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PHARMACY LAWS
- 1914 Harrison Tax Act
- In response to growing addiction to opiates and
cocaine containing medicines, this act establishes
that manufacturers, pharmacists, importers, and
physicians prescribing narcotics should be licensed
and required to pay a tax
- In response to growing addiction to opiates and
cocaine containing medicines, this act establishes
that manufacturers, pharmacists, importers, and
physicians prescribing narcotics should be licensed
and required to pay a tax
- Food, Drug, and Cosmetic
Act of 1938 (FDCA 1938)
- Created the FDA (Food and Drug
Administration)
- In response to the fatal poisoning of
107 people by an untested
sulfanilamide concoction
- All narcotics are required to be labeled
"Warning: May be habit-forming"
- New Drug Approval
- Phase 1
- 20-100 patients
- Time: several months
- Purpose: safety
- 20-100 patients
- Phase 2
- several hundred patients
- Time: several years
- Purpose: effectiveness and
short-term safety
- several hundred patients
- Phase 3
- Several hundred to
several thousand
patients
- Time: 1-4 years
- Purpose: safety, dosage,
effectiveness
- Several hundred to
several thousand
patients
- Phase 1
- Created the FDA (Food and Drug
Administration)
- Durham-Humphrey Act of 1951
- Separated drugs into two categories:
legend and nonlegend (OTC)
- Defines what drugs require a prescription by
a licensed practioner
- Prescribed drugs are required to have a label "Caution:
Federal law prohibits dispensing without a prescription"
- Allows verbal prescriptions
over the telephone
- Allows refills to be called in from a
physician's phone
- Separated drugs into two categories:
legend and nonlegend (OTC)
- Kefauver-Harris Amendment of 1962
- Requires all medications in the US to be pure,
safe, and effective
- Established procedures for both drug
applications and investigation drugs
- Signed into law because a new sleeping pill
containing the drug thalidomide was found to cause
severe birth defects when used by pregnant women
- Requires all medications in the US to be pure,
safe, and effective
- Food and Drug Act of 1906
- Prohibits the interstate transportation
or sale of adulterated and misbranded
food or drugs
- Prohibits the interstate transportation
or sale of adulterated and misbranded
food or drugs
- Controlled Substances
Act of 1970
- Classifies five levels of
controlled substances that
have potential for abuse
and therefore restricts
their distribution
- Classifies five levels of
controlled substances that
have potential for abuse
and therefore restricts
their distribution
- Poison Prevention
Packaging Act of 1970
- Enacted to reduce accidental
poisoning in children
- Non-childproof containers may only
be used if the prescriber or patient
requests one
- Some medications do not require child
proof containers
- ex. sublingual nitroglycerin tablets, oral
contraceptives...
- ex. sublingual nitroglycerin tablets, oral
contraceptives...
- Enacted to reduce accidental
poisoning in children
- Occupational Safety and
Health Act of 1979
- Created the Occupational Safety
and Health Administration (OSHA)
- Ensures a safe and
healthful
workplace for all
employees
- Requires a reporting system for job related injuries
- Established universal precautions
- Attempts to reduce hazards in the workplace
- Requires use of Safety Data Sheets (SDS) formerly
known as MSDS
- Created the Occupational Safety
and Health Administration (OSHA)
- Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) of 1984
- Allows for both the extension of drug patent terms and
quicker introduction of lower cost generic drugs
- Allows for both the extension of drug patent terms and
quicker introduction of lower cost generic drugs
- Anabolic Steroid Control Act of 1990
- Enacted harsher penalties for the abuse of
anabolic steroids and their misuse by athletes
- Enacted harsher penalties for the abuse of
anabolic steroids and their misuse by athletes
- Prescription Drug Marketing Act of 1987
- Forbids the sale or distribution of samples to
anyone other than those licensed to prescribe
them
- Requires drug wholesalers to be licensed by the state
- Forbids the sale or distribution of samples to
anyone other than those licensed to prescribe
them
- Omnibus Budget Reconciliation Act (OBRA) of 1987
- Established revisions to Medicare and Medicaid
Conditions of Participation regarding long-term care
facilities and pharmacy
- Established revisions to Medicare and Medicaid
Conditions of Participation regarding long-term care
facilities and pharmacy
- Omnibus Budget Reconciliation Act (OBRA) of 1990
- Offer counseling to patients regarding medications
- Offer counseling to patients regarding medications
- Health Insurance Portability and Accountability Act (HIPAA) of 1996
- Requires that health care providers ensure
that patient confidentiality be maintained
- Establishes conditions on the use and the disclosure of
protected health information (PHI) and requires patient
notification on how their PHI will be used
- Requires that health care providers ensure
that patient confidentiality be maintained
- Isotretinoin Safety and Risk Management Act of 2004
- Mandatory registry of all
patients, practitioners, and
pharmacists
- Monthly education of patients, both male and
female, regarding the need to avoid pregnancy
- Female patients need to have monthly pregnancy testing
- Female patients need to have monthly pregnancy testing
- No internet, phone, or mail order
prescription may be filled
- Yearly evaluation of treatment to ensure
compliance with program
- 30 day prescription
allotments
- Mandatory registry of all
patients, practitioners, and
pharmacists
- Combat Methamphetamine Epidemic Act of 2005
- Establishes strict controls on OTC sales
of pseudoephedrine, ephedrine, and
phenylpropanolamine
- 3.6g/day base product sales limit, a 9g/30day base
product purchase limit, a blister package requirement,
and mail order restrictions
- Establishes strict controls on OTC sales
of pseudoephedrine, ephedrine, and
phenylpropanolamine
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