2012-2014, what incident happened? - ANSWERA 2 year investigation concluded of
the New England Compounding center (NECC), where 14 individuals were charged with
131 criminal acts relating to compounding
caused widespread fungal meningitis
was not in compliance with 797 or state regulations
The FDA enforces what? - ANSWERThe USP's drug standards
The ____ can regulate compounding under the adulteration and misbranding provisions
of the 1938 Food, Drug, and Cosmetic Act... but it usually defers to ______________ -
ANSWERFDA
State boards of pharmacy
QUESTIONS & ANSWERS(RATED A+)
What happened during the roman empire - ANSWERExtemperoaneous compounding
dominated the practice of pharmacy
What changed in pharmacy in the post WWII era (1945-1970s) - ANSWERindustrial
pharmaceutical manufacturing boomed
Since the 1970s, the ____ has been concerned about patient injury and death as a
result of contaminated or incorrectly prepared CSPs - ANSWERFDA
What changed in the 1980-1990s era - ANSWERExtemporaneous compounding was
revitalized...
However, there were many incidents resulting in injury or death secondary to
contaminated eye drops, cardioplegia, parenteral nutrition, or other CSPs
The _________ and ____________ recognized USP797 in 2012... and in 2015 required
all hospitals to be compliant - ANSWERCenter for Disease Control and Prevention
(CDC) and Ceneters for Medicare and Medicaid Services (CMS)
In November 2014, the ___________________________ was enacted by congress.
Title I of this is the Compounding Quality Act which solidifies traditional pharmacy
compounding through 503A pharmacies regulated by the state boards of pharmacy and
503B outsourcing facilities regulated by the FDA - ANSWERDrug Quality and Security
Act (DQSA)
In 2012-2014, what incident happened? - ANSWERA 2 year investigation concluded of
the New England Compounding center (NECC), where 14 individuals were charged with
131 criminal acts relating to compounding
caused widespread fungal meningitis
was not in compliance with 797 or state regulations
The FDA enforces what? - ANSWERThe USP's drug standards
The ____ can regulate compounding under the adulteration and misbranding provisions
of the 1938 Food, Drug, and Cosmetic Act... but it usually defers to ______________ -
ANSWERFDA
State boards of pharmacy
