Jurisprudence Exam 1 Flashcards
1
Q
What is a democracy?
A
Government in which the supreme power is vested in the people
-exercised by them directly or indirectly through a system of representation usually involving periodically held free elections
2
Q
What is a republic?
A
Government in which supreme power resides in a body of citizens entitled to vote
-exercised by elected officers and representatives responsible to them and governing according to law
3
Q
Federally, all citizens are represented by what individuals?
A
2 United States Senators
(2 per state)
1 United States Representative
(1 per district)
4
Q
In Indiana, all citizens are represented by what individuals?
A
1 Indiana State Senator
1 Indiana State Representative
5
Q
What kind of legislature is Indiana?
A
Citizen Legislature
(lawmaking is not a full-time profession in Indiana)
6
Q
What is the General Assembly?
A
The legislative body of Indiana
-consists of senators and representatives
-meet in two sessions over two years
7
Q
What is the “long session”?
A
The first regular session of the general assembly in Indiana
-Starts in January and ends by April, can last 61 working days
-Odd years
8
Q
What is the “short session”?
A
The second regular session of the general assembly in Indiana
-Must end by March, can last 30 days
-Even years
9
Q
When there is a difference between the state law and the federal law, which law should you follow?
A
Whichever law is more strict
10
Q
What is a statute?
A
A written law enacted by the legislature
*Includes Federal Law
-Listed in the United States Code (USC)
*Includes Indiana Law
-Listed in the Indiana Code (IC)
11
Q
What is a regulation?
A
A rule having the force of law issued by an administrative agency
-Ex: FDA and DEA
*Includes Federal regulations
-listed in the Code of Federal Regulations (CFR)
*includes Indiana Regulations
-Listed in the Indiana Administrative Code (IAC)
12
Q
Where is Federal Law/Statutes listed?
A
United States Code (USC)
13
Q
Where is Indiana Law/Statutes listed?
A
Indiana Code (IC)
14
Q
Where are Federal Regulations listed?
A
Code of Federal Regulations (CFR)
15
Q
Where are Indiana Regulations listed?
A
Indiana Administrative Code (IAC)
16
Q
How do you site the United States Code (USC)?
A
Title USC $Section(subsection)
*Note that this is the same as the Code of Federal Regulations
17
Q
How do you site Indiana Code (IC)?
A
IC Title-Article-Chapter-Section
18
Q
How do you site the Code of Federal Regulations (CFR)?
A
Title CFR $Section(subsection)
*note that this is the same as the United States Code
19
Q
How do you site the Indiana Administrative Code (IAC)?
A
Title IAC Article-Chapter-Section
*note that this is the same as Indiana Code (IC) except that the name of the code moves behind the Title
20
Q
What are the 4 parts to include in a citation of the United States Code (USC) or Code of Federal Regulations (CFR)?
A
Title
Name of thing (USC/CFR)
Section
Subsection
21
Q
What are the 5 parts to include in a citation of the Indiana Code (IC) or Indiana Administrative Code (IAC)?
A
Title
Name of Thing (IC/IAC)
Article
Chapter
Section
22
Q
Which citations use dashes to differentiate different sections?
A
Indiana Code
Indiana Administrative Code
23
Q
Which citations use weird dollar symbols in their citations and where should these be added?
A
United States Code
Code of Federal Regulations
Add them before the “Section”
24
Q
What is criminal action?
A
You break the law
Punished by either the state or federal government
*Fines or Jail time
25
What is civil action?
*Private party sues another party
-they believe they have been harmed by something that was done
-attempt to receive restitution (payment) for the act
26
What does "nostrum" mean?
Patent medication
27
What is a patent medication?
Heavily advertised product that purported to cure numerous diseases
-had no regard to ingredients or the safety or effectiveness of the ingredients
(ex: cocaine tooth drops)
28
What is the Pure Food and Drug Act?
First federal law regulating medications
*Limited to drugs moving in interstate commerce
29
What are the 3 pieces of the Pure Food and Drug Act?
1. Recognized the US Pharmacopeia and the National Formulary as standard drug references
2. Defined "misbranding" and "adulteration" and assigned penalties to each practice
3. Established the Bureau of Chemistry in the U.S. Department of Agriculture as the responsible party for enforcement (Now renamed the FDA)
30
What 3 publications make up the Official Compendia?
-United States Pharmacopoeia (USP)
-National Formulary (NF)
-Homoeopathic Pharmacopoeia of the United States (HPUS)
31
What is adulteration?
Is the product inside the bottle what it is intended to be? If not, then it is adulterated
-Product contains poisonous/insanitary ingredients or lacks manufacturing controls
-Strength, quality, or purity differs from the official compendium
-Strength differs from representation (if not in compendium)
-Product is mixed with another substance to reduce quality or strength, or is substituted altogether
-Delayed, denied, or limited inspection, or refusal to permit entry for inspection
32
What are 2 examples of banned devices?
Prosthetic hair fibers
Powdered gloves
33
Banned devices are an example of what?
Adulteration of devices
34
What is a Class I device?
Not used to support human life and/or prevent impairment of human health
-Do not present a potential unreasonable risk of illness or injury
35
What is a Class II device?
Moderate with to use
*Require special controls to assure safety and effectiveness of device
36
What is a Class III device?
High risk to use
-Support or sustain human life or prevent impairment of human health
-Do present a potential unreasonable risk of illness or injury
37
What are the 3 subclasses a device can fall into?
Restricted
Custom
Banned
38
What is a restricted device?
Require a prescription
-potential for harm and need collateral measures to ensure proper use
-may require specific training, restricted to use by trained individuals
39
What are custom devices?
Devices personalized to meet the specific needs of a single patient
40
What are banned devices?
Devices excluded from US market
*these are adulterated if found on the market
41
What is misbranding?
Is the packaging containing the product (or which must accompany the product) what it is intended to be? If not, it is misbranded)
42
What is the established name?
Generic name
43
What is the proprietary name?
brand name
44
True or False: A proprietary name must be listed on the bottle or it is misbranded
False
-it does not have to have a proprietary name
45
What are 2 examples of times when a product would be both adulterated and misbranded?
A product is stored outside of its recommended temperature, leading its label to fall off due to adhesive failure
An expired drug is counted into a prescription bottle and then dispensed to a patient
46
What was a downside to the Pure Food and drug Act that was determined in court?
It only prevented false statements on the drug's identity, but not false or misleading efficacy claims
-note that this lead to the Sherley Amendment
47
What is the Sherley Amendment?
Amendment to the Pure Food and Drug Act
-Prohibits manufacturers from intentionally creating misleading claims about a drug's effectiveness
48
What made the Sherley Amendment hard to enforce?
The government had to prove the intent of a drug (to prove that a claim was misleading), which made it difficult to enforce
49
What is the Federal Food, Drug, and Cosmetic Act?
Requires new drugs to be shown ONLY SAFE before marketing
Repealed Sherley Amendment which required proving intent to defraud
Authorized factory inspections
Required selected dangerous drugs to be administered under the direction of a qualified expert (beginning requirement for prescription only medications)
50
What 4 criteria must something meet to be considered a "drug"?
(must meet all criteria)
-Article recognized in the official compendia
-Article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals
-Article (other than food) is intended to affect the structure or any function of the body of man or other animals
-Article is intended for use as a component of any article specified in the first 3 criteria
51
In order for a label to be considered "adequate directions for use" it must contain what?
-States the purposes and conditions for which the drug was intended
-Gives sufficient information to enable a layman to intelligently and safely self-medicate
52
What is the Durham-Humphrey Amendment?
Addressed the medications that were not safe for use except under supervision:
Created two classes of drugs:
-OTC medications
-Legend medications
*Also allowed verbal transmission of prescriptions and refills for prescription drugs
53
Under the Durham-Humphrey Amendment, OTC drugs could have what kind of labeling?
Could be labeled with "adequate directions for use"
54
Under the Durham-Humphrey Amendment, Legend medications had what requirements?
Had to be dispensed under the supervision of a health practitioner as a prescription drug
Had to carry the statement "Caution: Federal Law prohibits dispensing without a prescription"
55
What were the requirements for the Kefauver-Harris Amendment?
Required medications to be shown BOTH SAFE AND EFFECTIVE
Transferred jurisdiction over prescription drug advertising from the Federal Trade Commission (FTC) to the FDA
Established current Good Manufacturing Practice (cGMP) requirements
Added requirements to clinical investigations: includes informed consent of participants and reporting of ADRs
56
What drugs were required to prove safety + efficacy based on the Kefauver-Harris Amendment?
Drugs starting from 1938- 1962 (when the amendment was passed) and all new drugs
*note that the Federal Food, Drug, and Cosmetic act was passed in 1938 but only required proof of safety
57
Any manufacturer of drugs used in the US must be registered with the FDA and undergo inspection how often?
At least once every two years
58
If a manufacturer does not comply with cGMP, what does this mean about their product?
It is adulterated
59
If a manufacturer does not register with the FDA, what does this mean about their product?
It is BOTH adulterated and misbranded
(FDA regulates labeling and manufacturing)
60
What 3 categories can making drugs legally fall into?
Pharmacy or Traditional Compounding (503a)
Outsourcing Facilities (503b)
Manufacturing
61
If you are legally making drugs, and fall into category 503a, what are you doing?
Pharmacy or Traditional Compounding
62
If you are legally making drugs, and fall into category 503b, what are you doing?
Outsourcing Facility
63
What is Pharmacy/Traditional Compounding?
Compounding according to prescriptions specific to particular patients on an as needed basis
64
What is an outsourcing facility?
Manufacture large batches with or without prescriptions
-sold to facilities for office use only
65
What is manufacturing?
Mass production of drug products that have been approved by the FDA
66
What requirements must be met to be considered "compounding"?
Must have a prescription (or know one is coming)
Done for an individual patient
Done by a pharmacist, physician, or individual under their supervision
Ingredients are bulk substances complying with USP-NF
Cannot be a copy of a commercially available product (except if on shortage)
Can be done in advance, only on limited basis
67
Compounding pharmacies are exempt from what?
cGMP
Misbranding
New Drug Requirements
68
What requirements must be met by outsourcing facilities?
Can compound without a prescription
Must register, pay annual fees, and be inspected by the FDA
Compound cannot be a copy of a commercially available product
69
Product labels of an outsourcing facility must contain what?
Statement "this is a compounded drug"
Name, address, and phone # of outsourcing facility
Lot number or batch number
Established name of drug
Dose or strength
Quantity or volume
Beyond use date (not expiration)
Storage + Handling instructions
NDC
Statement "this is not for resale"
List of active and inactive ingredients
70
Outsourcing Facilities do not need to follow which law that Drug Manufacturers do?
New Drug Requirements
71
Under the Kefauver-Harris Amendment, drugs produced after 1938 had to be proven safe + effective, what happened to the drugs that came out before this?
They were "grandfathered" in
-Did not have to prove safety or efficacy as this was assumed
72
Under the Kefauver-Harris Amendment, drugs produced after 1938 but before 1962 (when the amendment was passed) had to undergo what?
Drug Efficacy Study Implementation (DESI)
-investigates the drugs for efficacy but not safety since this was already proved
-Products may remain on the market until a decision is made
73
What is Step 1 of the Drug Development Process?
*note this is not the same as the IND process
Preclinical Research
-in vivo animal testing
-used to record toxicity and pharmacology data
-data is used to decide whether to apply as IND
74
What is Step 2 of the Drug Development Process?
Investigational New Drug (IND)
75
What 3 things must an Investigational New Drug (IND) contain?
Animal Pharmacology + Toxicity Studies
Manufacturing Information
Clinical Protocols and Investigator Information
76
Once an IND is submitted the sponsor must wait how many days to hear back from the FDA before starting any clinical trials?
30 days
-if they do not respond, you can start
77
What is Step 3 of the Drug Development Process?
Clinical Research Phase 1
Clinical Research Phase 2
Clinical Research Phase 3
78
What is Clinical Research Phase 1 in Step 3 of the Drug Development Process?
*First phase of clinical trials with healthy human volunteers
-Evaluate safety and drug dosage
-Pharmacokinetic and pharmacologic properties are reviewed and reported
79
What is Clinical Research Phase 2 in Step 3 of the Drug Development Process?
Trial in human volunteers who have the disease/condition being studied
-Used to determine effectiveness of therapy
80
What is Clinical Research Phase 3 in Step 3 of the Drug Development Process?
Drug is given to patients in several geographic locations who have the disease/condition being treated
Compared to placebo
Goal is to demonstrate efficacy at a higher power and to expand information regarding adverse effects
81
What is Step 4 of the Drug Development Process?
New Drug Application (NDA) submission
82
A New Drug Application (IND) must include what?
Everything from the preclinical data up to the Phase 3 trial
-Proposed labeling
-Safety updates
-Drug abuse information
-Patent information
-Data from studies conducted outside the US
-Institutional review board compliance information
-Directions for use
83
How long can the FDA take to make a decision on New Drug Application (NDA) approval?
6-10 months
84
What is Step 5 in the Drug Development Process?
Post-Marketing Surveillance (Phase 4)
85
The FDA reviews what site for trends among adverse events in drugs?
MedWatch
-these are reported by health professionals + patients
86
What is the Orphan Drug Act?
Provided lower statistical burdens for proof of safety and efficacy when appropriate
Also allowed:
-Tax incentives for orphan drug production
-Enhanced patent protection and marketing
-Clinical research subsidies
-Government incentive to engage in drug research
(this was passed to increase development of drugs for rare diseases)
87
What is the Hatch-Waxman Act?
Passed to reduce the requirements for approval of generic prescription drugs
-generic companies can prepare for approval before brand patents expire (just cannot market)
-only have to prove bioequivalence and proof of acceptable manufacturing practices and controls
88
What is the Abbreviated New Drug Application?
Pathway for generic drug approval
-Does not need to include human or clinical trial data
-Need to prove bioequivalence
89
What are the requirements for proving bioequivalence of a generic drug?
Rate of absorption must be equivalent
Must deliver the SAME AMOUNT OF INGREDIENT in the SAME AMOUNT OF TIME
90
What is the Poison Prevention Packaging Act (PPPA)?
Requires prescription drugs and harmful chemicals to be packages in child RESISTANT containers (CRC) also known as "special packaging"
91
What is special packaging?
Targeted at kids UNDER age 5
Not difficult for normal adults to open
Most kids under 5 should struggle to open it, and those that do open it should be prevented from obtaining a toxic amount in a reasonable time
92
What products must have child resistant containers?
ORAL PRODUCTS ONLY
-both OTC and prescriptions
-controlled substances
-samples of oral products
93
What are the requirements to be considered "Child Resistant"?
20% or less of children can open it after 10 minutes
90% of adults can open it after 10 minutes
94
True or False: Oral bulk products must have child resistant containers
False
-unless it is intended to be dispense in the manufacturer's packaging
-not required since they are not given to patients
95
Failure to put an oral drug in a child resistant container when dispensing is what?
Misbranding
96
What are the 3 exemptions to special packaging?
Non-oral dosage forms
Waivers
Consumer Product Safety Commission (CPSC) Exemptions
97
What are the 2 types of special packaging exemption waivers?
Prescription-by-prescription waivers
Blanket waivers
98
What is a prescription-by-prescription waiver?
-Waives child resistant containers (CRC) for the life of a single prescription
-can be given by prescribers or patients *not by pharmacist
99
What are blanket waivers?
Waives the child resistant container packaging for all products that a patient gets
-patient authorization only
100
What are the requirements to be able to reuse packaging?
-Glass
-New cap
101
What is a recall?
VOLUNTARY- done by a company
Correction or removal, and notification to the company, of a product which is in violation of the law
*FDA cannot require a company to do a recall, they will do a seizure if it is bad enough
102
What is a Clas I Recall?
Drug product may cause serious adverse health consequences including death
-pharmacies must notify patients who received recalled drugs
*This is the worst type of recall
103
What is a Class II recall?
Drug may cause temporary or reversible effects but the probability of serious health consequences is remote
104
What is a Class III Recall?
Drug is unlikely to cause serious adverse health consequences
105
What is seizure?
Done by an agency, not the manufacturer
-FDA can remove products from the shelves and file an injunction in court, the product is likely adulterated or misbranded
-This is not voluntary
106
What are the 2 types of seizures?
FDA seizure
DEA seizure
107
What is an FDA seizure?
FDA may physically isolate a drug that is adulterated or misbranded while a CIVIL LAWSUIT is filed
108
What is a DEA seizure?
DEA may physically isolate a drug that is illegal to possess or distribute while a CRIMINAL LAWSUIT is filed, with probable cause and a warrant when necessary
109
What two important changes were put into place after the Chicago Tylenol Murders?
FDA requires tamper-evident packaging for OTC human drug products
-indicators/barriers to entry
-product designed to be distinctive
-capsules must be sealed
-tamper-evident features must be described on package
Federal Anti-Tampering Act makes tampering a federal crime
110
What is a Label?
Any printed, written, or graphic material on the product container
*only applies to stock bottles
111
What is the Package Insert (PI)?
-Part of the labeling
-Have to be with the prescription product, these are for the healthcare professional
-Not required to give to patient
*If drug is on the shelf in the pharmacy it must have the package insert secured to the bottle or it is misbranded
112
What are the 3 new pregnancy categories?
Pregnancy
Lactation
Females and males of reproductive potential
113
What is a patient package insert (PPI)?
*Always have to give these to a patient when a drug they correspond to is dispensed otherwise it is misbranding
*Requirements apply to any person who dispenses medications (includes institutions and practitioners)
*Estrogens + oral contraceptives are the only ones that must have these
114
What are Medication Guides (MedGuides)?
FDA-approved labeling written in patient-friendly language that explains issues related to a drug or drug class
-can be a QR code
115
When must Medication Guides be given to patients?
With new and refill prescriptions in an outpatient environment (all prescriptions)
116
When are MedGuides required?
-Labeling could prevent serious adverse effects
-Serious risks of use exist that patients need to be aware of
-Patient adherence is crucial
*note that 100s of drugs require these
117
If a MedGuide is not dispensed for a required drug what is it?
Misbranding
118
What is a Risk Evaluation and Mitigation Strategy (REMS)?
Used to address serious risks associated with using a medication or class of medications
*Can be required by the FDA as part of labeling
119
What are the 4 types of REMS?
Patient-Friendly Labeling
Communication Plans
Elements to Assure Safe Use (ETASU)
Implementation System
120
What is patient-friendly labeling?
REMS program
Includes medication guides and package inserts
Provides patients essential information about the drug
121
What is Communication Plans?
REMS program
Information sent directly to healthcare practitioners informing them about the drug and how to mitigate issues for patients
122
What is Elements to Assure Safe Use (ETASU)?
REMS
Required activities that must be done before prescribing, dispensing, or receiving a product
-Can be required from practitioners, patients, or pharmacists
123
What is an Implementation System?
REMS
A quality assurance process to ensure that risks are being mitigated successfully
124
What is Consumer Medication Information?
*Not a PPI or MedGuide*
*Not legally required and not regulated by FDA*
Extra information manufacturers want to give to patients
125
All OTC drugs are required to have what in their labeling?
A Drug Facts section
Expiration date (if not present it expires in 3 years)
Lot or batch code
Name + address of manufacturer, packer, or distributor
Net quantity of contents
Description of the tamper-evident packaging used
126
What sections are included in the Drug Facts portion of an OTC label?
Active Ingredients
Purpose(s)
Use(s)
Warning(s)
Directions
Inactive Ingredients
Other Information
127
What form is filled out by health professionals if they want to submit a report to MedWatch?
FDA Form 3500
128
What form is filled out by patients if they want to submit a report to MedWatch?
FDA Form 3500B
129
True or False: Prescribing power is defined by the federal government
False
-it is established by the Durham-Humphrey Amendment and determined by the states
130
What are the Big 4 prescribers that have authority to prescribe in every jurisdiction?
Physicians (MD/DO)
Dentists (DDS/DMD)
Podiatrists (DPM)
Veterinarians (DVM)
AKA "full prescribers"
131
What are mid-level prescribers?
All practitioners outside of the big four that have authority to prescribe
-do not necessarily have authority to prescribe across all states
132
What is the scope of practice of a physician?
Whole human body
133
What is the scope of practice for a dentist?
Mouth and maxillofacial (jaw and face area) for humans
+drugs needed for dentist anxiety or pain
134
What is the scope of practice for a podiatrist?
Feet, ankles, sometimes hands
135
What is the scope of practice for a veterinarian?
Whole body for animals
136
Why is there wide differences from state to state on prescription requirements?
There are no uniform federal standards for non-controlled prescriptions in the US
Federal law does not address prescription expiration or refills
137
What part of a prescription does the FDA address?
Prescription labels
-but not prescriptions, refills, or expiration dates
138
What are the requirements that have to be on a prescription label?
Name + address of dispenser
Serial number of prescription (prescription number)
Date of prescription OR its filling
Name of the prescriber
*THIS IS IT*
139
What additional information may be included on a prescription label?
Name of patient (if stated on the prescription)
Directions for use (if contained on the prescription)
Cautionary statements (if contained on prescription)
140
Prescriptions that are not controlled substances can be refilled for how long in Indiana?
One year
141
How long can controlled substances be refilled in Indiana?
Six months
142
How many full refills are allowed in Indiana for non-controlled drugs?
No rule
143
How many full refills are allowed in Indiana for controlled drugs?
5
144
When does the expiration clock for all prescriptions start clicking in Indiana?
Date issued
145
What is the Omnibus Reconciliation Act (OBRA '90) and what were its 4 primary requirements?
Targeted spending on medications by MEDICAID beneficiaries
Had 4 requirements for pharmacy practice:
-Prospective Drug Utilization Review (DUR)
-Retrospective Drug Utilization Review
-Offer to Conduct Patient Counseling
-Maintain Patient Records
146
What is a prospective drug utilization review?
Pharmacist must review drug therapy before each prescription is filled for accuracy and appropriateness
147
What is a retrospective drug utilization review?
States must review medication use of drugs and compare how they are being used against accepted standards
148
What are the requirements from OBRA '90 regarding patient counseling?
Requires an offer to have a pharmacist counsel the patient be made
*Only applies to Medicaid patients
Pharmacists should counsel on matters that they think are significant
*Nothing in this clause requires consultation when an individual refuses it
149
What is the Dietary Supplement Health and Education Act (DSHEA)?
Clarifies the place in the law for dietary supplements
Defined what a dietary supplement is
150
What is a 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
151
What are the 5 parts that all dietary supplement labels must contain?
1. Name of the product and phrase "dietary supplement"
2. Quantity of the contents
3. Manufacturer, packer, or distributor's name and address
4. Directions for use
5. Supplemental facts panel containing serving size, list of dietary ingredients, amount per serving size, list of dietary ingredients, amount per serving size, and percent daily value if established
152
What are the 3 types of claims dietary supplement manufacturers can make?
Health Claim
Nutrient Content Claim
Structure-Function Claim
153
What is a health claim?
Relationship between a product and its potential impact on an approved disease state or condition
154
What is a Nutrient Content claim?
Relative description of the nutrient or dietary substance in the product
155
What is a Structure-Function claim?
Description of maintaining proper body function independent of specific disease states
156
What claims made by dietary supplements must be FDA approved?
Health Claims
Nutrient content claims
157
What claims made by dietary supplements do not need to be FDA approved?
Structure-function claims
158
What is the Prescription Drug Marketing Act (PDMA)?
Goal was to protect the public against drug diversion by setting standards for the distribution of prescription drugs and drug samples
4 aspects:
-Reimportation
-Preferential pricing
-Samples and Coupons
-Wholesale Licensure
159
What regulations did the Prescription Drug Marketing Act (PDMA) put on reimportation?
-A drug cannot be reimported into the US unless done by the drug manufacturer for emergency use after FDA review
*this bans reimportation of drugs made in the US originally from foreign countries
*does not ban importation of drugs from another country
160
If a drug is unlawfully reimported into the US, is it misbranded, adulterated, or both?
Adulterated only
161
What regulations did the Prescription Drug Marketing Act (PDMA) put on preferential pricing?
Bans the sale, purchase, or trade of a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated/supplied by a charity
*only two entities that get the same preferential price can sell/trade with each other
162
What regulations did the Prescription Drug Marketing Act (PDMA) put on samples and coupons?
Bans the sale, purchase, or trade of a drug sample or coupon
Bans counterfeiting drug coupons
-Practitioners must ask for drug samples in writing
-Community pharmacies cannot have drug samples
-Established recordkeeping, storage, and handling requirements for drug samples
163
What regulations did the Prescription Drug Marketing Act (PDMA) put on wholesale licensure?
States are required to license wholesalers
Records related to PDMA must be maintained for *3 years*
Whistleblower rewards for reporting someone violating PDMA
164
What requirements did the Drug Supply Chain Security Act (DSCSA) put into place?
Manufacturers must put barcodes or QR codes on prescriptions
Manufacturers + wholesalers must verify product legitimacy within *24 hrs* of inquiry from pharmacy
Illegitimate products must be brought to FDA within *24 hrs* of discovery
Pharmacies must track lot numbers through the filling process
Product tracking must be documented for *6 yrs*
165
How many numbers are in an NDC?
11 total:
55555-4444-22
166
The first five numbers of an NDC identify what?
Manufacturer
*assigned by FDA
167
The middle four numbers of an NDC identify what?
Drug, Strength, Dosage form, Formulation
-Assigned by manufacturer
168
The last two digits on an NDC identify what?
Package size
-Assigned by manufacturer
169
Who regulates prescription drug advertising?
FDA
170
Who regulates nonprescription drug advertising?
Federal Trade Commission (FTC)
171
All advertisements made to professionals must include what information?
Established name of drug
Formula of drug
Adverse event info
Contraindications
Effectiveness
*Information cannot be false or misleading
*Cannot be biased in discussion of adverse events (misbranding)
172
Direct-to-Consumer Advertising must be compliant to what 5 standards?
Consumer-friendly language
Appropriate audio (understandable + good pacing)
For TV ads: Presented with audio + text
For TV ads: Text must be easily readable
Free of audio or visual elements that could interfere with comprehension of the major statement
173
What does the FDA currently not require direct-to-consumer advertising to do?
Make the complete labeling information available in the advertisement
174
What requirements must be followed for a manufacturer to be able to advertise off-label uses?
They can provide written information about off-label uses under certain conditions to health care professionals
Information must be complete, peer-reviewed journal articles published outside of company influence
Must have:
-Applied for approval of indication
-Submit copy of info *60 days* before disseminating
-Include multiple documents
175
HIPAA applies to which 3 groups (AKA covered entities)?
Health care providers
Health plans (insurance)
Health care clearinghouses (process PHI on behalf of other entities, ex. PBMs, EHRs)
176
What are the 4 parts of HIPAA rules?
1. Privacy Rule
2. Security Rule
3. Breach Notification Rule
4. Enforcement Rule
177
The privacy rule identifies personal health information as what?
Information (including demographics) relating to:
-An individual's past, present, or future physical/mental health or condition
-Provision of health care to the individual
-Past, present, or future payment for the provision of health care to the individual
*Information must be able to identify the patient or reasonably could
178
True or False: Deidentified health information is Protected Health Information?
False
179
When MUST a covered entity disclose PHI?
To individuals requesting access to their own PHI
To HHS when it is undertaking an investigation or review or enforcement of action
180
What are HIPAA's 3 permitted uses and disclosures?
Treatment
Payment
Health Care Operations
181
What is the HIPAA security rule?
Covered entities are required to maintain reasonable and appropriate administrative, technical, and physical safeguards of electronic PHI
182
What is the HIPAA Breach Notification Rule?
If a covered entity discovers a breach of unsecured PHI, it is obligated to report that breach
183
If a breach affects fewer than 500 individuals, what is required?
-Report breach to Secretary of Health and Human Services within *60 days of the end of the calendar year in which the breach was discovered*
184
If a breach affects 500 or more individuals what is required?
Report the breach to the Secretary of Health and Human Services *within 60 days from discovery of the breach*
-Report breach to prominent media outlets serving the State or jurisdiction
-List of these reports is available as the public domain
185
What part of the United States Pharmacopeia has the force of law?
Drug monographs
-not following them leads to adulteration or misbranding
186
What part of the United States Pharmacopeia does not have the force of law but is enforced by many states?
Information on the appropriate means for drug preparation and storage
187
What does USP <795> cover?
Nonsterile Compounding
188
What requirement does USP <795> put into place?
Beyond-use Dates (BUDs) must be assigned to nonsterile products
189
What does USP <797> cover?
Sterile Compounding
190
What does USP <800> cover?
Hazardous Substances
191
What are the 6 qualifications something can meet to be classified as hazardous? (only needs to meet one)
-Carcinogenic
-Teratogenic or Developmental Toxicity
-Reproductive Toxicity
-Organ Toxicity at low doses
-Genotoxicity
-New Drugs that mimic existing hazardous drugs
192
When an expiration date is only listed as a month and a year, what assumption do we make?
The product is good through the last day of the month noted
193
What is a Beyond Use Date (BUD)?
The date after which a product should not be used
-Cannot be later than an expiration date and is often sooner
194
What are the 2 considerations to make when setting a Beyond Use Date (BUD)?
A BUD cannot be later than the expiration date
OR
Is 1 year from the date the drug is dispensed, whichever is earlier
*this does not apply to repackaged products which have different BUDs
195
What are the 4 exemptions in repackaging where the FDA will not take action against companies for violating the FDCA?
-Prescription drug on the shortage list
-Drug product repackaged under supervision of a licensed pharmacist
-If repackaged by pharmacy, only distributed upon receipt of a valid prescription for an individual patient
-Repackaged product is assigned a BUD as described in the repackaging guidance
196
For a non-aqueous, repackaged drug, the BUD should follow what guidelines?
No more than 6 months from day the drug is dispensed
OR
Expiration date, whatever is first
197
For a water-containing oral repackaged drug, the BUD should follow what guidelines?
No more than 14 days from day the drug is dispensed
OR
Expiration date, whatever is first
198
For water-containing topical, mucosal, and semisolid formulations, the BUD should follow what guidelines?
No more than 30 days from day the drug is dispensed
OR
Expiration date, whatever is first
199
What 3 agencies may conduct inspections?
FDA
DEA
State Board of Pharmacy
200
Pharmacies are exempted from inspection by which agency, unless they manufacture, prepare, or compound drugs or devices?
FDA
201
Why might the FDA inspect a pharmacy?
To determine if they manufacture drugs and to verify compounding is done appropriately
202
Who is the DEA allowed to inspect?
Any place where controlled substances are kept
203
What 3 things must a DEA inspector do when requesting inspection?
-State the purpose of their inspection
-Show their credentials
-Provide written notice of inspection to the pharmacy owner or pharmacist in charge
204
What rights do you have during a DEA inspection?
-Right to require them to get an administrative inspection warrant
-Right to refuse inspection
-May withdraw you consent to inspection at any time
-You will get a copy of the NOI
205
True or False: Anything incriminating found during a DEA inspection may be seized and used against you in prosecution
True
206
What are the 3 types of DEA warrants?
Administrative Inspection Warrants (AIWs)
Search Warrants
207
During what hours can administrative warrants vs search warrants be served?
Administrative warrants: During regular business hours only
Search warrants: Anytime
208
Which agency can you not refuse an inspection by?
Board of Pharmacy
209
True or False: Board of Pharmacy inspectors can inspect without a warrant
True
210
What does the Orange Book do?
Provides equivalency ratings for many products
211
What does the Purple Book do?
Provides interchangeable biologic product information
212
To be therapeutically equivalent the product must be both?
Pharmaceutically Equivalent
(active ingredient, dosage form, strength, route, labeling)
Bioequivalent
(in vivo results, invitro results)
