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Pharmacy Technician Exam > Pharmacy Law and Regulations > Flashcards

Pharmacy Law and Regulations Flashcards

1
Q

What is the prescription order expiration date for DEA schedule II drugs?

A

No expiration

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2
Q

What is the prescription order expiration date for DEA schedule III-V drugs?

A

6 months

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3
Q

What is the prescription order expiration date for legend drugs drugs?

A

12 months

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4
Q

What are the refill guidelines for DEA schedule II drugs?

A
  • No Refills Allowed
  • Must be manually signed by the practitioner
  • May not be faxed or called in, except for emergency
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5
Q

What are the refill guidelines for DEA schedule III-V drugs?

A

-up to 5, but only 5 times

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6
Q

What are the refill guidelines for legend drugs drugs?

A

-up to 12 months worth

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7
Q

What is the FDA?

A

Food and drug Administration

Responsible for: drug approval, Regulate package inserts, Regulating advertising of drugs, Issue recalls,

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8
Q

What is the DEA?

A

Drug Enforcement Agency
Responsible for: Enforcing the Controlled Substance Act (CSA), track controlled substances manufactured and sold, investigates controlled substances violations

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9
Q

What is a schedule I drug?

A

No accepted medical use. Extremely high potential for abuse. High potential for psychological and physical dependency. A few examples are: Marijuana, Heroin and MDMA (Extasy).

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10
Q

What is a schedule II drug?

A

Does have medical use. High potential for abuse. Relative potential for psychological and physical dependency. A few examples are: Oxycodone, Codeine and Ritalin.

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11
Q

What is a schedule III drug?

A

Schedule III - Does have medical use. Moderate abuse potential exists, but less than Sch II. Examples are: Vicodin and Tylenol w/Codeine.

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12
Q

What is a schedule IV drug?

A

Schedule IV - Abuse potential exists, but less than Sch III. Examples are: Ambien, Darvocet and Lorazepam.

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13
Q

What is a schedule V drug?

A

Schedule V - Lowest abuse potential of the DEA Sch. Abuse potential exists, but less than Sch IV. Example: Cough medicine w/codeine or anti-diarrheals.

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14
Q

What is DEA form 222?

A

must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors. The forms are only available through the DEA and errors are not acceptable on the form. In the case of an error, the form must be voided and kept on file and a new form used. For Sch III - V, a form 222 is not necessary.

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15
Q

What is the BOP?

A

Board of Pharmacy (each state)
Responsible for: regulating licensing of pharmacists, regulating licensing of pharmacy technicians, set state laws/requirements, outline the operating guidelines in the pharmacy, investigate violations of the operating guidelines, determine state regulated controlled substances.

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16
Q

What is the joint commission?

A

Joint Commission on the Accreditation of Healthcare Organizations?
Responsible for: watching over healthcare organizations, third-party auditors/regulators for insurance providers.

17
Q

How to verify DEA numbers?

A
  • Add together 1,3, and 5th digits
  • Add together 2,4, and 6th digits. Double it
  • Add the two totals together
  • The second digit in that total is the last digit of the DEA number, the “check” digit
18
Q

What is a Class I recall?

A

Would be used in a case where there is a probability that, the use of or exposure to a violative product will cause serious adverse health consequences or death.

19
Q

What is a Class II recall?

A

Would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequences is remote.

20
Q

What is a Class III recall?

A

May be used in a situation in which use of a violative product is NOT likely to cause adverse health consequences, but has violated some FDA regulation.

21
Q

What is an FDA market withdrawal?

A

An example from the FDA Official website says, “A product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.”

22
Q

What is an FDA medical device safety alert?

A

Used only for medical apparatus equipment. This is when a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.

23
Q

What is the Federal Food and Drug Act of 1906?

A
  • Known as the Pure Food and Drug Act.
  • Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods.
  • Required that “Secret Elixirs” containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.
24
Q

What is the Narcotic Tax Act of 1914

A
  • Known as the Harrison Narcotic Act.
  • Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
  • Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS.
  • Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.
25
Q

What is the Federal Food, Drug and Cosmetic Act of 1938?

A
  • Known as FDCA 1938.
  • Replaced the Food and Drug act of 1906.
  • Provided better clarification about misbranding definitions.
  • Provided better clarification about adulteration definitions.
  • Gave the FDA authority to require adequate testing of new drugs for safety.
26
Q

What is the Durham-Humphrey Amendment of 1951?

A

• Created a distinction between “OTC” and “Legend Drugs”.
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
“Caution: Federal law prohibits dispensing without a prescription.”.
• Most people refer to Legend drugs simply as “Prescription Drugs”.
• The emphasis on this act was to insure safety through qualified medical supervision.

27
Q

What is the Kefauver-Harris Amendment of 1962?

A
  • Also known as the “Drug Efficacy Amendment”.
  • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
  • Required drug advertising to be more closely regulated and disclose accurate information about side effects
28
Q

What is the Controlled Substances Act of 1970?

A
  • Also known as the Controlled Substances Act (CSA)
  • Completely replaced the Harrison Act.
  • Required the use of DEA Numbers
  • Required comprehensive record keeping and transaction tracking.
  • Enforced by the DEA under the US Dept. of Justice
29
Q

What is the Poison Prevention Packaging Act of 1970?

A
  • Also known as the PPPA
  • Designed to reduce the risk of children ingesting dangerous substances.
  • Required locking caps on most prescriptions
30
Q

What is the Combat Methamphetamine Epidemic Act of 2005?

A
  • Enacted to regulate the OTC sales of pseudoephedrine.
  • Identity and address of each purchaser to be kept for two years.
  • Daily sales of regulated products not to exceed 3.6 grams.
  • 30 day purchase limit not to exceed 9 grams
  • 30 day purchase via mail order not to exceed 7.5 grams

Pharmacy Technician Exam (5 decks)

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