Laws, Acts, and Amendments

Health Insurance Portability and Accountability act

HIPAA

Standards to protect patient privacy information

PHI - Protected Health Information

Combat Methamphetamines Epidemic Act 2005’

CMEA
limit the use of pseudoephedrine

daily - 3.6g monthly - 9g

BTC, sales log book, ID, 18 (unless prescribed)

Drug listing Act 72’

Drugs have 10-digit national drug code (NDC)

4 - manufacturer

4 - product/active ingredients

2 - size

Food and Drug Act 09’

Drugs had to be pure, the medication written on the outside had to be in the bottle and nothing else.

Food Drug and Cosmetic Act 38"‘

Drugs in the bottle had to be Pure and Safe

adequate testing was required for a drug to be accessed by the public.

Kefauver - Harris Amendment 62’

Drugs in the bottle had to be Pure, Safe, and Effective.

Omnibus Budget Reconciliation Act 90’

Requires pharmacists to counsel all patients.

Durham - Humphrey Amendment 51’

Distinction between Rx and OTC
Rx - refilled, legend, legends have warnings, could only be dispensed with prescriptions

Drug Supply Chain Security Act (track and trace)

report any illegitimate drugs products in the supply chain.

Poison Prevention Packaging Act 70’

all meds should be in child proof containers.

except nitroglycerin which is an exception.

Orphan Drug Act

requires manufacturing of drugs that are rare ( 200,000 or less )

Medicare Modernization Act 2003’

Provides coverage for prescription drugs.

premium- coverage over time.

Deductible - pay ur part first and insurance covers the rest.

Center for Medicare and Medicaid Services

health insaurence coverage for medicaid and medicare.

Anabolic Steroid Act 90’

Limiting the use of anabolic steroids.

Joint commission

sets standard for all law enforcement and healthcare facilities.

FDA

was an organization that required adequate testing of Drugs.

DEA

Drug Enforcement Administration

prescription can be traced back to dispenser.

SBOP

Provides resources used by Proffetionals in law enforcement and healthcare.