Federal Law Flashcards
food drug and cosmetic act of 1938
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”
Durham Humphrey (“Rx Drug Amendment”) 1951
distinguished rx from otc; adequate directions for use requierd on OTC label
require RX only phrase on rx meds
Kefauver-Harris (Drug Efficacy Amendment) of 1961
NDA process, proof of efficacy (not just safety), informed consent required in clinical trials, DESI
manufacturing: CGMPs, FDA authority to inspect
orphan drug act of 1983
gave manufacturers financial incentives to bring drugs to market for rare diseases (<200,000 americans)
Waxman Hatch Law 1984 (Drug Price Competition Act)
abbreviated new drug application (NDA) for generics
Rx drug marketing act (1987)
samples
wholesaler licensing
Drug Quality and Security Act 2013
compounding and outsourcing facilities
drug supply chain security
FDA main functions are to
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.
what created the FDA
the US constitution under the interstate commerce power
what is a class I recall
reasonable probability of adverse health events
what is a class II recall
temporary or medically reversible
what is a class III recall
not likely to cause harm
definition of dietary supplement
examples?
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
adulteration definition
filthy, putrid, decomposed, insanitary etc.
inappropriate container or conditions
if strength, quality or purity differ from the standard
reduced quality or strength
misbranding
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
misbranding examples
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)
what is drug labeling and label tied to (law wise)
Durham Humphrey
label vs labeling
labeling is label plus supplemental info (med guide, package insert, etc.)
what does adequate directions for use include on an OTC drug
normal dose
freq
duration
route
preparation
admin tips (onset, meals etc.)
drug facts (purpose, uses, warnings, directions)
what is required on an stock bottle (rx)
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”)
what is required on a unit dose label
name
quantity
lot
exp date
bar code
what should a package insert include
BBW
adequate info for use
pregnancy warnings
brief summary
etc.
what is a new drug
never been FDA approved
crime to distribute in interstate commerce
not generally recognized as safe and effective
what does the FDA have the authority to do if they determine an adulterated drug or unapproved new drug is in possession
injunction
criminal proceedings
warning letters
recalls
what is the 505b1 process
NDA (new drug application) process
kicks of clinical trials
who is responsible for surveilling drugs after they are on the market
FDA
IND definition
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
what does an NDA involve
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
what is non malifecance
minimizing harm and risk
supplemental NDA
SNDA
supports manufacturers interest in changing dosage form, production, manufacturing, indication etc.
if new indication this will include clinical trials
what allowed the FDA to require new clinical trials after approval of
2007 Amendments
505b2 application
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
if a generic is approved how long do they have market exclusivity
3 years!
what is used for generic drug approval following a brand
ANDA
orphan drug act of 1983
</= 200,000 americans
tax incentives
7 years exclusivity
assistance with clinical trial design
facilitated review
what restricts dispensing of OTC plan B
none
additional restrictions are not allowed
what is done if a pharmacist refuses to dispense a medication based on moral/religious etc. beliefs
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
are patient package inserts required to be dispensed in hospitals
yes
when are patient package inserts and med guides required
w every dispense!
med guide not required in hospital
are off label uses allowed
yes
promotes innovation in profession
called ‘practice of medicine’
FDAs orange book
reference guide for therapeutic equivalents
equivalence ratings
now strictly a database
what qualifies a drug to be pharmaceutically equivalent to another
same
active ingredients, dosage form, strengthq
what qualifies a drug to be bio equivalent to another
rate and extent of absorption (PK) do not show a significant difference from listed drug
does substituting a B rated drug violate federal law
nope
what did the generic drug substitution act of 1977 do
‘less expensive drug equivalent shall be dispensed unless DAW written’
if brand only available, how does this work
depends if emergency
no emergency: dispense brand, charge generic
emergency (think ER): dispense brand, charge brand
are biosimilar products always interchangeable with reference products
no
who decides how pharmacists substitute biosimilars
the individual state
