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Pharmacy Policy and Law > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

Intro to Law, Regulations, and Policy

Define: Statutory Law

A

statute=law
passed by US congress (United States Code (USC)) or passed by state legislature (Indiana Code (IC))

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2
Q

Intro to Law, Regulations, and Policy

Define: Administrative Law

A

administrative agencies are given authority by statute/laws to create rules and regulations, also enforcement of statutes, rules, and regulations are also given by statute/laws to agencies

ex: FDA, Indiana Board of Pharmacy

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3
Q

Intro to Law, Regulations, and Policy

What is The Federal Register?

A

draft rules published by federal agencies where the public can comment and agency reviews

states have a similar policy

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4
Q

Intro to Law, Regulations, and Policy

Where are final federal rules/regulation published?

A

The Federal Register and Code of Federal Regulation

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5
Q

Intro to Law, Regulations, and Policy

How is the validity of regulations determined?

A
  • rule/regulation must be within the scope of the agency
  • it must be based on the atatute that gives the agency authority to promulgate the rule
  • it must have a relationship to public health, safety, and welfare
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6
Q

Intro to Law, Regulations, and Policy

How does the judicial branch make laws?

A

judicial opinions

known as “common law”

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7
Q

Intro to Law, Regulations, and Policy

Define: Preemptive Doctrine

A

federal law preempts state law unless the state law is stricter

always follow the stricter law

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8
Q

Intro to Law, Regulations, and Policy

Define: Civil Law

A

private party sues another (injury alledged) with the decision based on common law and/or statutory law

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9
Q

Intro to Law, Regulations, and Policy

Define: Criminal Law

A

law/statute violated and criminal action must be stated by the government- criminal charges may only occur if a statute exists prohibiting what occured

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10
Q

Intro to Law, Regulations, and Policy

Define: Administrative Law

A

statute or regulation violated and the agency must investigate and may give out warnings, fines, license revocation/suspension, probation

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11
Q

Intro to Federal Law

What did the Pure Food and Drug Act of 1906 establish?

A

prohibited adulteration and misbranding of foods and drugs in interstate commerce (does NOT include false or misleading claims)

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12
Q

Intro to Federal Law

What did the Food, Drug, and Cosmetic Act (FDCA) of 1938 establish?

A
  • no new drug could be marketed until proven safe for use described on the label and approved by the FDA
  • expanded definitions of adulterations and misbranding
  • labels must include “adequate directions for use” and warnings about habit-forming potential of certain medications

does not apply to drugs marketed before 1938 to be proven safe

added cosmetics and devices

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13
Q

Intro to Federal Law

What did the Durham-Humphrey Amendement of 1951 establish?

A
  • created prescription and OTC classes
  • added: “Caution: Federal Law prohibits dispensing without a prescription” to labeling
  • authorized oral prescriptions and refills of prescription medications
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14
Q

Intro to Federal Law

What did the Kefauver-Harris Amendment of 1962 establish?

A
  • drug must be proven safe and effective
  • FDA given jurisdiction over prescription drug advertising
  • established Good Manufacturing Practices (GMP)
  • informed consent of research subjects and reporting of adverse drug reaction in clinical trials
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15
Q

Intro to Federal Law

What did the Medical Device Admendment of 1976 establish?

A
  • classification of devices
  • premarket approval
  • performance standards
  • GMP regulations
  • record and reporting requirements
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16
Q

Intro to Federal Law

What is the legal definition of drug?

A
  1. articles recogonized in the official compendium or any supplement of the official compendium (United States Pharmacopeia (USP), National Formularly (NF), Homeopathic Pharmacopeia of the United States)
  2. AND intended for the use of diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal
  3. AND the article intends to affect the structure or any function of the body in man or animal
  4. AND the article is intended for use as a component of any article specified above
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17
Q

Intro to Federal Law

What is the legal definition of cosmetic?

A

articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applies to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, AND article intended for use as a component of any such articles (not soap)

articles can be a drug and a cosmetic

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18
Q

Intro to Federal Law

What characteristics allow a drug to be sold Over-the-Counter (OTC)?

A

safe and effective for use without supervision

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19
Q

Intro to Federal Law

Define: Orphan Drug

A

drugs for rare disease
used for conditions: affects less than 200,000 people in the US OR affects more than 200,000 people but the cost of developing and making the drug will not be covered from sales

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20
Q

Intro to Federal Law

What is the legal definition of dietary supplement?

A

product (other than tobacco) intended to supplement the diet that contains one or more of the following: vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the total dietary intake)

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21
Q

Intro to Federal Law

What was the purpose of Drug Efficacy Study Implementation (DESI)?

A

drugs introduced between 1938-1962 where known to be safe but efficacy was unknown- so effictiveness had to be proven or removed from market

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22
Q

Intro to Federal Law

What is considered a new drug?

A

new chemical, new condition for approval, new dosage form

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23
Q

Intro to Federal Law

What is the legal definition of device?

A

instrument or related article that is:
1. recognized in USP, NF, or any supplement AND
2. intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or animal AND
3. intended to affect the structure or any function of the body in man or animal, and which does not achieve its primary intended purpose through chemical action and which is not dependent upon being metabolized for the achievement of its intended purpose

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24
Q

Intro to Federal Law

How are Class I Devices classified?

A

least dangerous/low risk- do not support life, sustain life, or present an unreasonable risk of illness or injury with use

subject to general controls- conform with cGMP

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25
# Intro to Federal Law How are Class II Devices classified?
moderate risk with use- require special controls | syringes, tampons, condoms, HbA1c immunoassay
26
# Intro to Federal Law How are Class III Devices classified?
"dangerous"/high risk- support life, sustain life, prevent the impairment of human health, or prevent unreasonable risk of illness or injury, REQUIRE premarket approval
27
# Intro to Federal Law Define: Adulteration
- prepared, packaged, or held in condition where it MAY have been contaminated - exposed to a container that MAY have contaminated it - manufactured under condition that do not conform to CGMP
28
# Intro to Federal Law Define: Misbranding
false or misleading labeling- issues with words (prescription labels also fall under this)
29
# Approval Process What is a NDA?
New Drug Application
30
# Approval Process What products need to file NDAs?
Rx-only and OTC drugs
31
# Approval Process What characteristic of a drug make it "new"?
does not always mean "novel entity" - drugs that contain new substance - new combination of approved drugs - proportion of ingredients in combination changes - new intended use - dosage, method, or duration of administration or application changes - RX to OTC changes
32
# Approval Process What is needed to begin clinical trials?
Investigational New Drug (IND) application filed | may begin if the FDA has not responded in 30 days
33
# Approval Process What are the FDA classification system for drug approval?
- P= priority- no other effective drugs are avaliable, more effective than other drugs, important advantages to other avaliable drugs - S= standard - O= rare diseases
34
# Approval Process What is the importance of postmarketing surveillance?
- larger population is taking than medication than those who were tested on - long-term adverse effects may not be discovered until post-marketing
35
# Approval Process What is the purpose of postmarket clinical studies (Phase IV)?
- determine new uses or abuses for drug - obtain additional safety or efficacy data | could be required by the FDA
36
# Approval Process What did the Drug Price Competition and Patent Term Restoration Act 1984 (PTRA) establish? | aka Hatch-Waxman Amendment
- created abbreviated new drug application (ANDA) for generic drugs - generic drugs does not require clinical studues to establish safety and efficacy - generic drug MUST submit sufficient information to demostrate same active ingredient, route of administration, dosage form, and strength, bioequivalent to the parent drug - generic drug may vary +/- 20% from parent drug
37
# Approval Process How long does a patent last for innovator drugs?
20 years
38
# Approval Process How long does a patent last for new chemical entities approved under NDA?
5 years
39
# Approval Process How long does a patent last for a drug with new indications, dosages, or strength?
3 years
40
# Approval Process What drugs would utilize the Biologic License Application (BLA)?
insulin, insulin analogs, human growth hormone, pancreatic enzyme, reproductive hormones- application sent in once clinical trials and data has ben collected
41
# Recalls Device recalls are ___________ recalls.
mandatory
42
# Recalls Drug recalls are ___________ recalls.
voluntary
43
# Recalls What is the FDA reporting system for recalls?
MedWatch
44
# Recalls What is a Class I recall?
use or exposure to product may cause serious consequences or death
45
# Recalls What is a Class II recall?
exposure to or use of product may cause temporary or medically reversible adverse health consequences- chance of severe consequences is remote
46
# Recalls What is a Class III recall?
use or exposure to product is not likely to cause adverse health consequences
47
# Dietary Supplements What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 establish?
dietary supplement manufactures can make statements related to a structure or function of the body if the statement: - claims product will benefit a nutrient deficiency (as long as prevalence is disclosed as well) - describes the role of dietary supplement in affecting the strcture or function of the body - characterizes the documented mechanisms by which a nutrient or dietary supplement acts to maintain structure or function - describes the general well-being from consumption of a nutrient or dietary ingredient
48
# Dietary Supplements What must be on the label of all dietary supplements?
"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnosis, treat, cure, or prevent any disease."
49
# Dietary Supplements True/False: Premarket approval is NOT needed for supplements
true
50
# Dietary Supplements True/False: Dietary supplements must submit proof to the FDA that they are safe and effective
false
51
# Dietary Supplements True/False: Dietary Supplement manufactures must comply with CGMP
true
52
# OTC Labels What is required on an OTC label?
- statement of identify of product - name and address of manufacturer/packer/distributor - net quantity of contents - cautions and warnings to protect user - adequate directions for safe and effective use - Drug Facts panel
53
# OTC Labels What information must be in the OTC Drug Facts panel?
- active ingredients (including dosage units and quantity per dosage unit) - purpose - uses - warnings - directions - other information (as required by monograph or in approved labeling) - inactive ingredients - questions and/or comments followed by phone number
54
# OTC Labels What warnings must be included on OTC labeling?
- "for external use only/for rectal/for vaginal use only" - do not use if... - ask a doctor before you use if you have... (condition) - ask a doctor or pharmacist before use if you are... (drug-drug interactions) - when using this product... (side effects) - stop use and ask doctor if... (signs of toxicity/severe reactions) - pregnant or breastfeeding warning - "keep out of reach of children"
55
# OTC Labels What constitutes "adequate directions" for use on OTC labeling?
- quantity/dosage for each use - frequency - duration - time of administration/application - route - preparation necessary for use
56
# Prescription Labels What is required to be on prescription drug labels? | intended for the healthcare provider, not patient
- name and address of manufacture, packer, or distributor - established name - ingredient information - inactive ingredients - statement of identity - quantity (weight) - net quantity in container - recommended/usual dosage or reference to package insert - route of administration - identifying lot or control number - type of container needed to dispense drug - expiration date - RX only or "Caution: Federal law prohibits dispensing without prescription"
57
# Prescription Labels What are the federal requirements for dispensed prescription labeling?
- name and address of dispenser - name of prescriber - serial number of the prescription - date of the prescription or its filling - name of the patient (if on the RX) - directions for use (if on the RX) - cautionary statement (if on the RX)
58
# Prescription Labels What are the amount of refills allowed with CIII-IV prescriptions?
5-6 months
59
# National Drug Identifier Describe: National Drug Code (NDC)
3 part number (10-11 digits), first set of digits= manufacture code, second set of digits= drug code, third set of digits= package code
60
# Pregnancy and Lactation Labeling What did the Pregnancy and Lactation Labeling Rule (PLLR) establish?
new labeling regulations for prescription drugs to include relevent information related to pregnancy, lactation, and reproductive health
61
# Package Insert Define: Package Insert
labeling written by the manufacture and FDA intended for healthcare professionals that must remain with the product while in the pharmacy- may be given to patients
62
# Package Insert True/False: Package Inserts must be given to every patient for every prescription
false | they may be given to patients if they request
63
# Patient Package Insert What products require a Patient Package Inserts (PPI) when dispensing?
estrogens and oral contraceptives
64
# Patient Package Insert Who must dispense Patient Package Inserts (PPI)?
pharmacies, institutions and other practitioners who dispense medications
65
# Patient Package Insert When must Patient Package Insert (PPI) be dispensed to the patient?
- outpatient= new prescriptions and every refill - inpatient= 1st dispensing and every 30 days thereafter
66
# MedGuide Describe: Medication Guide
written by manufacture in patient friendly language that explains uses, risks, precautions of drug
67
# MedGuide When is a MedGuide required to be dispensed with the medication?
1. certain information is necessary to prevent serious adverse effects 2. patient decision-making 3. the drug product requires adherence to directions for use for drug efficacy
68
# MedGuide True/False: MedGuides must be dispensed with new prescriptions and refills while outpatient
true
69
# MedGuide When must a MedGuide be dispensed with prescription?
- outpatient with a new prescription and refills - when requested by patient or their representive - first time drug dispense to a healthcare professional for administration to a patient in an outpatient setting - first time drug dispensed in outpatient setting of ANY kind after a MedGuide change - when drug is subject to a REMS that includes reviewing or providing MedGuide
70
# REMS What is the purpose of REMS?
management of known or potentially serious risks of products
71
# REMS True/False: The FDA develops REMS program
false | manufacture develops and FDA reviews and approves
72
# REMS What are the types of REMS?
- medication guides/patient package insert - communication plans- educate healthcare practitioners - element to assure safe use (ETASU)- medical intervention required prio to prescribing/dispensing - implementation system
73
# REMS Describe: isotretinoin REMS
prevention of fetal exposure, pregnancy status must be accessed prior to initiation, patient must be on 2 forms of birth control, max day supply is 30 days
74
# REMS Describe: clozapine REMS
75
# REMS Describe: thalidomide REMS
76
# Child-Resistant Containers What did Poison Prevention Packaging Act (PPPA) establish?
legend drugs (oral dosage forms) must be in child-resistant packaging that is designed to be difficult for children under 5 to open and obtain a toxic or harmful amount within a reasonable amount of time
77
# Child-Resistant Containers True/False: Prescribers can initiate blanket waivers
false | only patient or representative, MD cab give waiver for 1 prescription
78
# Tamper-Evident Packaging What does the Federal Anti-Tampering Act apply to?
consumer products (OTC products)
79
# Prescription Drug Marketing Act What did the Prescription Drug Marketing Act (PDMA) establish?
- require states to license wholesale distributors of prescription drugs - ban sale, trade, or purchase of drug samples - mandate storage, handling, recordkeeping requirements for drug samples - ban the trafficking in or counterfeiting of drug coupons - prohibit resale of prescription drugs purchased by hospitals or healthcare facilities - ban reimportation of prescription drugs, except by the manufacturer or for emergency use
80
# Prescription Drug Marketing Act True/False: Practitioners can call to request drug samples
false | requests must be made IN WRITING
81
# Prescription Drug Marketing Act True/False: Retail pharmacies can recieve drug samples
false | hospital pharmacies may at the request of a practitoner
82
# Prescription Drug Marketing Act How long must records be kept after donating medication to charitable organizations?
3 years
83
# Prescription Drug Marketing Act What records must be kept after donating medication to charitable organizations?
date of donation, drug name
84
# Prescription Drug Marketing Act Define: "gray market"
selling prescription medications outside of the manufacturers authorized channels | prohibited by PDMA unless emergency use
85
# Importation US citizens/foreign nationals can import ___________ day supply of medication "on their person".
90
86
# Importation The Controlled Substances Act allows for a QUANTITY of ___________ dosage units of controlled substances transported personally, per patient.
50
87
# Drug Supply Chain and Security Act What did the Drug Supply Chain and Security Act (DSCSA) establish?
trading partners of prescription drugs (manufacturers, wholesalers, repackagers, dispensers (pharmacies)) MUST have systems in place to quarantine, investigate, notify FDA of suspect and illegitimate prescription drug products (must notify within 24 hours and must also notify trading partners)
88
# Compounding Compounding product in a 503A facility are exempt from:
- CGMP - labeling bearing adequate directions for use - approval for a new drug through IND/NDA/ANDA process
89
# Drug Supply Chain and Security Act What did the Drug Quality and Security Act (DQSA) 2013 establish?
new, voluntary category of compounders= outsourcing facilities (503B), they are subject to CGMP, may dispense patient specific or non-patient specific with order from provider- inspected by the FDA - more rules about labeling and sterility - list of accepted drugs to compound
90
# Drug Supply Chain and Security Act What are the labeling requirements for 503B facilities?
- "This is a coumpounded drug" - name, address, phone number of facility - lot/batch number - name of drug - dosage form and strength - quantity/volume - date compounded - expiration date - storage/handling instructions - NDC, if avaliable - "Not for resale" - if non-patient specific "Office use only" - list of active and inactive ingredients and quantity
91
# USP Compounding Non-sterile compounding is USP ___________________.
795
92
# USP Compounding Sterile compounding is USP _______________.
797
93
# USP Compounding Hazardous drug handling is USP ___________________.
800
94
# USP Compounding BUD for non-preserved aqueous (aw 0.6+) preparations:
14 days
95
# USP Compounding BUD for preserved aqueous (aw 0.6+) preparations:
35 days
96
# USP Compounding BUD for oral liquids (non-aqueous) (aw < 0.6) preparations?
90 days
97
# USP Compounding BUD for non-aqueous forms (aw <0.6) preparations:
180 days
98
# USP Compounding BUD for CSP Category 1:
< 12 hours room temperature and < 24 hours fridge
99
# USP Compounding BUD for CSP Category 2:
no sterility testing: 4 days room temp, 10 days fridge, 45 days freezer sterility testing: 30 days room temp, 45 days fridge, 60 days freezer
100
# USP Compounding BUD of CSP Category 3:
up to 180 days
101

Pharmacy Policy and Law (3 decks)

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