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Law Exam 1 > Federal Law Overview > Flashcards

Federal Law Overview Flashcards

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1
Q

Acquisition record

A

record of every Rx that comes in

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2
Q

Inventory record

A

record of every drug that comes in

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3
Q

Distribution/ disposition record

A

record of every drug that goes out of your store

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4
Q

Federal agencies that regulate pharmacy

A

FDA
CDER= Center for Drug Eval and Research
CMS= Centers for Medicare and Medicaid Services
DEA= Drug Enforcement Admin
OCR= Office of Civil Rights (oversees HIPAA)
FTC= Fed Trade Commission (OTC advertising)

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5
Q

U.S. Pharmacopeia (USP)

A

Founded 1820
Created syst of standards, a syst of quality control, and a national formulary
Revised at 10-year intervals

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6
Q

Drug Import Act

A

fed legislation recognized USP as official compendium

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7
Q

Federal Food and Drug Act of 1906

A

prohibited adulterated or misbranded food or drugs from interstate commerce

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8
Q

Why was the Fed Food and Drug Act of 1906 considered inadequate?

A

False statements from manufacturer were not considered misbranding, did not extend to cosmetics, did not grant authority to ban unsafe drugs, labels not required

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9
Q

International Opium Convention of 1912 and Harrison Narcotic Act of 1914

A

First attempt to regulate a specific type of product

Tried to limit import/export/use of opium

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10
Q

Food, Drug, and Cosmetic Act of 1938

A

Created FDA as we know it and FDA enforces it
Required only safe, effective, and properly labeled drugs be introduced into interstate commerce and assured that food and cosmetics were safe and properly labeled

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11
Q

DURHAM-HUMPHREY ACT OF 1951 !!

A

Created legend drugs; defined the types of drugs that cannot be used safely without medical supervision
Required to have the legend “Caution: Federal law prohibits dispensing w/o a prescription” or “Rx only”

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12
Q

Kefauver- Harris Amendments 1962

A

Thalidomide Disaster of 1962

Drug efficacy amendments/ defined investigational drug procedures (phase 1,2,3…)

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13
Q

Drug Abuse Control Amendments of 1965

A

controlled use of depressants, stimulants, and hallucinogens

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14
Q

Comprehensive Drug Abuse Prevention and Control Act of 1970

A

consolidate enforcement activities of various competing agencies

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15
Q

Orphan Drug Act of 1983

A

prompted by AIDS

defined rare disease

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16
Q

Waxman-Hatch Act AKA Drug Price Competition and Patent Term Restoration Act of 1984

A

Abbreviated new drug applications
Patent life extension up to 5 years
Decrease time needed to get approval for generic drugs

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17
Q

Prescription Drug Marketing Act of 1987

A

Established criminal and civil penalties for violations of the FFDC Act

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18
Q

Safe Medical Devices Act of 1990

A

Once the device is implanted in someone, you have to monitor for adverse effects (Really pertains to the person installing the device/ surgeon)

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19
Q

Dietary Supplement Health and Education Act of 1994

A 
Dietary supplements defined as a special class of foods
Specified labeling and "claims" made by manufacturers
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20
Q

FOOD AND DRUG MODERNIZATION ACT OF 1997 (FDAMA)

A

Opened the door for more pediatric studies of drugs
Fast track drugs= drugs that are showing a lot of promise so they can be put through trials a little quicker
Repealed phrase “Warning– may be habit forming”

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21
Q

OTC Labeling Requirements 1999

A

requires a new, easy-to-read, standardized format for OTC drug info

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22
Q

Food and Drug Administration Amendment (FDAAA) of 2007

A

addition to FDA authority
Rx Drug User Fee Act (PDUFA)
Medical Devices User Fee and Modernization Act (MDUFMA)
Drug supply chain security (tracking drugs)

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23
Q

Poison Prevention Packaging Act 1970 (PPPA)

A

prevent accidental poisoning of young children
implemented by the US Consumer Product Safety Commission (CPSC)
Look at pg 11-12 to see what does and does not need safety packaging

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24
Q

Omnibus Budget Reconciliation Act of 1990

A

Required every state to establish a drug review program (prospective)
Required retrospective drug review for Medicaid recipients (“State Drug Use Board” – state review board)/ called DUR – Drug Use Review
Tried to use DUR to reduce cost in State Medicaid programs but now it applies to ALL pts
Requires states to establish standards governing pt counseling (have to use professional judgement on what you deem significant) and maintaining pt records

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25
Q

Anabolic Steroids Control Act of 1990

A

required anabolic steroids be placed in Schedule III (helps build muscle/ athletes)

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26
Q

Health Insurance Portability and Accountability Act (HIPAA) of 1996

A 
Implemented and enforced by the Office of Civil Rights (OCR)
Requires protection and confidentiality and security or health care data, standardization of electronic interchange
Privacy standards (who can access the info), Security standards (to safeguard the info), transaction ad code sets rules (standard format for communicating info), identifier standards
27
Q

Drug

A

use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
If manufacturer makes therapeutic claim including prevention of disease, then the product is also a DRUG!
Does not include devices/ equipment

28
Q

Cosmetic

A

for cleansing, beautifying, promoting attractiveness, or altering the appearance
No classes of cosmetics and they can be put on the market w/o FDA approval

29
Q

Third Class of Drugs

A

drugs available only through a pharmacist

30
Q

Adulteration

A

Has to do with the drug product itself; whatever formulation it is

31
Q

Misbranded

A

If the label tells a lie
Also if packaged incorrectly (w/o childproof)
More people are likely to violate misbranding rather than adulteration (Adulteration is usually caught before going out into the public whereas a lot of misbranded stuff makes it through)

32
Q

Most common example of misbranding seen

A

when a pharmacist refills a Rx w/o authorization from the prescriber

33
Q

Class I Recall

A

will cause serious or fatal consequences

34
Q

Class II Recall

A

may cause serious but reversible side effects

35
Q

Class III Recall

A

not likely to cause adverse health consequences

36
Q

FDA Regulatory Action with drug recalls

A

FDA cannot order drug recall; has to be done by manufacturer
Can do: 1.) Injunction or restraining order from a court (civil procedure) AKA TRO 2.) seizure or embargo (civil procedure) 3.) regulatory letter (admin action by FDA)

37
Q

New drug

A

drug that still needs to go through approval process

38
Q

Approved drug

A

drug that has already gone through the process and had the application approved by the FDA

39
Q

Procedure for New Drug Application (NDA)

A

IND (investigational new drug) application filed with FDA –> FDA approves it –> clinical trials can begin

40
Q

Abbreviated New Drug Application (ANDA)

A

Part of Waxman-Hatch

Expedited the drug to get to the generic market (Do not have to go through Phase I-III)

41
Q

National Drug Code (NDC) ***

A

Not required but nearly everyone uses them
Consists of 10 characters (digits) divided into 3 segments
1. Labeler code= unique for the company that makes it
2. Drug product code= unique for the drug product and the strength
3. Package

42
Q

Label

A

affixed to container of the drug

Label is glued; It is not designed to be removed

43
Q

Labeling

A

Labeling IS designed to be removed; paper that is folded up on the box or bottle (can also be known as the package insert)

44
Q

Label on the manufacturers container

A

Not intended for pt use
Needs statement of usual dose (or reference to package insert for dosage info) along with admin, habit forming, type of container to be dispensed in, etc

45
Q

Labeling in manufacturers container

A

All the stuff in a package insert

Needs date of the most recent revision of the labeling

46
Q

Unit dose labeling

A

Required info: name/ quantity of drug, expiration date, lot #, name of manufacturer/packer/distributor, any statement required by compendia
Not required but recommended: special storage conditions, info to alert health professional, # of dosage units per container and strength of each dosage unit

47
Q

Labeling of Ipecac Syrup

A
  1. For emergency use to cause N/V in poisoning. Before using call physician, Poison Control, or ER
  2. “Warning: Keep out of reach of children. Do not use in unconscious persons….”
  3. Usual dosage is 1 tbs (15 ml) in individuals older than 1 year of age
48
Q

Therapeutic equivalence

A

both do the same thing, have similar drug profiles

NOT legal to substitute these

49
Q

Bioequivalence

A

both same generic, both absorbed and produce the same blood conc within an acceptable margin of error

50
Q

Pharmaceutical alternative

A

may consist of diff salts

do NOT allow substitution

51
Q

Orange Book

A

Updated monthly

For info on what and what cannot be substituted

52
Q

“A” rated products in Orange Book

A

bioequivalent and are thus “therapeutically equivalent”

53
Q

“B” rated products in Orange Book

A

not to be bioequivalent

54
Q

“AB” rated products in Orange Book

A

having actual or potential bioequivalence problems, may be acceptable substitutes if the equivalency prob has been resolved by in vivo and/or in vitro studies
“meets necessary bioequivalence requirements”

55
Q

“AA” products in Orange Book

A

not presenting bioequivalent probs in conventional dosage forms

56
Q

“AN” products in Orange Book

A

solutions and powders for aerosolization

57
Q

“AO” products in Orange Book

A

injectable products with oil solvents

58
Q

“AP” products in Orange Book

A

injectable solutions

59
Q

“AT” products in Orange Book

A

topical products

60
Q

FDA Pregnancy Category A

A

no risk on fetus

61
Q

FDA Pregnancy Category B

A

animal studies show no risk but no adequate and well-controlled studies in pregnant women

62
Q

FDA Pregnancy Category C

A

animal studies have shown adverse effect on fetus and no adequate and well-controlled studies in pregnant women but may want to use if benefits > risks

63
Q

FDA Pregnancy Category D

A

positive evidence of human fetal risk but may want to use if benefits > risks

64
Q

FDA Pregnancy Category X

A

DO NOT USE
animal and human studies show fetal abnormalities and positive evidence of human fetal risk
Risks clearly outweigh potential benefits

Law Exam 1 (2 decks)

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