Florida MPJE Practice Concepts with Complete Solutions

If a drug is gross, filthy, putrid, or doesn't follow cGMP. What is it considered? Correct Answer Adulterated If a drug is improperly labeled, or created by a facility not FDA-registered, or was improperly advertised. What is it considered? Correct Answer Misbranded Adulterated and Misbranded. Which is considered "inside the bottle" which is considered "outside the bottle? Correct Answer Adulterated is inside. Misbranded is outside. Under the Durham-Humphry Labeling Amendment, OTC drugs must be labeled with adequate drug facts label. What needs to be on that part of the label? Correct Answer Pregnancy and breastfeeding warning. Ca, N, Mg, and K content. Contact information to report ADR How long is an IND application on hold by the FDA until a study can proceed? Correct Answer 30 days What organization governs advertising of drugs for RXs? What about OTCs? Correct Answer RX - FDA. OTC - Federal Trade Commission What drugs don't need to have child-resistant containers? Correct Answer PCNBEE "Penicillin Bee" - Provera, Prednisone, Anhydrous Cholestyramine, Isosorbide Dinitrate, SL nitroglycerin, Birth Controls, Erythromycin, Effervescent ASA or APAP Can a patient make a blanket request to have non-child resistant caps? Can a doctor? Correct Answer Yes. A doctor cannot though. Doctor has to request it on each specific script. Who can make a blanket request to have non-child resistant caps? Who cannot? Correct Answer Patient may. Pharmacist and Physician may not. What types of containers can not be re-used in filling prescriptions? Correct Answer Plastic. May re-use glass containers but must switch the cap. Lozenges, dermatologicals, dentifrice, and insulin all are exempt from a federal law. What is it? Correct Answer They do not need to have tamper-resistant features. Which drug approval application do generic drugs based on bio equivalence apply to? Correct Answer ANDA