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Hatch-Waxman Act of 1984 - {✔✔ANSWER✔✔}-promoted the
manufacturing of generic drugs and new medications
Antibiotics - {✔✔ANSWER✔✔}-Drugs that block the growth and
reproduction of bacteria
Common side effects: diarrhea and yeast infections
Food, Drug, and Cosmetic Act of 1938 - {✔✔ANSWER✔✔}-purity, strength,
and safety
,Pure Food and Drug Act of 1906 - {✔✔ANSWER✔✔}-forbade the
manufacture or transport or sale of mislabelled or adulterated food or drugs and
poisonous patent medicines.
Durham-Humphrey Amendment of 1951 - {✔✔ANSWER✔✔}-• Created a
distinction between "OTC" and "Legend Drugs".
Patient Package Insert (PPI) - {✔✔ANSWER✔✔}-Manufacturer's patient
product information included with the product package.
Beta-lactams - {✔✔ANSWER✔✔}-penicillins, cephalosporins, carbapenems
Penicillin - {✔✔ANSWER✔✔}-V: oral
G: IV
Amox: oral
Ampicillin: oral and injection
Augmentin - {✔✔ANSWER✔✔}-amoxicillin/clavulanate
Cephalosporins - {✔✔ANSWER✔✔}-inhibit cell wall synthesis
Keflex - {✔✔ANSWER✔✔}-antibiotic
cephalexin
Ceftin - {✔✔ANSWER✔✔}-antibiotic
, cefuroxime
Omnicef - {✔✔ANSWER✔✔}-antibiotic
cefdinir
Carbapenems and monobactams - {✔✔ANSWER✔✔}-Drugs in these 2
classes are given only parenterally
Meropenem - {✔✔ANSWER✔✔}-Merrem (Carbapenem)
Etrapenem - {✔✔ANSWER✔✔}-Invanz
MedGuides - {✔✔ANSWER✔✔}-FDA-approved documents created to
educate patients about how to minimize harm from potentially dangerous drugs
Class I recall - {✔✔ANSWER✔✔}-Serious adverse effects on health or death
Class II recall - {✔✔ANSWER✔✔}-temporary or reversible adverse effects
Class III recall - {✔✔ANSWER✔✔}-Unlikely to cause adverse health
consequences
Market Withdrawal - {✔✔ANSWER✔✔}-permanent removal from the
market, drug is harmful of unapproved