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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