Federal Law

Question 1

food drug and cosmetic act of 1938

Answer 1

drugs now require FDA approval based on safety (only) PLUS
adequate directions for use on consumer label = OTC

“if we cannot put directions for use then it cannot be an OTC product”

Question 2

Durham Humphrey (“Rx Drug Amendment”) 1951

Answer 2

distinguished rx from otc; adequate directions for use requierd on OTC label
require RX only phrase on rx meds

Question 3

Kefauver-Harris (Drug Efficacy Amendment) of 1961

Answer 3

NDA process, proof of efficacy (not just safety), informed consent required in clinical trials, DESI
manufacturing: CGMPs, FDA authority to inspect

Question 4

orphan drug act of 1983

Answer 4

gave manufacturers financial incentives to bring drugs to market for rare diseases (<200,000 americans)

Question 5

Waxman Hatch Law 1984 (Drug Price Competition Act)

Answer 5

abbreviated new drug application (NDA) for generics

Question 6

Rx drug marketing act (1987)

Answer 6

samples
wholesaler licensing

Question 7

Drug Quality and Security Act 2013

Answer 7

compounding and outsourcing facilities
drug supply chain security

Question 8

FDA main functions are to

Answer 8

safety of med supply in US
drug approval and surveillance
regulation of profession
- compounding (503a)
- 795, 797, 800
- outsourcing (503b)
REMS
med guides
package inserts
poison prevention
etc.

Question 9

what created the FDA

Answer 9

the US constitution under the interstate commerce power

Question 10

what is a class I recall

Answer 10

reasonable probability of adverse health events

Question 11

what is a class II recall

Answer 11

temporary or medically reversible

Question 12

what is a class III recall

Answer 12

not likely to cause harm

Question 13

definition of dietary supplement
examples?

Answer 13

intended to supplement the diet via ORAL ingestion that bears or contains one or more of the following

vitamin
mineral
herb
botanical
amino acid
dietary substance

and is therefore removed from FDA regulations

Question 14

adulteration definition

Answer 14

filthy, putrid, decomposed, insanitary etc.

inappropriate container or conditions

if strength, quality or purity differ from the standard

reduced quality or strength

Question 15

misbranding

Answer 15

always about label/labeling

false or misleading
name and place of business, packer, distributor, etc not prominently placed

OTC without adequate directions for use

imitation of another drug

Question 16

misbranding examples

Answer 16

child resistant packaging when required

tamper resistant/evident (seal, wrap etc.)

OTC without directions for use

rx products without accurate information for use (not directions)

Question 17

what is drug labeling and label tied to (law wise)

Answer 17

Durham Humphrey

Question 18

label vs labeling

Answer 18

labeling is label plus supplemental info (med guide, package insert, etc.)

Question 19

what does adequate directions for use include on an OTC drug

Answer 19

normal dose
freq
duration
route
preparation
admin tips (onset, meals etc.)
drug facts (purpose, uses, warnings, directions)

Question 20

what is required on an stock bottle (rx)

Answer 20

mfr name and address
quantity of active ingredients
generic and proprietary names
“rx only”
route (if NOT oral)
NDC
lot
exp date
type of container (“light resistant”)

Question 21

what is required on a unit dose label

Answer 21

name
quantity
lot
exp date
bar code

Question 22

what should a package insert include

Answer 22

BBW
adequate info for use
pregnancy warnings
brief summary
etc.

Question 23

what is a new drug

Answer 23

never been FDA approved
crime to distribute in interstate commerce
not generally recognized as safe and effective

Question 24

what does the FDA have the authority to do if they determine an adulterated drug or unapproved new drug is in possession

Answer 24

injunction
criminal proceedings
warning letters
recalls

Question 25

what is the 505b1 process

Answer 25

NDA (new drug application) process kicks of clinical trials

Question 26

who is responsible for surveilling drugs after they are on the market

Answer 26

FDA

Question 27

IND definition

Answer 27

investigational new drug filed by manufacturer to FDA FDA approves and allows manufacturer to distribute drug via interstate commerce and be exempt from the NDA process

Question 28

what does an NDA involve

Answer 28

clinical trials components and composition sample proposed labeling/package insert manufacturing details approved when substantial evidence of safety and efficacy for intended use is est

Question 29

what is non malifecance

Answer 29

minimizing harm and risk

Question 30

supplemental NDA

Answer 30

SNDA supports manufacturers interest in changing dosage form, production, manufacturing, indication etc. if new indication this will include clinical trials

Question 31

what allowed the FDA to require new clinical trials after approval of

Answer 31

2007 Amendments

Question 32

505b2 application

Answer 32

for improved generics of drugs that no longer have patent protection same substances with Phamaceutical or therapeutic differences hybrid between NDA and abbreviated-NDA (ANDA) new dosage form, new indication, new delivery mechanism

Question 33

if a generic is approved how long do they have market exclusivity

Answer 33

3 years!

Question 34

what is used for generic drug approval following a brand

Answer 34

ANDA

Question 35

orphan drug act of 1983

Question 36

what restricts dispensing of OTC plan B

Answer 36

none additional restrictions are not allowed

Question 37

what is done if a pharmacist refuses to dispense a medication based on moral/religious etc. beliefs

Answer 37

pharmacist should alert employer and tell them they do not want to employer will ensure pharmacist will hand off to another pharmacist so as to avoid patient abandonment

Question 38

are patient package inserts required to be dispensed in hospitals

Answer 38

yes

Question 39

when are patient package inserts and med guides required

Answer 39

w every dispense! med guide not required in hospital

Question 40

are off label uses allowed

Answer 40

yes promotes innovation in profession called 'practice of medicine'

Question 41

FDAs orange book

Answer 41

reference guide for therapeutic equivalents equivalence ratings now strictly a database

Question 42

what qualifies a drug to be pharmaceutically equivalent to another

Answer 42

same active ingredients, dosage form, strengthq

Question 43

what qualifies a drug to be bio equivalent to another

Answer 43

rate and extent of absorption (PK) do not show a significant difference from listed drug

Question 44

does substituting a B rated drug violate federal law

Answer 44

nope

Question 45

what did the generic drug substitution act of 1977 do

Answer 45

'less expensive drug equivalent shall be dispensed unless DAW written'

Question 46

if brand only available, how does this work

Answer 46

depends if emergency no emergency: dispense brand, charge generic emergency (think ER): dispense brand, charge brand

Question 47

are biosimilar products always interchangeable with reference products

Answer 47

no

Question 48

who decides how pharmacists substitute biosimilars

Answer 48

the individual state