Question | Answer |
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 |