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What law required drugs to be proven safe before being marketed? - 🧠
ANSWER ✔✔Food Drug and Cosmetic Act
-Must prove safe before use
-Accurate labeling
-Gave FDA more power to inspect and seize unsafe products
,-Court enforced legal action
What law strengthened drug efficacy and safety? - 🧠 ANSWER
✔✔Kefauver-Harris Amendment
(in response to thalidomide disaster)
-Informed consent for clinical trials
-FDA drug ads
-ADR reporting
What was the first major law to tackle unsanitary practices and
mislabeling? - 🧠 ANSWER ✔✔Pure Food and Drug Act (Wiley Act)
-Prohibits adulterated and misbranded goods
-Impose proper labeling
What law prevents drug diversion (resale, counterfeits) and protects the
drug supply chain? - 🧠 ANSWER ✔✔Prescription Drug Marketing Act
(PDMA)
-Cannot sell drug samples
-Wholesalers must be licensed
-Restricted resale of drugs by hospitals
,What law helped split medications into RX vs OTC? - 🧠 ANSWER
✔✔Durham-Humphrey Amendment
-Categorized meds by RX vs OTC
-"Caution: federal law prohibits disp without RX"
-Allows verbal RXs
Class I Recall - 🧠 ANSWER ✔✔Serious ADRs/Death
Class II Recall - 🧠 ANSWER ✔✔Temporary/reversible ADRs
Class III Recall - 🧠 ANSWER ✔✔Not likely to cause any serious adverse
effects and does not go to the customer level
What agency is responsible for the federal Controlled Substances Act? - 🧠
ANSWER ✔✔Drug Enforcement Administration (DEA)
What is the Purple Book used for? - 🧠 ANSWER ✔✔Biologics/Biosimilar
equivalency
What is the Green Book used for? - 🧠 ANSWER ✔✔Animal Drugs
What is the orange book used for? - 🧠 ANSWER ✔✔Therapeutic and
bioequivalence of oral drugs
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, What is the red book used for? - 🧠 ANSWER ✔✔Drug pricing
What is required on the manufacturer's drug container label for an oral drug
product? - 🧠 ANSWER ✔✔Manufacturer name
Expiration Date
Name of drug
Net quantity packaged
What is the minimum age for someone to purchase a CS without a
prescription that contains opium? - 🧠 ANSWER ✔✔18 years old
How much can someone purchase of opium without an RX? - 🧠 ANSWER
✔✔NMT 8 oz or 48 doses
How much of a CS can someone purchase without an RX? - 🧠 ANSWER
✔✔NMT 4 oz or 24 doses
How often can someone purchase a CS without a prescription - 🧠
ANSWER ✔✔NMT every 48 hours
Which DEA form is used to report stolen CS? - 🧠 ANSWER ✔✔DEA Form
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