Pharm: Controlled Substances And Generic Products

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Schedule I

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drugs with high potential for abuse and no accepted medical use in the US (LSD,heroin,mescaline)

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Schedule II

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drugs with high potential for abuse that also have an accepted medical use; very likely to produce severe psychological and/or physical dependence (amphetamine, morphine, meperidine, secobarbital, fentanyl)

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Schedule III

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drugs with a lesser potential for abuse than I and II; have potential to produce less serious dependence than II (acetaminophen w/codeine products, aspirin w/codeine products)

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Schedule IV

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drugs with less potential for abuse than III, have potential for moderate dependence (diazepam, phenobarbital)

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Schedule V

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drugs with lowest abuse potential; some may be sold in a licensed pharmacy without prescription (diphenoxylate w/atropine, guafenesin w/codeine)

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Hatch-Waxman Amendments (1984) to Federal Food Drug and Cosmetic Act (FFD&C)

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established the current generic industry, allowed generic firms to rely on findings of safety and efficacy of innovator drug after expiration of patents

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bioequivalence

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pharmaceutical equivalents whose rate and extent of absorption are not statistically different when administered to patients or subjects at the same molar dose under similar experimental conditions

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bioavailability

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the rate and extent to which an active drug ingredient is absorbed from a drug product (and becomes available at the site of drug action)