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Federal Law Overview Flashcards

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
Anabolic Steroids Control Act of 1990
required anabolic steroids be placed in Schedule III (helps build muscle/ athletes)
26
Health Insurance Portability and Accountability Act (HIPAA) of 1996
``` 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
Drug
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
Cosmetic
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
Third Class of Drugs
drugs available only through a pharmacist
30
Adulteration
Has to do with the drug product itself; whatever formulation it is
31
Misbranded
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
Most common example of misbranding seen
when a pharmacist refills a Rx w/o authorization from the prescriber
33
Class I Recall
will cause serious or fatal consequences
34
Class II Recall
may cause serious but reversible side effects
35
Class III Recall
not likely to cause adverse health consequences
36
FDA Regulatory Action with drug recalls
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
New drug
drug that still needs to go through approval process
38
Approved drug
drug that has already gone through the process and had the application approved by the FDA
39
Procedure for New Drug Application (NDA)
IND (investigational new drug) application filed with FDA --> FDA approves it --> clinical trials can begin
40
Abbreviated New Drug Application (ANDA)
Part of Waxman-Hatch | Expedited the drug to get to the generic market (Do not have to go through Phase I-III)
41
National Drug Code (NDC) ***
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
Label
affixed to container of the drug | Label is glued; It is not designed to be removed
43
Labeling
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
Label on the manufacturers container
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
Labeling in manufacturers container
All the stuff in a package insert | Needs date of the most recent revision of the labeling
46
Unit dose labeling
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
Labeling of Ipecac Syrup
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
Therapeutic equivalence
both do the same thing, have similar drug profiles | NOT legal to substitute these
49
Bioequivalence
both same generic, both absorbed and produce the same blood conc within an acceptable margin of error
50
Pharmaceutical alternative
may consist of diff salts | do NOT allow substitution
51
Orange Book
Updated monthly | For info on what and what cannot be substituted
52
"A" rated products in Orange Book
bioequivalent and are thus "therapeutically equivalent"
53
"B" rated products in Orange Book
not to be bioequivalent
54
"AB" rated products in Orange Book
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
"AA" products in Orange Book
not presenting bioequivalent probs in conventional dosage forms
56
"AN" products in Orange Book
solutions and powders for aerosolization
57
"AO" products in Orange Book
injectable products with oil solvents
58
"AP" products in Orange Book
injectable solutions
59
"AT" products in Orange Book
topical products
60
FDA Pregnancy Category A
no risk on fetus
61
FDA Pregnancy Category B
animal studies show no risk but no adequate and well-controlled studies in pregnant women
62
FDA Pregnancy Category C
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
FDA Pregnancy Category D
positive evidence of human fetal risk but may want to use if benefits > risks
64
FDA Pregnancy Category X
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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