Federal Flashcards
how to cite federal law or rules/regulations
T USC &S(Ss)
T - title
S - section
Ss - subsection
how to cite Indiana laws
IC T-A-C-S
T - title
A - article
C - chapter
S - section
how to cite Indiana rules/regulations
T IAC A-C-S
what is the definition of a drug - 4 factors
1 - article recognized in the official compendium
2 - article intended for use in dx, cure, tx
3 - article intended to affect body
4 - articles for use as component
what components constitute the official compendium
USP, NF, HPUS
what is an orphan drug
used for a condition that affects <200,000 in the US OR affects >200,000 in the US with no expectation that the cost of developing the drug will be recovered from sales
who is responsible for naming generic drugs
USAN
who is included in USAN
FDA liaison, at-large member, AMA, USP, APhA representative
what is considered adulteration - 8 factors
1 - consists of filthy, putrid, decomposed
2 - prepared in unsanitary conditions
3 - don’t follow cGMP if manufactured
4 - container is poisonous
5 - unsafe color additive
6 - quality or purity falls below standard
7 - strength differs from compendium
8 - been in a place that denies inspection
what is cGMP and the requirements
minimum manufacturing requirements
manufacturers MUST be registered with the FDA - failure to register = adulteration AND misbranding
how often do manufacturers have to be inspected by the FDA for cGMP
2 years
what is considered misbranding - 10 factors
1 - labeling is false
2 - in package UNLESS contains labeling
3 - required information is missing
4 - if not recognized by official compendium
5 - not adequate directions
6 - container is misleading
7 - dose is dangerous to health
8 - color additive isn’t on label
9 - violates PPPA
10 - REMS not followed
what is excluded from cGMP
compounded drugs
pharmacies
what factors do compounded drugs need to be exempt from cGMP, misbranding, and new drug requirements - 3 factors
for an individual patient
based on prescription
compounded by licensed pharmacist or physician
when will a pharmacy be considered an outsourcing facility (have to register)
compound and distribute out of state >5% of total prescriptions and have to follow cGMP
outsourcing facilities (503b) labeling requirements
“compounded drug”
outsourcing facility information
batch number
expiration date
storage list of ingredients
what are the medical devices and examples of each
class I - simple (stethoscope)
class II - need surveillance (syringe, tampon, A1C)
class III - sustain human life (pacemaker, soft contact lenses)
restricted - requires prescription due to harm (contact lenses, diaphragms)
custom - orthopedic footwear
banned - not on US market (prosthetic hair fibers, powdered gloves)
If a new device is marketed, what class would it fall under
class III automatically unless the FDA determines it is equivalent to a different class
what are the classes of recalls
class I - serious consequence and death
class II - temporary, reversible harm
class III - no harm
what recalls are mandatory vs voluntary
biologics, devices, food are MANDATORY
drugs are VOLUNTARY
what is the durham-humphrey amendment of 1951
established qualities to make a drug prescription, who can prescribe, labeling requirements, refills
who has authority to prescribe & who are the BIG FOUR
BIG FOUR - physician, dentist, veterinarian, podiatrist
NP
PA
pharmacist
OD
prescription label requirements for FEDERAL
1 - name and address of dispenser
2 - serial number
3 - date filled
4 - name of prescriber
5 - name, directions, statements IF STATED
how to decipher an NDC
XXXXX-XXXX-XX
first 5 = manufacturer
middle 4 = drug
last 1-2 = package size
