(Prelims) DDS_2 Lec Flashcards
Organized sets of monographs or books containing such standards to be used by
those involved in the production of drugs and pharmaceutical products.
Pharmacopeia or Formularies
American Pharmacopeia is so called as what
Lititz Pharmacopeia
this is a 32page booklet containing information on 84 internal and 16 external drugs and
preparations.
American Pharmacopeia
Pharmakon meaning
Drug
Poiein meaning
make
Great Britain Pharmacopeia
British Pharmacopeia
father of the USP
Lyman Spalding
Precursor to the USP
Massachusetts Pharmacopeia
how many information of drugs in Massachusetts Pharmacopeia?
536 drugs and pharmaceutical preparations
Arsphenamine discovered by who
Paul Ehrlich and Sahachiro Hata
How many pages and drugs in USP?
272 pages, 217 drugs
submitted a plan to the Medical Society of the County of New York for the
creation of a national pharmacopeia.
Lyman Spalding
Arsphenamine started what era
era of chemotherapy
specific agent against syphilis
Arsphenamine
serve as therapeutic guide to the medical profession
United Stated Pharmacopeia
Denied admission to the USP
National Formulary
designating both the USP and NF as establishing legal standards for medicinal
and pharmaceutical substances.
President Theodore Roosevelt
Signed into law the first federal Pure Food and Drug Act
President Theodore Roosevelt
Section of Monographs for drug substances, dietary supplements, dosage forms, and
compounded preparations
USP Section
purchased the NF, unifying the official compendia and providing the mechanism
for a single national compendium
United Stated Pharmacopeial Convention, Inc.
such drugs also must comply with compendial standards for strength, quality, or
purity.
Adulterated
Section of Monographs for pharmaceutical excipients
NF Section
must comply with compendial standards for packaging and labeling
Misbranded
Homeopathy was coined by who
Samuel Hahnemann
Homoios meaning?
Similar
Pathos meaning
Disease
Ensures the quality of Homepathic drugs
Homeopathic Pharmacopeia of the United States
Sci name of Poison Ivy
Toxicodendron radicans
causes a red, itchy rash
Poison Ivy
published by the World Health Organization (WHO) of the United Nations
International Pharmacopeia
Mexican Pharmacopeia
Farmacopea de los Estados Unidos Mexicanos
what pharmacopeia does Canada use
USP-NF
Brazilian Pharmacopeia
Farmacopeia Brasilieira
is an international standard that provides guidelines specifically on
quality management systems. Ability to consistently provide products and
services that meet customer and regulatory requirements and to demonstrate
continuous improvement
ISO 9001
is a set of internationally recognized standards for quality assurance
and management
ISO 9000
gives guidelines for enhancing an organization’s ability to achieve
sustained success
ISO 9004
contains a model for quality assurance for the production, servicing and
installation of products.
ISO 9002
uses inspection and testing as a means to determine if final products or
services meet requirements.
ISO 9003
distributed by an otherwise reputable manufacturer as an elixir using diethylene
glycol as the solvent
Sulfanilamide
this amendment specifically prohibited false claims of therapeutic effects,
declaring such products misbranded.
Shirley Amendment
Established a legal distinction between prescription and over-the-counter (OTC) or
nonprescription drugs.
DURHAM-HUMPHREY AMENDMENT OF 1951
It is the responsibility of the ______ to either grant or deny permission to manufacture
and distribute a new product after review
FDA
Thalidomide was hoped to replace what
Barbiturates
recommended as a sedative and tranquilizer, was being sold OTC in Europe.
Thalidomide
Thalidomide given to women during pregnancy produced birth defects caused what
Phocomelia+
What is the use of thalidomide now
treatment of multiple myeloma
What is RA 9165
Comprehensive Dangerous Drugs Act
Determine if Sched 1-5?
no accepted medical use
potential for abuse ++++(high)
Sched 1
Determine if Sched 1-5?
accepted medical use
potential for abuse ++++ (high)
Sched 2
Determine if Sched 1-5?
accepted med use
potential for abuse +++ (moderate)
Sched 3
Determine if Sched 1-5?
accepted med use
potential for abuse ++ (low)
Sched 4
Determine if Sched 1-5?
accepted med use
potential for abuse + (low)
Sched 5
Determine if Sched 1-5?
Heroin
Sched 1
Determine if Sched 1-5?
Fentanyl
Sched 2
Determine if Sched 1-5?
Dihydrocodeine
Sched 5
Determine if Sched 1-5?
Tramadol
Sched 4