Pharmaceutical Laws Review
1906 Pure Food and Drug Act
o Prohibits foreign transport of misbranded or adulterated drugs (truthfu
info, prove effectiveness)
1914 Harrison Narcotics Act
o Curb recreational use of opium
o Must have a prescription
o Records are kept
1938 Food, Drug, and Cosmetic Act
o "Warning: May Be Habit Forming'
o Clearly defined adulterated and misbranding
1951 Durham and Humphrey Act
o Made original distinction between legend and over the counter/ non
Iegend drugs
1962 Kefauver-Harris Act
o Good Manufacturing Practice
: 1970 Comprehensive Drug Abuse Prevention and Control Act
o Established the DEA
o Stair Step Categories of Controlled substances (Schedule 1-5)
1970 Poison Prevention Packaging Act
o Childproof Caps
o Unless pt/dr request, emergency meds, etc
:1983 Orphan Drug Act
o Eased restriction for development for drugs for rare diseases
1987 Prescription Drug and Marketing Act
o Prevent counterfeit drugs
o Prohibits sale to anyone other than those who prescribed them
OBRA
0 REQUIRES COUNSELING
: HIPAA
o Pt right to protect their own information
:2000 Drug Addiction Treatment Act (DATA 2000)
o First letter in DEA # is X
o Can prescribe controlled substances for purposes of detoxification
. 2003 Medicare Modernization Act
o Drug Discount Cards
o Medicare PT D
:2005 Combat Meth Act
o Pseudoephedrine limited to purchase
2010 ACA and 2013 Drug Quality and Security Act
o Affordable Care Act
o EHR and Medication Quality
o Drug Quality
o FDATracking
Important People
FDA
o Protects food and drugs
o Enforced guidelines
o Under authority of Dept Health and Human Services
DEA
o Prohibits illegal distribution and misuse of controlled substances
Important to Note
MedWatch
o FDA program to report discrepancies, drug errors, or adverse reactions to
meds
: Class 1 Drug Recall
o Could cause serious harm or be proven fatal
Class 2 Drug Recall
o Product causing temporary health problem or pose a slight threat of
serious harm
Class 3 Drug Recall
o Product with minor defect or other conditions that would not harm the
patient
Narcotics
o Derived from opium
C1
o Strongest potential for abuse (Heroi