Practice Quiz #1 - Sections A-G

Which of the following is the first application form submitted to FDA before drug can be administered to humans? IND NDA ANDA SNDA

IND

Which of the following study phases initially evaluates PK profile (ADME)? Phase 1 Phase 2 Phase 3 Phase 4

Phase 1

Which of the following study phases involves large numbers of human subjects with a disease prior to the NDA? Phase 1 Phase 2 Phase 3 Phase 4

Phase 3

Which of the USP/NF chapters are federally enforceable by individual states? A. Chapters <1-999> b. Chapters <1000 and up>

A

Which of the following are exempt from the PPPA? A. Birth control pills B. Sublingual nitroglycerin C. Isosorbide dintrate 5mg oral tablets D. KCl 50 mEq tablets individually wrapped

A,B

Which of the following best describes the legislation that bans the sale of drug samples? A. The Dingle Bill B. The Prescription Drug Marketing Act of 1987 C. Kefauver Harris Amendment of 1962 D. The Drug Price Competition and Patent-Term Restoration Act E. The Waxman Hatch Act

A,B

The RLD for a drug is: A. The reference listed drug B. Usually the innovator drug C. Usually the generic drug D. The drug that should not be used E. A grandfathered drug F. The drug to which generic drugs are compared

A,B,F

One diltiazem long acting product (Drug 1) has been compared to another long acting diltiazem product (Drug 2) (same strength and dosage form). In which scenario are you permitted to generically substitute one for the other? A. TE code is A for both B. TE code is B for drug 2 C. TE code for both is AB D. TE code for both products is AB1 E. TE code for Drug 1 is AB1 and Drug 2 is AB2

A,C,D

Which of the following statements is true? A. Med guides are required for ibuprofen and sertraline Side effect statements are required for patients in a hospital B. PPI must be dispensed daily in a hospital setting as long as a patient is receiving an estrogen product C.Side effect notification requirement is satisfied if a med guide is dispensed D. Side effect statements must provide the FDA 800- telephone number E. Patients must be counseled on medications even if they refuse

A,C,D

Which of the following statements is true? A. PPIs must be given to patients for statins, estrogen and progesterone-containing products and isotretinoin B. Medications guides must be given to patients in inpatient and outpatient settings C. PPIs and med guides must be written in language that a layperson can understand D. PPIs must be given to by physicians who dispense and pharmacists who dispense

A,C,D

In which of the following situations is a pharmacist not allowed to compound? A. if there is not an established relationship between prescriber patient and pharmacist B. If there is a drug shortage C. In anticipation of a valid prescription order for a specific patient by a specific physician D. If there is an FDA approved product commercially available from the manufacturer that is available for purchase from a wholesaler. E. If the med is on the "Don Not Compound" list

A,D,E

Which of the following would a generic manufacturer need to complete prior to marketing of a generic drug when a brand name drug is close to losing its patent? IND NDA ANDA SNDA

ANDA

Which of the following best describes an SNDA? A. Generic manufacturer needs to complete prior to marketing of a generic drug when a brand name drug is close to losing its patent B. Brand manufacturer needs to complete prior to adding an indication for an existing prescription drug. C.. University needs to complete prior to studying a drug in human subjects D. Brand manufacturer needs to complete prior to marketing a drug that has completed Phase 3 studies.

B

Which of the following are required on a re-packaged unit dose label? A. Patient name B. Repackager name C. Manufacturer name D. Drug name, strength, and quantity if more than one E. Lot # assigned by repacker F. BUD assigned by repacker G. NDC number

B,C,D,E,F

Which of the following is required by federal law on a prescription label? A. Phone number of pharmacy (dispenser) B. Name of pharmacy (dispenser) C. Address of pharmacy (dispenser) D. Prescriber name E. Patient name F. Directions for use G. Drug name

B,C,D,E,F

Which of the following statements are true? A. Ipecac extract may be dispensed in 15 ml bottles B. Methyl salicylate requires a "must keep out of reach of children" warning and is considered dangerous if strength is greater than 5% C. Ipecac syrup must have a red boxed warning that it should not be used in patients with phenylketonuria D. Ipecac syrup, tartrazine, aspartame, sulfites, mineral oil and Oil of Wintergreen (if greater than 5%) all require special warning labels.

B,D

A BUD for water containing oral formulations should be: A. No later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient (API) or 6 months, whichever comes first. B. No later than 14 days when stored at controlled room temperatures. C. No later than 14 days when stored at controlled cold temperatures. D. No later than 30 days

C

Given the following NDC number 12345-0000-01, the four zeros would identify: A. The package size B. The manufacturer C. The identification of the exact drug

C

Section 503B of the FDCA addresses which of the two following groups? A. Pharmacists who compound in a normal retail setting B. pursuant to a prescription from an authorized prescriber C. Outsourcing facilities

C

Which of the following best describes the legislation that required ADR reporting? A. Pure Food and Drug Act of 1906 B. Food Drug and Cosmetic Act of 1938 C. Durham-Humphrey Amendment of 1951 D. Kefauver Harris Amendment of 1962 E. Orphan Drug Act of 1983 F. The Drug Price Competition and Patent-Term Restoration Act G. The Waxman Hatch Act

D

Which of the following best describes the legislation that required a drug to be safe and effective? A. Pure Food and Drug Act of 1906 B. Food Drug and Cosmetic Act of 1938 C. Durham-Humphrey Amendment of 1951 D. Kefauver Harris Amendment of 1962 E. Orphan Drug Act of 1983 F. The Drug Price Competition and Patent-Term Restoration Act G. The Waxman Hatch Act

D

Which of the following best describes the legislation that required consent from research subjects? A. Pure Food and Drug Act of 1906 B. Food Drug and Cosmetic Act of 1938 C. Durham-Humphrey Amendment of 1951 D. Kefauver Harris Amendment of 1962 E. Orphan Drug Act of 1983 F. The Drug Price Competition and Patent-Term Restoration Act G. The Waxman Hatch Act

D

Which of the following pregnancy categories indicate that a drug should be used only if benefits are acceptable despite the risk of taking the drug? A B C D X

D

The potency of a NTI drug: A. Is usually required by the FDA to be 100% of the labeled claim B. Is usually required by the FDA to be between 90-100% of the labeled claim C. Is usually required by the FDA to be 90-110% of the labeled claim D. Is usually required by the FDA to be 95-100% of the labeled claim E. Is usually required by the FDA to be 95-105% of the labeled claim F. Is sometimes defined by individual states

E,F

Which of the following best describes adulteration of a drug? A. The manufacturer cannot provide records of GMP B. The drug is expired C. The drug has been stored improperly D. The drug is a lower strength than what is represented on the label E. All of the above

E

Which of the following best describes the legislation that provided tax relief incentives for companies that develop drugs that are used to treat rare diseases? A. Pure Food and Drug Act of 1906 B. Food Drug and Cosmetic Act of 1938 C. Durham-Humphrey Amendment of 1951 D. Kefauver Harris Amendment of 1962 E. Orphan Drug Act of 1983 F. The Drug Price Competition and Patent-Term Restoration Act G. The Waxman Hatch Act

E

Which of the following best describes misbranding of a drug? A. Plasticizers found in nitroglycerin due to leaching from tubing B. Mold is found in a sterile vial C. The location of the manufacturer is not on the label D. The label is false or misleading E. All of the above F. The last two on the list.

F

True or False: The MedWatch Form 3500A is a mandatory form that must be completed by health care professionals or consumers when reporting adverse drug reactions for vaccinations.

FALSE

True or false: A label on a manufacturer's container requires the name and address of the pharmacy, the name of the drug, strength and quantity, and name of the physician, and the repackager.

FALSE

True or false: A pharmacist in the U.S. may use professional judgement to fill a prescription for lorazepam if it is written for a patient outside of the US by a physician who is not licensed in the United States.

FALSE

True or false: A pharmacist is required to fill a prescription for any reason.

FALSE

True or false: A physician may direct a pharmacist to fill all of a patient's prescriptions with an easy-off lid.

FALSE

True or false: All prescription medications are to be dispensed in "tamper evident" containers.

FALSE

True or false: PPPA states that child proof packaging for a prescription is acceptable if 20% of a panel of children can open the package within five minutes.

FALSE

True or false: Prescription records must be kept in a pharmacy for at least six years.

FALSE

True or false: the repackager beyond use date may be no more than 6 months regardless of the manufacturer expiration date.

FALSE

Which of the following best describes the legislation that required generic manufacturers to supply only proof of bioequivalence with the proprietary drug? A. Pure Food and Drug Act of 1906 B. Food Drug and Cosmetic Act of 1938 C. Durham-Humphrey Amendment of 1951 D. Kefauver Harris Amendment of 1962 E. Orphan Drug Act of 1983 F. The Drug Price Competition and Patent-Term Restoration Act G. The Waxman Hatch Act H.F+G

H

Which of the following drugs require registration with the Ipledge program? Thalidomide Rosiglitazone Clozapine Isotretinoin

Isotretinoin

True or False: A pharmacist has the responsibility to remove products from shelves upon a Class I recall.

TRUE

True or false: Section 503A of the FDCA covers pharmacists or physicians and describes sections where compounders are exempt from GMP, labeling and NDA or ANDA applications.

TRUE

Which of the following best describes the legislation that prohibited misbranded and adulterated foods from being distributed through interstate commerce? a.Pure Food and Drug Act of 1906 b.Food Drug and Cosmetic Act of 1938 c.Durham-Humphrey Amendment of 1951 d.Kefauver Harris Amendment of 1962 e.Orphan Drug Act of 1983 f.The Drug Price Competition and Patent-Term Restoration Act g.The Waxman Hatch Act

a

Which of the following best describes the legislation that allowed pharmaceutical manufacturer representatives to discuss medications for unapproved use? a. Food Drug and Cosmetic Act of 1938 b.Durham-Humphrey Amendment of 1951 c.The Drug Price Competition and Patent-Term Restoration Act d.The FDA Modernization Act of 1997

d

Which of the following is also known as the Health Care Reform Act? a.The FDA Modernization Act of 1997 b.Obamacare c.PPACA d.Patient Protection and Affordable Health Care Act of 2010 e.Three of the above f.All of the above

e

Which of the following are official compendia? a.Lexicomp b.Clinical Pharmacology c.United States Pharmacopeia/National Formulary (USP/NF) and any supplements d.Homeopathic Pharmacopeia of the US (HPUS) and any supplements e.All of the above. f. The last two on this list

f

True or false: An average pharmacist in a community pharmacy may substitute Novolin R for Humulin R without calling the physician.

false