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Questions and Answers
What was the major outcome of the 1938 Federal Food, Drug and Cosmetic Act?
What was the major outcome of the 1938 Federal Food, Drug and Cosmetic Act?
- Products must be safe and effective, and patents are restored
- Products must be safe and effective, and patents are terminated
- Products must be safe and pure, and required to submit NDA (correct)
- Products must be safe and pure, and required to conduct clinical trials
What is the primary purpose of the Hatch-Waxman Act of 1984?
What is the primary purpose of the Hatch-Waxman Act of 1984?
- To establish the FDA
- To ensure drug price competition and patent term restoration (correct)
- To require clinical trials for new drugs
- To prohibit generic drug substitutions
What is the term for drugs that have the same dosage form, route of administration, strength, and meet FDA's bioequivalence range of 80-125%?
What is the term for drugs that have the same dosage form, route of administration, strength, and meet FDA's bioequivalence range of 80-125%?
- Bioequivalence
- Generic equivalence
- Therapeutic equivalence
- Pharmaceutical equivalence (correct)
According to Iowa state law, what must a pharmacy obtain prior to requesting a substitution of a lower priced generic drug?
According to Iowa state law, what must a pharmacy obtain prior to requesting a substitution of a lower priced generic drug?
Why are generic prescription drugs substituted?
Why are generic prescription drugs substituted?
What is the term for the FDA's range for bioequivalence, which is between 80% and 125% of the Cmax and AUC values?
What is the term for the FDA's range for bioequivalence, which is between 80% and 125% of the Cmax and AUC values?
What is the main difference between brand-name and generic products?
What is the main difference between brand-name and generic products?
What is the purpose of pharmaceutical equivalence?
What is the purpose of pharmaceutical equivalence?
What is the primary reason for considering generic substitutes?
What is the primary reason for considering generic substitutes?
What type of drugs are not suitable for generic substitution?
What type of drugs are not suitable for generic substitution?
What is the purpose of the Orange Book?
What is the purpose of the Orange Book?
What does the 'AB' code signify in the Orange Book?
What does the 'AB' code signify in the Orange Book?
What does the 'BC' code signify in the Orange Book?
What does the 'BC' code signify in the Orange Book?
What is the significance of 'TE' in the context of the Orange Book?
What is the significance of 'TE' in the context of the Orange Book?
What is the purpose of assigning TE codes to drugs?
What is the purpose of assigning TE codes to drugs?
What is the significance of the 'RLD' abbreviation in the context of the Orange Book?
What is the significance of the 'RLD' abbreviation in the context of the Orange Book?
What is the primary benefit of generic substitution?
What is the primary benefit of generic substitution?
The 1962 Kefauver-Harris Amendments required products to be only safe, but not effective.
The 1962 Kefauver-Harris Amendments required products to be only safe, but not effective.
A pharmacy in Iowa can substitute a higher priced prescribed drug with a lower priced generic drug without the provider's approval.
A pharmacy in Iowa can substitute a higher priced prescribed drug with a lower priced generic drug without the provider's approval.
Generic drugs cost more than brand-name drugs.
Generic drugs cost more than brand-name drugs.
The Hatch-Waxman Act of 1984 aimed to increase drug prices and patent terms.
The Hatch-Waxman Act of 1984 aimed to increase drug prices and patent terms.
Bioequivalence refers to the same drug, dosage form, route of administration, and strength.
Bioequivalence refers to the same drug, dosage form, route of administration, and strength.
The FDA sets a bioequivalence range of 50-150% for generic drugs.
The FDA sets a bioequivalence range of 50-150% for generic drugs.
Pharmaceutical equivalence is only achieved if a drug has the same dosage form and route of administration.
Pharmaceutical equivalence is only achieved if a drug has the same dosage form and route of administration.
The 1906 Pure Food and Drug Act only established the FDA, but did not ensure drug purity and safety.
The 1906 Pure Food and Drug Act only established the FDA, but did not ensure drug purity and safety.
Hormones are suitable for generic substitution.
Hormones are suitable for generic substitution.
The Orange Book lists only brand-name drugs.
The Orange Book lists only brand-name drugs.
A generic company can identify reference products using TE codes.
A generic company can identify reference products using TE codes.
AB codes are assigned to drugs that are not therapeutically equivalent.
AB codes are assigned to drugs that are not therapeutically equivalent.
Generic substitution is only justified for economic reasons.
Generic substitution is only justified for economic reasons.
The 'B' codes are assigned to drugs that are therapeutically equivalent.
The 'B' codes are assigned to drugs that are therapeutically equivalent.
Therapeutic equivalence is determined by the cost of the drug.
Therapeutic equivalence is determined by the cost of the drug.
All multisource products have a single reference listed drug.
All multisource products have a single reference listed drug.
The purpose of assigning TE codes is to identify brand-name drugs.
The purpose of assigning TE codes is to identify brand-name drugs.
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