LAWS

Question 1

What is HIPAA?

Answer 1

1966 - Health Insurance Portability & Accountability Act. Federal law that required the creation of national standards to protect sensitive patient health info from being disclosed without patient consent or knowledge.

Question 2

What did the Combat Methamphetamine Act do?

Answer 2

2005 - restricted quantity and frequency of ephedrine, pseudoephedrine, and phenylpropanolamine

Question 3

What is the Drug Listing Act?

Answer 3

1972 - requires drug establishments to establish and list all of their commercially marketed drug products with the FDA

Question 4

What is the Food and Drug Act?

Answer 4

1906 - set standards for purity and strength of ingredients; outlawed interstate transport or transaction of contaminated and misbranded drugs

Question 5

What is OBRA 90?

Answer 5

1990 - Omnibus Budget Reconciliation Act; established the DUR + patient counseling at pharmacies

Question 6

What did the Durham-Humphrey Amendment do?

Answer 6

1951 - required all drug products to have sufficient directions for use

Question 7

What is bioequivalence and what are the laws related to it?

Answer 7

Generic substitution: If two drug products containing the same active chemical entity can reach the site of absorption in similar times and be absorbed to the same extent, bioequivalence can be established.

Question 8

What is the Food, Drug, and Cosmetic Act?

Answer 8

1938 - set of laws passed by Congress giving the FDA the authority to oversee safety of food, drugs, medical devices, and cosmetics

Question 9

What did the Poison Prevention Packaging Act do?

Answer 9

1970 - The Poison Prevention Packaging Act created childproof packaging + containers

Question 10

What is the Anabolic Steroid Act?

Answer 10

1990 - added anabolic steroids to schedule III controlled substances; defines anabolic steroid as any drug that alters muscle growth similar to testosterone

Question 11

What are the Centers for Medicare and Medicaid Services?

Answer 11

CMS

Question 12

What is OSHA?

Answer 12

Occupational Safety and Health Administration - sets standards of safety in workplaces

Question 13

What is the Joint Commission?

Answer 13

accredits and certifies healthcare organizations and programs

Question 14

What is the FDA?

Answer 14

federal agency that regulates safety of food, drugs, medical devices, radiation emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products

Question 15

What are some laws related to refilling and partial filling NON-CONTROLLED substances?

Answer 15

Pharmacists, in general, can partially fill any prescription for non-controlled substances.

Question 16

What is the Drug Supply Chain Security Act?

Answer 16

2013 - Track and Trace of manufactured drugs

Question 17

What did the Kefauver-Harris Amendment (Drug Efficacy Amendment) do?

Answer 17

1962 - all drugs must be pure, safe and effective before approval

Question 18

What is the Orphan Drug Act?

Answer 18

1983 - facilitates development of drugs for rare diseases in the U.S. i.e. Huntington’s, ALS, Tourettes

Question 19

What is the Medicare Modernization Act?

Answer 19

2003 - brought many changes to Medicare program including addition of Medicare part C and D

Question 20

What is the DEA?

Answer 20

1973 - Drug Enforcement Administration; enforces controlled substances laws and oversees drug trafficking