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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
HPUS	Homeopathic Pharmacopeia of the US
Homeopathy is based on the law of similar; “like cures like” by who?	Samuel Hahnemann
IP	International Pharmacopeia/ Pharmacopeia Internationalis (1951)
Provides additional guidelines for drug quality required by certain practitioners and agencies	International Pharmacopeia
EP or Ph Eur	European Pharmacopeia
The Mexican pharmacopeia	Farmacopea de los Estados Unidos Mexicanos
part of the MERCOSUR Pharmacopoeia, comprising Argentina, Brazil, Paraguay, and Uruguay.	Brazilian Pharmacopeia (Farmacopeia Brasilieira)
ISO	International Standardization Organization
It is an international consortium of representative bodies constituted to develop and promote uniform or harmonized international standards.	ISO
ISO standards used in the pharmaceutical industry are those in the series __ to __	ISO 9000 to ISO 9004. Standardization includes: QA, QC, QM
first federal law in the United States designed to regulate drug products manufactured domestically	Food and Drug Act of 1906 drugs marketed interstate to comply with their claimed standards for strength, purity, and quality.
prohibited false claims of therapeutic effects, declaring such products misbranded.	1912 Sherley Amendment
Sulfanilamide tragedy Additional Drug Standardization Agency Prohibits the distribution and use of any new drug or drug product without the prior filing of a New Drug Application (NDA) and approval of the FDA.	Federal FD&C Act of 1938
established a legal distinction between prescription and over-the-counter (OTC) or nonprescription drugs. Prescription drugs must bear the symbol “Rx Only” or the legend “Caution: Federal Law Prohibits Dispensing Without Prescription.”	Durham-Humphrey Amendment of 1951
ensure a greater degree of safety for approved drugs, and manufacturers were now required to prove a drug both safe and effective before it would be granted FDA approval for marketing	Kefauver-Harris Amendments of 1962
Five Schedules for classification and control of drug substances that are subject for abuse:	Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)
It is the strictest warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug.	Black Box Warnings
Gives the FDA the authority to compile a list of currently marketed drugs. ___ each drug is assigned a unique and permanent drug code called ___	1 Drug Listing Act of 1972 2 National Drug Code (NDC)
Ten Characters that identify manufacturer or distributor, drug formulation, size and type of packaging	National Drug Code (NDC)
A law passed in the US to facilitate development of orphan drug. - “rare diseases and conditions”	Orphan Drug Act of 1983
Orphan Diseases	1 Huntington's disease, 2 myoclonus, 3 ALS, 4 Tourette syndrome and 5 muscular dystrophy which affect small numbers of individuals residing in the United States.
Informally known as the Hatch-Waxman Act, is a 1984 US federal law which encourages the manufacture of generic drugs by the pharmaceutical industry. The Act provides some protection for drug innovators while facilitating and providing incentives for companies to file ANDAs. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.	The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)