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Federal Pharmacy Laws

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quasizen's version from 2015-06-25 06:30

Important Federal Acts

Question Answer
this prohibited interstate commerce in misbranded and adulterated foodsPure Food and Drug Act of 1906
this act defined the terms of misbranding and adulterationPure Food and Drug Act of 1906
this act is considered the beginning of the FDAThe Pure Food and Drug Act of 1906
this was a US federal law that regulated and taxed production, importation, distribution, and use of opiatesHarrison Narcotics Tax Act of 1914
this act served as a replacement of the Pure Food and Drug Act of 1906Food, Drug, and Cosmetic Act of 1938
weakness of 1906 actdid not prohibit false therapeutic claims
this act eliminated the Shirley Amendment requirement to prove intent to defraudFood, Drug, and Cosmetic Act
this act required new drugs to be shown safe before marketingFood, drug, and Cosmetic Act
this Act is AKA the Prescription Drug AmendmentDurham-Humphrey Amendment of 1951
this act established two classes of drugs --Rx and OTCDurham-Humphrey Amendment of 1951
this act established verbal orders and refillsDurham-Humphrey Amendment of 1951
this act established what minimal information should go on a labelDurham-Humphrey Amendment of 1951
this is aka the Efficacy AmendmentKefauver-Harris Amendment of 1962
this amendment came around during the time of thalidomideKefauver-Harris Amendment of 1962
this amendment established drug discovery, phase 1, 2, 3 studiesKefauver-Harris Amendment of 1962
this was passed by Congress --provides for classification, acquisition, distribution, registration/verification of controlled SubstancesComprehensive Drug Abuse Prevention and Control Act of 1970
this act provided the legal framework for the DEAComprehensive Drug Abuse Prevention and Control Act of 1970
this act created OSHA and NIOSHOccupational Safety and Health Act of 1970
these were signed in 1976 to amend the Food, Drug, and Cosmetic ActMedical Device Amendments of 1976
this was designed to eliminate the deficiencies that occurred with medical devices and pacemakersMedical Device Amendments of 1976
this act defined devices similarly do drugsMedical Device Amendments of 1976
this act created different device classesMedical Device Amendments of 1976
this act was created after poisoning from TylenolFederal Antitampering Act of 1983
this act was created to make sure that drugs are created for diseases that affect fewer than 200,000 people or low prevalenceOrphan Drug Act of 1983
this act sets forth the process by which marketers of generic drugs file ANDAsDrug Price Competition and Patient-Term Restoration Act of 1984
this act defines samplesPDMA of 1987
this OBRA Act was enacted to protect the rights of LTC patientsOBRA-87
this act was intended to minimize the use of anabolic steroids for non-medical usesAnabolic Steroids Control Act of 1990
this act involves counseling obligations, ProDUR, record-keepingOBRA-90
this act defines dietary supplementsDSHEA 1994
this act involves privacy rules, PHI, etc.HIPAA 1996
this act was designed to regulate PSECombat Methamphetamine Epidemic Act of 2005
memorize

Federal CS

Question Answer
Class that has high potential for abuse, no accepted medical useCI
this class has high potential for abuse, sufficient medical use justify RxCII
this class has potential risk for abuse, misuse, and dependenceCIII
this class has low potential for abuse and limited risk of dependenceCIV
this class has low potential for abuse and misuseCV
this schedule must be ordered on a DEA 222 formCII
pharmacy retains which sheet of DEA 222third sheet
these schedules can be ordered by a pharmacy on a general formIII-IV
DEA is affiliated with this departmentUS Department of Justice
this is the name of the ordering system for CIIsControlled Substances Ordering System (CSOS)
how long does the supplier have to notify DEA about order2 business days
are CS shipped in separate containers?yes
how are CII stored?separate in a secure place or disbursed throughout
if a theft of a CS occurs, do thiscontact the local police, DEA, BNE
type of DEA form for CS theftDEA form 106
memorize

CMEA

Question Answer
how long must you keep PSE logbook?2 years
three drugs regulated by CMEAephedrine, PSE, phenylpropanolamine
max PSE per day3.6g
max PSE per 30 days9g
monthly limit of PSE via mail order7.5g
memorize