Exam One Flashcards
True or False: The United States and Indiana operate as both a democracy and a republic
True
Democracy
a government in which the supreme power is vested in the people and exercised by them directly or indirectly through a system of representation usually involving periodically held free elections
Republic
a government in which supreme power resides in a body of citizens entitled to vote and is exercised by elected officers and representatives responsible to them and governing according to law
Federally, how are all citizens represented?
- Two US State Senators (6 year term)
- One US State Representatives (2 year term)
In Indiana, how are all citizens represented?
- One Indiana State Senator (4 year term)
- One Indiana State Representative (2 year term)
How long is each federal congress convened over?
a rolling two year term
True or False: Bills carried can be carried over from the first session?
- Yes
- must be passed by the end of the second session
What type of legislature is Indiana?
- Citizen’s legislature
- lawmaking is not a full-time profession in Indiana
What is the General Assembly?
- legislative body of Indiana consisting of senators and representatives
- two sessions over two years
How long is a long session?
61 days, ends by April 30th
How long is a short session?
30 days, ends by March 15th
Statute
a written law enacted by the legislature
Where is federal law listed?
United States Code
Where is Indiana law listed?
Indiana Code (IC)
Regulation
a rule having the force of law issued by an administrative agency
Which two agencies issue federal rules or regulations related to pharmacy?
FDA and DEA
Where are federal regulations listed?
Code of Federal Regulations
Where are Indiana regulations listed?
Indiana Administrative Code
How to cite Federal Statues and Rules
Title USC/CFR Section(subsection)
How to cite Indiana Code
IC Title-Article-Chapter-Section
How to cite Indiana Administrative Code
Title IAC Article-Chapter(Rule)-Section
Criminal Action
you break the law and are punished by the state or federal government, traditionally through fines or jail time
Civil Action
a private party sues another party because they believe they have been harmed by something that was done in an attempt to receive restitution (payment) for the act
Administrative Action
a professional (like a pharmacy) violates a law or regulation, and an administrative agency (like the board of pharmacy) investigate and may restrict licensure or abilities to act under a license
What drug developed in 1952 given to pregnant women caused fetal malformations?
Thalidomide
What amendment was passed largely in result of the thalidomide disaster
Kefauver-Harris Amendment
What did the Kefauver Harris Amendment require?
- required all meds to be demonstrated as not only safe, but also effective (drugs marketed between 1938-1962 and new drugs)
- transferred jurisdiction of prescription drug advertising from FTC to FDA
- established cGMP requirements
- added requirements to clinical investigations including informed consent and adverse drug reaction reporting
Which amendment established cGMP requirements?
Kefauver Harris Amendemnt
Which amendment transferred jurisdiction of drug advertising from FTC to FDA?
Kefauver Harris Amendment
What are the minimum requirements for the manufacturing processes of drug products according to cGMP?
- design
- monitoring
- control
How often does a FDA registered drug manufacturer undergo inspection according to cGMP?
at least once every 2 yeaars
What happens to the drug if a manufacturer does not comply with cGMP
the drug is alduterated
What happens to the drug if a manufacturer does not register with the FDA?
the drug is aldulterated and misbranded
What are the three general categories of drug making
- pharmacy or traditional compounding (503a)
- outsourcing facilities (503b)
- manufacturing
503a
- pharmacy or traditional compounding
What category would compounding according to prescriptions specific to particular patients on as a needed basis fall under
503a compounding
503b
- outsourcing facility
What category would manufacturing large batches with or without prescriptions to be sold to facilities for office use only fall under?
503b compounding
What is manufacturing
mass production of drug products that have been approved by the Food and Drug Administration
What is required for something to be considered 503 a compounding?
- compound pursuant to prescription only
- for an individual person
- bulk substances comply with USP-NF
- compound cannot be copy of commercially available product
- can be done in advance on a limited basis
Can you compound commercially available products under a 503a pharmacy?
- no, unless there is a drug shortage (on FDA list)
What requirements are 503a pharmacies exempt from?
- cGMP
- misbranding (related to drug labeling)
- New Drug Requirements
Do you need a prescription for a 503b pharamcy?
No
What is required of a 503b pharmacy?
- must register, pay annual fees, and be inspected by FDA
- compounding cannot be a copy of commercially available product
What is required on a 503b product label
- “This is a compounded drug”
- Name, address, phone number of the outsourcing facility
- lot number or batch number
- established name of the drug
- dosage or strength
- quantity or volume
- BUD
- storage and handling instructions
- NDC
- “Not for resale”
- list of active and inactive ingredients
Drug manufacturers are not exempt from what?
- misbranding
- cGMP
- and new drug requirements
What are outsourcing facilities (503b) exempt from
- new drug requirements
- misbranding if labeling/packaging requirements are not there
- need cGMP!
What are grandfathered drugs?
- drug that was introduced before 1938 and was still on the market in 1962
- assumed safe for use and effective based on their longevity on the market
What are DESI drugs?
- drugs that entered the market between 1939 and 1962
- were assumed to be safe but not considered effective
- drugs were a part of dESI program where they were in studies to prove their efficacy
True/False: products a part of DESI were allowed to stay on the market until a decision was made
yes
What describes step one of the drug development process?
- Preclinical Research
- In vivo animal testing utilized to record data on toxicity and pharmacology of the product
What describes step two of the drug development process?
- Investigational New Drug
- Once IND has been submitted, sponsor must wait 30 days before initiating any clinical trials to allow the FDA to review the IND
If a drug shows the possibility for safe and effective use, what can the manufacturer submit?
an IND
What information does the IND have to contain?
- animal pharmacology and toxicology studies
- manufacturing information
- clinical protocols and investigator information
what describes step three of the drug development processes
clinical research phases
What are reviewed and reported in phase 1?
baseline human PK and pharmacological properties
What percent of drugs move on to phase 2?
70%
Who is included in phase 1?
- 20-100 healthy human volunteers receive the drug to evaluate the safety and dosage of the compound
Who is included in phase 2?
several hundred human volunteers who have the disease or condition that is being studied
What is the primary goal of phase 2?
expand information about safety and adverse effects of the drug, and to determine the effectiveness of the therapy
Who is included in phase 3?
hundreds or thousands of patients in several geographical locations who have the disease or condition that is being treated
What is the goal of phase 3?
- demonstrate efficacy at a higher power, and to expand information around adverse effects
What is step 4 of the drug development process?
New Drug Application
Where is the NDA submitted to?
the sponsor submits to the FDA
What needs to be included in the NDA
- everything from preclinical data to phase 3 trial data
- proposed labeling
- safety updates
- drug abuse information
- patent information
- any data from studies that may have been conducted outside the US
- institutional review board compliance information
- directions for use
How long can it take the FDA to review an NDA
6-10 months
What is step five of the drug development process?
- post marketing surveillance through MedWatch
- adverse events reported by health professionals and patients
Which act provided lower statistical burdens for proof of safety for drugs indicated for rare diseases?
Orphan Drug Act of 1983
What did the Orphan Drug Act allow?
- tax incentives for orphan drug production
- enhanced patent protection and marketing
- clinical research subsidies
- government incentive to engage in drug research
What led to the development of the Orphan Drug Act
- due to the Kefauver Harris Amendment, medications became costly to develop
- most drug manufacturers only developed medications for common disease states to ensure they could recoup developmental costs and maintain profitability
- rare diseases were ignored
Which act was passed to reduce requirements for approval of generic prescription drugs?
1984 Hatch Waxman Act
Why was the Hatch Waxman act passed?
to reduce requirements for approval of generic prescription drugs
What does the Hatch Waxman Act allow?
- generic companies can prepare for approval without impinging on patent
- only had to prove bioequivalence and proof of acceptable manufacturing practices and controls
What is the Abbreviated New Drug Application
pathway for generic drug approval
Which act led to the abbreviated NDA
Hatch Waxman Act
Why is the abbreviated NDA termed abbreviated?
applicant does not need to include animal or human clinical trial data to establish safety and efficacy, only bioequivalence
What is bioequivalence
demonstration that rate of absorption of the generic drug is equivalent to the innovator drug (must deliver the same amount of ingredient in the same amount of time)
Which act requires prescription drugs to be packaged in child resistant containers or special packaging?
1970 Poison Packaging Act (PPPA)
What is Special Packaging?
- targeting at kids under 5 years old
- not difficult for normal adults to access
- most kids under 5 should struggle to open, and those that can open it will be prevented from obtaining a toxic amount in a reasonable time
What does the PPPA apply to
only oral drugs!
Child resistant means ___% of children or less can open after ___ minutes
20,10
At least __% of adults can open CRC after ___ minutes
90, 10
What are considered covered products under the PPPA
- drugs for oral administration require special packaging
- OTC and prescription drugs, controlled substances, and samples
- drugs intended to be dispensed in manufacturers packaging
What products do not need special packaging
bulk products and unit dose containers
If dispensing a bulk product or unit dose product and it is not in an appropriate CRC, what is the drug considered
misbranded
What are the exemptions to special packaging
- non-oral dosage forms
- waivers
- consumer product safety commission exemption (23 product)
Prescription by prescription wavers
- can be given by prescribers and patients
- waives CRC packaging for the life of a single prescription
Blanket waviers
- patient authorization only
- waives CRC packaging for all products
Notable CPSC Exemptions
- sublingual nitroglycerin
- oral contraceptives in mnemonic dispenser packages
- steroid dose packs
- some oral powder formulations
- unit dose potassium
When can you reuse packaging
- only if its in a glass vial and a new cap is used
What is a recall
the correction or removal and notification to the company of a product which is in violation of the law
Class I Recall
drug product may cause serious adverse health consequences including death (pharmacies notify patients who receive recalled drugs)
Class II recall
- drug may cause temporary or reversible side effects, but probability of serious health consequence is remote
Class III recall
drug product is unlikely to cause serious adverse health consequences
FDA seizure
FDA may physically isolate a drug thta is adulterated or misbranded while a civil lawsuit is filed
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
True or False: A drug recall is not voluntary
FALSE, a drug recall is voluntary, a seizure is not
What act was passed after the chicago tylenol murders?
Federal Anti-Tampering Act
What is the basis of the federal anti-tampering act
- makes tampering a federal crime
What is considered tamper evident packaging
- must have indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred
- product must be distinctive by design and not be able to be dublicated with
- any two piece hard gelatin capsule must be sealked
- tamper evident features must be described on the packaging
If packaging does not have tamper evident technology, then the drug is considered what?
misbranded
What is the label
any printed, written, or graphic material on the product container (not the Rx label)
what is labeling
all labels and written, printed, or graphic material on the container, container wrapper, or accompnaying the product
True or False: labeling includes anything accompanying the product, including advertisements and spoken words by drug reps
TRUE
What is a package insert
required as part of the labeling of prescription drugs and biological products
Are package inserts intended for healthcare professionals or patients
healthcare professionals
If a drug on a self does not have a package insert, it is considered what
misbranded
What are the 3 reproductive categories?
- pregnancy
- lactation
- females and males of reproductive potential
What are patient package inserts
FDA approved labeling written in patient friendly language which covers drug uses, risks, and precautions
Is it required to dispense a PPI with the drug to a patient?
YES, if not it is misbranding
What drugs require PPIs
estrogens and oral contraceptives
What are MedGuides
FDA approved labeling written in patient friendly language that explains issues related to a drug or drug class
When to dispense MedGuides
must be provided with new and refill prescriptions for patients in an outpatient environment
When are MedGuides Required
- labeling could help prevent serious adverse effects
- serious risks of use exist which patients should be made aware of
- patient adherence to directions is crucial to drug effectivness
Failure to dispense a MedGuide deems the drug what?
misbranded
What are the four types of REMS
- patient friendly labeling
- communication plans
- elements to assure safe use
- implementation system
Patient friendly labeling
- med guides and PPIs
Communication plans
info sent directly to healthcare practioners informing them about the drug and how to mitigate issues for the patients
ETASU
required activities that must be done before prescribing, dispensing, or receiving a product
Implementation System
a quality assurance process to ensure that risks are being mitigated successfully
Does consumer medical information replace formal counseling done by pharmacists?
no
What is required on the drug facts OTC labeling
- active ingredients
- purpose
- use
- warning
- directions
- inactive ingredients
- other information
In addition to the drug Facts label, what else does an OTC label need to have?
- expiration date when applicable
- lot or batch code
- name and address of manufacturer, packer, or distributor
- net quantity of contents
- a descriptions of the type of tamer-evident packaging utilized
Which MedWatch form do health professions fill out
FDA Form 3500
Which MedWatch form do patients fill out
FDA 3500B
Purpose of MedWatch
to report serious adverse events associated with drugs or FDA covered products
Who are the Big Four prescribers?
- physicians (MD/DO)
- dentists (DDS, DMD)
- podiatrists (DPM)
- veterinarians (DVM)
What are full prescribers?
- prescriptions from full prescribers are honored in any part of the United States as long as they are licensed in at least one jurisdiction of the US
What are examples of mid-level prescribers?
- NPs
- PAs
- Optometrists
- Pharmacists
Describe the extent to which prescriptions from mid-level prescribers are honored?
- do not necessarily have authority to prescribe across all states
- may not be honored in all jurisdictions
What can physicians prescribe for?
- whole body authority for humans
What can dentists prescribe for?
- mouth
- maxillofacial area for humans
What can podiatrists prescribe for?
- feet
- ankle
- sometimes hands for humans
What can veterinarians prescribe for?
- whole body authority for all animals
Scope of Practice vs Speciality Practice
- Scope of Practice: can prescribe based on licensure (dermatologist is an MD, so technically can prescribe for URI since MD has authority over all human body)
- Specialty Practice: subset speciality of authority
What is Agency Law?
- utilized when a prescriber authorizes an agent to deal with a third party
- nurse or MA calling in a prescription on behalf of the prescriber
What cant an agent do?
- make decisions on behalf of the prescriber
Are there federal uniform standards for non-controlled prescriptions in the US?
NO
Does federal law address prescription expiration or refills?
NO
What does the federal government address about prescriptions?
requirements of prescription labels
What is always required on prescriptions labels to be exempt from misbranding?
- the name and address of dispenser
- the prescription number
- the date of the prescription or its filling
- the name of the prescriber
What should be on the prescription label if given?
- name of the patient
- any directions for use
- any cautionary statements
True or False: the prescription label must have the name of the pharmacy
FALSE! must have name of the dispenser (central fill pharmacy must list the final pharmacy address, not its own address)
How long can an OTC or Rx, non-control prescription be refilled?
one year
How many refills are allowed for otc and rx only non controled substances
no rule
How long can a OTC or RX only CIII-CV be refilled
six months
How many refills can a OTC or RX only CIII-CV have
five
How long can a Rx prescription be refilled
one year
How many refills are allowed for and RX only CII
not refillable
What law targeted spending on medications by Medicaid beneficiaries?
OBRA ‘90
What are the four primary requirements of OBRA ‘90
- Prospective DUR
- Retrospective DUR
- Off to conduct patient counseling
- maintaining patient records
What is a prospective DUR
- pharmacist must review drug therapy before each prescription is filled for accuracy and appropriateness
What is a retrospective DUR
- states must review medication use of drugs and compare how they are being used against acceptable standards
What is required of pharmacists in terms of patient counseling in regards to OBRA ‘90
- law requires an offer to have a pharmacist counsel the patient be made
- this only applies to Medicaid patients
- nothing requires consultation when an individual refuses such consulations
What does OBRA ‘90 say about patient records?
- a reasonable effort must be made by the pharmacist to obtain, record, and maintain records
- name, address, telephone number, DOB, gender
- individual history like PMH, allergies, drug reactions
- pharmacist comments relevent to therpay
- only applies to Medicaid patients
What act defined a dietary supplement?
Dietary Supplement Health and Education Act (DSHEA)
What is a definition of a dietary supplement?
product (other than tobacco) intended to supplement the diet that contains one or more of the following
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
What is required on all dietary supplement labels?
- name of the product and the phrase (dietary supplement)
- quantity of the contents
- manufacturer’s, packer’s, or distributor’s name and address
- directions for use
- supplemental facts panel containing serving size, list of dietary ingredients, amount per serving size, and percent daily value if established
What types of claims can manufacturers make about dietary suppolements
- health claims
- nutrient content claim
- structure function claim
Health Claim
a relationship between a product and its potential impact on approved disease state or condition
Nutrient Content Claim
- relative description of the nutrient or dietary substance in the product
Structure Function Claim
- description of maintaining proper body function independent of specific disease states
Which dietary supplement claims must be FDA approved
- health claim
- nutrient content claim
Which dietary supplement claim does not need FDA approval?
- structure function claim
What motivated Congress to pass the 1987 Prescription Drug Marketing Act (PDMA)
counterfeit ovulen 21
What was the goal of the Prescription Drug Market Act
established procedures, requirements, and minimum standards for the distribution of prescription drugs and drug samples
What are the four main aspects of the PDMA
- reimportation
- preferential pricing
- samples and coupons
- wholesale licensure
What was discussed under the reimporation section of the PDMA
- drug cannot be reimported into the US unless reimported by drug manufacturer or for emergency use after FDA review
- bans importation of american made drugs from foreign countries, not importation of drugs from a foreign country
American drugs bought in other countries at a discount and reimported into the US are considered what?
aldulterated
What was discussed under the preferential pricing section of the PDMA
bans the sale, purchase, or trade of a prescription drug purchased at reduced price by hospital or other healthcare facility or donated or supplied to charities
TRUE or FALSE: two entities who have access to the same preferential pricing can sell or trade with one another
true
What was discussed under the samples and coupons section of the PDMA
bans the sale, purchase or trade of a drug sample or drug coupon, and bans counterfeiting of drug coupons
How can samples and coupons be requested?
- practitioners must ask for drug samples in writing
- community pharmacies cannot have drug samples at any time
- established recordkeeping, storage, and handling requirements for drug sample
Are OTC drugs and starter packs considered sample?
no
What was discussed under the wholesaler section of the PDMA
states were required to license wholesalers
How long are records related to the PDMA kept?
3 years
What is the whistleblower award?
$125,000 awarded for reporting someone violating PDMA
What was passed to further increase supply chain security?
Drug Supply Chain Security Act (DSCSA)
What became required after the passing of the DSCSA
- barcodes or QR codes to prescription packages to allow better tracing and verification
- pharmacies must track specific lot numbers throughout filing process
When do manufacturers and wholesalers have to verify the legitimacy of products in question when inquired by a pharmacy?
within 24 hours
When do illegitimate products have to be brought to the FDA when discovered?
within 24 hours
How long must product tracking records under DSCSA be kept?
6 years (for all parts of the supply chain)
NDC First 5 numbers
identify the manufacturer, assigned by FDA
NDC Second 4 numbers
drug, strength, dosage form, and formulation of the product, assigned by the manufacturer
NDC last 2 numbers
identify the package size, assigned by the manufacturer
Who regulates prescription drug advertising?
FDA
Who regulates nonprescription drug advertising
FTC
Advertising to professionals must include
- established name
- formula of the drug
- adverse event information
- contraindications
- effectiveness
If information advertised to professionals is false, misleading, or biased in its discussion of adverse effects as compared to effectiveness, it is what?
misbranded
How many standards does DTC adversing have to comply with?
5
What are the 5 DTC advertising standards
- consumer friendly language
- appropriate audio
- audio and text (tv)
- text must be readable (tv)
- free of audio or visual elements that may interfere with the comprehension of the major statement
off label use
indication other than that approved by the FDA and thus not included in the approved drug labeling
What is required of off label advertising
any information must be complete, peer reviewed journal articles published outside of company influence
In order to diseeminate journal articles, any company that wants to advertise off label indications must do what
- have applied for approval for that indication
- submit a copy of the information and any clinical trial data the company has at least 60 days before disseminating
What documents need to be included when disseminating journal articles for off label advertising
- a disclosure noting the information has not yet been approved
- a copy of the official labeling for the product
- any other products that have been approved for off-label use
- the funding source for the studies relating to the use
- a bibliography of publications relating to the use
What are the three covered entities of HIPAA
- health care providers
- health plans
- health care clearinghouses
Health care providers (HIPAA)
- who electronically transmit any health information
- individual or group providers
Health plans (HIPAA)
- health insurance
- government payers (Medicare/Medicaid)
- HMOs
Health Care Clearinghouses
(HIPAA)
groups that process PHI on behalf of another entity (PBM, EHRs)
What are 4 rules related to HIPAA
- privacy
- security
- breach notification
- enforcement
What is considered PHI
Information related to:
- individuals past, present or future physical or 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
Is de-identified health information PHI
NO
When must a covered entity disclose PHI
- individuals requesting access to their own PHI
- HHS when it is undertaking an investigation or review or enforcement action
A covered entity may disclose PHI for what reasons
- treatment, payment, and health care operations
- to the individual
- for an opportunity to agree or object
- incidental use and disclosure
- public interest
- limited data set
HIPAA Permitted Uses and Disclosures: Treatment
provision, coordination, or management of health care and related services for an individual by one or more health care providers
HIPAA Permitted Uses and Disclosures: Payment
acitivites of a health plan to obtain premiums, determine or fulfill responsibilities for coverage and benefits, and furnish or obtain reimbursement
HIPAA Permitted Uses and Disclosures: Health Care Operations
- quality assessment and improvement activities
- medical reviews, audits, legal services
What does the HIPAA Security Rule require?
- covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards of electronic PHI
HIPAA Breach Notifcation: < 500 people
- report breach to secretary of HHS within 60 days of the end of the calendar year in which the breach was discovered
HIPAA Breach > 500 individuals
- report breach to secretary of HHS within 60 days from discovery of breach
- report breach to prominent media outlets serving the state or jurisdiction
- reports available to public
Drug monographs within the USP have what?
the force of law
Not following drug monographs within the USP leaves a drug what?
adulterated or misbranded
TRUE or FALSE: the information published by the USP regarding the appropriate means for drug prep and storage has force of law
NO, not federally
What is USP 795
nonsterile compunding
What does USP 795 require
BUDs to be assigned to nonsterile products
What does USP 797 cover
sterile compounding requirements, including personnel, training, facilities, environmental monitoring, and storage and testing of finished products
What does USP 800 cover
- discusses the handling of hazardous drugs in healthcare settings
What are the expiration date requirements for USP
- expiration date is the last date the product will meet the requirements of the USP monograph for strength and stability
What is a BUD
date after which a product should not be used
Repackaging
- location takes a drug from a manufacturer’s bottle and puts it into new package without doing other things
What must repackaging meet?
all provisions of FDCA
TRUE or FALSE: taking a drug out of a stock bottle and placing into a prescription bottle for dispensing meets the criteria for repackaging
NO
What are the FDA exemptions of repackaging?
- prescription drug product on shortage list
- repackaged under direct supervision of 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
Non aquous formulation BUD
no more than 6 months
water containing oral formulation BUD
- no more than 14 days
water containing topical, mucosal, semisolid formulation
no more than 30 days
How are pharmacy inspections conducted
- routine inspection (periodically at random)
- inspection triggered by knowledge, suspicion, or formal complaint of wrongdoing that may be a danger to public safety
Who are exempted from FDA inspections per FDCA
pharmacies unless the pharmacy manufacturers, prepares, or compounds drugs or devices
Why would the FDA inspect a pharmacy
to determine if they manufacture drugs and to verify compounding is done appropriately
How may FDA inspectors request entry to a pharmacy
Notice of Inspection (FDA form 482) and credentials
What does the DEA inspect
any place where controlled substances are kept
What does a DEA inspector look for?
- may examine records and reports related to controlled substances
- inspect the premise
- inventory controlled substances
Does the DEA need a warrant?
no, but you can refuse t hem entry or revoke consent at any time and require a warrant
When requesting inspection, a DEA inspector must
- state the purpose of their inspection
- show their credentials
- provide written notice of inspection to the pharmacy owner or pharmacist in charge
DEA NOI Rights
- require the DEA to get AIW
- to refuse inspection (at which they will get a AIW)
- anything incriminating can be seized and used against you
- will get a copy of the NOI
- may withdraw consent to inspection
Who can sign an NOI
owner, operator, or agent in charge
AIW
provided for anything considered a valid public interest (low bar to clear)
Search warrant
provided if an officer can convince a judge that a reasonable person would believe that a crime has been or will be committeed on the premises to be serached or that evidence related to a crime exists at the premises
When can AIWs be served
only during regular business hours
When can search warrants be served
anytime
Are there situations where a warrant is not required
YES (consent, imminent danger, emergency situation)
Can you say no to a BoP inspection
No
Do BoP inspectors need a warrant
NO
Orange Book
The Approved Drug Products with Therapeutic Equivalence Evaluations provides equivalancy rating for the product
RLD
- original brand name product in Orange Book
- utilized by the generics when submitting an abbreviated new drug application
RS
the product to which generic has to demonstrate equivalency
To be therapeutically equivalent, the product must be both
pharmaceutically equivalent and bioequivalent
phamaceutical equivalence
- active ingredient
- dosage form
- strength
- route
- labeling
Bioequivalence
- in vivo results (human)
- in vitro results (kinetics, dynamics, clinical effects)
TE Code First Letter
indicates relevant therapeutic equivalence code
TE Code Second Letter
indicates dosage form
Three Character TE CODE
Drugs with a three-character code are considered therapeutically
equivalent only to other drugs with the same three-character code
(AB1 = AB1, AB1 ≠ AB2)
TE Code A
no concern related to pharmaceutical equivalence or bioequivalence if first letter
TE Code B
not therapeutically equivalent if first letter
What was the first federal law regulating medications?
1906 Pure Food and Drug Act
What did the Pure Food and Drug Act do?
- recognized the US pharmacopeia and NF as standard drug references
- defined misbranding and adulteration and assigned penalties to each practice
- established Bureau of Chemistry in the US Department of Agriculture as reasonable party of enforcement
What does the Official Compendia consist of?
USP, NF, HPUS
Product contains any poisonous or insanitary ingredients or lacks adequate controls in manufacture
adulterated
strenght, quality, or purity differs from the official compendium
adulterated
strength differs from representation if not found in official compendium
adulterated
product mixed with another substance to reduce its quality or strength or substituted altogether
adulterated
delayed, denied, or limited inspection, or refusual to permit entry or inspection
aldulterated
What are the only two banned devices
prosthetic hair fibers and powered gloves
What makes a device adulterated
- not in conformity with performance standards
- certain class III devices that do not have appropriate approval for use
- banned devices
- manufacture, packaging, or instillation of device not conforming
- failure to comply with requirements under which a device was exempted for investigational use
Class I Device
not used for supporting human life and/or preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury
Class II device
moderates risk to use, require special controls to assure safety and effectiveness of devices
Class III devices
high risk to use, supports or sustain human life or preventing impairment of human health and do present a potential unreasonable risk of illness or injury
labeling that is false or misleading
misbranding
labeling that does not contain the manufacturer, packer, distributor, and an accurate statement of the quality of the contents in terms of weight, measure, or count
misbranding
require informationis not predominantly displayed or clearly stated
misbranding
established name not included and at least 1/2 as large as the proprietary name
misbranding
directions and required warnings not included on label
misbranding
Established name
generic name
proprietary name
brand naem
Not in compliance with official compendia standards for packaging
misbranding
product is liable to deteriorate unless packaged appropriately and notes an expiration date
misbranding
if the drug container is developed in a misleading way or is an imitation of another drug
misbranding
if use of the drug prescribed is dangerous to health
misbranding
if an ingredient is a color additive only and not in compliance labeled appropriately
misbranding
if advertisments do not include required information
misbranding
if packaging safety requirements are not met
misbranding
if REMS required and not appropriately addressed
misbranding
if a product identifier is required and not included (Rx only, Controlled Substance Marking)
misbranding
Pure Food and Drug Act United States v Johnson
supreme court ruled that the Pure Food and Drug Actt only prevented false statements on the drug’s identify, and not false or misleading efficacy claims
Which act prohibits manufacturers from intentionally misleading claims about a drugs effectiveness
The 1912 Sherley Amendment
To address the Supreme Court Ruling in US v Johnson, what did congress pass
The Sherley Amendment in 1912
What was a limitation of the Sherley Amendement
the onus was on the government to prove intent, which made this amendement extremely difficult to enforce
What act permitted FDA control over cosmetics and therapeutic devices
Federal Food, Drug, and Cosmetic Act
Whaat did the FDCA do
- required new drugs to be shown safe before marketing
- repealed Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
- authorized factory inspection
- required selected dangerous drugs to be administered under the direction of a qualified expert
What is a definition of a drug according to the FDCA
- articles recognized in the official compendia
- intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
- articles other than food intended to affect the structure or any functions of the body of man or other animals
Alberty Food Products v US
in order for labeling of a drug to bear adequate directions for use, it must state the purposes and conditiosn for which the drug was intended and sufficient information to enable a layman to intelligently and safely attempt self medication
Durham Humphry Amendment
- OTC meds could be labeled witth adequate directions for use
- legend meds had to be dispensed under the supervision of a health practitioner as a prescription drug and carry statement “caution: federal law prohibits dispensing without a prescription”
- verbal transmission of prescriptions and refills for prescription drug
