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Drug law & regulations

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  • Forms, ordering, disposal, storage
  • Transcript

    • 1. Development of Drug Regulations FDA Food & Drug Administration FTC Federal Trade Commission DEA Drug Enforcement Agency
    • 2.  
    • 3. A Timeline
      • 1906 Pure Food and Drug Act
      • 1938 Food, Drug and Cosmetic Act
      • 1951 Durham-Humphrey Amendment
      • 1962 Kefauver-Harris Amendment
      • 1970 Controlled Substances Act
      • 1990 Omnibus Budget Reconciliation Act
      • 1996 Health Insurance Portability & Accountability Act (HIPAA)
    • 4. Controlled Substances
      • Schedule I
        • Heroin,THC
      • Schedule II
        • Methadone
      • Schedule III
        • Valium, Vicodin
      • Schedule IV
        • Alprazolam, Darvocet
      • Schedule V
        • Lomotil
    • 5.  
    • 6.  
    • 7. Security Rx Form Tamper Resistant Features
      • Thermochromic ink
        • Symbl/text temp. changes color w/heat
      • Single or Multiple Drug Statement
      • Description of security features
        • Required by law
      • Refills/DNS/Unit/Quantity Check box
      • Opaque Writing
        • Disappears if rx is lightened
    • 8. More Security Components
      • Prescriber information
      • Batch/Lot Number
      • Latent Repetitive Void
        • Appears if scanned, copied, or faxed
      • Watermark
        • California Security Prescription printed on back, seen at an angle
      • Chemical Void Appears
        • prevents chemical washing
    • 9.  
    • 10.  
    • 11. Public Safety ~ Recalls
      • Adverse Effect
      • Recall
      • Classification
        • Class I
        • Class II
        • Class III
      • Reports of adverse reaction
      • Manufact. Agrees
      • Patients contacted
      • Publicly listed
    • 12. LABELING Legend Drugs Over-the-counter(OTC)
      • Prescription ONLY
      • Legend Statement
        • ‘ Federal law prohibits dispensing of this drug without a prescription’
      • Transfer Warning
        • ‘ State or federal law prohibits the transfer of this drug to any person other than the person to whom it was prescribed’
      • Prescription is not required
        • Safe,effective
        • Taken w/o medical supervision
        • Dose low (Why?)
        • Negligible abuse potential
          • Maybe????
    • 13. California State Board of Pharmacy
      • Over site agency
      • Consumer Affairs Department
      • Licensure Requirements
      • Board Inspections
      • Disciplinary action
      • www.pharmacy.ca.gov

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