The pharmaceutical industry - drug classification

The pharmaceutical industry - drug classification - 1 The...

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Unformatted text preview: 1 The Pharmaceutical Industry: Drug Classification 71 FDA Drug Classification Class 1- New molecular entity Class 2- New ester, new salt, or other noncovalent derivative Class 3- New formulation Class 4- New combination Class 5- New manufacturer Class 6 - New Indication Class 7- Drug already marketed, but without an approved NDA 2 72 Drug Classifications Drugs are also classified in many other ways: By the way they are dispensed OTC or Prescription By the substance by which they are derived Plant, mineral or animal By the way they are administered Mouth, injection, inhalation or applied to the skin By the form they take Capsule, liquid or gas 73 Drug Classifications Drugs are classified in many other ways, cont: By their name Chemical, generic or proprietary name, or brand or trade name By the way they act toward disease or disorders Chemotherapeutic or Pharmocodynamic By its potential for abuse Schedule I to V class of drugs By the effect on a particular area of the body or a particular condition Most common 3 74 Drug Schedules From: http://www.deadiversion.usdoj.gov/schedules/schedules.htm -The Controlled Substance Act regulates the manufacture and distribution of drugs, and places all drugs into one of five schedules (21 CFR 1300): According to US Drug Enforcement Agency 1. SCHEDULE I Has no current accepted medical use Has a high potential for abuse Examples: Heroin, Methaqualone, LSD 2. SCHEDULE II Has current accepted medical use Has high potential for abuse Examples: Dilaudid, Demerol, Methadone, Cocaine, PCP, Morphine 3. SCHEDULE III Has current accepted medical use Has medium potential for abuse Examples: Opium, Vicodan, Tylenol w/codeine 4. SCHEDULE IV Has current accepted medical use Has low potential for abuse Examples: Darvocet, Xanax, Valium, Halcyon, Ambien, Ativan 5. SCHEDULE V Has accepted medical use Drug has lowest potential for abuse Examples: Lomotil, Phenergan, and liquid suspensions...
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The pharmaceutical industry - drug classification - 1 The...

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