Pure Food and Drug Act of 1906
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Pure Food and Drug Act of 1906
Did not require manufactures to list ingredients or directions for use
Pure Food and Drug Act of 1906
Did not regulate cosmetics or medical devices
Food, Drug and Cosmetic Act of 1938
- Any new drug had to be proven safe when used according to label directions
-label had to include adequate directions for use and habit-forming warnings
- first law that applied to food, drugs, cosmetics, and devices
-drugs marketed prior to 1938 were exempt from regulation
Food, Drug and Cosmetic Act of 1938
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Food, Drug and Cosmetic Act of 1938
labels had to include: adequate directions for use and habit forming warnings
Food, Drug and Cosmetic Act of 1938
first law to apply to cosmetics and medical devices
Food, Drug and Cosmetic Act of 1938
drugs marketed prior to 1938 were exempt from regulation
Durham-Humphrey Amendment of 1951
-Established 2 classifications of drugs
-Prescription or legend drugs: drug that requires medical
supervision for safe use; did not require "adequate directions
for use" on the label from the manufacturer; adequate directions
for use is when the pharmacist places the directions on the label;
required "caution: federal law prohibits dispensing without a prescription"
- non prescription drugs or over the counter
-do not require medical supervision
-required adequate direction for use on the label
- provided for oral prescriptions and refills
Durham-Humphrey Amendment of 1951
-Established 2 classifications of drugs
Durham-Humphrey Amendment of 1951
-Prescription or legend drugs: drug that requires medical supervision
for safe use; did not require "adequate directions for use"
on the label from the manufacturer; adequate directions for use is
when the pharmacist places the directions on the label; required
"caution: federal law prohibits dispensing without a prescription
Durham-Humphrey Amendment of 1951
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Durham-Humphrey Amendment of 1951
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Kefauver-Harris Amendment of 1962
- drug efficacy amendment
-required all drugs marketed in the US be safe and effective
extended to products between 1938-1962
-Created Good Manufacturing Practice (GMP)
- Prescription drug advertising is the FDA (Food and Drug Administration)
-Nonprescription drugs advertising is the FTC (Federal Trade Commission)
-Required informed consent for research subject in clinical investigations
Kefauver-Harris Amendment of 1962
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Kefauver-Harris Amendment of 1962
-required all drugs marketed in the US be safe and effective extended
to products between 1938-1962
Kefauver-Harris Amendment of 1962
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Kefauver-Harris Amendment of 1962
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Kefauver-Harris Amendment of 1962
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Kefauver-Harris Amendment of 1962
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Comprehensive Drug Abuse Prevention and Control Act of 1970
- AKA Controlled Substance Act (CSA)
- Created 5 Schedules for controlled substances
-est. explicit record keeping and inventory requirements
-significant penalties for violating the CSA
Comprehensive Drug Abuse Prevention and Control Act of 1970
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Comprehensive Drug Abuse Prevention and Control Act of 1970
- Created 5 Schedules for controlled substances
Comprehensive Drug Abuse Prevention and Control Act of 1970
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Comprehensive Drug Abuse Prevention and Control Act of 1970
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Poison Prevention Packaging Act of 1970
-failure to comply with packaging requirements is considered misbranding
-legend drugs and controlled substances must be in child resistant
containers: exceptions are sublingual NTG, anhydrous cholestyramine,
oral contraceptives and pancrelipase
-OTC must be sold in child resistant packaging: except manufactors
may market one size of an OTC product for the elderly/ handicapped but
must say "this package for households without young children
Poison Prevention Packaging Act of 1970
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Poison Prevention Packaging Act of 1970
#NAME?
Poison Prevention Packaging Act of 1970
-OTC must be sold in child resistant packaging: except manufactors
may market one size of an OTC product for the elderly/ handicapped but
must say "this package for households without young children
Medical Device Amendment of 1976
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Medical Device Amendment of 1976
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Medical Device Amendment of 1976
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Medical Device Amendment of 1976
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Medical Device Amendment of 1976
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Orphan Drug Act of 1983
- provided tax and licensing incentives to manufacturers in exchange
for developing "orphan drugs"
-orphan drugs are used to treat rare diseases affect 1 in 200,000 people
Orphan Drug Act of 1983
- provided tax and licensing incentives to manufacturers in exchange
for developing "orphan drugs
Orphan Drug Act of 1983
-orphan drugs are used to treat rare diseases affect 1 in 200,000 people
Hatch-Waxman Amendment of 1984
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Hatch-Waxman Amendment of 1984
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Hatch-Waxman Amendment of 1984
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Hatch-Waxman Amendment of 1984
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Prescription Drug Marketing Act of 1987
- placed more stringent controls on the distribution of prescriptions
and samples by:
1. requiring licensing of prescription drug wholesalers
2. banned re-importation of prescription drugs produced in the US
3. banned the sale, trade or purchase of drug samples
4. specified storage, handling and record keeping requirements for
drug samples
5. prohibited resale of prescription drugs purchased by hospitals or
health care facilities
Prescription Drug Marketing Act of 1987
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Prescription Drug Marketing Act of 1987
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Prescription Drug Marketing Act of 1987
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Prescription Drug Marketing Act of 1987
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Prescription Drug Marketing Act of 1987
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Omnibus Reconciliation Act of 1990
-outlined expectations of the pharmacist with regards with patient interaction
-primary goal was to save the federal government money by improving
therapeutic outcomes:
1.pharmacist counseling obligations
2.prospective drug utilization review requirements
3.record keeping mandates
Omnibus Reconciliation Act of 1990
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Omnibus Reconciliation Act of 1990
-primary goal was to save the federal government money by improving
therapeutic outcomes:
1.pharmacist counseling obligations
2.prospective drug utilization review requirements
3.record keeping mandates
Health Insurance Portability and Accountability Act of 1996
-privacy rule component took place on April 14, 2003
-regulations designed to safeguard privacy of protected health info (PHI)
-imposed 5 key provisions
1. Pharmacies must take reasonable step to limit use, disclosure,
and the request of PHI
2. Individuals must be informed of the privacy practices of the pharmacies
3. a compliance officer within the pharmacy must be identified and
manage and ensure compliance
4. all employees must receive HIPAA training
5. when PHI disclosure is required it is disclosed to a second party
for the purposes only engaged by the pharmacy
Health Insurance Portability and Accountability Act of 1996
-privacy rule component took place on April 14, 2003
Health Insurance Portability and Accountability Act of 1996
#NAME?
Health Insurance Portability and Accountability Act of 1996
-imposed 5 key provisions
1. Pharmacies must take reasonable step to limit use, disclosure,
and the request of PHI
2. Individuals must be informed of the privacy practices of the pharmacies
3. a compliance officer within the pharmacy must be identified and
manage and ensure compliance
4. all employees must receive HIPAA training
5. when PHI disclosure is required it is disclosed to a second party
for the purposes only engaged by the pharmacy
FDA Modernization Act of 1997
-provided fast track review of some NDA's with the intent to expedite
approval of drugs used to treat serious or life threatening conditions
-clarification under extemporaneously compound prescriptions
-replaced prescription drug legend with "RX Only"
-removed the "warning-may be habit forming" labeling requirement
-encouraged manufacturers to conduct research for new uses for
currently approved drugs
-encouraged manufacturers to perform pediatric drug studies
FDA Modernization Act of 1997
-provided fast track review of some NDA's with the intent to expedite
approval of drugs used to treat serious or life threatening conditions
FDA Modernization Act of 1997
#NAME?
FDA Modernization Act of 1997
-replaced prescription drug legend with "RX Only
FDA Modernization Act of 1997
-removed the "warning-may be habit forming" labeling requirement
FDA Modernization Act of 1997
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FDA Modernization Act of 1997
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Medicare Prescription Drug Improvement and Modernization Act of 2003
- AKA Medicare Modernization Act (MMA)
- encompasses four programs A, B, C, and D
-established formal medication therapy management programs
Medicare Prescription Drug Improvement and Modernization Act of 2003
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Medicare Prescription Drug Improvement and Modernization Act of 2003
- encompasses four programs A, B, C, and D
Medicare Prescription Drug Improvement and Modernization Act of 2003
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Combat Methamphetamine Epidemic Act of 2005
-part of the patriot act
-regulates retail over the counter sales of ephedrine,
pseudoephedrine, and phenylpropanolamine products:
1. sales limits and record keeping
2. regulated product placement
3. set minimum age requirements for purchasers
4. required packaging for manufactures
5. self certification for sellers
Combat Methamphetamine Epidemic Act of 2005
#NAME?
Combat Methamphetamine Epidemic Act of 2005
-regulates retail over the counter sales of ephedrine,
pseudoephedrine, and phenylpropanolamine products:
1. sales limits and record keeping
2. regulated product placement
3. set minimum age requirements for purchasers
4. required packaging for manufactures
5. self certification for sellers
Medicaid Tamper-Resistant Prescription Law of 2007
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Food and Drug Administration Amendments of 2007
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Food and Drug Administration Amendments of 2007
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Food and Drug Administration Amendments of 2007
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Food and Drug Administration Amendments of 2007
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Patient Protection and Affordable Care Act of 2010
-requires all individuals have health insurance
-requires standards for financial and administrative transactions
-timely and transparent claims using standard electronic transaction format
-stops agreements between manufacturers that limits or delays
competition by generics
-phases out the catastrophic threshold "donut hole" for
medicare part D
Patient Protection and Affordable Care Act of 2010
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Patient Protection and Affordable Care Act of 2010
#NAME?
Patient Protection and Affordable Care Act of 2010
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Patient Protection and Affordable Care Act of 2010
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Patient Protection and Affordable Care Act of 2010
-phases out the catastrophic threshold "donut hole" for
medicare part D
Drug Quality and Security Act of 2013
-address issues related to oversight of prescription compounding and
establishes standards for a national "track and trace"
systems for drug distribution
-created voluntary registration for "outsourcing facilities"
-Outsourcing facilities are:
1. subject to certain requirements similar to those that currently
govern traditional drug manufacturers
2. subject t inspection by the FDA
-est. a 10 year plan to electronically track each drug product unit
from the manufacturer all the way to the patient
Drug Quality and Security Act of 2013
-address issues related to oversight of prescription compounding and
establishes standards for a national "track and trace"
systems for drug distribution
Drug Quality and Security Act of 2013
-created voluntary registration for "outsourcing facilities"
-Outsourcing facilities are:
1. subject to certain requirements similar to those that currently
govern traditional drug manufacturers
2. subject t inspection by the FDA
Drug Quality and Security Act of 2013
-est. a 10 year plan to electronically track each drug product unit
from the manufacturer all the way to the patient