Laws and Regulations module Flashcards
What is a required for a drug to be marketed through the drug monograph process?
An approved dose An approved indication Non-adulterated Non-misbranded CGMP compliant
Durham-Humphrey Amendment of 1951
Separated Rx from OTC
Rx-only if:
- Habit-forming
- Unsafe w/out monitoring
- Limited to Rx per manufacturer’s NDA
Exemptions from PPFA
Patient blanket waiver
Prescriber single Rx waiver
Pharmacists CANNOT do this
Definition of diseases that qualify for orphan drug development:
Affect < 200k in US
No reasonable expectation to make your money back on the drug
Generic drugs have to have the same what as brands?
Active ingredient
Route
Dosage
Formulation
Pure Food and Drug Act of 1906
Labels are required
ingredients must meet USP/NF standards
The label must be true to what is in the product
Dietary supplements are…?
Foods.
They cannot make health claims.
Federal Anti-Tampering Act of 1982
Preceded by the cyanide in Tylenol OTC
OTC tamper resistance packaging
What does a IND allow for?
Testing in humans
OTC Drug approval
NDA or Drug Monograph - Rare - Caffeine is an example
Food, Drug, and Cosmetic Act (FDCA) of 19383
Drugs must be proven safe
No alduteration/misbranding
Ingredients must be on label
FDA can inspect manufacturers/distributers
Hatch-Waxman (Price and Patent) 1984
Established ANDA for development of generics
Designated originators as RLDs
Gave patent patent protection rights to brands though?
Phase II testing
Humans - about 200 Relatively clean patients Main concerns are: - Safety - Efficacy especially - Dose ranging Usually 2-5 years long
Drug Listing Act of 1972
Required NDC numbers
Phase IV
In conjunction with FDA
Mass data
Can be used to revise indications, safety warnings, etc.
Phase III testing
Humans - about 2,000 Slightly more diverse population May be multicenter and multinational Can really nail down efficacy here and continue to assess safety and dosing Usually 3-5 years Submitted as part of the NDA
sNDA are for:
New labels, formulations, packages, manufacturers, or indications
NDA are for:
Brand drugs
NADA are for:
Animal drugs
Orphan Drug Act of 1983
Incentivized drug development for orphan-disease states by providing:
- Tax credits
- Extended exclusivity
- Facilitated approval process
OBRA ‘90
Required offer to counsel to Medicaid patient’s
- Has spread really to all states and prescriptions
Required a DUR record
ANDA are for:
Generics drugs
BLA are for:
Biologics
NDC components
10 digits, three segments
- Manufacturer
- Drug/strength
- Pack size
Pre-clinical testing
Animals - 2 species
Pharmacology Toxicity - Carcinogenicity - Teratogenicity - Mutagenicity Dose estimation
ANADA are for:
Animal generic drugs?
Prescription Drug Marketing Act of 1987
You can’t buy drugs outside of the US and bring that back unless:
- 90 day supply
- For you only
- They really need it or we don’t have it…
Wholesalers have to register with state they operate in
Hosptial drug sale restrictions
Can’t sell samples
Can’t sell coupons
Kefauver-Harris Amendment of 1962
Preceded by thalidomide:
Safety AND efficacy
Adverse rxn’s from trials must be reported to FDA
Created NDA and sNDA
Created IND and role of the IRB
Poison Prevention and Packaging Act (PPFA) of 1970
Applies to Rx drugs
CR-packaging; originally meant to target children 5 and younger
Think about that Rx drugs don’t have air-tight seals on them; that is for OTC’s.
Not a part of the FDCA
DSHEA 1994
Now supplement Manufacturers can make some sort of claims about their products
“This product will make you feel great in the morning”
Phase I testing
Humans - about 20
Healthy male volunteers
Main concern here is safety
Usually 1 year long
Bioequivalence is based on what?
Cross-over studies b/w generic and brand
