Laws & Regulations

Question 1

State Board of Pharmacy

Answer 1

enforcing pharmacy laws + regulations + traditional compounding pharmacies

Question 2

Food and Drug Administration (FDA)

Answer 2

enforces drug manufacturing laws + regulates prescription drug advertising

Question 3

Drug Enforcement Agency (DEA)

Answer 3

enforces the federal Controlled Substances Act (CSA) + makes decisions regarding the classification of certain drugs as controlled substances

Question 4

Occupational Safety & Health Act (OSHA)

Answer 4

enforces health and safety laws + attempts to reduce hazards in workplace

Question 5

Federal Trade Commission (FTC)

Answer 5

regulates over-the-counter drug, medical device, cosmetic, and food advertising

Question 6

Poison Prevention Packaging Act (PPPA)

Answer 6

required drugs to be dispensed in child-resistant packaging

• nitroglycerin sublingual tablets exempt from the PPPA because it helps with chest pains and prevent heart attack

Question 7

Omnibus Reconciliation Act of 1900 (OBRA ‘90)

Answer 7

requiring drug utilization reviews (DUR) + pharmaceutical care (pharmacist counseling) for Medicaid patients

Question 8

Health Insurance Portability + Accountability Act (HIPAA)

Answer 8

to protect the privacy of individual health info.

referred to in the law as “protected health info” aka PHI

Question 9

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

Answer 9

to regulate, among other things, retail OTC sales of following products because of their use in the manufacture of illegal drugs : pseudoephedrine, ephedrine, phenylpropanolamine

・pseudoephedrine- is an otc to relieve nasal/sinus congestion but can be used illegally to prodace meth
・daily sales is limited to: 3.6g/day
・monthly sales is to : 9g/30 days
・purchased via mail order to 30-day period: 7.5g
・records sales must be kept for 2 years

Question 10

The Food, Drug, and Cosmetic Act

Answer 10

guarantees a safe, effective, and unadulterated drug product that is appropriately labeled.

Question 11

Controlled Substances Act

Answer 11

serves to protect the public by regulating abusable drugs in an effort to prevent addiction and the destructive behavior that may be associated with these drugs.

Question 12

Federal Hazardous Substances Act

Answer 12

mandates safety measures to

prevent accidental poisoning on