I-Pharmacy Law

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Pure Food and Drug Act of 1906

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to protect people from unsanitary and poorly labeled food

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Food, Drug and Cosmetic Act of 1938

Back 2

suggests that new drug can be marketed until proven safe by the DFA for public use

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Durham Humphrey Amendment of 1951

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-also known as Prescription Drug Ammendment
-differentiates bet prescription & OTC drugs
-authorizes oral prescriptions and prescription refillls
-suggest thet each drug should be labeled"Caution:Federal law prohibits dispensing without a prescription."

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Kefauver Harris Amendment of 1962

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-Drug Efficacy Amendment
-new approved drugs must be safe as well as effective
-Good Manufacturing Practice Requirements

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Medical Device Amendment of 1976

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-classification of medical devices
-safety and efficacy of medical devices

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Orphan Drug Act of 1983

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-passed for orphan drugs (drugs for diseases that affect very few people);to provide tax relief and other incentives for the manufacturers to develop & market orphan drugs

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Drug Price Competition & Patent Term Restoration Act of 1984

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-Waxman Hatch Amendment
-to make generic drugs more readily available to the public
-provides more incentive to innovative pharmaceutical companies & encourages them to develop new drugs

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National Drug Code Number

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- 10-11 letters

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1st 2 chars of NDC

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name of the manufacturer/distributor

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middle 4 chars of NDC

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drug name strength

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last 2 chars of NDC

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identify the package

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OTC Drug Category 1

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includes ings generally considered safe, effective and not misbranded

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OTC Drug Category II

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includes ings that are not considered safe, effective & not misbranded

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OTC Drug Category III

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includes ings for w/c data are insufficient to permit the classification

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OBRA Act of 1990

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-Omnibus Budget Reconciliation Act of 1990
-reqiures that pharmacist should offer patient counseling

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Therapeutic Equivalence Coding
AA

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available in conventional dosage forms and have no bioequivalence standards

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Therapeutic Equivalence Coding
AT

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topical drugs that meet bioequivalence standards

Front 18

Therapeutic Equivalence Coding
AB

Back 18

meeting the necessary bioequivalence requirement

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Therapeutic Equivalence Coding
BC

Back 19

extended release dosage form with bioequivalence issues

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Therapeutic Equivalence Coding
BT

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topical drugs with bioequivalence issues

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Therapeutic Equivalence Coding
BX

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adequate information not available to determine the bioequivalency

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Poison Prevention Act

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to prevent the death of children from accidental poisoning; passed in 1973; indicates that all dispensed drugs must required to be in a child proof container

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Schedule II controlled Drugs

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-cannot be refilled in any circumstances

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Partial filling of Schedule II drugs should be dong within

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72 hours of initial filling

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form required to order shedule II drugs

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DEA 222

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Controlled III, IV and V Drugs cannot be refilled

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more than 5X

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Controlled III, IV and V Drugs cannot be filled for the prescription older than

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6 months

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Dispensing Controlled III, IV and V do not require what form to fill the order

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DEA 222

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Form needed to destroy controlled Substance

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DEA 41