PTCE Exam Q&A
Pure Food and Drug Act - =Prevents the manufacturing, sale/transportation of misbranded or
adulturated drugs, poisoned or contaminated drugs
Adultered drugs - =Any drug that is not pure
misbranded drug - =Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) - =drugs must comply with standards of safety
and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and
cosmetics
FDA (Food and Drug Administration) - =a division of USDHHS responsible for regulating food
and drug products sold to the public. Handles drug approvals, sold, and recalls of drugs
3 types of Drug Recalls - =1. Most severe: permanent health hazard or death
2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from drugs
MedWatch Program - =Reports to FDA side effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System - =Database that contains information on
adverse event and medication error reports submitted to the FDA; designed to support the FDA's
post-marketing safety surveillance program.
VAERS (Vaccine Adverse Event Reporting System) - =keeps track of all adverse effects
associated with vaccines
IND (Investigational New Drug) - =A drug not yet approved for marketing by the FDA but
available for use in experiments to determine its safety and efficacy.
,FDA drug approval process - =1. Hypothesis: comes up with the drug and reports findings
(dosage, research and findings) to FDA
2. Pre-phase: consists of animal testing then human testing to small population (reports correct
dosing and side effects)
3. Large Human Trial: tests on wider population with longer procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent
tall man lettering - =medication names that have mixed case lettering in the description name,
which helps reduce errors between medication names that either look or sound alike
FAERS and VAERS - =Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 - =• Created a distinction between "OTC" and "Legend
Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
Kefauver-Harris Amendment of 1962 - =• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs
before approval .
• Required drug advertising to be more closely regulated and disclose accurate information about
side effects
Harrison Narcotic Act - =a 1914 congressional act that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 - =established schedules of
controlled substances and moved enforcement to the Justice Department (C-1 to C-5)
, Established the DEA
DEA - =Enforces the controlled substance act under the DOJ. Makes sure all controlled
substances are manufactured, distributed, and stored properly.
Control 1 (C-1) drugs - =High abuse. Considered not medical use or street drugs. (Marijuana,
ecstasy, heroin, LSD)
Control 2 (C-II) drugs - =Consists of narcotics, pain killers, ADHD drugs. Highly addicting
(Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs - =Mild pain killers, anabolic steroids and caffeine pills, can be
moderately abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)
Control 4 (C-IV) drugs - =Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite
suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax, Carisoprodol/soma,
clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)
Control 5 (C-V) Drugs - =Low Codeine amounts in cough suppressants. Considered the least
abusive (phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory - =exact count for schedule II and an estimated count for III-V drugs must be
performed every 2 years
C-II Supply - =Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? - =Yes, and there are exceptions: for patients in
community care or in long term IV care
Expiration date for C-II? - =No expiration date but just be filled in 1 month or in a 10 day period
Pure Food and Drug Act - =Prevents the manufacturing, sale/transportation of misbranded or
adulturated drugs, poisoned or contaminated drugs
Adultered drugs - =Any drug that is not pure
misbranded drug - =Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) - =drugs must comply with standards of safety
and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and
cosmetics
FDA (Food and Drug Administration) - =a division of USDHHS responsible for regulating food
and drug products sold to the public. Handles drug approvals, sold, and recalls of drugs
3 types of Drug Recalls - =1. Most severe: permanent health hazard or death
2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from drugs
MedWatch Program - =Reports to FDA side effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System - =Database that contains information on
adverse event and medication error reports submitted to the FDA; designed to support the FDA's
post-marketing safety surveillance program.
VAERS (Vaccine Adverse Event Reporting System) - =keeps track of all adverse effects
associated with vaccines
IND (Investigational New Drug) - =A drug not yet approved for marketing by the FDA but
available for use in experiments to determine its safety and efficacy.
,FDA drug approval process - =1. Hypothesis: comes up with the drug and reports findings
(dosage, research and findings) to FDA
2. Pre-phase: consists of animal testing then human testing to small population (reports correct
dosing and side effects)
3. Large Human Trial: tests on wider population with longer procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent
tall man lettering - =medication names that have mixed case lettering in the description name,
which helps reduce errors between medication names that either look or sound alike
FAERS and VAERS - =Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 - =• Created a distinction between "OTC" and "Legend
Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
Kefauver-Harris Amendment of 1962 - =• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs
before approval .
• Required drug advertising to be more closely regulated and disclose accurate information about
side effects
Harrison Narcotic Act - =a 1914 congressional act that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 - =established schedules of
controlled substances and moved enforcement to the Justice Department (C-1 to C-5)
, Established the DEA
DEA - =Enforces the controlled substance act under the DOJ. Makes sure all controlled
substances are manufactured, distributed, and stored properly.
Control 1 (C-1) drugs - =High abuse. Considered not medical use or street drugs. (Marijuana,
ecstasy, heroin, LSD)
Control 2 (C-II) drugs - =Consists of narcotics, pain killers, ADHD drugs. Highly addicting
(Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs - =Mild pain killers, anabolic steroids and caffeine pills, can be
moderately abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)
Control 4 (C-IV) drugs - =Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite
suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax, Carisoprodol/soma,
clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)
Control 5 (C-V) Drugs - =Low Codeine amounts in cough suppressants. Considered the least
abusive (phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory - =exact count for schedule II and an estimated count for III-V drugs must be
performed every 2 years
C-II Supply - =Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? - =Yes, and there are exceptions: for patients in
community care or in long term IV care
Expiration date for C-II? - =No expiration date but just be filled in 1 month or in a 10 day period
