Pharm Laws & Regulations

Question 1

Regulates privacy and security of health information

Answer 1

Health Insurance Portability and Accountability Act of 1996

Question 2

Counseling requirement for all new Rx and medicaid at point of sale

Answer 2

Omnibus Budget Reconciliation Act of 1990

Question 3

HIPAA protects PHI, which is?

Answer 3

protected health information

Question 4

miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.

Answer 4

Federal Food and Drug Act of 1906

Question 5

Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.

Answer 5

Narcotic Tax Act of 1914

Question 6

Gave the FDA authority to require adequate testing of new drugs for safety and requires new drugs to be proven safe when used according to labeled directions, requires that labels include warnings about habit-forming risk?

Answer 6

Federal Food, Drug and Cosmetic Act of 1938

Question 7

Required Legend Drugs to carry the statement:
“Caution: Federal law prohibits dispensing without a prescription.”.
Allows verbal new prescriptions to be called in over the phone and allows refill okays to be done over the phone.

Answer 7

The Durham-Humphrey Amendment of 1951

Question 8

Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval

• Also to disclose accurate info about side effects
• Requires manufacturers to:
  1) register annually
  2) be inspected every 2 years
  3) report any drug reactions

Answer 8

The Kefauver-Harris Amendment of 1962

Question 9

• Required the use of DEA Numbers

* Required comprehensive record keeping and transaction tracking.

Answer 9

Drug Abuse Prevention / Control Act of 1970

Question 10

Required locking caps on most prescriptions

Answer 10

Poison Prevention Packaging Act of 1970

Question 11

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

Answer 11

Combat Methamphetamine Epidemic Act (2005)

Question 12

Which entity regulates OVER THE COUNTER, non-legend drug advertising?

Answer 12

Federal Trade Commission, or FTC

Question 13

Which entity regulates LEGEND drug advertising?

Answer 13

The Food and Drug Administration, or FDA

Question 14

Which legislation provides tax and licensing incentives to manufacturers to develop drugs used to treat rare diseases?

Answer 14

Orphan Drug Act of 1983

Question 15

1984. Which legislation provides for the EXTENTION of drug patents in certain circumstances?

Answer 15

Hatch-Waxman Amendment or Drug Price Competition and Patent-Term Restoration Act of 1984

Question 16

What does Medicare part A cover?

Answer 16

Hospitalization, or [A] hospital stay

Question 17

What does Medicare part B cover?

Answer 17

Physician services, or services [B] by a physician

Question 18

What does Medicare part C cover?

Answer 18

Managed [C] care

Question 19

What does Medicare part D cover?

Answer 19

Prescription [D] drugs

Question 20

What is the primary purpose of the I. N. D., Investigational New Drug Application?

Answer 20

To prove a NEW DRUG, not new indication, is safe for human trials.

Question 21

who may order and receive C2 (CII)controlled substances.

Answer 21

pharmacists only

Question 22

How many refills are allowed by federal law for C2 (CII)substances?

Answer 22

No refills for C2 substances are allowed.

Question 23

How many refills are allowed for scheduled drugs in schedules other than C1 (CI) or C2 (CII)?

Answer 23

The original fill and five refills within six months of the date the prescription was written.

Question 24

How many refills are allowed for non-scheduled drugs?

Answer 24

As many as the physician allows up to one year from the date the original prescription was written.

Question 25

PPI’S - Patient Package Inserts are regulated by who?

Answer 25

by the FDA

Question 26

Must supply a PPI to patients receiving the following medications:

Answer 26

PPI'S - Patient Package Inserts - Regulated by the FDA
- Must supply a PPI to patients receiving the following medications: 
• Oral contraceptives 
• Estrogen 
• Progestin
• Isotretinoin (Accutane) 
• Intrauterine devices 
• Inhalers

Question 27

all pharmacies must has MSDS’s, stands for:

Answer 27

Material safety data sheets, for any hazardous materials

Question 28

Control II’s , refillable??

Answer 28

No, not refillable.

Question 29

Control III-V’s, refeillable?

Answer 29

Yes, 5 times within 6 months

Question 30

Limitations of pharm tech duties

Answer 30

1) pharmacy technician shall not receive oral prescriptions over the phone
2) shall not exercise professional judgment in any matter of pharmacy practice
3) can not transfer prescriptions.

Question 31

which class of drugs :exposure to the product is not likely to cause adverse health hazards?

Answer 31

Class 3

Question 32

Repackaging of meds, how to/ things listed on the label

Answer 32

• generic name of drug
• strength
• dosage form
• manufacturer and lot number
• expiration date after repackaging
• repacked medication is 50% of expiration date on stock bottle to max of 1 year.

Question 33

Drug Use Evaluation

Answer 33

ensures medications are used safely, effectively, and appropriately.

Question 34

Pharmacy’s registration to the DEA

-Must re-new every 3 years. (which dea form?)

Answer 34

dea form224