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FDA Drug Product Classification

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Questions and Answers

What type of drug products are coded with 'B' codes?

Therapeutically equivalent products

Products that are under regulatory review

Products that are approved by the state

Products that are not therapeutically equivalent to other pharmaceutically equivalent products (correct)

What is a common misconception about generic drugs?

They are not FDA-approved

They are more expensive than brand-name drugs

They are not as potent as brand-name drugs (correct)

They are only available for certain diseases

What is the main purpose of product substitution?

To promote brand-name drugs

To ensure therapeutic equivalence (correct)

To bypass FDA approval process

To reduce the cost of drug products

What is a benefit of generic substitution?

Reduces costs and prevents drug shortages Signup and view all the answers

According to the FDA, which type of products have documented bioequivalence problems?

Drugs with documented BE problems Signup and view all the answers

What type of drugs may not be suitable for generic substitution?

Hormones Signup and view all the answers

What is the main factor considered by insurance providers when deciding on formularies?

Cost Signup and view all the answers

What is the main purpose of the FDA guidance on therapeutic equivalence?

To ensure therapeutic equivalence Signup and view all the answers

What is required before a pharmacy can request a generic substitution in Iowa?

Prescribing practitioner's approval Signup and view all the answers

What is the main consideration for professionals when deciding on drug products?

Professional judgment Signup and view all the answers

What phase of drug development is specific to brand-name products?

Phase 3 Signup and view all the answers

What is a major difference between brand-name drugs and generic drugs?

Patent terms Signup and view all the answers

What is a requirement for a generic product to gain FDA approval?

Meet the same requirements for identity, strength, purity, and quality Signup and view all the answers

What is therapeutic equivalence (TE) based on?

Pharmaceutical equivalence (PE) and Bioequivalence (BE) Signup and view all the answers

What is the purpose of FDA's Orange Book list?

To identify multisource products and determine therapeutic equivalence Signup and view all the answers

What does an 'AB' code indicate?

The product has therapeutic equivalence Signup and view all the answers

What is the assumption of therapeutic equivalence (TE) products?

TE products are equally safe and effective Signup and view all the answers

What is bioequivalence (BE) evaluation based on?

Cmax, tmax, and AUC Signup and view all the answers