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Pharmacy Law > Controlled Substance: Distribution > Flashcards

Controlled Substance: Distribution Flashcards

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1
Q

Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act)

A

Established a closed system for manufacturing, distributing, and dispensing of controlled substances enforced by the DEA

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2
Q

Three titles of the Controlled Substances Act

A

Title I: rehabilitation for drug abusers
Title II: registration and distribution of CS
Title III: importation and exports of CS

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3
Q

Do states have individual CS laws?

A

Yes

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4
Q

Responsibility of DEA under the Controlled Substances Act

A
  1. Prevent diversion and abuse of CS

2. Ensure adequate and uninterrupted supply to meet country’s legitimate medical, scientific, and research needs

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5
Q

What are the 2 separate classifications of Controlled Substances?

A

Narcotics and nonnarcotics

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6
Q

What is a narcotic

A

Any drug derived from opium

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7
Q

What 3 factors influence which controlled schedule drugs fall under

A

currently accepted medical use, abuse potential, and degree to which drug may cause physical or physiological dependence

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8
Q

What is a C-I drug?

A

drugs that have no accepted medical use and may not be prescribed, dispensed, or administered from medical use

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9
Q

Which CS schedule has the highest potential for abuse

A

C-I/C-II

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10
Q

What are C-II drugs?

A

drugs that currently have an accepted medial use in treatment in the U.S.

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11
Q

Are there any exceptions to C-II drugs?

A

yes, but they must have severe restrictions

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12
Q

The abuse of C-II drugs may lead to

A

severe physical or psychological dependence

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13
Q

what are examples of C-II drugs

A

morphine, amphetamine, methylphenidate, lisdexamfetamine, cocaine, fentanyl, oxycodone, hydrocodone, methadone, meperidine, hydromorphone

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14
Q

what are examples of C-I drugs

A

marijuana, LSD, peyote, mescaline, heroin, bath salts, THC, GHB, ecstasy

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15
Q

What are C-III drugs

A

have a potential for abuse less than C-I or C-II drugs and have a currently accepted medical use

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16
Q

examples of C-III drugs

A

anabolic steroids (oxandrolone, testosterone), dronabinol, ketamine, buprenorphine

17
Q

are there any exceptions to C-III drugs

A

yes, tablet products that contain no more than 90 mg codeine per dosage unit

18
Q

What are C-IV drugs

A

drugs that have a lower potential for abuse than C-III drugs and may lead to limited physical or psychological dependence

19
Q

examples of C-IV drugs

A

phenobarbitol, benzodiazepines (alprazolam, diazepam, lorazepam), butorphanol, carisoprodol, tramadol, lorcaserin, modafinil, suvorexant, zaleplon, zolpidem, eszopiclone

20
Q

What are C-V drugs

A

drugs that have a low potential for abuse relative to C-IV drugs and abuse may lead to physical or psychological dependence

21
Q

examples of C-V drugs

A

codeine suspensions, diphenoxylate/atropine, pregablin, lacosamide, ezogabine

22
Q

Who schedules controlled substances?

A

the attorney general, however they must request scientific and medical evaluation of the drug and have recommendation from secretary of DHHS

23
Q

Do you have to be registered to handle controlled substances?

A

yes, every person who handles controlled substances must be registered with the DEA or be exempt from registration

24
Q

Who does not have to register with the DEA to handle CS?

A

agents or employees of registrants, drug reps, common carriers, ultimate users, prescribers/dispensers in the service of the US government, and law enforcement officers

25
Q

How do practitioner’s at hospitals register

A

they use the hospital’s dea registration number

26
Q

what is the definition of dispensing CS?

A

to deliver a CS to an ultimate user pursuant to the lawful order of a practitioner

27
Q

what does dispensing include

A

prescribing, administering, and dispensing

28
Q

do community pharmacists have to register with the DEA

A

no, they are agents of an institutional practitioner and are exempt

29
Q

What is the definition of manufacturing

A

the production, preparation, compounding, or processing of a drug as well as packaging, repackaging, labeling, or relabeling

30
Q

What must manufacturers ensure when labeling CS

A

each bottle must contain identification symbol of the schedule

31
Q

what is the definition of distributing

A

to deliver CS other than administering or dispensing

32
Q

can practitioners return CS to the manufacturer or supplier?

A

yes and they don’t need to register as a distributor as long as appropriate records are maintained

Pharmacy Law (2 decks)

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