EXCPT EXAM
Pure Food and Drug Act (1906)
Prohibits interstate commerce of misbranded and adulterated drugs and
foods.
Misbranded
a drug product is misbranded if its labeling is inaccurate, incomplete, or
misleading
Adulterated
a drug product that fails to meet quality, strength, or purity standards
Federal Food, Drug, and Cosmetic Act of 1938
Requires drug manufacturers to provide the FDA with evidence of safety by
submitting a New Drug Application before marketing them.
This act essentially created the FDA and started a new system of drug
regulation.
If the FDA does not take any action within 60 days, the drug is automatically
approved. (Note: the Kefauver-Harris Amendment of 1962 invalidated this
aspect of the Act.)
Durham-Humphrey Amendment of 1951
defines two categories for drug products: legend drugs (prescription-only) and
OTC medication
Kefauver-Harris Amendment of 1962
requires drug manufacturers to scientifically prove a medication is not only
save but effective
Controlled substances act (CSA) (1970)
,federal drug policy that regulates the manufacture, importation, possession,
use and distribution of controlled substances
controlled substances have 5 schedules
I , II, III, IV, V
drugs are places in their prespectivee schedules based on
medical use and potential for abuse or dependence
legend drugs
only dispensed with a proper prescription
Schedule I drugs
Have high potential for abuse with no accepted medical use
Schedule II drugs
- Drugs have high potential for abuse
- Drugs have currently accepted medical uses
Schedule II drugs examples
Most ADHD medications (Adderall, Ritalin, methamphetamines)
oxycodone, codeine, morphine, methylphenidate
Schedule III Substances
moderate to low potential for physical dependence but potential for
psychological dependence
Schedule IV Controlled Substances (anxiety, sleep)
lower potential for abuse but can still lead to addiction.
EX) benzo's, carisoprodol, tramadol, and zolpidem
, Schedule V
Lowest potential for abuse
cough, nerve pain
Non-controlled prescription drugs
expire one year after date written
C-II
no refills, new prescription needed for each fill
C-III - IV drugs
5 refills or refills for up to six months from date issuance- whichever comes
first
C-II partial fill
remainder must be filled within 72 hours
C-II cannot be transferred
True
C-III-V transferred
one time between two pharmacies
Drugs need to be stored at room temp of
20 to 25 C
68 to 77 F
Macrolide allergy cannot take
Azithromycin
Medication for cough
Pure Food and Drug Act (1906)
Prohibits interstate commerce of misbranded and adulterated drugs and
foods.
Misbranded
a drug product is misbranded if its labeling is inaccurate, incomplete, or
misleading
Adulterated
a drug product that fails to meet quality, strength, or purity standards
Federal Food, Drug, and Cosmetic Act of 1938
Requires drug manufacturers to provide the FDA with evidence of safety by
submitting a New Drug Application before marketing them.
This act essentially created the FDA and started a new system of drug
regulation.
If the FDA does not take any action within 60 days, the drug is automatically
approved. (Note: the Kefauver-Harris Amendment of 1962 invalidated this
aspect of the Act.)
Durham-Humphrey Amendment of 1951
defines two categories for drug products: legend drugs (prescription-only) and
OTC medication
Kefauver-Harris Amendment of 1962
requires drug manufacturers to scientifically prove a medication is not only
save but effective
Controlled substances act (CSA) (1970)
,federal drug policy that regulates the manufacture, importation, possession,
use and distribution of controlled substances
controlled substances have 5 schedules
I , II, III, IV, V
drugs are places in their prespectivee schedules based on
medical use and potential for abuse or dependence
legend drugs
only dispensed with a proper prescription
Schedule I drugs
Have high potential for abuse with no accepted medical use
Schedule II drugs
- Drugs have high potential for abuse
- Drugs have currently accepted medical uses
Schedule II drugs examples
Most ADHD medications (Adderall, Ritalin, methamphetamines)
oxycodone, codeine, morphine, methylphenidate
Schedule III Substances
moderate to low potential for physical dependence but potential for
psychological dependence
Schedule IV Controlled Substances (anxiety, sleep)
lower potential for abuse but can still lead to addiction.
EX) benzo's, carisoprodol, tramadol, and zolpidem
, Schedule V
Lowest potential for abuse
cough, nerve pain
Non-controlled prescription drugs
expire one year after date written
C-II
no refills, new prescription needed for each fill
C-III - IV drugs
5 refills or refills for up to six months from date issuance- whichever comes
first
C-II partial fill
remainder must be filled within 72 hours
C-II cannot be transferred
True
C-III-V transferred
one time between two pharmacies
Drugs need to be stored at room temp of
20 to 25 C
68 to 77 F
Macrolide allergy cannot take
Azithromycin
Medication for cough
