Pharmacy Law and Ethics - FDA

this act established a record keeping requirement for the receipt and dispensing of opium or coca leaf products

Harrison Narcotic Act

the Harrison Narcotic Act established a tax on what products?

opium and coca leaf products

were physicians allowed to prescribe opium/coca leaf products in the course of legitimate treatment to patients under the Harrison Narcotic Act?

yes

under the Harrison Narcotic Act, the possession of narcotics without a ________ became illegal

prescription

the FDA has the primary responsibility of enforcing what act?

Federal Food, Drug, and Cosmetic Act of 1938

what lead to the passage of the FD&C act?

the Sulfanilamide Disaster

prior to the FD&C, what was the only form of regulation?

taxes

the FD&C Act focuses on _______

safety

what were the original three requirements for the FD&C Act?

drugs to be proven safe not efficacious, directions for use, adequate warnings

FD&C Act requires that only ______, _______, and _______ ______ drugs may be introduced

safe, effective, and properly labeled

the FD&C Act requires _______ _________ _________ ________ be followed

Current Good Manufacturing Practices

according to the FD&C Act: prescription drugs be dispensed to an individual only pursuant to a _________ or administered directly by a _______ or other _________ _________

prescription; physician; authorized prescriber

according to the FD&C Act: drug prescriptions can be refilled only ___ ____________

as authorized

according to the FD&C Act: specific labeling must be used for both __________ and ____________ ______

prescription and nonprescription drugs

according to the FD&C Act: dispensing a drug for distribution in violation of the Act's ________ requirements is misbranding

labeling

according to the FD&C Act: drugs containing filthy, putrid, and decomposed substances and drugs packed and held under ____________ conditions be deemed ___________

unsanitary; adulterated

according to the FD&C Act: the FDA is authorized to perform limited __________ of pharmacies in certain circumstances

inspections

according to the FD&C Act: __________ or _________ of drugs must register with the FDA

manufacturers or repackagers

the FD&C act began the approval process for _____ ________

new drugs

according to the FD&C Act: approval for a new drug requires a _____ _______ ________

new drug application (NDA)

the FD&C provided a grandfather clause exempting certain drugs on the market prior to the act regarding what requirement?

the requirement for an NDA

what amendment to the FD&C defined prescription drugs as legend drugs to distinguish between OTC drugs

Durham-Humphrey Amendment

the Durham Humphrey Amendment authorized _______ on prescriptions

refills

the Durham Humphrey Amendment authorized ______ prescriptions

oral

what triggered the Kefauver-Harris Amendment?

Thalidomide Disaster

what was the Thalidomide Disaster?

a morning sickness pill that lead to countless deformities in the babies; was outlawed in US before mass distribution of drug occurred

the Kefauver-Harris Amendment increased scrutiny on _______

safety

the Kefauver-Harris Amendment was the first to require what before marketing?

evidence of effectiveness

the Kefauver-Harris Amendment requires compliance with ________ _________ ________ ________

current good manufacturing practices

do pharmacies register with the FDA?

no!

what describes the minimum requirements for the methods, facilities, or controls used in manufacture, processing, packaging, or holding of a drug product?

current good manufacturing practices (CGMP)

what does the CGMP apply to?

manufacturers and pharmacies engaged in activities deemed to be manufacturing

what amendment is credited for the modern day drug approval process framework

Kefauver-Harris Amendment

the Kefauver-Harris Amendment added additional ________ requirements

labeling

prescription drug advertising is regulated by the _______

FDA

nonprescription advertising is regulated by who?

the Federal Trade Commission (FTC)

what amendment defined a medical device?

the Medical Device Amendment

a medical device has no _______ _______

chemical action

how many classes of medical devices are there?

3

which device class: needles, scissors, stethoscopes, and toothbrushes

class 1

which medical device class has the least regulation

class 1

which device class: insulin syringes, electric heating pads, thermometers

class 2

which device class: pacemakers, replacement heart valves

class 3

which device class must have premarket approval because they are life supporting or life sustaining?

class 3

what act extended the ANDA to generics, thereby making generic approval easier?

the Drug Price Competition and Patent Term Restoration Act of 1984

what does an ANDA not require for generics?

proof of safety and efficacy through clinical trials

why are generics so much cheaper?

they do not require clinical trials/research which is extremely expensive

through an ANDA, generics only need to show the drug is ________ and ________ to the innovator drug

bioavailable and bioequivalent

what does ANDA stand for?

Abbreviated New Drug Application

what is a grant of a property right to the inventor issued by a specific office of the United States?

patent

what office issues patents?

Patent and Trademark Office of the United States

the life of a patent is ?

20 years from the date of first filing of the application

patents allow for ______ ________

brand exclusivity

because manufacturers usually file for patent protection ______ to product marketing, the effective term of the patent is less than ______ years

prior; 20

the Drug Price Competition and Patent Term Restoration Act of 1984 provides manufacturers with an opportunity to extend the life of the patent for an additional ____ ________

5 years

how many times can a manufacturer extend the life of their patent?

1

the total patent life of a drug cannot exceed _______ years from the approval date of the drug product aka when it goes on the market

14

the _______ ________ Amendment Act set three track for FDA approval of exported drugs

Drug Export

The Prescription Drug Marketing Act (PDMA) banned what?

the sale of drug samples

the ___________ ____________ ________ _________ Act of 1992 authorizes three different fees to cover the costs incurred for review of applications

The Prescription Drug User Fee Act

what are the three different fees the Prescription Drug User Fee Act incur?

drug application fees, annual establishment fees, and annual product fees

pharmacy compounding law still remains ___________

unsettled

compounding pharmacies do not follow ___________ or register with the ________

CGMP; FDA

the compounding section of the ___________ was overturned by the Supreme Court on April 29, 2002, as an unconstitutional infringement on __________ __________

FDAMA; commercial speech

in Thompson vs. Western States Medical Center, the Supreme Court held that prohibition by the FDA on the ability of a pharmacist to _________ or _________ a product compounded by prescription was an infringement on the right of free speech

promote or advertise

what are the two branches of the Drug Quality and Security Act of 2013?

quality and security

what pharmacy had a fungal meningitis disaster that led to an increase in compounding pharmacy regulation?

New England Compounding Center

what are the three requirements the DQSA exempts compounding pharmacies from if they comply to their regulations?

1. compliance with current good manufacturing practices

2. FDA required labeling

3. FDA approval prior to marketing

__________ ________ are designed for immediate administration and require less information

prescription orders

according to the DQSA, compounding can occur subsequent to a ___________ ________ only

prescription order

according to the DQSA, traditional pharmacies cannot compound ____________ ___________ in advance

large quantities

according to the DQSA, traditional pharmacies cannot compound drugs that were withdrawn from market due to _________ issues

safety

according to the DQSA, traditional pharmacies cannot sell compounded products to anyone other than the ___________

patient

according to the DQSA, traditional pharmacies cannot compound for _______ use

office

according to the DQSA, traditional pharmacies cannot compound copies of __________ _________ drugs

commercially available

according to the DQSA, traditional pharmacies a proper _________ _________ _________ relationship must exist

patient-prescriber-pharmacist

according to the DQSA, traditional pharmacies must comply with ______ ________ _______ standards

United States Pharmacopeia

according to the DQSA, traditional pharmacies must have a _________ ________ to complete the compounding

licensed practitioner

according to the DQSA, outsourcing pharmacies will be inspected by the _______ according to a risk-base schedule

FDA

according to the DQSA, outsourcing pharmacies must comply with _________ requirements

CGMP

according to the DQSA, outsourcing pharmacies do not require a _________

prescription

according to the DQSA, outsourcing pharmacies are allowed to compound products for _______ use

office

according to the DQSA, outsourcing pharmacies a _________ must supervise the compounding

pharmacist

according to the DQSA, outsourcing pharmacies no limits are placed on the ________ that can be compounded

amounts

according to the DQSA, outsourcing pharmacies cannot distribute compounded drugs to a ________

wholesaler

what are the 4 aspects of the FD&Cs definition of a drug?

1. recognized by the USP or other reference

2. intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, in man or other animals

3. intended to affect the structure of any function of the body of man or other animals

4. not a device

the _________ of the manufacturer or distributor is key to determine whether a particular item is a drug

intent

legend drugs are __________ drugs

prescription

defined as a drug intended for use by a man which because of its toxicity or other potential harmful effect, or other method of use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug

legend drug

commercial containers must have "______ only" or "Caution, federal law prohibits dispensing without a ________" on the bottle

Rx; prescription

defined as any drug that has not received general recognition by medical experts as being both safe and effective for the intended use

new drug

________ drugs are defined as safe and effective for the general public

OTC

OTC drugs have a _______ potential for misuse and abuse

low

what are the 7 labeling requirements for OTC drugs?

1. active ingredient

2. purpose

3. use(s), indications

4. warnings

5. directions

6. other information

7. inactive ingredients

what are the four contents that need to be labeled on OTC drug labels?

sodium, calcium, magnesio, potassium

if something is wrong with the drug product itself, it has been ______

adulterated

if something is wrong with the packaging of a drug, it has been _________

misbranded

if a prescription is not packaged with a safety cap, it has been _________

misbranded

what act rules that medication must be dispensed with a safety cap?

Poison Prevention Packaging Act

for non-sterile solid and liquid

pharmaceutical products repackaged into

unit-dose or single-unit containers, pharmacists must affix a __________ _______ that is ______ year or _______

beyond-use date; one year or less