Drug law & regulations

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  • Forms, ordering, disposal, storage
  • Drug law & regulations

    1. 1. Development of Drug Regulations FDA Food & Drug Administration FTC Federal Trade Commission DEA Drug Enforcement Agency
    2. 3. A Timeline <ul><li>1906 Pure Food and Drug Act </li></ul><ul><li>1938 Food, Drug and Cosmetic Act </li></ul><ul><li>1951 Durham-Humphrey Amendment </li></ul><ul><li>1962 Kefauver-Harris Amendment </li></ul><ul><li>1970 Controlled Substances Act </li></ul><ul><li>1990 Omnibus Budget Reconciliation Act </li></ul><ul><li>1996 Health Insurance Portability & Accountability Act (HIPAA) </li></ul>
    3. 4. Controlled Substances <ul><li>Schedule I </li></ul><ul><ul><li>Heroin,THC </li></ul></ul><ul><li>Schedule II </li></ul><ul><ul><li>Methadone </li></ul></ul><ul><li>Schedule III </li></ul><ul><ul><li>Valium, Vicodin </li></ul></ul><ul><li>Schedule IV </li></ul><ul><ul><li>Alprazolam, Darvocet </li></ul></ul><ul><li>Schedule V </li></ul><ul><ul><li>Lomotil </li></ul></ul>
    4. 7. Security Rx Form Tamper Resistant Features <ul><li>Thermochromic ink </li></ul><ul><ul><li>Symbl/text temp. changes color w/heat </li></ul></ul><ul><li>Single or Multiple Drug Statement </li></ul><ul><li>Description of security features </li></ul><ul><ul><li>Required by law </li></ul></ul><ul><li>Refills/DNS/Unit/Quantity Check box </li></ul><ul><li>Opaque Writing </li></ul><ul><ul><li>Disappears if rx is lightened </li></ul></ul>
    5. 8. More Security Components <ul><li>Prescriber information </li></ul><ul><li>Batch/Lot Number </li></ul><ul><li>Latent Repetitive Void </li></ul><ul><ul><li>Appears if scanned, copied, or faxed </li></ul></ul><ul><li>Watermark </li></ul><ul><ul><li>California Security Prescription printed on back, seen at an angle </li></ul></ul><ul><li>Chemical Void Appears </li></ul><ul><ul><li>prevents chemical washing </li></ul></ul>
    6. 11. Public Safety ~ Recalls <ul><li>Adverse Effect </li></ul><ul><li>Recall </li></ul><ul><li>Classification </li></ul><ul><ul><li>Class I </li></ul></ul><ul><ul><li>Class II </li></ul></ul><ul><ul><li>Class III </li></ul></ul><ul><li>Reports of adverse reaction </li></ul><ul><li>Manufact. Agrees </li></ul><ul><li>Patients contacted </li></ul><ul><li>Publicly listed </li></ul>
    7. 12. LABELING Legend Drugs Over-the-counter(OTC) <ul><li>Prescription ONLY </li></ul><ul><li>Legend Statement </li></ul><ul><ul><li>‘ Federal law prohibits dispensing of this drug without a prescription’ </li></ul></ul><ul><li>Transfer Warning </li></ul><ul><ul><li>‘ State or federal law prohibits the transfer of this drug to any person other than the person to whom it was prescribed’ </li></ul></ul><ul><li>Prescription is not required </li></ul><ul><ul><li>Safe,effective </li></ul></ul><ul><ul><li>Taken w/o medical supervision </li></ul></ul><ul><ul><li>Dose low (Why?) </li></ul></ul><ul><ul><li>Negligible abuse potential </li></ul></ul><ul><ul><ul><li>Maybe???? </li></ul></ul></ul>
    8. 13. California State Board of Pharmacy <ul><li>Over site agency </li></ul><ul><li>Consumer Affairs Department </li></ul><ul><li>Licensure Requirements </li></ul><ul><li>Board Inspections </li></ul><ul><li>Disciplinary action </li></ul><ul><li>www.pharmacy.ca.gov </li></ul>

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