Laws / Acts Flashcards
Pure Food and Drug Act of 1906
Prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded
DID NOT:
- require mfg to list ingredients or label directions for use
- regulate cosmetic products or medical devices
Food, Drug, and Cosmetic Act of 1938
107 deaths from sulfanilamide (solvent diethylene glycol) in 1937 ->
- Required new drugs to be proven safe when used according to directions on label
- Labels must include directions and warnings about habit-forming ingredients
- Included cosmetics and medical devices
- drugs marketed before 1938 were grandfathered in
Durham-Humphrey Amendment of 1951
Amendment to FDCA
Established legend drugs (Rx) vs OTC drugs
Legend drugs:
- require medical supervision
- exempt from instructions for use on label
- “Caution: Federal law prohibits dispensing without a prescription on the label
Kefauver-Harris Amendment of 1962
AKA Drug Efficacy Amendment
Amendment to FDCA due to thalidomide
- all new drugs had to be showed to be safe AND effective
- Regulated Rx advertising under FDA
- research requires informed consent
- required reporting ADRs
- GMP requirements (defined conditions for drug manufacture in the US)
Medical Device Amendment of 1976
Amendment to FDCA
Provides better classification of medical devices
- specific function
- performance standards
- Pre market approval requirements
- Conformance w/ GMP
- record and reporting requirements
Orphan Drug Act of 1983
Orphan drugs- used to treat rare diseases
Provided tax and licensing incentives to manufacturers to continue making orphan drugs
Drug Price Competition and Patent-Term Restoration Act of 1984
Amendment to FDCA aka Waxman-Hatch Amendment
Attempted to resolve dispute between generic drug and brand name manufacturers
- streamlined new drug approval
- provided manufacturers with incentives to develop new drugs
Prescription Drug Marketing Act of 1987
- control distribution of Rx samples
- prevent reselling pharmaceuticals to other businesses
FDA Modernization Act of 1997
Big boi
- expedite approval of new drugs for serious/life threatening conditions
- States should regulate compounding
- pharmacies are exempt from GMP standards and requirements for submitting NDAs
- “Caution: Federal law prohibits dispensing without a prescription” changed to “Rx only”
- eliminated the requirement for some substances to be labeled “Warning- May be habit forming”
Poison Prevention Packaging Act (PPPA)
Childproof packaging
Exception, non-childproofed packaging allowed for elderly or disabled patients, but must have a warning on it
HIPAA
Privacy of identifiable health info and security of electronic PHI
Health Information Technology for Economic and Clinical Health (HITECH) Act (2009)
Extended HIPPA privacy protections in the wake of EHRs
Define adulteration
a drug or device that…..
- consists of any putrid substance
- prepared, packaged or held in unsanitary conditions
- drugs with containers made from toxic material that may make the meds harmful
- if it’s strength differs from, or quality and purity fall below what is written on the label
Misbranded definition
A drug or device is misbranded if….
- its labeling is false or misleading
- any required word or statement is not prominently placed on the labeling
- if it contains habit forming substances without a warning
- if it is a drug and it’s container is made/filled in an attempt to mislead
- imitation of another drug
- offered for sale under the name of another drug
- bears a copy, counterfeit, or colorable imitation of the trademark label of another drug
- if it is dangerous when used in the dosage recommended on the labeling
- e
FDA Class 1 Recall
there is a reasonable probability that the use of, or exposure to a violative product will cause serious adverse health consequences or death
Key words:
- reasonable probability
- serious ADEs and/or death
