Pharmacy Law Exam 1 Liz

prescribe

Individual practitioners who are agents or employees of another Individual practiioners (other than a mid-level) may administer or dispense controlled substances, but not_______.

F

Initially, the registration number started with the letter A and moved from B and now till ___

95-105%

Narrow therapeutic index drug (lithium, warfarin, levothyroxine) requires a range of ___to___.

FDA

No drug can be added unless approved by ______

DEA Form 224

The dispenser registration form is

2

The orange book uses a ____letter rating system, most common with the letter A

Compendia

USP or homeopathic

Federal Register and Code of Federal Regulations

regulations are published in the ______and______

needs

abilify needs/does not need a medication guide

DATA

enacted in 2000 with intent of allowing addicts to be treated for addiction in office-based settings

Poison Prevention Packaging Act

establishes the standards for child-resistant (NOT CHILD PROOF) containers -administered by the Consumer Product Safety Commission

manufacturer

first segment of national drug code

federal register

proposed regulation is put on

strength, dosage form and formulation

second segment of national drug code

DEA (Drug Enforcement Administration)

Non control drugs are not regulated by _____

80-125%

Non therapeutic index drug (ex ibuprofen) the FDA allows a range from ___to____%.

Durham-Humprey Amendment

OTC and prescription drugs were distinguished

Generic Drug Enforcement Act of 1992

Occurred when some FDA staff accepted bribes from generic drug industry personnel in order to facilitate the approval process of certain generic drug products. ?FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies. ?Imposes severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.

indication

On an off label: FDA hasnt approved______

inventory

On the day of transfer, a complete ______of controlled substances must be taken.

Subutex and Suboxone

Only permitted DATA drugs are_____ and _____tablets

individual practitioner

Only pharmacists,technicians, and _______ (if permitted by state law) made dispense controlled substances

DEA Form 222

Ordering a Schedule II controlled substance is done utilizing which form?

prescription

Over the counter medications dont need a ______for

Schedule II

Oxycodone is classified under the Federal Controlled Substance Act as a:

FDA believes it's necessary to ensure benefits outweigh risks

Purpose of Risk Evaluation and Mitigation Strategy with medication guides

need to

Manufacturers and distributors (need/ do not need) to be registered with DEA

invoice

To distribute from a pharmacy to another practitioner, for C3,4,and 5 drugs, an ______is required, while Form 222 is required for C2 products

invoice

To order a schedule 3,4,or5 you dont use a form you use a _____.

Form 106

To record theft or loss which DEA form do you use?

224

To register a pharmacy with the DEA, this form is used?

DEA form 224 , every 3 years

To register new pharmacy which DEA form should you use and how often should registration be renewed

14 days in advance

To transfer a business, notify DEA at least_____in advance

invoice

To transfer schedule III drugs, you need an _______not a form.

true

True or False 40mg strength methodone is not found in retail pharmacies

True

True or False C3,4,and 5 drugs may be dispensed pursuant to written, faxed, electronic, or oral order.

True

True or False: Schedule 2 drugs can be faxed

True

True or False? Treatment of pain is a legitimate medical purpose.

U.S. Constitution

What is the supreme law in that no federal or state laws may conflict with it?

stare decisis

What is this an example of? When a court faces a legal argument, if a previous court ruled on the same or loosely related issue, then the court will make their decision in alignment with the previous court's decision

C2,3,4,5

What schedule of drug can pharmacies hold for DEA form 224?

Not a controlled substance

What schedule of drug is amoxicillin

C5

What schedule of drug is cheratussin

C2

What schedule of drug is cocaine

C 2

What schedule of drug is fetanyl

not controlled

What schedule of drug is warfarin

de minimis violation

What would this be an example of? Your pharmacy states you have a glass graduated cylinder. You accidentally break it; health inspector comes next day with board of pharmacy, they come, inspect it, and finds a violation

storage info, highlights, full prescribing information, etc.

What's contained on a nonprescription drug insert?

pharmacological category or principal intended use cautions and warnings adequate directions for use and Drug Facts panel

What's included on on a nonprescription drug labeling

beginning or end

When an inventory is taken, every 2 years, inventory must be taken at the _____ or_____ of the business day and must be written, typed, or printed.

They DONOT expire.

When do C2 expire under federal level?

do not expire

When do schedule 2 drugs expire

C2's do not expire

When do schedule 2 drugs expire?

6 months after written

When do schedule 3, 4, 5 expire

They do not expire

When do schedule 5 drugs expire under federal law?

federal law

When federal and state law conflict, ______will be supreme/preempt under the supremacy clause of the U.S. Constitution.

date of issuance

When you transfer, you still need to know original ________ __ ____________.

Federal Register

Where would administrative post new regulation?

DEA Form 224

Which DEA Form should be completed to register a new pharmacy?

DEA Form 106

Which DEA Form should be completed to report a theft or significant loss of any controlled substance?

DEA Form 222

Which DEA Form should be completed to transfer schedule II substances?

DEA form 41

Which DEA form would be used to destroy controlled substances?

Fourth Amendment

Which amendment protects individuals from unreasonable searches and seizures

Executive branch

Which branch of government enforces laws and make regulations ex. Board of Pharmacy, FDA, Drug Enforcement Agency

C1

Which controlled substances are not allowed in a retail pharmacy?

For a patient enrolled in a hospice care program

Which one of the following may a faxed Schedule II Controlled Substance prescription serve as an original prescription under Federal Law?

C2,3,4,5 Drugs need to be labeled within and outside labels cannot say there's a drug inside

Which schedule of drugs can be mailed with no restrictions?

C5

Which schedule of drugs: Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC and Phenergan with Codeine).

CIV

Which schedule of drugs? Tramadol, alprazolam, clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion)

C5

Which schedule of drugs? includes antitussives, containing codeine and antidiarrheals containing an opiate

C2

Which schedule of drugs? High potential for abuse and abuse may lead to severe physical or psychological dependence

C3

Which schedule of drugs? Includes many C2 drugs in combination with a noncontrolled ingredient, or in smaller dosages, or in a less abusable dosage form. Also includes certain stimulants, anabolic steroids, dronabinol, ketamine, paregoric, and GHB approved by the FDA

C3

Which schedule of drugs? Lesser potential for abuse than C2 drugs, and abuse may lead to moderate or low physical dependence or high psychological dependence

C1

Which schedule of drugs? No accepted medical use, as opposed to drugs in the other schedules. -HIGH potential for abuse and lack accepted information on safety of use.

C5

Which schedule of drugs? low potential for abuse relative to C4 drugs, and abuse may lead to limited physical r psychological dependance relative to C4 drugs

C4

Which schedule of drugs? lower potential for abuse than C3 drugs and abuse may lead to limited physical or psychological dependence

C4 drugs

Which schedule of drugs? narcotic drugs such as dextropropoxyphene, depressants such as alprazolam, chloral hydrate, barbital, benzodiazepines, stimulants such as diethylpropion, phentermine, tramadol

C2

Which schedule of drugs? opium and many other opiates including products containing hydrocodone;cocaine; stimulants such as amphetamine and methamphetamine, depresseants such as amobarbital, glutethimide, secobarbital, and pentobarbital

person who signed most recent registration or person who is power of attorney

Who can sign DEA form 222

U.S. Congress

Who makes federal laws?

pharmacies, hospitals, research, wholesales, prescribers/physicians, reverse distributors (destroy controlled substances), manufacturers

Who needs to be registered to have controlled substances?

The prescription expires 6 months from the date of issuance

With regard to Schedule III prescriptions, which of the following is correct under federal law?

A pharmacy must conduct a controlled drug inventory every 2 years

With regard to a federal controlled substance inventory, which of the following statements is correct regarding how many times should a controlled drug inventory be taken?

Code of Federal Regulations

compilation of final regulations divided and indexed by subject matter

Federal Controlled Substances Act

created a closed system via registration establishes national uniformity enforced by DEA (Drug Enforcement Administration)

The Biologics Price Competition and Innovation Act

created a regulatory framework in 2010 for biosimilars or "follow on" biologics

Third Class of Drugs/Behind the Counter/ Nonprescription Under Conditions of Safe Use

creating a class of drugs that can only be sold from the pharmacy department

reverse distributor

destroys controlled substances that may be adulterated or misbranded

orange book

evaluates pharmaceutically equivalent products on the basis of bioequivalence -products contain same active ingredients and are identical in strength and dosage form -also therapeutically equivalent (having same clinical safety and efficacy)

misbranding and adulteration

failure to manufacture in a tamper-resistant container when required by law is ____and_____.

due process

fair treatment through the normal judicial system, especially as a citizen's entitlement.

Dietary supplements

ex. vitamin, mineral, herb, other botanical amino acid substance used to work with a diet to increase total dietary intake

Current Good Manufacturing Practices (CGMPs)

exhaustive set of standards directed at manufacturers

criminal acions

government vs. private party -charged with a crime as prohibited by a statute and subject to penalties specified by stature

identification symbol C with roman numeral

labels and labelling of commercial containers of controlled substance must contain the ________________of the schedule

common law and judicial opinions

law made by courts

Prescription Drug Marketing Act

law requires state licensing of wholesalers

outsourcing facilities

may compound non-sterile drugs -may dispense to individual patients -cannot have a separate area functioning as a section 503A pharmacy

Compounding Quality Act of 2013

passed as part of Drug Quality and Security Act in response to New England Compounding Center tragedy

DEA registration number

nine digits composed of letters and numbers (two alphabet letters followed by seven numbers)

exempt

nitroglycerin and isosorbide dinitrate, anhydride Cholestyramine are ___from poison prevention packaging act

device

drug, device, or both wheelchair, bandaid, heart/lung ,machine

drug and device

drug, device, or both inhaler and epipen

Medical Device user fee and modernization act of 2002

established user fee requirement for premarket reviews of medical devices and also established performance goals for many types of premarket reviews, inspections that can be conducted at establishments by accredited third parties and new regulatory requirements for reprocessed single use devices

civil actions

private party vs private party -may be based upon law or common law legal right (ex- if someone sues you) ex. person who stole or gave amoxicillin to someone and they had allergic reaction

Memorandum of Understanding

required between state and FDA in order to allow a compounder to distribute more than 5% of total prescriptions dispensed or distributed

Medication Guides (MedGuides)

required for drugs FDA has determined as posing "serious and significant concerns" required for new and refill prescriptions must be approved by FDA

distribute

to deliver a controlled substance

dispense

to deliver a controlled substance pursuant to the lawful order of a practitioner; includes prescribing and administering

Controlled Substance Ordering System

What is the CSOS?

Rx only

What is the federal legend

market failures

What is the reasons to regulate drugs?

1. that the immediate administration of the controlled substance is necessary for the proper treatment of the intended ultimate user AND 2. that no appropriate alternative treatment is available, including giving a controlled substance that is not schedule II AND 3. that it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to the dispensing

*All three situations where in an emergency, controlled substances in schedule 2 may be dispensed upon orally or electronically transmitted prescription

misbranding

- Labeling must not be false or misleading, including healthcare economic information - Labeling must include a listing of active ingredients and quantity and listing of inactive ingredients in alpha order - Labeling must contain "adequate directions for use" and "adequate warnings against use" by children and others for whom use might be dangerous - If drug cannot be labeled with "adequate directions for use", it must contain "adequate information for use" - It is _____ if a drug imitates another drug

Food Additives Amendment of 1958

-First law that directly affected packaging -Anything that directly or indirectly becomes part of the food, is considered an additive - includes packaging components; they must receive premarket approval for safety

adulteration and misbranding

2 prohibited acts: ______and______

1. within scope of board's authority (ex. Board of Pharmacy issues pharmacy laws) 2. based on statutory authority (powers and duties assigned to a government official through a law passed by Congress or state legislature

2 validity tests of a regulation

True

Anabolic Steroids are classified as a Schedule III controlled substance under the Federal Controlled Substance Act. True or False

manufacturer-product-package/size

3 parts of national drug code

-protection of public against adulterated and misbranded drug products -necessity of balancing "direct regulation" and "indirect regulation" -government takes on paternalistic view on protecting its citizens

3 rationales for federal drug regulation

schedule III

Anabolic steroids are what schedule of drug?

cannot because it used for opioid treatment programs

40mg of methadone can/cannot be sold at retail level

"new drug"

A drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling

Thalidomide

A mild tranquilizer that, taken early in pregnancy, can produce a variety of malformations of the limbs, eyes, ears, and heart. -Due to the FDA refusal to allow marketing of the drug in the US, the number of birth defects in the US was low

3

A pharmacy's registration with DEA expires every ____ years.

IP suffix

A resident or intern who hasnt registered with DEA would use hospital's DEA # but with a __________.

black box warning

A type of warning that appears in a drug's prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug.

registration

Each pharmacy or place of business where controlled substances are administered, dispensed, or stored has its own ________. There isn't one ______ per chain.

Federal Register

An official document, published every weekday, which lists the new and proposed regulations and notices of executive departments and regulatory agencies.

True

Acetaminophen 325mg is considered an Over the Counter (OTC) product and can be purchased without a prescription in the United States. True or False

C3

Acetaminophen with codeine schedule of drug

III

Acetaminophen with codeine tablets is classified under the Federal Controlled Substance Act as a:

Federal Register

Administrative agency wants to make a law, where would they post their proposed regulation

third party audit or DEA approved entity

All application systems must be approved by a _______________________or certified by a ____________________.

notice-and-comment rulemaking

An administrative rulemaking procedure that involves the publication of a notice of a proposed rulemaking in the Federal Register, a comment period for interested parties to express their views on the proposed rule, and the publication of the agency's final rule in the Federal Register.

-add new substance, new combination of approved drugs, change in proportion of ingredients, new intended use, dosage, method, or duration of administration or application is changed (tablet-> injection)

An approved drug can become a new drug under certain conditions:

1000

An estimated count is permissible for other schedules (3,4,5) unless container holds more than __________units

C1 or C2

An exact count must be made for ____ or _____drugs

fundamental notion of fairness custom of history involved command of a public entity best balance between conflicting societal interests

Factors taken account when making decisions

Safe Medical Devices Act of 1990

FDA additional authority over medical devices. Postmarketing approval. Require health care facilities to report problems to FDA. FDA new authority to recall.

does

FDA does/does not have the right to inspect a pharmacy to determine if the pharmacy is compounding or manufacturing.

are not

Long term care facilities are/are not registered with DEA

Food, Drug, and Cosmetic Act

FDA to provide regulation to ensure safety of food, drugs, etc.

Orange book

FDA's Approved Drug Products with Therapeutic Equivalence Evaluations -for drugs to see if they are substituted (generic vs biologic)

drugs

FDAAA established FDA authority to order drug recalls for certain products, but not _____

Yes because one of the following statements was true $500 or greater replacement cost of controlled substance or a person suffers "significant" injury, or interstate commerce is involved in the planning or execution of the crime

Drug was $500, no one was hurt, no interstate commerce happened does the controlled substance registrant protection act apply

clinical

Drugs need _____trials

misleading

Claims cannot be _____, where the label must be a disclaimer

2

Cocaine and codeine 30mg are schedule ___ drugs

Durham-Humphrey Amendment

Durham-Humphrey Amendment

Schedule V

Antitussive preparations that contain codeine is classified under the Federal Controlled Substance Act as a:

state law

At the federal level, Control 4 substances can have 5 refills, but a state law says no more refills on schedule 4 controlled substances. Which law do you follow

attorney general

Authority for scheduling is vested in the ____ ____ who must request a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS. ___ _____ can schedule drugs based on abuse and DEA.

priority rating

Drug ratings: P?

standard rating

Drug ratings: S?

purple book State law needs to permit this

Biosimilar biologics are included in what book?

C2 narcotic

C2 narcotic or nonnarcotic C2 oxycodin, hydrocodone, acetaminophen, morphine

nonnarcotic C2

C2 narcotic or nonnarcotic C2 adderall methyl phenylate

9

Combat Meth Act relates to sudafed, pseuoephedrine, phenylpropanolamine, ephedrine with a ___gram limit

3.6

Combat Methamphetamine Epidemic Act of 2005 and Methamphetamine Prevention Act of 2008 limits sale to no more than ______grams of ephedrine, pseudoephedrine, or phenylpropanolamine to a single purchaser per day

pseudoephedrine

Combat Methamphetamine Epidemic Act of 2005 and Methamphetamine Prevention Act of 2008 placed restrictions on OTC drugs used to manufacture methamphetamine including ______

3

Complete the following DEA number AB123456_

True

Compounding "regularly or inordinate amounts" of products that are "essential copies" of "Commercially available products" is prohibited unless a change for an identified patient produces a signifiant difference. True or False

Board of Pharmacy and FDA

Compounding Quality Act of 2013 allows compounders of sterile products to voluntarily register as outsourcing facilities with the ____ and_____.

Drug Quality and Security Act of 2013

Compounding Quality Act: clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMP, labeling and the new drug approval process adds "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products

30

Comprehensive Care Act can partially fill schedule 2 for up to ___days

2/3 vote

Congress can override a presidential veto by ...

Prescription Drug Marketing Act

Congress enacted this act in response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and safety. Further this law establishes sales restrictions and record keeping requirements for prescription drug samples and prohibits hospitals and other healthcare entities from reselling their purchases to other businesses and requires the state licensing of drug wholesalers.

Orphan Drug Act

Congress passes this Act to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of "rare diseases or conditions (defined as those affecting fewer than 200,000 Americans.)

patient counseling

Consumer Medication guide is not a substitute for _____ ________.

individual pharmacist

Controlled substances are registered with DEA from pharmacy but not ______ ______.

Board of Pharmacy

DEA has close relationsihip with state ______ ______. If DEA does inspection and finds controlled violation, they notify ________ __ ______

suffix

DEA numbers for intern use hospital DEA with a _____

prior

DSHEA excludes an article as a dietary supplement if it was approved as a drug ______to being marketed as a dietary supplement

Schedule IV

Diazepam is classified under the Federal Controlled Substance Act as a:

adverse events

Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers report serious_______.

do not

Dietary supplements (do/do not) require premarket approval

No

Do supplements need clinical trials?

identified individual patient

Doctor cannot write a prescription for office use it must be for an ____ ____ ____, based on the receipt of a valid prescription order.

administer

Doctors office can dispense and ______a drug.

Track and Trace Provisions

Drug Supply Chain Security is based on and will be implemented in November 2023. (who had contact and control of the drug as it made its way to the patient.

Orphan drugs

Drug ratings: O?

compliance

End of day reports with prescription number allows for keeping _______.

Durham Humphrey Amendment

Establishes criteria for distinguishing prescription drugs from OTC drugs -legally establishes oral prescriptions and refills -specifies the minimum information that a dispensed Rx label must contain

Orange book

Evaluates pharmaceutically equivalent products on the basis of bioequivalence. uses a two-letter rating system; some products use two letters and a number Pharmacists must comply with state law when substituting and exercise professional judgment substituting B-rated products. Bioequivalent pharmaceeutical equivalents are generally presumed therapeuticaaly equivalent- having the same clinical safety and efficacy.

state

Every ___permits pharmacists to substitute generically in some manner

-inventory -drugs received -drugs dispersed

Every registrant must keep a complete and accurate record of all controlled substances and there are three types of records involved:

labeling, advertising, nature of product Did someone make a therapeutic claim?

Evidence a product is a drug? ____,_____,_____

schedule 1

Example of what schedule drugs: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4 methylenedioxymethamphetamine

schedule 2

Example of what schedule drugs: narcotics include morphine, codeine, and opium hydrocodone, methadone, meperidine, oxycodone, and fentanyl

schedule 2

Example of what schedule drugs: amphetamine, adderall, methamphetamine,methylphenidate, lisdexamfetamine, cocaine, amobarbital, and glutethimide

Morphine Cocaine Fentanyl Morphine Cocaine Fentanyl

Example(s) of a Schedule II controlled substance under the Federal Controlled Substance Act is/are:

the pharmacy receiving/purchasing the drugs

Example: Independent pharmacy wants to transfer codeine (30mg) (C2) + a bottle of tylenol with codeine (C3), who fills out the DEA form 222?

prtecting individual freedoms deminimis violations (minor) certain human relationships (families, professions, religious groups)

Examples of limits to the law

Office of Medical Products and Tobacco Center for Drug Evaluation and Research (New drug application) Center for Biologics Evaluation and Research (Vaccines, insulin)

Examples of office under commisioner of FDA

C3

Examples of which schedule of drugs: narcotics include morphine combination products containing not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts, and products containing not more than 90 milligrams of codeine per dosage unit with an equal or greater quantity of an isoquinoline alkaloid of opium (Tylenol with codeine). buprenorphine products benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone

prescriber requests patient requests insitutionalized patients certain drug products such as sublingual nitroglycerin and SL and SL and chewable isosorbide dinitrate -for manufacturer: may market one size in noncompliant package with appropriate statement

Exemptions for Poison Prevention Packaging Act

emergency situations narcotic compounded drug for direct administration by infusion long term care facility patients (including for hospice patients for narcotic C2 drugs) electronic

Exemptions for dispensing C2 drugs:

if the patient requests Sublingual (SL) dosage forms of nitroglycerin Sublingual (SL) isosorbide dinitrate in dosage strengths of 10 milligrams or less Anhyrdous cholestyramine in powder form

Exemptions under the Poison Prevention Packaging Act

Interstate Commerce Clause

Federal authority to regulate drugs generally arises from which clause?

computer generated number check

Following the letters of a DEA number, the next 6 positions are a________________________unique to registrant and the last and 9th position is a computer calculated ______digit

Drug- FDA would say they are making a therapeutic claim.

Food or Drug? Company manufactures alfalpha tablets and on advertising it states that tables can cure ulcers but it is not a drug

regulated as a supplement

Food or Drug? Manufacturer says cranberry tablets can promote urinary health.

Drug (articles other than food intended to affect the structure or function of the body)

Food or Drug? Pregnancy birth control

regulated as a drug

Food or drug? Claim that tablets treat health

regulated as a supplemet

Food or drug? Cranberry tablets can promote urinary tract health

FDA wouldnt consider it as a drug because label doesnt say so.

Food or drug? You buy this dimethyl sulfoxide at home depot. You say you're going to eat it to relieve pain.

drug (articles intended for use in diagnosis, cure, mitigation treatment, or prevention of disease)

Food or drug? Claiming cheerios will lower cholesterol by 10%

6

For C 3 and C4 drugs, there is a limit of ______months after date or issuance or FIVE times, whichever comes first for refills

P or R

For DEA numbers, distributors begin with ___.

M

For DEA numbers, midlevel practitioners begin with ___.

503A

For compounding by hospitals and health systems, they must comply with section ______.

predating or postdating

For controlled substance prescriptions the date of issuance (date it is signed) is required which means no_____or _____.

form 41 Reverse distributor because they are the ones buying it to then destroy.

For disposal and destruction, which DEA form is required and who fills it out?

name of person

For drugs 2, 3,4,and not 5, federal law prohibits the transfer of this drug to another person without ______________on prescription.

archive

For electronically transmissioned prescriptions, the pharmacy must digitally sign and the pharmacy must ________the prescription

90

For multiple Control 2 prescriptions for same drug and patient on same day, each Rx must be on a separate blank and the total quantity prescribed does not exceed a ______ day supply and prescription must read "DO NOT FILL BEFORE" if there's a refill.

substantially constructed cabinet

For security, individual practioners must securely lock controlled substances in a __________________

M A,B,G,F

For validating a DEA # -midlevel practitioner begins with ___ Physician has ___,___,___,or ____

2, 3, 4

For what schedules is the registration number of prescriber required

106

Form for significant loss or theft

1. benefits a classical nutrient deficiency disease 2. describing role of Drug supplement in affecting structure/function of body 3. Characterizing the mechanism by which a drug supplement acts to maintain structure or function 4. statements of general well being

Four types of nutritional support claims under DSHEA?

-rulemaking -issue guidance documents (policy documents with gray area within regulation) -incorporate advice from standing advisory committees of outside experts

Functions of FDA?

suffix

IPs(such as nurse practitioners) who are agents or employees of a hospital or other institution has been assigned a specific internal code number to the IP as a _________ to the institution's DEA number

True

Guidance prohibits supplying compounded drugs for "office use", the drug product being compounded must be for an identified individual patient based on the receipt of a valid prescription order. True or False

federal level label

Have to look at _______to see if it is a prescription or over the counter. If it's prescription, it will say Rx.

Schedule I

Heroin is classified under the Federal Controlled Substance Act as a:

1. Member of Congress introduces legislation or bill. The bill is sent to a committee in Congress where hearings and investigations are held. They determine if bill goes to House of reps or Senate. If approved, it goes to the other house for approval and then once approved goes to the executive branch where it could be vetoed or approved.

How does bill become a law?

within one business day

How fast do you need to report theft?

10 digit, 3 segment code

How long is the national drug code number

5

How many classifications of controlled substances are there? Placement is determined on abuse potential and degree to which drug may cause physical or psychological dependence

9

How many grams per month is the sale of OTC pseudoephedrine limited to? Assume this is a retail sale and not mail order.

5 phases

How many phases for a biologic new drug application

5-monthly refills

How many refills for 3,4,5

none

How many refills for schedule 2

36

How many tablets 120 pseudoephedrine HCl

38

How many tablets 120mg pseudoephedrine sulfate

175

How many tablets? 25mg ephedrine HCl

146

How many tablets? 30mg pseudoephedrine HCl

155

How many tablets? 30mg pseudoephedrine sulfate

73

How many tablets? 60mg pseudoephedrine HCl

77

How many tablets? 60mg pseudoephedrine sulfate

186

How many tablets?25mg ephedrine sulfate

add the first, third, and fifth digits add the (sum of the second, fourth, and sixth digits)multiplied by 2, to the first sum determine if the right most digit of this sum corresponds with the ninth check digit

How to check the validity of a DEA number

cannot

If DEA agents have a warrant, pharmacist (can/cannot) refuse inspection.

information

If a drug cant have adequate directions for use, it must contain adequate_________for use.

standards

If a drug is recognized in USP or HPUS, the drug product must meet all _____of the compendia

do not fill because back pain is not in the optometrist's scope of practice.

If an optometrist prescribes a medicine for back pain, what should pharmacist do?

terminated

If doctor dies or pharmacy closes, DEA is notified and registration is _______.

last day of the month

If expiration date is 12/2022, when does it expire

wholesaler

If pharmacy is out of stock from controlled substance they must order from a ___________.

de novo

If substantial evidence lacking, court will conduct an entirely new trial

NOT EMERGENCY because there has to be either legitimate reason or no alternative and in this case it would have been possible to have written a prescription

If you receive a call for emergency C2 codeine 30mg tablets and doctors office is upstairs is that an emergency situation?

product selection education of patients as opposed to promotion of products restrictions regarding display of dietary supplement publications

Implications of Dietary Supplement Health and Education for pharmacists:

customers.

In a recall, manufacturers responsible for notifying seller, and seller is responsible for notifying _____if necessary.

valid reason

In order for a prescription to be legitimate (corresponding responsibility), there needs to be a ____________ ________ why this is being prescribed

DEA.

In order to have controlled substances, pharmacies must be registered with the ______

power of attorney

In order to sign the DEA form, you need _________ ___ ______.

DEA form 222. 14

In order to transfer C2 drugs, you need to use what form? and proposal must be submitted to the DEA at least ______days prior to transfer.

C5

In some states C___products may be sold without a prescription if dispensed only by a pharmacist, purchaser is at least 18, the purchaser furnishes suitable identification, and the sale is a recorded in a bound record book with all required information.

3 clinical +1 post market

In total, there are 4 phases for a drug

must contain full name and address of patient, drug name, strength, dosage form, and quantity prescribed; directions for use; and name, address, and registration number of practitioner written in ink, indelible pencil, or if typed, manually signed.

Information on Controlled Substance Prescriptions

Poison Prevention Packaging Act

Intent of the act is to protect chlidren from accidential poisonings due to "household substances". Administered by the Consumer Product Safety Commission. The law establishes the standards for child-resistant containers. Container may not be reused unless glass or threaded plastic and then only with a new closure.

transferring

Labels must include all required information plus a cautionary statement prohibiting the ultimate user from ___________the drug.

is not

Lasix (is/is not) a controlled substance under federal drug law

Sulfanilamide Tragedy of 1937

Led to the passage of the Food, Drug, and Cosmetic Act of 1938, more than 100 people died after the use of sulfanilamide. Dissolved sulfanilamide into diethylene glycol (antifreeze). Produced the drug in an elixir form with diethylene glycol.

stare decisis

Let the decision stand; decisions are based on precedents from previous cases opinions are binding on lower courts in the same jurisdiction and serve as precedent

adulteration, meningtis

NECC were working under insantiary conditions where _____occurred and a ____outbreak occured

need

NSAIDS such as motrin (ibuprofen), napricyn,naproxin needs/does not need a medication guide

9 7.6

No consumer may purchase more than _____ grams of ephedrine, pseudoephedrine, or phenylpropanolamine within a 30 day period from retail pharmacy or______ within a 30 day period by mail order.

disperse them throughout the stock of noncontrolled substances

Pharmacies and institutional practictioners may lock up controlled substances (3,4,5) or ____________________________. Controlled 2 substances must be in a safe.

True

Pharmacies compounding for their patients pursuant to a prescription are exempt from FDCA manufacturing provisions. True or False

exempt

Pharmacies compounding for their patients pursuant to prescription are _____from FDCA manufacturing provisions

5 distributor

Pharmacy can transfer drugs but at ___%, if it's more, you're considered a ________.

1

Pharmacy would not have DEA registration for schedule___ drugs.

approved and in 2006, it became an over the counter

Plan B has been approved/not approved to be Rx only in 1999

prescription

Prescription drugs need a _____for.

Prescription Drug Marketing Act of 1987

Prevents re-importation of a drug into US Prohibited hospital and healthcare entities from reselling their pharamaceuticals -establishes sales restrictions and record keeping requirements for prescription drug samples

-determining legislative intent -ordinary meaning of words -rights of the individual

Principles of interpretation

purpose of inspection

Prior to inspection, the inspector is required to state the __________________and present the owner or PIC with credentials and written notice of inspection

False

Procardia XL 30mg and Lasix 40mg tablets are classified under the Federal Controlled Substance as a Schedule IV. True or False

biologics

Products derived from living organisms (e.g., vaccines, blood and blood components, allergenics, tissues, etc.).

Pure Food and Drug Act of 1906

Prohibit the manufacturer, sale or transportaion of mis-brandished and adulterated foods and drugs (hard to enforce because the government would have to prove that someone intentionally wrongly to put the false statement on the label)

Federal Food, Drug, and Cosmetic Act

Protects consumers against misbranded or adulterated food, drugs, medical devices, or cosmetics (must be both SAFE and EFFECTIVE)

Orphan Drug Act of 1983

Provided tax and exclusive licensing incentives for the development of orphan drugs for treatment of rare diseases

10

Records for Fraud, Waste, and Abuse must be kept for ____years.

2

Records for refills of C3 and C4 prescriptions must be maintained for ______years

2

Records of controlled substances must be kept for ____years

Medication Guides

Required for drugs that the FDA has determined as posing "serious and significant concerns" Required for new prescriptions Content of the _____ must be approved by the FDA Required for refill prescriptions

Color Additive Amendments of 1960

Required manufacturers to establish the safety of color additives in food drugs and cosmetics.

Medical Device Amendment of 1976

Requires life-sustaining and life-supporting devices to have premarket approval from the FDA, classification of devices according to their function, establishment of performance standards, adherence to record and reporting requirements, conformance with GMP regulations

severe pain

Retail pharmacy can sell methadone if used for Not legal to prescribe or dispense methadone as an antitussive (cough)

90

Rules for multiple issuance for schedule 2 is that you can receive up to ____day supply

separate

Schedule 2 files are ______than 3,4,or 5

C1

Schedule of drugs that includes hallucinogenics, some opiates, methaqualone, and unapproved GHB

503A and 503B

Section _______and ______ do not exempt repackaged drugs from Compounding Quality Act

Alprazolam Flurazepam Lorazepam Meprobamate Alprazolam Flurazepam Lorazepam Meprobamate

Select all that apply. Example(s) of a Schedule IV controlled substance under the Federal Controlled Substance Act is/are:

U.S. constition which is supreme legislature admnistrative agencies courts

Sources of law

Legislative, Executive, and Judicial Branches

State legislatures model after Congress with ____,____,______,_____ _____.

Legislative Branch

Statutory law including U.S. Congress, State constitutions, state legislatures who make state laws, and political subdivisions (ordinances)

CIII

Subutex and Suboxone are what schedule CS?

tax free alcohol

Tax paid or tax free alcohol? -available to hospitals for medicinal, mechanical, and scientific purposes and in treatment of patients. may be used only for inpatients. -charity clinics may use for medicines for outpatients if they do not charge

tax paid alcohol

Tax paid or tax free alcohol? -used in compounding in community pharmacies -obtainable from outlets that sell liquor at retail

True

The Compounding Quality Act was passed as part of the Drug Quality and Security Act as a response to the New England Compounding Center tragedy. True or False

30 day

The Comprehensive Abuse and Recovery Act law allos pharmacies to provide partial fills of a C2 medication up to ________days from the date of the prescription if state law does not prohibit.

does not The prescriber must issue the prescription to the pharmacy and the pharmacist must authorize nurse to dispense from the kit

The DEA does/ does not consider a nurse as an agent of the prescriber for utilizing an emergency kit within a long term care facility.

adulterated

The FDA can only remove a dietary supplement on the basis of the product being ______, presenting significant risk of illness or injury.

Department of Health and Human Services (DHHS)

The FDA is housed under the _______.

President, Senate

The FDA secretary is appointed by _______with confirmation of _______.

does not

The Food drug and cosmetic Act does/does not permit mixing, diluting, or repackaging of biologicals

reactive

The U.S. is usually ______ with events and implementing policies.

Purple

The ___ book lists biological products, including any biosimilar and interchangeable biological products licensed by the FDA under the Public Health Service Act (PHSA).

notice of inspection

The ______must contain the name of the owner or PIC, name and address of the business, date and time of inspection, and a statement that the _____was given.

Prescription Drug User Fee Act

The act requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies. The fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and speed up the NDA reviews. In addition, this Act must be reauthorized every 5 years.

Kefauver-Harris Amendment

This amendment is also called the Drug Efficiency Amendment, it strengthen the new drug approval process by requiring that drugs be proved not only safe but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962. In addition, the amendment also transferred jurisdiction of prescription drug advertising form the FTC to the FDA, established GMP requirements and added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions .

less

The greater the controlled substance, the (more/less) potential for abuse

initial filling

The label must include date of filling if a C2 drug and date of _________ _____________if in another schedule

FDA Safety and Innovation Act

The law allows the FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals. It also adds the Generic Drug User Fee Act and Biosimilar User Fee Act. The purpose of imposing fees on these manufacturers is to increase resources for the FDA in order to speed the generic drug and biosimilar approval process. The law also contains several provisions directed at reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines. Additionally this law enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.

last name

The second letter of the DEA number is usually, but now always, the first letter of the registrant's ____________

10th amendment

The state authority to regulate generally derives from the ____ ______ to the U.S. Constitution and under its inherent police powers.

5

The total number of dosage units distributed to another registrant must not exceed ____% of total units of controlled substances distributed and dispensed in one year

5

There are ____ offices under commission of FDA.

3

There are ___classes of recalls

200

There is a limit _____mg of codeine per 100ml. for C5 drugs

1.8

There is a strength limit of ____of codeine per 100ml for C3 drugs

Food and Drug Administration Amendments Act

This act reauthorized and amended many drug and medical device provisions that were set to expire, also provided the FDA with new funding and significantly more authority over drug safety. This act allows the FDA broader use of the fees generated by PDUFA, while increasing the fees. The law also provides the FDA with significantly enhanced responsibilities and authorization to regulate drug safety, authority to mandate labeling changes related to safety, require clinical trial data reporting and registries, require postmarket clinical studies to assess risk, and require companies to implement risk evaluation and mitigation strategies (REMS) when necessary.

FDA Reauthorization Act of 2017

This act reauthorized the user fee programs and enhanced the goals of the Cures Act and created a new category of OTC hearing aids.

The Generic Drug Enforcement Act

This act resulted from a scandal that occurred when some FDA staff accepted bribed from generic drug industry personnel in order to facilitate the approval process of certain generic drug products. This law authorizes the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.

Food and Drug Administration Modernization Act

This act was passed primarily to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. The intent of this act is to eliminate backlogs in the approval process and ensure the timely review of applications. This act creates a fast-track approval process for drugs intended for serious or life threatening diseases, establishes a databank of information on clinical trials, authorizes scientific panels to review clinical investigations and expands the rights of manufacturers to disseminate unlabeled use information. This act also expands the FDA's authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients. The law also affects the regulation of medical devices in part by mandating priority review for breakthrough technologies in medical devices and allowing the FDA to contract with outside scientific experts for review of medical device applications.

pharmacist

This person is responsible for knowing of product recalls.

Drug Quality and Security Act

Two titles under this act. Title 1 also called the Compounding Quality Act, clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities. The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMOP, labeling and the new drug approval process. Title II known as the Drug Supply Chain Security Act, adds "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products. Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers. The law also mandates an electronic, interoperable product tracing system by 2023, strengthens wholesaler and third party logistics licensure requirements and requires manufacturers to serialize drugs by 2017.

tax paid or tax free

Two types of usage of alcohol in pharmacy practice; either _____or______

dated, signed

Valid prescription must be ____ and _____on date issued. must also have drug name, drug strength, dosage form, quantity prescribed, directions for use, # refills authorized

faith

Violation of FDCA is subject to strict liability Good______ excuse is applicable

Drug Price Competition and Patent Term Restoration Act of 1984

Waxman Hatch Amendment -streamline a generic approval process while giving patent extensions, in some circumstances, to innovator drugs -make generic drugs more readily available to the public while providing incentives to manufacture new drugs

public goods, externality, monopoly, and information asymmetry

What are the four market failures?

compensation to injured party

What are the objectives of civil actions?

Deter, punish, rehabilitate

What are the objectives of criminal actions?

Phase 1: healthy volunteers (absorption & metabolism) Phase 2: safety and efficacy on research studies (low # of participants) Phase 3: large multicellular study, randomized control trial

What are the three clinical trial for the new drug application process?

House of Representatives and Senate

What are the two parts of Congress?

Judicial Branch

What branch of government interprets laws by rendering decisions pursuant to hearings such as court proceedings

-Created a new special category of food called "dietary supplements" (DSs)

What did the Dietary Supplement Health and Education Act do?

Drug Enforcement Administration (DEA)

What does DEA stand for?

Dietary Supplement Health and Education Act

What does DSHEA stand for?

Federal Food and Drug Administration

What does FDA stand for?

national drug code

What does NDC stand for

Pharmacist in charge

What does PIC mean?

To document the surrender of controlled substances which have been forwarded by registrants to DEA for disposal.

What is a DEA form 41?

State Electronic Drug Rx Monitoring Programs (PDMPs)

What is a PDMP?

a) articles recognized in the U.S. Pharmacopoeia or homeopathic pharmacopoeia or b) articles intended for use in diagnosis, cure, mitigation treatment, or prevention of disease or c) articles other than food intended to affect the structure or function of the body

What is a drug?

ndc#, federal legend (Rx only), expiration date, lot number

What is on a label for controlled substance product

change ex. patient is allergic to dye

You cant make an essential copy of a product unless there's a _____for an identified patient, producing a significant difference

stricter law

You follow the _____law,if state law is ______, than follow that one.

Administrative agencies

__________ __________ are created by legislatures to administer or enforce the laws(experts to make laws)

"X"

_____or "DATA-waived," registration allows providers holding the registration to avoid U.S. Drug Enforcement Agency (DEA) registration requirements for narcotic treatment programs

adulterated

a drug is adulterated if its strength, quality, or purity differs from compendia standards, unless plainly stated on label

shredded

a mistake on a DEA form cannot be

medwatch

a voluntary reporting system to which health care professionals, consumers, and patients can report adverse events, product use errors, and product quality issues related to medications

statue

a written law passed by a legislative body

adulteration

add dirt on a tablet or drop tablets on floor and put it back

needs

adderall needs/does not need a medication guide

generic drugs

after patent giving exclusive rights to a company is done or expired, ____________are created

administrative actions

agency vs. private party: disciplinary determination which may include warning, fines, licensure revocation or suspension, probation ex. Board of pharmacy vs. private pharmacist ex. state level->violation of law in Massachusetts

FDA Safety and Innovation Act of 2012

allows FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals adds to generic drug user fee act and Biosimilar User Fee Act reduces drug counterfeiting, blocks the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines

controlled substance prescriptions

an order for medication dispensed to or for an ultimate user

off label indication

any indication not on approved drug insert

5

caution label needs to be on 2,3,and 4 but not __, that would be misbranding

Ryan Haight Act

defines a valid Rx as one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in person medical evaluation of the patient For online pharmacy prescriptions

Dietary Supplement Health and Education Act of 1994

defines dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA (regulate dietary supplements more as foods than as drugs)

72

for a partial fill due to pharmacy being out of stock, you have ___hours to fill remaining

purple book

for biologics to see if there is a different one (generic vs. biosimilar)

list

for bulk drug substances, it is required that all compounding substances must appear on a _____as developed by the FDA pursuant to regulation

7

for emergency need to follow up within ___days in a hard copy

Patient Package Insert (PPI)

found within stock bottle of drug requires for manufacturers and pharmacists to distribute to patients -any estrogen containing drugs, DES, estrotabs, and contraceptives will have these inserts law applies to institutional pharmacy as well as community.

2 years

how long do you retain records for controlled substances

advertising

if the written, printed, or graphic material is not labeling it is_______.

on hand

in possession of or under the control of the registrant

Food, Drug, and Cosmetic Act of 1938

indicated that mis-branding and adulteration of drug is illegal. It also required manufacturers to provide package inserts and to follow FDA guidelines to present evidence of safety for new drugs before marketing. Labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs. This law also gives the FDA authority to issue food standards and inspect factories/

Poison Prevention Packaging Act

intent of act to protect children from accidental poisonings due to "household substances"

Consumer Medication Information (CMI)

mandated that written info is provided to patient for EVERY drug every time a new Rx is dispensed. Provides consumers with info such as how to take it, storage info, etc.

Nutrition Labeling and Education Act of 1990 (NLEA)

mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations

automated dispensing systems

mechanical system that stores, packages, counts, labels, and dispenses medications and maintains transaction information -purpose is to reduce stocks of excess controlled substances in long term care facilities

addiction

methodone can be dispensed for pain not _____

De minimis violation

minor violation; okay as long as they dont interfere with patient safety directly

adulteration

misbranding or adulteration? New England Compounding Center fungus was added to bottle

not regulated by FDA

motrin and lisinopril are (federally/not federally) regulated by DEA

narcotic

natural or synthetic opium or opiates or derivatives including cocaine, which is not an opiate derivative

public goods

necessary and beneficial commodities that private entities will not supply because there are no incentives ex. orphan drugs

administrative inspection warrant

no consent required probable cause requirement created by supreme court as alternative to Search warrant Ex. pharmacy out of blue orders C2 drugs. The wholesaler calls DEA because they never had C2 drugs before, _______can be ordered.

Is legal

off-label prescribing and dispensing is/is not legal under Food Drug and Cosmetic Act

may

pharmacists (may/may not) make changes or add information after consultation with practitioner and documentation, except for patient's name, name of controlled substance (except generic substitution), or prescriber's signature for controlled 3,4,and 5 substances

practitioner

physician, dentist, veterinarian, scientific investigator, pharmacy, pharmacist, hospital, or others licensed by their jurisdiction to be involved with controlled substances

can cause birth defects

pregnancy warnings range from A, B,C,D,X, where X ________

Judicial Review

process where a court will review the record to determine if the decision was based on enough evidence

manufacturing

production, preparation, compounding, or processing of a drug; also packaging, repackaging, labeling, or relabeling

Food and Drug administration amendments act of 2007

provides FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting and registries, requiring postmarked clinical studies to assess risk and requires companies to implement risk evaluation and mitiation strategies

U.S. Pharmacopeia (USP)

published by the USPC (private organization) -sets uniform standards for handling sterile and nonsterile compounding, and handling hazardous materials.

provide information so patient can review drug they are receiving and they can determine the risks are (such as bleeding)

purpose of medication guide

Prescription Drug User Fee Act of 1992

requires manufacturers to pay fees for the applications and supplements when the FDA must review clinical studies Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review

orphan drugs

safe and effective but less than 200,000 need them , so it is not commercially feasible for a manufacturer to market them. They aren't a major priority or in a company's best interest to create them because they won't make that much money from them.

2

signature of pharmacist is required for substance _____

law

standards for society to act or not act in a certain way -requirements for human conduct applying to all person's within their jurisdiction

less

state law cannot be _____strict than federal law. Pharmacists should follow the stricter law.

The 21st century Cures Act of 2016

streamline and add flexibility and innovation to the drug development and approval process, primarily by creating new clinical trial design options and by accelerating the pathways to market for drugs intended to treat certain serious or life threatening diseases provides billions of dollars of additional funding to the National Institute of Health

Food and Drug Administration Modernization Act of 1997

streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices Creates fast track approval process for drugs intended for serious or life threatening diseases, establishes a database of information on clinical trials, authorizes scientific panels to review clinical investigations, and expands the rights of manufacturers to disseminate unlabeled use information

orange book

substituting brand with generic is found within

Controlled Substance Registrant Protection Act

the purpose of the law is to make it a federal crime if robbery results in $500 or greater replacement cost of controlled substance or a person suffers "significant" injury, or interstate commerce is involved in the planning or execution of the crime

labels

the term labelling includes

Tax-paid alcohol is used in compounding in community pharmacies. Tax-paid alcohol is obtained from outlets that sell liquor at retail. Tax-free alcohol (190 proof ethyl alcohol) is available to hospitals for medicinal, mechanical and scientific purposes and in the treatment of patients. May be used only for inpatients. Tax-free alcohol (190 proof ethyl alcohol) charity clinics may use for medicines for outpatients if they do not charge a fee for the alcohol.

the use of alcohol in pharmacy practice

package size and type of drug

third segment of national drug code

information asymmetry

when the consumer is uninformed about the true value of a good ex. prescription only drugs; written consumer information for certain drugs--> only healthcare providers are informed

monopoly

when the fixed costs of providing a good are high, relative to the variable costs -ex. patents and market exclusively for new drugs

externality

when the production or consumption of a good affects someone who does not fully consent to the effect -when the costs of the good are not fully incorporated in the price of a good ex. antibiotics and misuse of them

conscientious objection

whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists

labeling

written or printed or graphic matter accompanying of the article

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . EFFICACY REQUIREMENT ESTABLISHED GOOD MANUFACTURING PRACTICES • Required drug advertising to be more closely regulated and disclose accurate information about side effects

Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs or Prescription drugs". provided that the labels of prescription drugs need not contain "adequate directions for use" so long as they contain the legend "Caution: federal law prohibits dispensing without a prescription." -also authorizes oral prescriptions (telephone prescription from doctor) and refills of prescription drugs