Reading 1

Question 1

What is a statute?

Answer 1

• “A written law enacted by the legislature”
• These come from elected officals

Question 2

Where are statutes listed at the Federal Level?

Answer 2

• In United States Code [USC]
• uscode.house.gov

Question 3

Where are statutes listed at the State [Indiana] Level?

Answer 3

• In Indiana Code [IC]
• Indiana General Assembly site

Question 4

What is a regulation?

Answer 4

• “Rule” that has the force of law issued by administrative agencies
• These come from NON-elected officials

Go to the public too before becoming final (unlike statutes)

Question 5

Who are the agencies that help created the regulations for pharmacy?

Answer 5

• FDA & DEA = Federal
• State Boards = State Specific

Question 6

Where are regulations listed at the Federal Level?

Answer 6

• Code of Federal Regulation [CFR]
• ecfr.gov

Question 7

Where are regulation listed at the State Level?

Answer 7

• Indiana Administrative Code [IAC]
• Indiana General Assembly Site

Question 8

What are the Federal Statutes & Regulations and how are there citations written?

Answer 8

• USC & CFR
• Title [T], Section [S], Subsection [Ss]

• EX: T USC §S(Ss)

Question 9

What are the Indiana Specific Statutes & Regulations and how are there citation written?

Answer 9

• IC & IAC
• Title [T], Article [A], Chapter [C], Section [S]

EX: T IAC A-C-S or IC T-A-C-S

Question 10

For state statute or regulations, if the body wants to add another article, chapter, or section to be add, what happens within the law itself?

When new articles, chapters, or sections are ad to statue or regulations, how do they change it? [State]

Answer 10

• Add a decimal to the area of the law (there might be a letter added too)

Ex: 3.1 or 3a

Question 11

What are the three legal actions that a pharmacist might be subjected too?

Answer 11

• Criminal
• Civil
• Administrative

Question 12

What are the Criminal actions?

Answer 12

• When you Break the law and face punishment fromt he state or federal goverment related to the breach
• This could result in jail time, fines or both

Question 13

What are Civil actions?

Answer 13

• One party sues another because they believe they were harmed by someone
• “Compensate the Injuried party”

Question 14

What are Administrative actions?

Answer 14

• When a professional violates the statutes or regulations OR an administrative agency wants an investigation

Question 15

Practice Question 1

Match the area of law with its abbreviation?

A. Indiana Code……………………………….. I. CFR
B. Code of Federal Regulations………… II. USC
C. United States Code………………………. III. IAC
D. Indiana Administrative Code…………IV. IC

Answer 15

• A = IV
• B = I
• C = II
• D = III

Question 16

Practice Question 2

Match the area of law with whether it lists statutes or rules and whether it lists federal or Indiana Information?

A. Indiana Code…………………………….. I. Federal Statues
B. Code of Federal Regulations……… II. Indiana Rules
C. United States Code……………………. III. Indiana Statues
D. Indiana Administrative Code…….. IV. Federal Rules

Answer 16

• A = III
• B = IV
• C = I
• D = II

Question 17

Practice Question 3

A patient believes they were harmed when a pharmacist dispensed a prescription form their physician. Which action is most likely to apply?

a. Civil
b. Administrative
c. Criminal

Answer 17

• A. Civil

“believes they were harmed”

Question 18

Practice Question 4

A pharmacist provides the citation 21 CRR 1306.07 (f) (2) (l). What does the number (2) indicate?

a. The section where information can be found
b. A second subsection under subsection (f)
c. It provides the title information for the citation
d. The area of law where information is found

Answer 18

• b. a second subsection under subsection (f)