Federal Law Overview Flashcards
US Pharmacopeia (USP) founded
1820
creation of USP lead to
a system of quality control and a national formulary & standards; 11 members attended
first USP revision
1830; 7 members
USP revisions continue at what interval?
10 year
1848
drug import act- federal legislation recognizes the USP as an official compendium
1850
COPs invited to participate in USP revisions
State boards of pharmacy forms; USP becomes a state board requirment
1800-1890s
act passed following concern over unsanitary practices in food & drug industries
federal food & drug act of 1906
federal food & drug act of 1906 era was concerned with:
purity
1906 act was considered inadequate bc:
- false statements made about a drug by a manufacturer were help by the courts not to be misbranding
- did not extend to cosmetics
did not grant authority to ban unsafe drugs - labels were not required to identify contents
the first attempts to control a specific drug class (narcotics)
international opium convention of 1912 & Harrison narcotic act of 1914
what made the import & export of narcotics a government supervised activity?
the second opium conference of 1925
created the FDA as we know it today
food, drug & cosmetic act of 1938
the food, drug & cosmetics act assures that food & cosmetics are
safe, effective & properly labeled
Durham-Humphrey Amendment of 1951
amendment to the FDCA; created policy regarding OTC & Rx status, how RX were to be dispensed, oral & written RX, refills, & dispensing directly by a practitioner
created legend (Rx) drugs
Durham-Humphrey amendment of 1951
kefauver-harris amendments of 1962
Thalidomide disaster of 1962; drug efficacy amendmentsl proof of effectiveness, proof of safety, goof manufacturing practices, drug advertising, investigational drug procedures
drug abuse control amendments of 1965
precursor to controlled substances act of 1970; controlled use of depressants, stimulants & hallucinogens (nothing really came from it)
comprehensive drug abuse prevention & control act of 1970
consolidated enforcement agencies-> DEA 1973
medical device amendment of 1976
broadens the FDA authority by requiring safety & effectiveness of life-sustaining & life-supporting devices (pre-market approval)
orphan drug act of 1983
facilitate commercialization of drugs for rare diseases
rare disease
one that affects 200,000 in US & for which there is no reasonable expectation of recovering the developments cost of the drug
Prescription Drug Marketing act of 1987
bans sale, trade or purchase of samples, mandates storage, handling & record-keeping requirements of drugs; establishes criminal & civil penalties for violations of the act
prohibits resale of RX meds purchased by hospitals
safe medical devices act of 1990
granted FDA broader authority- recall a device that would cause serious health consequences of death; user is required to report adverse events to FDA in 10 days
dietary supplement health & education act of 1994
dietary supplements defines as a special class of food
food & drug modernization act of 1997 (FDAMA)
RX only wording; pediatric studies of drugs, pharmacy compounding, PET compounding, expediting study & approval of fast track drugs; info program on clinical trials for serious of life-threatening diasease
OTC labeling requirement 1999
requires new, easy to read, standardized OTC drug info
food & drug administration amendments act (FDAAA) of 2007
expand FDA authority to ensure it can conduct complex & comprehensive reviews of new drugs & devices; encourage research & development for peds treatment; (PDUFA, MDUFMA, BPCA, PREA). trace & track technologies
poison prevention packaging act of 1970 (PPPA)
prevent accidental poisoning of young children
responsible for implementation of PPPA
US consumer product safety commission (CPSC)
non-compliant means
doesn’t have child safety cap
may be non-compliant if:
- manufacturer also supplies substance in packages which no comply
- the packages have labeling stating “for households without young children”
omnibus budget reconciliation act of 1990 (OBRA)
establishment of a drug review program by states- standards for counseling for medicaid pts; DUR, maintain pt records, review boards for medicaid
anabolic steroids control act 1990
required drugs related to testosterone that promotes muscle growth be schedule III
Health insurance portability & accountability act (HIPAA)1996
aka kennedy-kassenbaum act; privacy, security, transaction ad code sets & identifier rules
unique identifier rules
establish uniform #s for patients, providers, health plans & employers
transaction & code sets rules
standard format used to communicate using a standardized coding system
security standards
safeguards in place concerning storage, maintenance, transmission & access to PHI
Privacy standards
limit use & release of PHI
federal food, drug & cosmetic act (FDCA) is designed to
protect public health
FDCA requirements
F&C be safe & properly labeled, medical devices be safe & effective, comply with CGMP, FDA enforces it, OTC be labeled & safe, seizure of misbranding & adulterated drugs, FDA can perform limited inspections of pharmacies, broad over other stuff
misbranding
dispensing of a drug for distribution in violation of labeling requirements
adultered
drugs containing filthy, putrid & decomposed substances & drugs packed & held under unsanitary conditions
types of drugs covered under the FDCA
legend/RX drugs, OTC, controlled substances, third class of drugs
third class of drugs
prescriptive authority for pharmacists
pharmacists who engage in manufacturing must
register with the FDA & file a list of drugs manufactured every 6 months
most common example of misbrandingis when
a pharmacist refills an RX w/out authorization from the prescrier
recall classifications class I
for products that will cause serious FATAL consequences
recall classifications class II
for drugs or devices that may cause serious but REVERSIBLE effects
recall classifications class III
for products that are not likely to cause adverse health effects
3 basic forms of regulatory action FDA can impose
- injunction or restraining order from a court- civil procedure
- seizure or embargo- civil procedure
- regulatory letter- administrative action by FDA
Who orders a drug recall?
manufacturer or distributor
FDA CANNOT do it!
patient package insert (PPI) required to be dispensed with
isoproterenol, oral contraceptives, oral postcoital contraceptives, injectible contraceptives, estrogens, progestagional drug products
record keepeing (FDCA)
must keep record when drugs arrive at pharmacy, sit in pharmacy & leave pharmacy
new drug if:
new chemical, new dosage form, new medical claim, new dosage level, new/novel packaging material
phase I of new drug
looking for safety, some early ideas on route of administration
phase II of new drug
30-50 pts; have the disease you are trying to treat
phase III of new drug
huge, multi-site, data collection process; usually blinded; safety & efficacy for intended use studied
phase IV pf new drug
drug has hit the market- post market studies
National Drug Code (NDC) is requested
but not required in and on all drug labeling
how many digits(characters) are in an NDC?
10
labeler code of NDC
first 5 numbers- unique for the company that makes it
drug product code 0f NDC
middle numbers- unique for drug & strength
package of NDC
3rd section- package size
label
upon the immediate container
labeling
all labels & other material that accompanies drug
RX label must hav
name & address of dispenser(pharmacy), serial number of RX, date, Dr name, pt name, direction, precautions
not required by federal law; left to discretion of states
pt address, pharmacist initials, pharmacy #, drugs name, strength & lot #, BUD, manufacturer/distributor
prescription drug exemption
legend drugs in bulk containers not intended for pt use, manufacturer is exempt from some labeling
LABEL on manufacturer container of RX-only drug must contain:
name, quantity of each active ingredient, declaration of new quantity, statement of usual dosage, RX only. route if not oral, habit-forming, lot #, exp date
LABELING on manufacturer container of RX-only drug must contain:
description (names), pharmacology, indications & usage, CIs, warnings, precautions, adverse rxns, drug abuse/dependence, overdose, dosage, how supplied, date of most recent revision of labeling
unit dose labeling- on actual container
name & quantity of active ingredient per dosage unit, exp date, lot #, name & place of business `of manufacturer, pack or distributor, any statement required by compendia
drugs facts pamphlet
drug facts- title active ingredients- inc. amount purpose use warning directions other info inactive ingredients ?- phone #
pharmaceutical alternative
drug products that contain same therapeutic moiety but may contain different salts, esters, complexes, dosage forms, strengths
orange book
“A” rated products
bioequivalent & therapeutically equivalent - can substitute
orange book
“B” rated products
found not to be bioequivalent
orange book
“AB” rated products
actual or potential bioequivalence problems- acceptable if resolved in vivo/invitro- meets “necessary BE requirements”
orange book
AA
products not present bioequivalence problems in conventioal dosage forms
orange book
AN
solutions & powders for aerosolization
orange book
AO
injectable products with oil solvents
orange book
AP
injectable solutions
orange book
AT
topical products
prego category A
studies failed to show risk to fetus
prego category B
animal studies failed to show risk, no human studies
prego category C
animal studies show adverse effects on fetus- potential benefits may out way risk, no human studies
prego category D
positive human fetal risk-potential benefits may out way risks
prego category X
studies in animals & humans show fetal abnormalities- risks clearly out way benefits
what prompted the orphan drug act?
AIDS
drug price competition & patent term restoration act of 1984
aka Waxman-hatch act.
ANDA, patent extension, decreased time necessary to approve generic drugs
file IND
after animal studies before human studies
