Laws

Question 1

Pure Food & Drug Act

Answer 1

First law to regulate the development of compounding, distribution, storage, and dispensing of drugs.
No false or misleading info on label about drug strength or purity.
No interstate transport or sale of adulterated or misbranded food or drugs

Question 2

Food, Drug, & Cosmetic Act (FDCA)

Answer 2

Clearly defined adulteration and misbranding.
Created the federal agency call the Food & Drug Administration (FDA).
Required that products be safe for human use.

Question 3

Durham-Humphrey Amendments to FDCA

Answer 3

Distinguished between prescription (legend) and non-Rx drugs. Required that all drug products have adequate directions or bear the legend “Caution: Federal Law Prohibits without Prescription”.
Allowed verbal Rx and refill requests to pharmacies by phone

Question 4

Kefauver-Harris Amendment to FDCA

Answer 4

Required that drugs not only be safe but effective as well.
Required that pharmaceutical manufacturers file an Investigational New Drug Application (INDA) before starting clinical trials on human subjects.

Question 5

Comprehensive Drug Abuse Prevention & Control Act (Controlled Substance Act)

Answer 5

Established the federal agency called the Drug Enforcement Agency (DEA).
Classified drugs that havethe potential for abuse and or addiction into five classes

Question 6

Poison Prevention Packaging Act

Answer 6

Required child-resistant containers for most Rxs and OTC drugs to prevent accidental ingestion and poisoning

Question 7

Drug Listing Act

Answer 7

Required National Drug Code (NDC) numbers to be assigned to every market drug.

Question 8

Orphan Drug Act

Answer 8

Provided tax incentives for developing and marketing drugs used to treat rare conditions (orphan drugs).
Established lifelong exclusive license to manufacturer that developed orphan drugs

Question 9

Drug Price Competition & Patent Term Restoration Act

Answer 9

Streamlined the FDA approval process for marketing generic drugs. Extended the term of patents for companies that develop new drugs

Question 10

Prescription Drug Marketing Act

Answer 10

Prohibited the reimportation of drugs to the US except by the manufacturer.

Question 11

Anabolic Steroid Control Act

Answer 11

Redefined anabolic steroids as Schedule III controlled substances.

Question 12

Omnibus Budget Reconciliation Act (OBRA)

Answer 12

Required pharmacists to engage in drug utilization reviews (DUR).
Required pharmacists to offer counseling to patients about their Rxs w/o charge

Question 13

Dietary Supplement Heath & Education Act (DSHEA)

Answer 13

Treated herbal supplements as food products rather than drugs.
Prohibited manufacturers of herbs and dietary supplements from making claims thta their prodcuts treat or cure any specific disease or illness

Question 14

Health Insurance Portability & Accountability Act (HIPAA)

Answer 14

Addressed patient privacy concerns. Allowed employees to more easily move their health insurance from one job to another

Question 15

Medicare Modernization Act

Answer 15

Provided a voluntary prescription drug plan for medicare patients, for additional cost (Medicare-D).
Created a type of health insurance called health savings accounts.

Question 16

FDA Modernization Act

Answer 16

Changed federal legend to “Rx only”

Legalized compounding

Question 17

Combat Methamphetamine Epidemic Act

Answer 17

Restricted sales of OTC drugs in the manufacture of methamphetamines, such as pseudoephedrine and ephedrine

Question 18

Which federal law required child resistant containers?

Answer 18

Poison Prevention Packaging Act

Question 19

What does OBRA stand for?

Answer 19

Omnibus Budget Reconciliation Act

Question 20

What does HIPAA stand for?

Answer 20

Health Insurance Portability and Accountability Act

Question 21

This federal law requires purchasers of Sudafed and other products to show ID & sign

Answer 21

Combat Methamphetamine Epidemic Act

Question 22

This law required that all legend drugs say this on the bottle “Caution: Federal Law Prohibits w/o a Prescription”

Answer 22

Durham-Humphrey Amendments to FDCA

Question 23

This law made it illegal to talk to patients family members concerning the patients care, treatment, or drug therapy.

Answer 23

HIPAA

Question 24

What law required the NDC number to be on every marketed drug

Answer 24

Drug Listing Act

Question 25

This law created HSA accounts and also Medicare part D

Answer 25

Medicare Modernization Act

Question 26

This law treated herbal supplements as food products

Answer 26

Dietary Supplement Health and Education Act (DSHEA)

Question 27

This law established the federal agency called the Drug Enforcement Agency

Answer 27

Comprehensive Drug Abuse Prevention & Control Act (Controlled Substance Act)

Question 28

Which law required that pharmaceutical manufacturers file an Investigation New Drug Application (INDA) before starting clinical trials on humans

Answer 28

Kefauver-Harris amendment to FDCA

Question 29

This law changed the wording of “Caution: Federal Law Prohibits without Prescription” to “Rx only”

Answer 29

FDA Modernization Act