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Federal Law
Federal Laws That Affect Pharmacy
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Federal Law, Pharmacy Law & Time
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Federal Laws That Affect Pharmacy
Hazardous Substances Labeling Act
JCAHO (Joint Commission on Accreditation of Health Care Organizations
The Anabolic Steroids Control Act of 1990
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Federal Laws That Affect Pharmacy
Click Here to Print Topic Help File , .pdf
(Internet Access is Required for this Feature)
Click Here for Glossary Index!
1906: The Pure Food and Drug Act "PFDA"
Required all foods and drugs to meet a standard of strength and purity
1914: The Harrison Narcotic Act
Regulated drugs that produced or sustain physical or psychological dependence. The
importation, sale, manufacture and use of:
Opium
Marijuana
Synthetic agents
Derivatives
1938: The Federal Food, Drug, and Cosmetic Act (FFDDCA)
Required that:
Manufacturers of drugs and cosmetics must prove that their products are safe
Medical devices must be proved effective
Gave the FDA limited authority to remove products from the marketplace if they are found
to be ineffective or unsafe
1952: The Durham-Humphrey Amendments to the FFDCA
Further clarified the distinction between prescription and over-the-counter (OTC) drugs
based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially
harmful
Required a physician's consent in order to dispense refills, giving rise to the legend,
"Caution: Federal law prohibits dispensing without a prescription" must be affixed to
prescription containers for Schedules II-IV
1962: The Kewfauver-Harris Amendments to the FFDCA
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Required drug manufactures to prove the safety and efficacy of their products before
approval was given by the FDA for marketing
Hazardous Substances Labeling Act
1970: Poison Prevention Packaging Act
Requires child-proof packaging
1970: Controlled Substances Act (CSA)
Classified drugs based on their potential for abuse Schedule I, II, III, IV, & V
JCAHO (Joint Commission on Accreditation of Health Care
Organizations
The mission of the JCAHO is to improve the quality of care provided to the general public
1990: Omnibus Budget Reconciliation Act (OBRA-90)
Required Pharmacists to offer counseling to Medicaid patients regarding medications
The Anabolic Steroids Control Act of 1990
Places "any drug or hormonal substance chemically and pharmacologically related to
testosterone under regulatory provisions of the Controlled Substance Act
1997: FDA Modernization Act
Changed the legend requirements to "Rx Only" to be phased in by February 2003
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