1906-1960
1906-Pure Food and Drug Act(FDA)
Regulated all foods and drugs to meet standard of strength and purity
1970-Poison Prevention Packaging Act
-Required child-proof packaging
-Required new and clean containers
1976-Medical Device Amendment
-regulated safety and efficacy of medical devices
-1990
-defined "anabolic steroids" as any drug or hormonal substance that promotes muscle growth in a way similar to testosterone
-added Anabolic Steroids as schedule 3 (III) substance
Anabolic Steroids Act
-2005
-Improved patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients
Patient Safety and Quality Improvement Act of 2005
-1938
-defined adulteration and misbranding
-gave FDA authority to remove drugs from marketplace if found unsafe or ineffective
Federal Food,Drug,and Cosmetic Act (FFDCA)
-1970
-assured safe and healthful working conditions by setting and enforcing standards
-provided research,information,education,and training in the field of occupational safety and health
Occupational Safety and Health Act
-1982
-required medications and devices be placed in tamper-proof packaging
Federal Anti-Tampering Act
1994-Dietary Supplement Health and Education Act
-regulated that dietary supplements are classified as "foods" and can be marketed without FDA review
-2009
-restricted tobacco marketing and sales to youth
-required smokeless tobacco products have warning labels
Required Disclosure of ingredients in tobacco products
Family Smoking Prevention and Tobacco Control
-1951
-Defined Distinction between prescription and over-the-counter medication
-Required a physician's order to dispense legend drugs
-Label for legend state drugs,"Caution:Federal Law prohibits dispensing without prescription"
Durham-Humphrey Amendments to the FFDCA
-1962
-required drug manufacturers to prove the safety and efficacy of products prior to FDA approval
Kefauver-Harris Amendments to the FFDCA
-1983
-passed to expedite development of orphan drugs for rare diseases
Orphan Drug Act
-1996
-protected health insurance coverage when someone loses their job
-comprehensive federal regulations designed to safeguard the privacy of protected health information(PSI)
Health Insurance Portability and Accountability Act of 1996 (HIPPA)
-2005
-regulated retail sales of following:ephedrine,pseudo ephedrine,phenylpropanolamine
-regulated sales of pseudoephedrine to 3.6g per day or 9g per month
-records of sales must be kept for two years
-Incorporated systems like MethCheck and NPLEx to aid in tracking sales
The Combat Methamphetamine Epidemic Act
-1914
-regulated drugs with a physical or psychological dependence
-regulated importation,sale,manufacture and use of the following:Opium,Marijuana,Synthetic agents & derivatives
Harrison Narcotic Act
-1970
-classified drugs based on potential for abuse,schedules (I-V)
-Required following statement after controlled substance is dispensed:"Federal Law prohibits the transfer of this drug to any person other than patient for whom prescribes"
Controlled Substances Act (CSA)
-1990
-required pharmacist to offer medication counseling to medicaid patients
-required a DUR every time when prescription is processed
-required manufacturers to provide lowest price to medicaid patients
Omnibus Budget Reconciliation Act (OBRA-90)
-1997
-changed the legend requirements to prescription only (Rx only)
FDA Modernization Act
-2003
-also called the Medicare Modernization Act,or MMA
-Largest overhaul of medicare in history of program
-created Medicare Part D programs to subsidize costs of prescription drugs for medicare beneficiaries
Medicare Prescription Drug,Improvement,and Modernization Act
-Required Hazardous household products labeled with cautioning of potential hazards and how consumers can protect themselves
-Gave Consumer Product Safety Commission authority to enforce these requirements
1960-Federal Hazardous Substances Act
-1972
-required registered drug establishments to provide FDA with current list of all drugs manufactured,prepared,propagated,compounded,or processed by it for commercial reasons
-Required each drug be issued a National Drug Code
Drug Listing Act
-1987
-amended the FFDC act
-addressed prescription drug-marketing practices that contributed to diversion of drugs into a secondary gray market
Prescription Drug Marketing Act
-2000
-allowed prescribers to obtain a waiver to prescribe controlled substances to treat opioid addiction outside a treatment facility
-required prescribers to possess second DEA number that begins with letter x
Drug Addiction Treatment Act
-2013
-also known as "Track and Trace"
-outlined steps to build system to identify and trace certain prescription drugs distributed in the US
-improved detection and removal of potentially dangerous drugs from the drug-supply chain
-established national licensure standards for wholesale distributors and third-party logistics providers
-enhanced ability of FDA to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful
Drug Supply Chain Security Act (DSCSA)