Pharmacy Law & Regulations
Study online at https://quizlet.com/_hui4q5
1. Pure Food & Drug Act of 1906: Enacted to prohibit the interstate transportation or sale of adulterated
and misbranded food or drugs.
2. Pure Food & Drug Act of 1938 (FDCA 1938): * The U.S. Food and Drug Administration (FDA)
was created under FDCA 1938.
* All new drug applications must be filed with the FDA.
*Clearly defined adulteration and misbranding of drugs & food products.
3. Adulteration: Containing unsafe additives, filthy, nasty, decomposed substance, prepared or packed in un-
sanitary conditions, misrepresenting a label.
4. Misbranding: Labeling that is false or misleading, packaging doesn't have a label, failure to carry a label
indicating "Warning-may be habit forming" if the product is habit forming, failure to label directions of use.
5. Durham-Humprhey ACT of 1951: *All products must have adequate directions for use unless they
contain federal legend "Caution: Federal law prohibits dispensing without a prescription."
* separated drugs into two categories: legend and nonlegend (OTC)
*A legend drug requires a prescription, but a nonlegend doesn't
*Allows verbal prescriptions, over the telephone
*Allows refills to be called in from a physician's office
6. Kefauver-Harris Amendment of 1962: *Requires all medications in the U.S. to be pure, safe, and
effective
* Established procedures for both drug applications and investigational drugs
* Drug manufacturers are required to be responsible for Good Manufacturing Process
7. Comphrensive Drug Abuse Prevention And Control Act of 1970: (DEA) The Drug
Enforcement Agency was created. Controlled substances are placed in one of five schedules based on potential abuse
and accepted medical use in the U.S.
8. Schedule I: No accept medical use in the U.S.
Examples of Schedule I narcotics:
Crack, crystal methamphetamine, ecstacy, hashish, hash oil, heroin, marijuana, opium, peyote. (Note: There are more,
but I just didn't list them all.)
9. Schedule II: Schedule II medications have a medical use, but have a high potential for abuse and severe
psychological or pyshical dependency.
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Study online at https://quizlet.com/_hui4q5
1. Pure Food & Drug Act of 1906: Enacted to prohibit the interstate transportation or sale of adulterated
and misbranded food or drugs.
2. Pure Food & Drug Act of 1938 (FDCA 1938): * The U.S. Food and Drug Administration (FDA)
was created under FDCA 1938.
* All new drug applications must be filed with the FDA.
*Clearly defined adulteration and misbranding of drugs & food products.
3. Adulteration: Containing unsafe additives, filthy, nasty, decomposed substance, prepared or packed in un-
sanitary conditions, misrepresenting a label.
4. Misbranding: Labeling that is false or misleading, packaging doesn't have a label, failure to carry a label
indicating "Warning-may be habit forming" if the product is habit forming, failure to label directions of use.
5. Durham-Humprhey ACT of 1951: *All products must have adequate directions for use unless they
contain federal legend "Caution: Federal law prohibits dispensing without a prescription."
* separated drugs into two categories: legend and nonlegend (OTC)
*A legend drug requires a prescription, but a nonlegend doesn't
*Allows verbal prescriptions, over the telephone
*Allows refills to be called in from a physician's office
6. Kefauver-Harris Amendment of 1962: *Requires all medications in the U.S. to be pure, safe, and
effective
* Established procedures for both drug applications and investigational drugs
* Drug manufacturers are required to be responsible for Good Manufacturing Process
7. Comphrensive Drug Abuse Prevention And Control Act of 1970: (DEA) The Drug
Enforcement Agency was created. Controlled substances are placed in one of five schedules based on potential abuse
and accepted medical use in the U.S.
8. Schedule I: No accept medical use in the U.S.
Examples of Schedule I narcotics:
Crack, crystal methamphetamine, ecstacy, hashish, hash oil, heroin, marijuana, opium, peyote. (Note: There are more,
but I just didn't list them all.)
9. Schedule II: Schedule II medications have a medical use, but have a high potential for abuse and severe
psychological or pyshical dependency.
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