34 Questions
What was the major outcome of the 1938 Federal Food, Drug and Cosmetic Act?
Products must be safe and pure, and required to submit NDA
What is the primary purpose of the Hatch-Waxman Act of 1984?
To ensure drug price competition and patent term restoration
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%?
Pharmaceutical equivalence
According to Iowa state law, what must a pharmacy obtain prior to requesting a substitution of a lower priced generic drug?
Approval of the provider
Why are generic prescription drugs substituted?
Because they are cheaper
What is the term for the FDA's range for bioequivalence, which is between 80% and 125% of the Cmax and AUC values?
Bioequivalence range
What is the main difference between brand-name and generic products?
Their prices
What is the purpose of pharmaceutical equivalence?
To ensure that generics work the same as brand-name drugs
What is the primary reason for considering generic substitutes?
To reduce the cost of drugs
What type of drugs are not suitable for generic substitution?
Drugs with critical dose and narrow therapeutic ratio
What is the purpose of the Orange Book?
To list approved drug products with therapeutic equivalence evaluations
What does the 'AB' code signify in the Orange Book?
Drugs that are therapeutically equivalent
What does the 'BC' code signify in the Orange Book?
Extended release oral products
What is the significance of 'TE' in the context of the Orange Book?
Therapeutic equivalence
What is the purpose of assigning TE codes to drugs?
To identify multisource products
What is the significance of the 'RLD' abbreviation in the context of the Orange Book?
Reference Listed Drug
What is the primary benefit of generic substitution?
Reduced cost of drugs
The 1962 Kefauver-Harris Amendments required products to be only safe, but not effective.
False
A pharmacy in Iowa can substitute a higher priced prescribed drug with a lower priced generic drug without the provider's approval.
False
Generic drugs cost more than brand-name drugs.
False
The Hatch-Waxman Act of 1984 aimed to increase drug prices and patent terms.
False
Bioequivalence refers to the same drug, dosage form, route of administration, and strength.
True
The FDA sets a bioequivalence range of 50-150% for generic drugs.
False
Pharmaceutical equivalence is only achieved if a drug has the same dosage form and route of administration.
False
The 1906 Pure Food and Drug Act only established the FDA, but did not ensure drug purity and safety.
False
Hormones are suitable for generic substitution.
False
The Orange Book lists only brand-name drugs.
False
A generic company can identify reference products using TE codes.
True
AB codes are assigned to drugs that are not therapeutically equivalent.
False
Generic substitution is only justified for economic reasons.
False
The 'B' codes are assigned to drugs that are therapeutically equivalent.
False
Therapeutic equivalence is determined by the cost of the drug.
False
All multisource products have a single reference listed drug.
False
The purpose of assigning TE codes is to identify brand-name drugs.
False
Test your knowledge of FDA legislation and drug product substitution, including the Pure Food and Drug Act, Federal Food, Drug and Cosmetic Act, and more. Learn about the history of drug regulation and its impact on the industry.
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