PTCE Exam
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1. Pure Food and Drug Act: Prevents the manufacturing, sale/transportation of misbranded or adulturated
drugs, poisoned or contaminated drugs
2. Adultered drugs: Any drug that is not pure
3. misbranded drug: Not labeled correctly
4. 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
5. 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
6. 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
7. MedWatch Program: Reports to FDA side effects or adverse effects of any drugs
8. (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.
9. VAERS (Vaccine Adverse Event Reporting System): keeps track of all adverse effects associ-
ated with vaccines
10. 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.
11. 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
12. 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
13. FAERS and VAERS: Reports to the CDC (centers of disease control) as well
14. 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:
, PTCE Exam
Study online at https://quizlet.com/_hu5oe4
"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.
15. 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
16. Harrison Narcotic Act: a 1914 congressional act that criminalized the sale and use of narcotics
17. 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
18. DEA: Enforces the controlled substance act under the DOJ. Makes sure all controlled substances are manufac-
tured, distributed, and stored properly.
19. Control 1 (C-1) drugs: High abuse. Considered not medical use or street drugs. (Marijuana, ecstasy,
heroin, LSD)
20. Control 2 (C-II) drugs: Consists of narcotics, pain killers, ADHD drugs. Highly addicting (Percocet, Endocet,
Norco, Fentanyl, Morphine)
21. 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)
22. 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/Ati-
van, temazepam/restoril)
23. Control 5 (C-V) Drugs: Low Codeine amounts in cough suppressants. Considered the least abusive
(phenergan w/Codeine, guaifenesin w/codeine)
24. Biennial Inventory: exact count for schedule II and an estimated count for III-V drugs must be performed
every 2 years
25. C-II Supply: Only for 30 days. No partial filling or given for 90 day supply
26. 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
27. Expiration date for C-II?: No expiration date but just be filled in 1 month or in a 10 day period
28. Can doctor make a phone prescription for C-II?: Only for extreme emergencies. A hard copy
must be sent to the pharmacy in 7 days or pharmacy can report the doctor to DEA
Study online at https://quizlet.com/_hu5oe4
1. Pure Food and Drug Act: Prevents the manufacturing, sale/transportation of misbranded or adulturated
drugs, poisoned or contaminated drugs
2. Adultered drugs: Any drug that is not pure
3. misbranded drug: Not labeled correctly
4. 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
5. 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
6. 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
7. MedWatch Program: Reports to FDA side effects or adverse effects of any drugs
8. (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.
9. VAERS (Vaccine Adverse Event Reporting System): keeps track of all adverse effects associ-
ated with vaccines
10. 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.
11. 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
12. 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
13. FAERS and VAERS: Reports to the CDC (centers of disease control) as well
14. 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:
, PTCE Exam
Study online at https://quizlet.com/_hu5oe4
"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.
15. 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
16. Harrison Narcotic Act: a 1914 congressional act that criminalized the sale and use of narcotics
17. 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
18. DEA: Enforces the controlled substance act under the DOJ. Makes sure all controlled substances are manufac-
tured, distributed, and stored properly.
19. Control 1 (C-1) drugs: High abuse. Considered not medical use or street drugs. (Marijuana, ecstasy,
heroin, LSD)
20. Control 2 (C-II) drugs: Consists of narcotics, pain killers, ADHD drugs. Highly addicting (Percocet, Endocet,
Norco, Fentanyl, Morphine)
21. 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)
22. 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/Ati-
van, temazepam/restoril)
23. Control 5 (C-V) Drugs: Low Codeine amounts in cough suppressants. Considered the least abusive
(phenergan w/Codeine, guaifenesin w/codeine)
24. Biennial Inventory: exact count for schedule II and an estimated count for III-V drugs must be performed
every 2 years
25. C-II Supply: Only for 30 days. No partial filling or given for 90 day supply
26. 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
27. Expiration date for C-II?: No expiration date but just be filled in 1 month or in a 10 day period
28. Can doctor make a phone prescription for C-II?: Only for extreme emergencies. A hard copy
must be sent to the pharmacy in 7 days or pharmacy can report the doctor to DEA
