Notes on Laws & Requirements: FD&C, PPPA, HIPAA, HITECH, Adulterated vs. Misbranded

Question 1

Laws & Requirements:
FD&C - Federal Food, Drug, and Cosmetic Act

Answer 1

1938 FD&C:
* Gave FDA ability to oversee safety of Food, Drugs, Medical Devices, & Cosmetics

Question 2

Laws & Requirements:
FD&C - Durham-Humphrey Amendment

Answer 2

1951 Durham-Humphrey FD&C Amendement:
* Split Medications into Legend (Rx) & OTC Categories

Question 3

Laws & Requirements:
FD&C - Kefauver Harris Amendment

Answer 3

1962 Kefauver Harris FD&C Amendment:
* 1938 Law Only Required Proof of Safety: Changed by Thalidomide Trial - which was found to produce deformed newborns in other countries & wasn’t approved in US.
* Granted FDA Power to Demand Retroactive Proof of Drug Efficacy By Manufacturers
* Requires Reporting of Adverse Events (ADRs)
* Transferred Rx Drug Advertising Regulation to FDA
* Established Clinical Trail Procedures
* Required Informed Consent

Question 4

Laws & Requirements:
Poison Prevention Packaging Act (PPPA)

Answer 4

1970 Poison Prevention Packaging Act:
* Required child-resistant packaging to be used on certain items (includes household products!)

Question 5

Laws & Requirements:
Health Insurance Portability and Accountability Act (HIPAA)

Answer 5

1996 HIPAA:
* Protects Patient Health Information (PHI)
* Protects Electronic Patient Health Information (ePHI)
* Minimum PHI Use Necessary for Care
* Security Safeguards Promoted (physical, technical, administrative)

Question 6

Laws & Requirements:
Health Information Technology for Economic and Clinical Health Act (HITECH)

Answer 6

2009 HITECH Act - Part of American Recovery & Reinvestment Act:
* Encourages EHR Implementation (Financial Incentives)
* Strengthens HIPAA via Notification of Privacy Breaches: 60 days to inform patients & business associates.
* Breach involving 500+ Individuals: Must report to media & Department of Health & Humans Services (HHS).

Question 7

Laws & Requirements:
Adulterated Definition in IA

Answer 7

Adulterated = Altered Substance:
* Differs In Strength, Quality, or Purity
(tainted, thinned, diluted, or weakened)
* Contains Unsanitary, Putrid, or Decomposed Substances
(contaminated, impure, polluted)

Question 8

Laws & Requirements:
Misbranded Definition in IA

Answer 8

Misbranding = Mislabeling:
* False Label or NO Label