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1906 The Pure Food and Drug Act
Prohibit the interstate transporting or sale of altered and misbranded food and drugs.
1938 The Food, Drug and Cosmic Act
FDCA Important legislation in pharmaceutical history New drug application
1951 Durham Humphrey Amendment
CAUTION federal law prohibits dispensing without a prescription Legend or prescription drugs OTC or over the counter
1962 The Kefauver Harris Amendment
Human Testing Investigational new drug application
1970 The Comprehensive Drug Abuse Prevention and Control Act
Controlled substance act (schedule narcotics) C1 highly abusive and illegal C2 highly abusive and medical usage C3 medium abuse and medical usage C4 low abuse and medical usage
1970 The Poison Prevention Act
Child resistance containers
1972 Drug Listing Act
National Drug Code - NDC 0085-0024-25 First set of # 0085 is the manufacturer Second set of # 0024 is the drug strength and dosage Thirs set of # 25 is the package size
1983 The Orphan Drug Act
Quick market drugs NOT approved by FDA
1984 Drug Price Competition and Patent-term Restoration Act
Brand and Generic drugs Tylenol brand; Acetaminophen generic 7yrs no one can use the name or make brand version BUT generic Generi are 90% bio-equivalent to brand only federal government can change that
1987 Prescription Drug Marketing Act
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1990 Anabolic Steroids Control Act
Abuse problems of Anabolic steroids and misuse by athletes
1990 The Ominbus Budget Reconciliation Act
OBRA 90 Counsel Medicare/Medicaid patients when dispensing a prescription
1996 Health Insurance Portability and Accountability Act
HIPPA Privacy practices used to protect health information Federal law
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