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1. Which of the following is TRUE regarding the Drug Quality and Security Act (DQSA)?

A. The DQSA created Section 503A of the Food, Drug, and Cosmetic Act (FDCA) B. The DQSA amended Section 503B of the FDCA, which was originally created by the Food and Drug Administration Modernization Act (FDAMA) in 1997 C. The DQSA removed the advertising clauses of FDAMA D. The DQSA was enacted in response to deaths related to inappropriately compounded sulfanilamide elixir

2. The DQSA addresses which of the following practices?

A. The manufacturing of sterile drugs for veterinary use B. The dispensing of non-sterile drugs for human use C. The compounding of sterile drugs for human use D. The prescribing of drugs for investigational use

3. Which of the following Titles of the DQSA is correctly matched to its intent or purpose?

A. Title I: defines traditional compounding pharmacies and outsourcing facilities B. Title I: increases the amount of interstate commerce in which a pharmacy can participate C. Title II: establishes a 'track and trace' system of drug distribution over the next 10 years to increase prosecution related to counterfeit medicines D. Title II: provides standards for non-sterile compounding

4. Which of the following is required for pharmacies who intend to engage in compounding, as defined in Section 503A of the DQSA?

A. The final compounded product must be approved by the Pharmacy Compounding Advisory Committee B. The ingredients in the compounded product must have monographs available that confirm strength, purity, and quality C. The product must be compounded in multiple dosage forms D. The compounded product must be identical to a product currently on the market

5. The PCAC has recommended that which of the following drugs be included on the “Do Not Compound” list?

A. Ophthalmic solutions of bromfenac sodium B. Acetaminophen with less than or equal to 325 mg per dosage unit C. Rosuvastatin D. Propoxyphene

6. The provision that states that no more than 5% of a pharmacy's products may be distributed or sold out of state applies to which of the following facilities?

A. Traditional compounding pharmacies, as defined under Section 503A, that have entered into a memorandum of understanding with the state B. Traditional pharmacies registered under Section 503A that maintain state-specific compounding licenses C. Outsourcing facilities registered under Section 503B that are located within a health system or group of hospitals D. Outsourcing facilities registered under Section 503B that have more than 1 geographic location

7. Which of the following activities is considered “compounding” according to the Food and Drug Administration's definition of “compounding”?

A. A pharmacy reconstituting a powdered antibiotic B. A skilled nursing facility repackaging tablets into unit dose packs C. A hospital creating a sterile admixture D. A physician using bulk substances to create a new medicinal product for an individual patient

8. Which of the following is TRUE of a pharmacy that decides to register as a 503B outsourcing facility?

A. The pharmacy must maintain a compounding license issued by its state board of pharmacy B. The pharmacy must have an established relationship with physicians and patients C. The pharmacy is subject to investigation under a risk-based protocol D. The pharmacy can only compound sterile products

9. What are the minimum requirements to be listed on FDA's website as a 503B outsourcing facility?

A. Undergo an inspection by FDA to verify compliance with current good manufacturing practices B. Register with FDA and pay the appropriate fees C. Employ at least 2 licensed pharmacists and pass a licensing examination administered by the state board of pharmacy D. Pay the appropriate fees and submit a list of products intended for compounding to FDA

10. Which of the following is TRUE, when considering the similarities and differences between Sections 503A and 503B of the DQSA?

A. Both sections prohibit compounding for “office use” B. Both sections address requirements for sterile compounding C. Both sections define limits for the quantity of drug that can be compounded at 1 time D. Both sections allow for the compounding of products involved in drug shortages