EXAM 1 Flashcards
Pharmacopeia
term coined in 1580 in
Bergamo, Italy
Pharmakon
drug
Poietin
make
Dr. Spalding of NY (1817)
called for a
unified, national pharmacopeia
U.S. divided into 4 districts and each
district met to…
discuss ideas and elect
delegates
First United States Pharmacopeial
Convention
delegates met in Washington DC
Ideas, recipes, and other items were…
considered and consolidated
1820
-First United States Pharmacopeia published
-almost exclusively physicians at USP Convention
United States
Pharmacopeia
-first met every 10 years, now meets
every 5 years
-non-governmental, nonprofit scientific
organization
-considers objective, science-based standards
-ensure quality of medications, dietary
supplements and some foods
-seven elected members and an Executive Director/Secretary person (8)
1870
almost exclusively pharmacists at
USP Convention
USP standards
mandated by law for
medications in the USA
USP regulation
enforceable by the
Food and Drug Administration (FDA)
1852
American Pharmaceutical Association
(APhA)
USP was the ONLY…
drug standard book available
Many drugs commonly used but without scientific
merit were…
excluded from the USP
Some pharmacists with the help of APhA published
the…
National Formulary of Unofficial Preparations
1906
Shortened title to National Formulary (NF) as a
part of the 1906 Food and Drug Act
USP and NF
-designated to establish legal standards for medicinal and therapeutic substances
-both became Official Compendia
-early editions are a source of recipes, directions, formula
1975
-USP purchases the NF and they are combined
-not published as a
single source until 1980
monographs
-legal documents
-standards must
be adhered to either in large-scale manufacture or small town compounding
USP section
includes all monographs of therapeutically active drug substances
NF section
includes all monographs of pharmaceutical agents
USP 795
-Nonsterile Compounding
-SC Board of Pharmacy uses this as a template for
pharmacy inspections
-pharmacies must incorporate the elements of 795 into their Policies and Procedures
-forever changed how we compound
USP 797
-Sterile Compounding
-emphasis on microbial
contamination risk containment and
verification of this risk containment
-different facilities requirements
-need “ante-area” and “clean room”
-many more regulations than with 795