Shared Flashcard Set

Details

Pharmacy Law
PTCB
22
Medical
Undergraduate 1
09/17/2019

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Cards

Term
Which government agency enforces controlled substance law and regulation
Definition
DEA
Term
The third set of digits (two numbers) in a National Drug Code represents
Definition
The pack size
Term
Prescription Drugs are covered be which part of Medicare
Definition
Part D
Term
Which Act allowed for market exclusivity of brand name medications
Definition
Waxman-Hatch Act
Term
Which Act created National Drug Codes
Definition
Drug Listing Act
Term
The first set of digits (five numbers) in a National Drug Code represent
Definition
The manufacturer
Term
Which Act shortened the required text for prescription medication bottles to read "Rx Only"
Definition
FDA Modernization Act
Term
Which Act allowed for research grants, tax incentives, and market exclusivity for medication that treat rare diseases
Definition
Orphan Drug Act
Term
What is the max limit on the amount of pseudoephedrine a patient can buy a month
Definition
9 grams
Term
What is the limit on the amount of pseudoephedrine a patient can buy in a day
Definition
3.6 grams
Term
What does HIPPA stand for
Definition
Health Insurance Portability and Accountability Act
Term
The Anabolic Steroid Control Act requires that Anabolic Steroids are in what drug schedule
Definition
C-III
Term
What piece of legislation standardized labeling requirements, required package inserts and a good manufacturing process
Definition
Kefauver-Harris Amendment
Term
Which Act required child safety caps?
Definition
Poison Prevention Act
Term
What does OSHA stand for
Definition
Occupational Safety and Health Administration
Term
The second set of digits (four numbers) in a National Drug Code represents
Definition
The product strength and dosage form
Term
Which Act requires that ever patient be offered counseling on every fill of every prescription
Definition
OBRA
Term
What was the first federal law regulation drugs that prevented inaccurately labeled medication from crossing state lines
Definition
Pure Food and Drug Act
Term
Which piece of legislation separated medication into two groups, OTC and Legend Drugs
Definition
Durham-Humphrey Amendment
Term
Which Act allowed for the creation of the DEA
Definition
Controlled Substances Act
Term
What does NDC stand for
Definition
National Drug Code
Term
A patient wants pseudoephedrine and she asked why it's behind the counter? You should tell her that
Definition
The federal government keeps track of its sale because it can be converted to Methamphetamines
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