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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