FREE STANDARDIZED TESTS AND STUDY GAMES ABOUT

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FREE STANDARDIZED TESTS AND STUDY GAMES ABOUT

MPJE FEDERAL LAW

Actual Qs and Ans Expert-Verified Explanation

This Exam contains:

-Guarantee passing score -85 Questions and Answers -format set of multiple-choice -Expert-Verified Explanation

Question 1: Grandfathered Drugs

Answer:

Any drug marketed prior to 1938 that was exempt from the labeling and proof of safety standards of Food, Drug and Cosmetic Act (2ndary to diethylene glycol-antifreeze-in sulfanilamide elixirs Ex: Digoxin, Nitroglycerin, Levothyroxine, phenobarbital

Question 2: Red Book

Answer:

Lists all NDCs and equivalents

Question 3: Treatment INDs

Answer:

Treatment Investigational New Drugs. Allow admin of investigation new drug to patietns that have not been enrolled, but they must have an imminent lifethreatening stage of illness for wh/ no cure exists or present drugs suck. DRUG IN phase II OR III only

Question 4: Adulteration cont.

Answer:

-contains drug w/ strength, purity, or quality < official standards-container composed of deleterious substance that may leach into product-Contains any ingredient as sub for active ingredient

Question 5: Manufacturer label ingredients

Answer:

Alphabetical. Separate active ingredients. Exception to labeling are flavors and fragrances which can just be listed by a generic name like Red Dye.Inert gases may not be listed either at times

Question 6: DEA Form 222

Answer:

Required for each sale or transfer of a schedule I or II controlled substanceMay be obtained only by persons registered to handle controlled substances AND to EXPORT them Question 7: Drug Price Competition and Patent-Term Restoration ActAKAWaxman Hatch Amendment

Answer:

Congress streamilined drug approval process for generics & provided innovation drug manufacturers w/ incentives to develop new drug products -->Pioneer drug firm has +5 yrs of exclusivity to market after drug is approved

Question 8: ANDA

Answer:

Abbreviated New Drug Application. Require less data. Require proof that pharmacokinetics, bioavailability & clinical activity are similar to innovator's product.

Question 9: PF

Answer:

Pharmacopoeia Forum Bimonthly publication of proposed changes to USP/NF

Question 10: Prescription Drug Marketing Act of 1987

Answer:

Rx wholesalers must be licensed by respective states Banned reimportation of Rxs made in US Banned sale,trade,purchase of Rx samples Specified storage,handling,recordkeeping for samplesProhibited resale of Rx drugs purchased by hospitals/HCfacilities

Question 11: Dingle Bill AKA Drug Marketing Act of 1987

Answer:

-Requires proper storage of drugs and maintenance of appropriate distribution records-Prohibits shipping b/t states w/o being registered in state from wh/they are being shipped-Prohibits re-importation to US except by the manufacturer

Question 12: Dingle Bill AKA Drug Marketing Act of 1987 cont.

Answer:

-permits pharmacies in healthcare facilities to receive Rx drug samples only if licensed Rxer has requested them and records maintained of their dispostion. They must be stored separately from normal drug stock

Question 13: Type 6 new drug FDA chemical class

Answer:

New therapeutic indication for a drug

Question 14: Dingle Bill AKA Drug Marketing Act of 1987 cont.

Answer:

-allows practitioners licensed to Rx to receive samples provided that a WRITTEN REQUEST is made with name, address, medical specialty, signature, name of drug, quantity, manufacturer and date of request. Manufacturers must have receipt Xs 3 yrs

Question 15: Misbranded in terms of pharmacies

Answer:

Pharmacy dispenses Rxonly drug without Rx

Question 16: Type N

Answer:

Nonprescription

Question 17: !!Ipecac Syrup Special Label Warning Requirements!!

Answer:

"Warning:Keep out of reach of children.Do not use in unconscious persons or for poisoning w/ corrosives (lye, strong acids) petroleum distillates such as kerosene, gasoline, cleaning fluids or strychnine"Dose=15mL if >1 y/oSOLD ONLY IN 30mL packages!

Question 18: Dingle Bill AKA Drug Marketing Act of 1987 cont.

Answer:

-Prohibits drug products from being resold by hospitals or other healthcare facilities if they were purchased at special prices-sales reps responsible for inventory of samples/must take inventory/yr Question 19: FDA Modernization Act of 1997(Part 3 (could not fit it all on two))

Answer:

Encouraged peds studies of drugs by giving +6months of marketing exclusivity Question 20: FDA Modernization Act of 1997 (Part 2 (could not fit it all on one))

Answer:

No more "Warning-May be habit forming" requirement on label Manufacturers may publicly disseminate limited info about unapproved indications of drugs provided they issue a statement saying the indication is not approved/cleared by FDA

Question 21: Misbranded

Answer:

Refers to label. If label-is false or misleading-missing name or locations of manufacturer/packer/distributor-missing word, statement or other info required by law to be displayed in prominent readable manner Question 22: FD&C Yellow No 5 AKA tartrazine Special Label Warning Requirements

Answer:

Allergic reactions possible

Question 23: Adulteration

Answer:

Refers to composition-Contains any filthy, putrid, or decomposed substance-prepared, packaged, or held under unsanitary conditions (contaminiation risk)-manufactured at < GMPs-contains unapproved color additive

Question 24: Type S new drug FDA therapeutic class

Answer:

FDA classification of new drugs. Similar to other drugs on market. S=Standard.