unit test 1-3
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| pure food and drug act of 1906-- PURITY | act was to prohibit the interstate transportation or sale of adulterated and misbranded(contaminated) food or drugs
requires labels not contain false information about the drug's strength and purity
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| Food, Drug, and cosmetic act of 1938--SAFETY | created the FDA and required pharmaceutical manufactures to file a NDA with each new drug. Manufactures needed to prove that the drug was SAFE for use by humans.
--safe for human consumption but not effective
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| Durham-Humphrey amendment of 1951--LEGEND DRUGS | stated that drug stock container do not have to include "adequate directions for use" as long as they bear the legend "Caution: Federal Law Prohibit Dispensing without Prescription."
separated prescription drugs and OTC drugs
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| Kafauver-Harris amendment of 1962--DRUGS SAFE AND EFFECTIVE | Amendment requires that drugs not only be safe for humans but also effective.
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| Comprehensive Drug Abuse Prevention and Control Act of 1970--CONTROLLED SUBSTANCES | Created to combat and control drug abuse. Classified drugs with potential for abuse as controlled substances and ranked them into five categories or schedules. DEA is responsible for this act.
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| Poison Prevention Packaging Act of 1970 (PPPA)--CHILD RESISTANCE CONTAINERS | Prevent accidental childhood poisoning form prescription and nonprescription products. Child- resistant container.
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| Drug Listing Act of 1972-- NDC NUMBER | The FDA has a list of currently marketed drugs-- each new drug is assigned a unique and permanent product code, known as a NDC, consisting of 10 characters that identify the manufacture or distributor.
0000-00-000
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| Orphan Drug Act of 1983 | Encourage the development of orphan drugs by providing tax incentives and allowing manufactures to be granted a time for exclusive licenses to market such drugs
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| Drug Price Competition and Patent-Term Restoration Act of 1984 | Also known as the Waxman-Hatch Act encouraged the creation of both generic drugs and innovative new drugs by streamlining the process for generic drug approval and by extending patent licenses as a function of the time required for the NDA approval proces
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| Prescription Drug Marketing Act of 1987 | Prohibits the re-importation of a drug into the US by anyone except the manufacturer. Also, prohibits the sale of trading of drug samples.
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| Anabolic Steroid Act of 1990 | (illegal) Anabolic steroids are a synthetic version of human hormone testerone. act identifies anabolic steroids a schedule 3 class of drugs and allows the FDA to enforce the law for legal drugs as well as illegal imports.
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| Omnibus Budget Reconciliation Act of 1990(OBRA-90)--DRUG UTILIZATION REVIEW (DUR) | Requires that, as condition of participating in the state medicaid reimbursement program, states must establish standards of practice for drug utilization review (DUR) by pharmacist. meaning give counseling regarding medication
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| Dietary supplement health and education act of 1994 (DSHEA) | Unlike prescription and OTC drugs, manufactures are not required by law to prove safety, efficacy, or standardization to the FDA. FDA many only review "false claims" avertisements and monitor safety.
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| Health Insurance Portability and Accountability Act of 1996--PATIENT CONFIDENTIALITY | HIPAA mostly affects confidentiality of patient's medical records including prescription records
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| Food and Drug Administration Modernization Act 2004 | products labeled with "Caution: Federal Law Prohibits Dispensing without a Prescription" were changed to read "[Rx Only]"
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| medicare prescription drug, improvement, and modernization act of 2003 | providing prescription drug coverage to patients eligible for medicare benefits.
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| combat methamphetamine epidemic act of 2005 | designed to reduce the availability of drugs used to illegally produce meth amphetamine--pseudoephedrine
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