Exam 1 Flashcards
Law/statute
Law that comes from a body of elected officials
Ex: US code (USC), Indiana Code (IC)
Rule/regulation
Rule having the force of law issued by an administrative agency (non-elected officials in area)
Ex: FDA, DEA, CFR, BOP, Indiana administrative code (IAC)
Format of United States Code citations?
Title number, US Code abbreviation, section number (subsection)
Ex: 21 USC 353(b)(1)(A)
Format of Code of Federal Regulations citations?
Title number, CFR, section number (subsection)
Ex: 21 CFR 1306.04(a)
Format of Indiana Code citations?
IC, title - article - chapter (or rule) - section
Ex: IC 25-26-13-15(a)
Format of Indiana Administrative Code citations?
Title number, IAC, article - chapter - section
Ex: 856 IAC 1-3.1-11(b)(1)
Drug
1) article recognized in official compendium or supplement of official compendium AND
2) intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal AND
3) intended to affect structure or function of body of man or animal AND
4) intended for use as component of any article specified above [not inactive ingredients]
What are the official compendia?
US pharmacopeia, national formulary, (now USP-NF) and HPUS
Cosmetic
1) article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to human body AND
2) articles intended for use as component (except soap)
True or false: the terms drug and cosmetic are mutually exclusive
FALSE, article can be both drug and cosmetic (dandruff shampoo)
Prescription drug
Intended for use by man which
A) because of toxicity or potential for harm, method of use, or collateral measures necessary to use, is not safe for use except under supervision of practitioner OR
B) limited by an approved application under section 355 for use under supervision (new drug)
*MUST have “Rx only” on label
OTC/nonprescription drug
Drug that is safe and effective for use without a prescriber’s supervision for certain conditions
- doesn’t need supervision
- *can be OTC for one indication, Rx for another
BTC drug
Unofficial class, generally drugs sold only by pharmacist
Ex: C-V drugs sold OTC
Controlled substance
Drug that has depend liability and/or potential for abuse
Orphan drug
for condition that
Affects <200,000 people in US
OR
Affects >200,000 but cost of development will not be recovered from sales in US
*Drug NEVER loses orphan drug status, even if found to be useful for other things
Dietary supplement
product (other than tobacco) intended to supplement diet that contains one or more of following:
vitamin, mineral, herb, botanical, amino acid, dietary supplement
OR concentrate/metabolite/extract/combination of any of above ingredients
New drug
NOT generally recognized as safe and effective or is recognized but not been used in the conditions/dosage form for sufficient time.
aka, unapproved drug
New drug application
NDA = what is sent to FDA after clinical trials/data are collected
Investigational new drug
IND is application that you submit to FDA to START clinical trials on new drug
abbreviated new drug application
ANDA is used by generic manufacturers to prove bioequivalence and proof of CGMP
Pre-‘38 drugs
assumed safe/effective by longevity.
Ex: thyroid, morphine, codeine, nitro
DESI drugs
Assumed safe, but had to prove efficacy
Established/generic name
applicable official name designated pursuant to section 358 OR official title in compendium OR common/usual name
Label
THING on a container
written, printed, or graphic matter upon the immediate container of any article
Labeling
all labels and other written/printed/graphic matter upon any article, its containers or wrappers, OR accompanying such article.
*includes label, but more broad
Special packaging
Packaging designed/constructed to be significantly difficult for children <5yo to open/obtain a toxic or harmful amount of the substance within a reasonable time AND not difficult for normal adults to use properly
does not mean packaging children cannot open within reasonable time
Pharmaceutical equivalent
Products with same active ingredient, same dosage form, and same strength
(may have different release mechanism)
Ex: Ventolin, Proair are pharmaceutical equivalents but not therapeutic equivalents
Therapeutic equivalents
Pharmaceutical equivalents that are likely to have the same clinical and safety profile
Device
1) recognized in USP, NF, or supplement AND
2) intended for use in diagnosis of disease, cure, mitigation, treatment, or prevention of disease in man or animal AND
3) intended to affect structure or function WITHOUT achieving primary function through chemical action, NOT dependent upon being metabolized.
Person
includes individual, partnership, corporation, and association
plural is persons
State
Any state or territory of the United States, the District of Columbia, and Commonwealth of Puerto Rico
Territory
Any territory or possession of the United States, including DC, and excluding Commonwealth of Puerto Rico and the Canal Zone
Paraphrased description of adulteration
issues with product itself or CHANCE of issues with product
1) contains filthy substance
2A) prepared/stored in insanitary conditions that could contaminate
2B) manufacturing did not conform to cGMP
3) container has poison within it
4A) contains unsafe color additive
4B) strength/quality/purity of compendium drug falls below standard in compendium (unless stated on label)
4C) strength/purity of drug not in compendium different from what is claimed
4D) if mixed/packed to reduce quality/strength (substituted/cutting)
4J) if owner of factory/warehouse denies/limits an inspection
Adulteration, misbranding, both or neither:
Pharmacy’s air conditioners break and temperature in pharmacy reaches 95F, above maximum excursion temperature of most products
Adulteration
Adulteration, misbranding, both or neither:
Pharmacist instructs a patient to take ibuprofen 600mg q6h for osteoarthritis
Misbranding - dose above max OTC dose of 1200mg daily
Adulteration, misbranding, both or neither:
Tablets counted on tray, but tray is not cleaned before counting the next drug, leaving residue on medication
Adulteration
Pharmacist reconstitutes face gel with ethyl alcohol instead of purified water specified in instructions
Adulteration (misbranding?)
Adulteration, misbranding, both or neither:
A sales rep elaborates on potential uses for a drug beyond FDA-labeled indications.
Misbranding
What is CGMP?
Regulations that establish minimum requirements for manufacturing drug products. Apply to manufacturers and not pharmacies (unless pharmacy manufactures)
Mostly tied to adulteration
What is misbranding?
issue with words associated with product generally
A) if labeling is false or misleading (weird exception for health care economic information)
B) if packaged without a label that has 1) the name and address for manufacturer/distributor and 2) accurate statement of the quantity of the contents (weight, measure, or count)
B) if any required information is not placed conspicuously and in terms that an ordinary individual under customary conditions could read and understand
E) if doesn’t have established name, quantity/proportion of API (and including alcohol and bunch of random old drugs), and each inactive ingredient in alphabetical order, API generic name at least half trade name height
F) bears adequate directions for use and adequate warnings (unless Rx only)
G) drug that deteriorates unless packaged in such form and label bears precaution
H) Dangerous to health when used in suggested manner
I) advertising doesn’t include established name, ingredients, and side effects/contraindications/effectiveness or is misleading
J) in violation of PPPA
P) dispensed without meeting REMS requirements
Limits on compounding
Can’t be commercially available product or contain a drug that has been withdrawn from the market. May make ahead in limited quantities based on history of receiving prescriptions.
Compounding does not include reconstitution.
Can’t compound more than 5% of prescriptions dispensed unless some set up w/ state and FDA
Class I device
Not used to sustain human life, doesn’t present a potential unreasonable risk of illness or injury.
Ex: stethoscope, toothbrush
Usually just need to list products with FDA and cGMP
Class II device
Require special controls to assure safety and effectiveness.
Ex: syringes, tampons, condoms, HbA1c test
May need postmarked surveillance, patient registries, guidelines, etc
Class II device
REQUIRE premarket approval. Used to sustain/support human life, or substantial importance in preventing morbidity, or potential unreasonable risk of illness.
Ex: pacemaker, replacement heart valves, soft contact lenses
Devices automatically III unless FDA decides otherwise
Restricted device
Requires prescription due to potential for harm.
Ex: contact lenses and diaphragms
Custom device
ordered by HCP to fit a single patient.
Ex: braces, canes permanently height adjusted, etc
Banned device
Not allowed in US: prosthetic hair fibers.
True or false: The FDA has the authority to require a manufacturer to recall a drug
False – all drug recalls are voluntary, but FDA has the authority to take seizure or injunction action if manufacturer does not comply
True or false: The FDA has the authority to require a manufacturer to recall a device.
TRUE
Class I recall
Most serious –> if good probability that product will cause serious consequences or death
Class II recall
If product could cause temporary or medically reversible health consequences OR if probability of serious health consequences is remote
Class III recall
Least serious –> exposure not likely to cause adverse health consequences.
Adulteration, misbranding, both or neither:
Federal authorities discover that a state’s lethal injection drugs came from India
Both - adulterated b/c not sure where it came from (storage condition), misbranded because not from registered manufacturer
Practitioner
An individual authorized to prescribe
Who are the big four practitioners recognized in all states?
Physicians, veterinarians, podiatrists, dentists
What is a practitioner’s scope of practice determined by?
Their degree, not their specialty.
What is a dentist’s scope of practice?
Things relating to the mouth, oral cavity, maxillary area. Must be related. (some things may have a connection you don’t realize initially)
What is a podiatrist’s scope of practice, in Indiana?
Feet, ankles, and associated structures.
True or false: In order to prescribe for exotic animals, veterinarians must have special training.
False – vets can prescribe for any type of animal with same degree.
Name some midlevel practitioners
NP, PA, pharmacist, optometrist, etc.
Under what circumstances are drugs exempted from parts of the misbranding law?
If dispensed pursuant to prescription and labeled appropriately
What are the federal labeling requirements?
Name/address dispenser Name prescriber Prescription number Date of prescription or its filling Name of patient (if on Rx) Directions for use (if on Rx) Cautionary statements (if on Rx)
What is the refill limit and expiration of a regular prescription?
No refill limit
Expire 1 year from issue date
What is the refill limit and expiration of a CIII-CV prescription?
Refill limit 5 full refills
Expire 6 months from issue date
What is the refill limit and expiration of a C-II prescription?
NO refills
Expire 1 year from issue date
Paraphrase requirements of PPPA
Difficult for children <5yo to open or obtain toxic amount of substance within a reasonable time
90% adults should be able to open without difficulty
85% naive children unable to open container 5 minutes
80% children cannot open package after being shown in 5 minutes
What does the PPPA apply to?
Legend drugs (oral dosage form ONLY), controlled substances, things that go Rx to OTC.
When can an exception be made to the PPPA?
When prescriber grants waiver for a prescription (including its refills) or patient/patient rep gives blanket waiver
What are the PPPA exempt drugs?
SL nitroglycerin, isosorbide dinitrate 10mg or
Can you reuse a child resistant container?
Not if plastic, only glass or metal.
What is preemption?
Federal government’s ability to dictate all law on a particular subject (preempts state law)
PPPA is total preemption – can pass identical law or no law at all (unless requiring more CRC)
Are package inserts permitted to include animal studies?
Yes, if clearly marked as animal studies.
True or false: it is inappropriate to give a package insert to a patient.
False
Adulteration, misbranding, both or neither:
A drug is shipped to your pharmacy without a package insert
Misbranding
True or false: Patient package inserts must be dispensed with the drug the first time and for each subsequent refill.
True
- Estrogens and oral contraceptives
- also applies to hospitals
When is a med guide required for a drug?
New and refill prescriptions when:
1) labeling could help prevent serious adverse effects
2) product has serious risks relative to benefits that could affect patient’s decision to use
3) drug important to health and patient adherence is crucial.
* only for outpatient
What were the main actions of the prescription drug marketing act?
Preventing reimportation of prescription drugs (per se adulterated - unless done by manufacturer for emergency, approved by FDA)
Prohibited sell/trade/purchase of drugs among institutions to take advantage of preferential pricing - anti-trust x3
Prohibited sell/trade drug sample or drug coupons (retail can never have Rx samples, OTC okay)
Whistleblower awards
Records of PDMA stuff maintained 3 years
What are the five criminal acts created by the federal anti-tampering act?
Tampering (messing with package), tainting (messing with product), communicating false information, threatening to tamper, conspiracy to tamper or taint
What are the requirements for tamper-evident packaging?
Labeling identifying tamper-evident features must be prominently placed, will not be lost if tamper-evident features are removed AND one or more indicators or barriers to provide visible evidence of tampering, must be distinctive, on immediate or secondary container. Reasonable handling must not destroy features.
Manufacturers can make statements about dietary supplements affecting a body structure/function if it includes:
*must notify FDA within 30 days of first marketing
Benefits related to nutrient deficiency [NOT a disease] and discloses prevalence of such deficiency
Describes role of nutrient in humans
Characterizes mechanism by which nutrient helps body
Describes general well being from consumption
AND disclaimer “statement has not been evaluated by FDA. not intended to diagnose, treat, cure or prevent any disease” in boldface type, prominently.
Must have evidence that claim is truthful, not misleading
True or false: the burden or proof of safety and efficacy always falls on a drug or supplement manufacturer.
False – burden of proof is on FDA in case of dietary supplements
What is the meaning of pregnancy category A?
Adequate human studies demonstrate no risk - ok to use
What is the meaning of pregnancy category B?
No adequate human studies have been done but animal studies show no risk
What is the meaning of pregnancy category C?
No adequate human studies done and animal studies not conducted or show risk
What is the meaning of pregnancy category D?
Some number of human studies or marketing experience have shown risk to a fetus. Make mother aware. But benefits might still outweigh risk.
What is the meaning of pregnancy category X?
Demonstrated risk to fetus, risk outweighs benefits. Statements should be added to contraindications.
What is the purpose of an FDA pharmacy inspection?
To ensure that pharmacy not manufacturing or compounding in excessively large amounts.
Don’t need a warrant or to state a reason, just show credentials.
Where do DEA agents have jurisdiction?
Any place where controlled substances are kept, but must state purpose of the inspection and provide credentials/written notice of inspection.
What is the DEA able to inspect without a warrant?
Records and reports relating to controlled substances, inspection of the premises, inventory of controlled substances
*cannot review sales/pricing/financial data
True or false: You can refuse a DEA inspection.
True - this would require them to get an administrative inspection warrant. However, you cannot refuse if they have an AIW.
When does a DEA agent not need a warrant?
Situations where pharmacy owner or PIC consents, if imminent danger to public health/safety, emergency situation where warrant isn’t practical, when not constitutionally required
How is an AIW different than a search warrant?
Easier to satisfy the requirements to get one, can only be served during business hours.
True or false: You can refuse a BOP inspection.
No, even if don’t have a warrant.
What is the purpose of the Orange Book?
Helps pharmacists determine generic products for substitution (e.g. are pharmaceutic equivalents also therapeutic equivalents)
*doesn’t do pharmaceutical or therapeutic alternatives
Interpret the A/B system in the Orange Book
A rated: can be substituted, therapeutically equivalent
B rated: cannot be substituted, potential bioequivalence issues
When may a company start clinical trials following submission of an IND application?
If no response within 30 days
*apply for each phase of testing
How long does the FDA have to respond to a NDA?
180 days, but often takes longer, manufacturer can sue for delays
True or False: The need for a REMS program is determined at the time of NDA review by the FDA.
False - the FDA may require development of a REMS at any time.
Who develops and reviews REMS programs?
Manufacturers develop it but the FDA reviews and approves them
What are the four potential components of REMS programs?
Med guides (for patients) Communication plans (to educate HCP) ETASU (required medical interventions: iPLEDGE, clozapine) Implementation system
