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unit test 1-3

QuestionAnswer
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
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
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
Kafauver-Harris amendment of 1962--DRUGS SAFE AND EFFECTIVE Amendment requires that drugs not only be safe for humans but also effective.
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.
Poison Prevention Packaging Act of 1970 (PPPA)--CHILD RESISTANCE CONTAINERS Prevent accidental childhood poisoning form prescription and nonprescription products. Child- resistant container.
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
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
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
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.
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.
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
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.
Health Insurance Portability and Accountability Act of 1996--PATIENT CONFIDENTIALITY HIPAA mostly affects confidentiality of patient's medical records including prescription records
Food and Drug Administration Modernization Act 2004 products labeled with "Caution: Federal Law Prohibits Dispensing without a Prescription" were changed to read "[Rx Only]"
medicare prescription drug, improvement, and modernization act of 2003 providing prescription drug coverage to patients eligible for medicare benefits.
combat methamphetamine epidemic act of 2005 designed to reduce the availability of drugs used to illegally produce meth amphetamine--pseudoephedrine