Pharmacy Law Final

Front 1

Instruments, apparatus and contrivances, including thier components, parts and accessories intended for use in diagnosis, cure, mitigation, treatment, etc.

Back 1

Device

Front 2

A drug or device that consists in whole or in part of any filthy, putrid, or decomposed substance, etc.

Back 2

Adulterated drug or device

Front 3

Which of the following will result in a drug product being misbranded under TN law?

Back 3

Offered for sale under the name of another drug; Imitation of another drug; Container is so made, formed, or filled to be misleading

Front 4

If a drug is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof, then the product will be

Back 4

Misbranded

Front 5

Any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce directly or indirectly, the purchase of the food, drug, or cosmetic, is

Back 5

Advertisement

Front 6

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into...doesn't include soap

Back 6

Cosmetic

Front 7

A display of written, printed, or graphic matters upon the immediate container of any article, is

Back 7

Label

Front 8

Official compendium, as defined by the TN FD&C Act

Back 8

United States Pharmacopoeia & supplements; Official Homeopathic Pharmacopoeia of the US & supplements; Official National Formulary & supplements

Front 9

A TN pharmacist who fails to store, under conditions of refrigeration, a legend drug that requires refrigeration & causes harm to product, could be liable for the act of

Back 9

Adulteration

Front 10

Which of the following substances, when sold in TN, must include on the label of the substance the words "Warning - May be Habit Forming?"

Back 10

Cocaine, codeine, opium - Narcotics or hypnotics- misbranded if not on there

Front 11

If the labeling of a drug does NOT contain adequate directions for use and such adequate warning against use in those conditions...

Back 11

Misbranded

Front 12

Pursuant to the TN FD&C Act, the Commissioner of _____ shall have free access to all reasonable hours to any factory, warehouse, or establishment in which food, drugs, cosmetics or devices are manufactured, processed, packed, or held for introduction into commerce

Back 12

Agriculture

Front 13

Which of the following is NOT a recognized prescriber under TN law?

Back 13

Chiropractor -- physician, dentist, and vet are

Front 14

Which of the following may legally possess a legend drug in TN without a valid prescription order?

Back 14

A licensed pharmacy, licensed wholesaler, licensed, authorized prescriber

Front 15

Prior to the destruction of any drugs or devices deemed to be adulterated, the owner or person in legal possession thereof shall be given written notice of the intent to destroy the drug or device and the reason thereof. The owner or person in legal possession shall have ___ days from the receipt of said written notice to request in writing a hearing as to the pending destruction

Back 15

10

Front 16

Any person, firm, or corporation possessing, selling, bartering, or giving away any drug in violation of Chapter 10 of Title 53 of the TN Code Annotated shall, upon conviction, be guilty of a

Back 16

Misdemeanor (Class C)

Front 17

The registered trademark name of a drug given by its manufacturer, etc.

Back 17

Brand name

Front 18

The TN Affordable Drug Act of 2005 mandates prescribers to allow for substitution with a generic equivalent of a brand name drug under all circumstances. Which is NOT one of the exceptions to this?

Back 18

A generic equivalent manufacturer doesn't have sales reps. on clinical support services available to the prescriber

Front 19

All TN pharmacists who handle controlled substances must register with

Back 19

TN Board of Pharmacy

Front 20

Which of the following is NOT one of the criteria for the TN Board of Pharmacy to issue a registration to a pharmacist who handled controlled substances?

Back 20

Licensure as a pharmacist for not less than 5 years.

Front 21

Which of the following is NOT one of the grounds upon which the TN Board of Pharmacy may suspend or revoke a registration of a TN pharmacist to handle controlled substances?

Back 21

None of the above - Furnished false or fradulend info in any application for registration; been convicted of a felony under any state or federal law relating to any controlled substance; had a federal registration to manufacture, distribute, or dispense controlled substances suspended or revoked

Front 22

A person who is registered under TN law to handle controlled substances and who distributes or dispenses any controlled substances for any purpose other than those authorized...is guilty of a

Back 22

Felony (Class D)

Front 23

Which of the following shall be open for inspection to any federal, state, county, or municipal officer whose duty it is to enforce the laws or regulations of this state or of the US relating to controlled substances or narcotic drugs?

Back 23

Prescriptions, stocks of controlled substances, records of receipt and dispensing of controlled substances

Front 24

According to the TN Controlled Substances Monitoring Act of 2002, which of the following is NOT one of the items of info that dispensers of controlled substances must submit under the Act?

Back 24

Retail price of controlled substance dispensed - Must have patient identifier, controlled sub. dispensed, estimated days supply of controlled substance dispensed

Front 25

If one pharmacy practice site "loans" a commercial container of a CII controlled substance to another pharmacy practice site w/o the proper order forms (222), the fine authorized for such a violation is (In TN)

Back 25

$100,000

Front 26

Which of the following federal laws serves as the principal base for the present regulation of all drug products distributed through interstate commerce?

Back 26

Food, Drug, & Cosmetic Act of 1938

Front 27

Which of the following amendments to the FD&C Act created the legal distinction b/c legend and non-legend drug products?

Back 27

Durham-Humphrey

Front 28

Which of the following amendments to the FD&C Act established the requirement of proof of safety and efficacy of new drug products?

Back 28

Kefauver-Harris

Front 29

Which of the following drug product incidents led to the enactment of federal law requirements as to BOTH safety and efficacy testing?

Back 29

Thalidomide disaster

Front 30

A disposable hypodermic syringe is

Back 30

Class II medical device

Front 31

Which of the following federal laws provides an incentive to develop drugs for the treatment of "rare diseases?"

Back 31

Orphan Drug Act of 1983

Front 32

Which of the following federal laws created the federal drug legend "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian?"

Back 32

Prescription Drug Marketing Act of 1987

Front 33

According to the Safe Medical Devices Act, a user facility such as a hospital or nursing home MUST report to the US FDA, within ___ working days, the death or serious bodily injury caused to a person by a medical device

Back 33

10

Front 34

A drug, or the container or labeling of which, without authorization bears the trademark, tradename, or other identifying mark of a drug manufacturer other than the person who in fact manufactured the drug is a

Back 34

Counterfeit drug

Front 35

A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the dietary ingredients of a vitamin, mineral, herb, or other botanical or amino acid is a

Back 35

Dietary supplement

Front 36

Which of the following represents the authorized penalty under federal law for a FIRST conviction for knowingly selling, purchasing, or trading a drug sample or coupon in violation of federal law?

Back 36

Imprisonment for not more than 10 years and/or fined not more than $250,000

Front 37

According to federal law, a drug product that consists in whole or in part of any filthy, putrid or decomposed substance is a

Back 37

Adulterated drug

Front 38

According to federal law, a drug product that does NOT contain labeling bearing adequate directions for use and adequate warnings against improper use is referred to as a(an)

Back 38

Misbranded drug

Front 39

The label of a manufacturer's container of a legend drug product MUST bear which of the following?

Back 39

The "Rx only" symbol

Front 40

According to federal law, a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug is a

Back 40

Drug sample

Front 41

According to federal law, a form which may be redeemed, at not cost or at a reduced cost, for a prescription drug, is a

Back 41

Coupon

Front 42

Which of the following is NOT one of the recognized exemptions from the prohibition on public or private hospitals selling prescription drugs previously purchased by the hospital?

Back 42

A sale to dispose of inventory that will expire within 30 days of the sale date

Front 43

Which of the following may NOT legally receive prescription drug samples from a manufacturer or authorized distributor of record?

Back 43

A free standing, community pharmacy

Front 44

Which of the following is NOT required to be contained on a written request for a drug sample?

Back 44

The name of the individual representative of the manufacturer obtaining the written request for the drug sample

Front 45

According to federal law, which of the following is exempt from registration with the FDA as a manufacturer?

Back 45

A pharmacy compounding a product pursuant to a lawful prescription order

Front 46

A device which is a life-supporting system and whose failure might cause death or serious injury is a

Back 46

Class III device

Front 47

According to federal law, the rate and extent to which the active ingredient is absorbed from a drug and becomes available at the site of action is

Back 47

Bioavailability

Front 48

A new drug that received expedited review, where the drug is intended for the treatment of serious or life-threatening condition...

Back 48

Fast track drug

Front 49

According to federal law, the term "rare disease or condition" means any disease or condition which affects less than ___ persons in the US or more than ___ persons in the US...

Back 49

200,000

Front 50

Which of the following is exempt from registration as a manufacturer of drug products under federal law?

Back 50

A pharmacy compounding a prescription drug in the regular course of pharmacy practice & pursuant to a lawful prescription order

Front 51

The direct application of a controlled substance, whether by injection,...

Back 51

Administer

Front 52

A controlled substance which, or the container or labeling which, without authorization bears the trademark, etc. of a manufacturer other than the person who infact manufactuered...

Back 52

Counterfeit substance

Front 53

The act of dispensing, for purposes of the TN Drug Control Act, includes which of the following associated activities necessary to the delivery of a controlled substance?

Back 53

Prescribing, packaging, labeling

Front 54

Marijuana, for purposes of the TN Drug Control Act, is defined as NOT including which of the following?

Back 54

Mature stalks of the cannabis plant -- does include seeds, leaves, resin

Front 55

Which of the following is NOT included in the definition of a narcotic drug, as provided for in the TN Drug Control Act?

Back 55

None of the above -- opium, any salt, compound, derivative, or preparation of opium or opiate, coca leaves

Front 56

Which of the following is NOT included in the definiton of practitioner as provided by the TN Drug Control Act?

Back 56

pharmacist -- physican, scientific investigator, & pharmacy are

Front 57

Which of the following is NOT included in the def of an ultimate user as provided by the TN Drug Control Act?

Back 57

None of the above - person who possesses a controlled substance for his or her own use; for the use of a member of the person's household; for administration to an animal owned by them or a member of their household

Front 58

Which of the following TN agencies does NOT have direct authority for the scheduling of controlled substances in TN?

Back 58

Board of Pharmacy - Dept. of Mental Health and Mental Retardation & Department of Health do

Front 59

Which of the following is NOT a consideration according to the TN Drug Control Act for scheduling controlled substances in TN?

Back 59

Current schedule status under federal law

Front 60

A substance having a high potential for abuse and having NO accepted medical use in the US...

Back 60

Schedule I controlled substance

Front 61

Any material containing not more than 1.8 grams of codeine per 100 mL or not more than 90 mg per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium is a Schedule __ controlled substance in TN

Back 61

III

Front 62

Any material containing not more than 200 mg of codeine per 100 mL or per 100 grams is a Schedule __ in TN

Back 62

V

Front 63

Any material containing not more than 0.5 mg of difenozin and not less than 25 mcg of atropine sulfate per dosage unit is a Schedule __ in TN

Back 63

V

Front 64

Butyl nitrite is a Schedule __ in TN

Back 64

VII

Front 65

A drug or hormonal substance which is chemically & pharmacologically related to testosterone (other than estrogens, progestins, or corticosteroids) that promotes muslce growth is a Schedule __ in TN

Back 65

III

Front 66

Unless otherwise authorized by law, which of the following is a criminal offense under the TN Drug Control Act?

Back 66

Manufacturing, selling, or possessing a controlled substance with intent to manufacture, deliver, or sell

Front 67

Failure to conform to the laws governing substitution of a generic equivalent for a brand name drug, as set forth in Part 2 of Chapter 10 of Title 53 of TCA is a

Back 67

Class C misdemeanor

Front 68

In the state of TN, a methamphetamine precursor may be sold at retail only by licensed pharmacies

Back 68

TRUE

Front 69

In determining whether a particular object is drug paraphernalia, which of the following is NOT likely to be considered?

Back 69

None of the above - expert testimony concerning use, manner in which the object is displayed for sale, statements by the owner of the object as to its use

Front 70

The mandatory minimum fine for a first conviction of a felony drug offense for a violation with respect to a controlled substance is

Back 70

$2,000

Front 71

The TN Criminal Sentencing Reform Act establishes __ classes of felony

Back 71

5

Front 72

In TN, there are __ misdemeanor offenses

Back 72

3

Front 73

A defendant who has no prior felony convictions will be classified, under the TN Criminal Sentencing Refrom Act as

Back 73

Especially mitigated offender

Front 74

With respect to anabolic steroids, which is unlawful?

Back 74

All of the above - for a practitioner to prescribe to enhance performance, increase muslce mass, strength or weight w/o medical necessity, and for any person to possess an anabolic steroid with intent to manufacture

Front 75

The authorized term of imprisionment for a Class D felony is not less than __ years nore more than __ years

Back 75

2; 12

Front 76

According to federal Controlled Substances Act, if a pharmacy "loans" to another pharmacy a commercial container of a Schedule II controlled substance w/o proper order forms (222), the possible punishment is

Back 76

A term of imprisionment of not more than 4 years & a fine of not more than $30,000