Drug law & regulations
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Transcript of Drug law & regulations
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Development of Drug Regulations
FDAFDA Food & Drug Administration
FTCFTC Federal Trade Commission
DEADEA Drug Enforcement Agency
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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)
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Controlled Substances Schedule I
Heroin,THC Schedule II
Methadone Schedule III
Valium, Vicodin Schedule IV
Alprazolam, Darvocet Schedule V
Lomotil
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Security Rx FormTamper 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
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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
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Public Safety ~ Recalls Adverse Effect Recall Classification
Class I Class II Class III
Reports of adverse reaction
Manufact. Agrees
Patients contacted
Publicly listed
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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????
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California State Board of Pharmacy
Over site agency Consumer Affairs Department Licensure Requirements Board Inspections Disciplinary action www.pharmacy.ca.gov