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
what is the Poison Prevention Packaging Act of 1970
requires special packaging (CRC)
what is required to be considered CRC
at least 90% of adults can open
at least 85% of children UNDER 5 cannot open
at least 80% of children UNDNER 5 cannot open within 5 minutes after an adult showing them
what drugs require CRC - only required for OUTPATIENT
PO legend drugs
Rx to OTC drugs
PO OTC drugs
sample packages for medications that require special packaging
what drugs do NOT need special packaging - generally & 19 specific drugs
drugs not for PO administration (including topical application to teeth or inhalation)
1 - SL nitroglycerin
2 - SL isosorbide dinitrate <10mg
3 - erythromycin ethylsuccinate oral suspension <8g
4 - erythromycin ethylsuccinate tablets <16g
5 - anhydrous cholestyramine packets
6 - potassium supplements <50 mEq
7 - sodium fluoride liquid and tablets <264mg
8 - betamethasone tablets <12.6mg
9 - mebendazole tablet <600mg
10 - methylprednisolone tablet <84mg
11 - colestipol powder <5g
12 - pancrelipase tablet, capsule, powder
13 - ORAL contraceptives
14 - prednisone tablets <105mg
15 - conjugated estrogen tablets <32mg
16 - norethindrone tablets <50mg
17 - medroxyprogesterone tablets
18 - sacrosidase (sucrase) in glycerol and water
19 - hormone replacement therapy
when can special packaging NOT be used if required
patient makes blanket waiver
prescriber provides waiver each rx basis
which drugs require PPI and who gets them - each new rx and refill
INPATIENT AND OUTPATIENT
estrogen and PO contraceptives
which drugs require MedGuides and who gets them - each new rx and refill
OUTPATIENT
NSAIDs, amphetamines, PPIs, mood stabilizers, opioids
what is the Prescription Drug Marketing Act of 1987
to protect public health against drug diversion
prohibits drug reimportation and bans sale or trade of drugs and samples
when can a drug be reimported into the US
reimported by the manufacturer
emergency use after FDA review
how can drug samples be given
prescribers asks in writing to the manufacturer
hospital/clinic pharmacies can have samples for providers after the provider requests
NOT OTC
PDMA recordkeeping and violations
records must be kept for 3 years
whistleblowers can get 1/2 criminal fine in rewards
what is the federal anti-tampering act
for OTC
MUST have one or more barriers to entry
what are the 5 crimes to the federal anti-tampering act
tampering or attempting to tamper
tainting
communicating false information that a product is tainted
threatening to tamper
conspiring to tamper
what is the DSHEA
manufacturers can make claims relating to supplement’s effect on structure or function in the body if:
- related to nutrient deficiency
- describes the role of a nutrient
- characterizes mechanism
- describes general well-being
what are the requirements for the manufacturer to market a supplement under DSHEA
“this has not been evaluated by the FDA”
notify FDA within 30 days of first marketing product
is it mandatory for all drugs to use the new pregnancy categories
NO - drugs before June 2001 can choose which one follow. after 2001 is required in the new form
what happens during an FDA inspection
for anyone that manufactures, compounds
request entry with NOI (form 482) and credentials
CAN refuse
what happens during a DEA inspection
for controls
provide NOI (form 82)
if refused - will get AIW or search warrant
what happens during BOP inspection
inspect without warrant and CANNOT refuse
what are the ratings for generic substitutions
AA - can substitute
BX - not sufficient data CANNOT substitute
AN - bioequivalent solutions and powders for aerosolization
A can substitute
B cannot substitute
INDA process
submit for each clinical trial phase - can start 30 days after submission unless denied
MUST submit annual reports to FDA
what are the different phases in human trials
phase I - <100 patients without disease
phase II - <1000 patients with disease
phase III - 1000s of patients
NDA process
send INDA information and FDA has 180 days to respond
ANDA process
to show the drug is bioequivalent (generic drugs)
what are the four types of REMS
MedGuide
communication plans
ETASU (iPLEDGE)
implementation system - review ETASU
what is excluded from cGMP
compounded drugs
pharmacies
what is the max quantity of isotretinoin prescribed for patients
7 days for people that can get pregnant
30 days for people that can’t get pregnant
NO REFILLS
