Pharm Law - Fed Law - Final

Front 1

Which part of the government appoints the administrative agency (DEA, Board of Pharmacy)?

Back 1

Legislative branch

Front 2

What are the three different types of laws?

Back 2

Criminal law
Civil law
Administrative law

Front 3

Which laws, if broken, can lead to jail?
Which laws, if broken, do not lead to jail?

Back 3

Jail - Criminal, Civil laws
No jail - administrative law

Front 4

In the case of pharmacy, the state Board of Pharmacy is the _______ agency

Back 4

Administrative

Front 5

What functions of the Board of Pharmacy include enforcement responsibilities for inspections of pharmacies?

Back 5

Executive

Front 6

What functions of the Board of Pharmacy include enacting regulations?

Back 6

Legislative

Front 7

What functions of the Board of Pharmacy act to interpret violations of the statues and regulations?

Back 7

Judicial

Front 8

What is the statute of limitations for negligence?

Back 8

Two years

Front 9

What does CFR stand for?

Back 9

Code of Federal Regulations

Front 10

CFR21 is an act by which agency of the government?

Back 10

FDC

Front 11

Under Georgia Laws - OCGA, what Title deals with Food, Drugs, and Cosmetics?

Back 11

Title 26

Front 12

Under Georgia Laws - OCGA, what Title deals with Crimes and Offenses?

Back 12

Title 16

Front 13

True or False - Your license is a revocable privilege

Back 13

True

Front 14

How long can a pharmacist be imprisoned for pleading guilty to one count of felony insurance fraud and felony theft?

Back 14

Six months

Front 15

When was the FDA established?

Back 15

1906

Front 16

When was the 16th amendment passed?

Back 16

1913

Front 17

What was the 16th amendment?

Back 17

Income taxes

Front 18

The establishment of the FDA was also known as what act?

Back 18

Wiley Act
(first chemist employed by the FDA)

Front 19

What is a patent medicine?

Back 19

Trademarked medicine

Front 20

What was the act with the basic premise of "Unlawful for any person to manufacture any article of food or drug which is adulterated or misbranded"?

Back 20

Food and Drug Act of 1906

Front 21

What is the term for adding extraneous, improper, or inferior ingredients?

Back 21

Adulterated

Front 22

What is the term for misleading label or fraudulent?

Back 22

Misbranded

Front 23

A violation of the Food and Drug Act of 1906 is a (misdemeanor/felony)

Back 23

Misdemeanor

Front 24

What were the fines/punishments for violation of the Food and Drug Act of 1906?

Back 24

Up to $500 or one year's imprisonment

Front 25

What two things did the Food and Drug Act of 1906 fail to require for medicinal product labeling?

Back 25

Did not require ingredient listing or directions

Front 26

What medication and vehicle combination prompted the Food, Drug, and Cosmetic Act of 1938?

Back 26

Sulfanilamine (diethylene glycol)

Front 27

When was the Food, Drug, and Cosmetic Act enacted?

Back 27

1938

Front 28

The Food, Drug, and Cosmetic Act did NOT require what?

Back 28

Proof of effectiveness

Front 29

True or False - All medications required proof of safety after the Food, Drug, and Cosmetic Act was passed

Back 29

False - Grandfathering of currently available medications was allowed

Front 30

Which Act established the FDA?

Back 30

Food and Drug Act of 1906

Front 31

What were three requirements of the Food, Drug, and Cosmetic Act of 1938?

Back 31

New drugs had to be proven safe
Labels must contain directions
Warnings about habit-forming drugs

Front 32

In 1939, the Georgia General Assembly passed what act?

Back 32

Dangerous Drug Act

Front 33

Which Act is the basis for the Dangerous Drug Act (in Georgia) of 1939?

Back 33

Food, Drug, and Cosmetic Act

Front 34

What court case held that because the Sulfathiazole product of 1948 had been in interstate commerce that the provisions of the Food, Drug, and Cosmetic Act of 1938 applied?

Back 34

US v. Sullivan

Front 35

Which act requires the following three things:
1) Internet pharmacy websites must display information identifying the business, pharmacist, and physician associated with the website
2) The bill bars the selling or dispensing of a prescription drug via the internet when the website has referred the customer to a doctor who then writes a prescription without ever seeing the patient
3) The bill provides states with new enforcement authority modeled on the Federal Telemarketing Sales Act that will allow a state attorney general to shut down a rogue site across the country, rather than only bar sales to consumers of his or her state

Back 35

Haight Act of 2008

Front 36

What primary thing did the Durham-Humphrey Amendment of 1951 establish?

Back 36

Two classes of drugs
1) Legend drugs
2) Non-prescription drugs

Front 37

What were additional components of the Durham-Humphrey Amendment of 1951?

Back 37

Directions required
Oral prescriptions
Prescription refill regulation

Front 38

The Thalidomide disaster prompted what legislation?

Back 38

Kefauver-Harris Amendment of 1962

Front 39

What did the Kefauver-Harris Amendment of 1962 require proof of?

Back 39

Efficacy
(in addition to safety)

Front 40

Which amendment was retroactive in regards to drug safety and efficacy?

Back 40

Kefauver-Harris Amendment of 1962

Front 41

What 6 things did the Kefauver-Harris Amendment of 1962 require?

Back 41

1) Efficacy (in addition to safety)
Retroactive
2) Prescription drug advertising regulated by FDA
3) Informed consent for clinical studies
4) Reporting of ADRs
5) Creating of Good Manufacturing Principles
6) NDA established

Front 42

When was the NDA process established?

Back 42

Kefauver-Harris Amendment of 1962

Front 43

True or False - Thalidomide is banned in the United States

Back 43

False - in 1998, the FDA approved thalidomide for limited use in the US (two forms of contraception and to submit to biweekly pregnancy tests)

Front 44

Which act provided tax and licensing incentives to manufacturers for drugs used to treat rare diseases?

Back 44

Orphan Drug Act of 1983

Front 45

What population is defined by the Orphan Drug Act?

Back 45

< 200,000 people in the US

Front 46

Which piece of legislation provided generic companies with the option of an ANDA?

Back 46

Waxman-Hatch Amendment of 1984

Front 47

The Waxman-Hatch Amendment of 1984 assured innovater companies of ___ years of exclusive marketing after the approval process, and exclusive rights to marketing for ___ years after patent REGISTRATION

Back 47

5 years of exclusive marketing after approval process

Exlusive rights to marketing for 17 years after patent registration, not approval

Front 48

Which bill removed samples from community pharmacies?

Back 48

Prescription Drug Marketing Act of 1987 (Dingell Bill)

Front 49

The Prescription Drug Marketing Act of 1987 is also known as what?

Back 49

Dingell Bill

Front 50

What did the Prescription Drug Marketing Act of 1987 establish for drug wholesalers?

Back 50

Wholesaler licensure requirements
Security of drug stocks
Record-keeping including drug lot number tracking for all drug distribution

Front 51

What three primary components were required with OBRA 90?

Back 51

Patient information
Prospective DUR
Patient counseling

Front 52

What is defined as "the watchfulness, attention, caution, and prudence that a reasonable person in the circumstances would exercise"?

Back 52

Standard of care

Front 53

What act updated many FDA activities?

Back 53

FDA Modernization Act of 1997

Front 54

What did the FDA Modernizzation Act of 1997 update?

Back 54

1) Fast-track review of some NDAs
2) Clarification of pharmacy compounding
3) Legend --> Rx only
4) Elimination of "Warning - may be habit forming"
5) Supplemental NDA for new uses of existing drugs
6) Pediatric studies - 6 month extension of exclusivity

Front 55

What act established Medicare Part D?

Back 55

Medicare Prescription Drug Improvements and Modernization Act of 2003

Front 56

True or False - Mail order may be required for some Medicare Part D programs

Back 56

False - mail order may NOT be required

Front 57

True or False - Importation of drugs from Canada and elsewhere is allowed for Medicare Part D

Back 57

True

Front 58

The reimbursement for Medicare Part D prescriptions changed from ____ to ____

Back 58

From AWP to ASP

Front 59

What drug categories must have multiple drug options for Medicare Part D? (6)

Back 59

Anticonvulsants
Antineoplastic
Antiretrovirals
Antidepressants
Antipsychotics
Immunosuppressants

Front 60

What was the cost to bring a drug to market as of 2005?

Back 60

$250 billion

Front 61

What is required before a drug can proceed with clinical trials on humans?

Back 61

IND
(Investigational New Drug Application)

Front 62

Which phase of Clinical Trials makes sure a drug is safe at projected dosages, determines route of administration, and is tested on normal healthy adults?

Back 62

Phase 1

Front 63

Which phase of Clinical Trials studies patients with the disease/condition to be treated and assesses efficacy?

Back 63

Phase 2

Front 64

Which phase of Clinical Trials studies widespread groups, does double-blind studies, compares the drug to placebo, and is the most costly and time consuming?

Back 64

Phase 3

Front 65

What special type of IND is for use of a non-approved drug, for patients not enrolled in the clinical trials, and for patients in an imminent life-threatening stage?

Back 65

Treatment IND

Front 66

What is submitted after Phase 3 Clinical Trials are complete?

Back 66

NDA
(New Drug Application)

Front 67

A fast track drug is requested by the applicant to who?

Back 67

Secretary of Health and Human Services

Front 68

What must generic drugs submit for approval?

Back 68

ANDA
(Abbreviated New Drug Application)

Front 69

An ANDA (abreviated new drug application) requires proof of what?

Back 69

Bioavailability and chemical activity

Front 70

If a manufacturer wants to change a drug already on the market (i.e. formulation, dosage form, strength, packaging, indication), what must it submit for approval?

Back 70

SNDA
(Supplemental New Drug Application)

Front 71

What are the two therapeutic classifications for NDAs?

Back 71

Type P (Priority)
Type S (Standard)

Front 72

The Orphan Drug Act of 1983 extends exclusivity of a drug by how many years over the patent limit?

Back 72

7 years

Front 73

When a generic challenges the patent of a brand medication, what is the exclusivity period?

Back 73

180 days

Front 74

What do the NDC numbers stand for?

Back 74

First 5 digits - manufacturer
Middle 4 digits - drug
Last 2 digits - package type/size

Front 75

What is required on labeling for manufacturer containers that are supplied to hospitals?

Back 75

Bar codes

Front 76

Bar codes on products supplied to hospitals must contain what?

Back 76

NDC number, not a UPC code

Front 77

True or False - Listing of therapeutically inactive ingredients is a GMP requirement

Back 77

True

Front 78

The new package inserts contain a _______ section as part of their new "streamlined" design since 2006?

Back 78

Highlights

Front 79

True or False - Only Rx medications require drug imprints

Back 79

False - Rx and OTC medications require drug imprints for ID purposes

Front 80

What is the expiration date for repackaging items?

Back 80

25% of remaining expiration time or 6 months (whichever is less)

Front 81

Bar coding is only required on packages for what types of institutitons?

Back 81

Only required on hospital product packages (by FDA)

Front 82

What program is for monitoring and reporting of adverse drug events?

Back 82

MedWatch Program

Front 83

What adverse drug event initiative is hospital based?

Back 83

MedMARx

Front 84

What adverse drug event initiative is for reporting of device problems?

Back 84

Safe Medical Device Act (SMDA)

Front 85

What Class of recall occurs because of risk of serious effects or death?

Back 85

Class I
(recall stock, notify patients)

Front 86

What Class of recall occurs because of risk of temporary or reversible adverse effects?

Back 86

Class II
(recall stock)

Front 87

What Class of recall occurs even if there is little risk of adverse effects?

Back 87

Class III

Front 88

What are the expiration dates for compounds of solids and non-aqueous liquids?

Back 88

NMT 25% of remaining expiration date with a maximum of 6 months

Front 89

What are the expiration dates for compounds of non-aqueous solutions with solid drugs?

Back 89

NMT 14 days under refrigeration

Front 90

What are the expiration dates for miscellaneous compounds?

Back 90

30 days or the duration of therapy

Front 91

What types of compounds are exempt from compounding standards?

Back 91

Radiopharmaceuticals (including PETs)

Front 92

Sterile products follow what USP guidelines?

Back 92

797

Front 93

What is the term for anything that includes "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man and other animals"?

Back 93

Drug

Front 94

What is the term for anything that includes "articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article"?

Back 94

Food

Front 95

What characteristics differentiate a dietary supplement from food? (6)

Back 95

1) vitamin
2) mineral
3) herb or botanical
4) amino acid
5) supplement the diet by increasing dietary uptake
6) concentrate, metabolite, extract, or combination of any ingredient described

Front 96

What is the term for "articles intended to be rubbed, poured, spinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of any such articles; except that such term shall not include soap"

Back 96

Cosmetic

Front 97

What acronym/organization describes federal law and is specific for the state as well?

Back 97

MPJE

Front 98

True or False - According to Georgia law, you may not compound products that are available commercially

Back 98

False - Georgia law says you may compound products which are and are not available as commercial products (federal law says you may NOT)

Front 99

What are the four "practitioner" or "practitioner of the healing arts" professions?

Back 99

Physician
Dentist
Podiatrist
Veterinarian

Front 100

True or False - Chiropracters are not allowed to prescribe or administer medications

Back 100

True

Front 101

What are the limits for prescribing controlled medications for optometrists?

Back 101

Non-narcotic oral analgesics
Schedule III or IV controlled substances for ocular pain, with NMT 72 hours without talking to physician

Front 102

If a patient has what disease state, he/she must be referred to an ophthamologist immediately?

Back 102

Closed angle glaucoma

Front 103

True or False - You can receive C-IIs by both e-RX and fax

Back 103

False - Can NOT get controlled medications by e-prescribing in Georgia

Front 104

What are the only three acceptable circumstances for filling a C-II fax as an original?

Back 104

Terminally ill patients
LTCF
Hospice

Front 105

What three things can be changed to a CII prescription?

Back 105

strength
quantity
directions
(talk directly to prescriber, note on prescription)

Front 106

True or False - It is required that a pharmacist put his/her initials and license number on a CII prescription upon filling it

Back 106

False - NOT initials, license # not required

Front 107

What three pharmacist requirements must be placed on a controlled medication?
How do CIIs differ from CIIIs, CIVs, and CVs?

Back 107

All controls - dispensing date and prescription/serial number

CIIs - pharmacist SIGNATURE
CIIIs-CVs - pharmacist INITIALS