Federal MPJE

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 statements in a drug advertisement could be considered _____. - misbranding

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) May dispense partial fill C2 for LTCF patients for up to 60 days Partial Filling for C3-5 No dispensing beyond 6 months Where and how long inventory records must be maintained 2 years a...

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) May dispense partial fill C2 for LTCF patients for up to 60 days Partial Filling for C3-5 No dispensing beyond 6 months Where and how long inventory records must be maintained 2 years a...

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". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Kefauver-Harris Amendment of 1962 1...

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". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Kefauver-Harris Amendment of 1962 1...