Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statemen...
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Arizona state board of pharmacy consists of what type of members? Six pharmacists (at least one hospital pharmacist and retail pharmacist) One pharmacy tech Two public members Qualifications to be on Arizona State Board of pharmacy for pharmacists Licensed pharmacist for 10 yrs Pharmacists/res...
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Add to cartArizona state board of pharmacy consists of what type of members? Six pharmacists (at least one hospital pharmacist and retail pharmacist) One pharmacy tech Two public members Qualifications to be on Arizona State Board of pharmacy for pharmacists Licensed pharmacist for 10 yrs Pharmacists/res...
What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs/Prescription". • Au...
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Add to cartWhat did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs/Prescription". • Au...
Codeine Limitation for Schedule III Not more than 18 mg/mL Not more than 90 mg per dosage unit Codeine Limitation for Schedule V Not more than 2 mg/mL and must have additional non- narcotic API Emergency C2 prescription hard copy must be delivered in 72 hours (7 days for federal, PA more strict...
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Add to cartCodeine Limitation for Schedule III Not more than 18 mg/mL Not more than 90 mg per dosage unit Codeine Limitation for Schedule V Not more than 2 mg/mL and must have additional non- narcotic API Emergency C2 prescription hard copy must be delivered in 72 hours (7 days for federal, PA more strict...
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