PHARMACY LAW &
REGULATIONS|UPDATED QUESTIONS AND
VERIFIED ANSWERS
GRADED A+
QUESTIONS & ANSWERS
Pure Food & Drug Act of 1906. ANSWER -Enacted to prohibit the interstate
transportation or sale of adulterated and misbranded food or drugs.
Pure Food & Drug Act of 1938 (FDCA 1938). ANSWER -* 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.
Adulteration. ANSWER -Containing unsafe additives, filthy, nasty, decomposed
substance, prepared or packed in unsanitary conditions, misrepresenting a label.
Misbranding. ANSWER -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.
Durham-Humprhey ACT of 1951. ANSWER -*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
, Kefauver-Harris Amendment of 1962. ANSWER -*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
Comphrensive Drug Abuse Prevention And Control Act of 1970. ANSWER -(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.
Schedule I. ANSWER -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.)
Schedule II. ANSWER -Schedule II medications have a medical use, but have a high
potential for abuse and severe psychological or pyshical dependency.
Examples of Scedule II drugs: Adderall, Amytal, Cocaine, Codeine, Demerol, Ritalin.
(Note: There are more Schedule II drugs.)
Schedule III. ANSWER -Schedule III drugs have accepted medical use, and the
abuse potential is less than with Schedule I and II drugs.
Schedule IV. ANSWER -Schedule IV drugs have less abuse potential than with
Schedule III, but administration may lead to limited physical or psychological
dependence.
Schedule V. ANSWER -Schedule V drugs have less abuse potential than Schedule IV
drugs. This schedule includes exempt narcotics.
REGULATIONS|UPDATED QUESTIONS AND
VERIFIED ANSWERS
GRADED A+
QUESTIONS & ANSWERS
Pure Food & Drug Act of 1906. ANSWER -Enacted to prohibit the interstate
transportation or sale of adulterated and misbranded food or drugs.
Pure Food & Drug Act of 1938 (FDCA 1938). ANSWER -* 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.
Adulteration. ANSWER -Containing unsafe additives, filthy, nasty, decomposed
substance, prepared or packed in unsanitary conditions, misrepresenting a label.
Misbranding. ANSWER -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.
Durham-Humprhey ACT of 1951. ANSWER -*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
, Kefauver-Harris Amendment of 1962. ANSWER -*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
Comphrensive Drug Abuse Prevention And Control Act of 1970. ANSWER -(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.
Schedule I. ANSWER -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.)
Schedule II. ANSWER -Schedule II medications have a medical use, but have a high
potential for abuse and severe psychological or pyshical dependency.
Examples of Scedule II drugs: Adderall, Amytal, Cocaine, Codeine, Demerol, Ritalin.
(Note: There are more Schedule II drugs.)
Schedule III. ANSWER -Schedule III drugs have accepted medical use, and the
abuse potential is less than with Schedule I and II drugs.
Schedule IV. ANSWER -Schedule IV drugs have less abuse potential than with
Schedule III, but administration may lead to limited physical or psychological
dependence.
Schedule V. ANSWER -Schedule V drugs have less abuse potential than Schedule IV
drugs. This schedule includes exempt narcotics.
