View Exam | PowerPak

1. There is historical evidence that more than 4000 years ago there was a category of persons who would prepare products for use by others in the treatment of physical ailments. Where was this historical evidence found?

A. The Amazon jungle B. Ancient Mesopotamia C. Siberia D. Eastern Europe

2. In what year was the Drug Quality and Security Act passed?

A. 1951 B. 1962 C. 1984 D. 2013

3. Why might a pharmacist be asked to compound a pharmaceutical product for a patient?

A. The patient is allergic to a component of a manufactured product B. The patient can't swallow a product that is commercially available only as a solid dosage form C. The taste of a product is unpalatable for a patient D. All of the above

4. Compounding is regulated by the profession itself through which of the following groups:

A. The Colleges of Pharmacy B. The State Boards of Pharmacy C. American Pharmacists Association D. The U.S. Food and Drug Administration (FDA)

5. Chapter 797 has been adopted to establish stringent requirements for compounding of sterile products. What organization adopted Chapter 797?

A. United States Pharmacopeia (USP) B. National Association of Boards of Pharmacy (NABP) C. Institute for Safe Medication Practices (ISMP) D. FDA

6. During what decade did the FDA start to become concerned about large multistate compounding businesses that were licensed by the state as a pharmacy, but in reality were only pretending to be a pharmacy and instead were using their pharmacy license to avoid regulation as a pharmaceutical manufacturer?

A. 1950s B. 1960s C. 1980s D. 1990s

7. Which of the following is TRUE with regard to the initial adoption of the Compliance Policy Guide (CPG) for pharmacy compounding:

A. It was first adopted in 1952 B. FDA used the traditional “notice and comment” process of rulemaking C. The CPG was advisory only D. The CPG was the law, as enacted by Congress, and did not represent FDA policy

8. In what year was the Food and Drug Administration Modernization Act (FDAMA) legislation passed?

A. 1997 B. 1998 C. 1999 D. 2000

9. On what grounds did the Supreme Court of the United States strike down the prohibition against advertising contained in Section 503A of the FDAMA legislation?

A. Interference with interstate commerce B. Freedom of speech C. Unfunded mandate D. States' rights

10. According to a committee staff report provided to Congress, how many vials of an injectable solution from 3 contaminated lots were shipped by New England Compounding Center (NECC) in the summer and fall of 2012?

A. More than 17,000 B. More than 27,000 C. More than 37,000 D. More than 47,000

11. According to a committee staff report provided to Congress, how many people have died from complications associated with fungal meningitis related to NECC products?

A. Less than 10 B. Less than 25 C. Less than 50 D. More than 50

12. According to a committee staff report provided to Congress, as early as what year had potential problems been identified at NECC?

A. 2002 B. 2005 C. 2008 D. 2012

13. The Drug Quality and Security Act creates a safe harbor for compounding pharmacies. What section of the Federal Food, Drug, and Cosmetic Act incorporates this safe harbor for compounding pharmacies?

A. 502A B. 502B C. 503A D. 503B

14. According to the provisions of federal law, compounding may be done by a state licensed pharmacist in a state licensed pharmacy before the receipt of a valid prescription, subject to 2 conditions. What is one of these conditions?

A. The pharmacist has historically received valid prescriptions for compounding the drug B. The pharmacist compounds only generic products C. The pharmacist does not require that the patient pay for the compounded product D. The pharmacist delivers the compounded product to the patient through a mail order business

15. According to the provisions of federal law, in a state with no memorandum of understanding (MOU) between the state and the FDA, what is that maximum percent of drugs compounded by a pharmacy that may be distributed outside the state where they are compounded?

A. 5% B. 10% C. 15% D. 20%

16. The Drug Quality and Security Act creates a safe harbor for compounding outsourcing facilities. What section of the Federal Food, Drug, and Cosmetic Act incorporates this safe harbor for compounding outsourcing facilities?

A. 502A B. 502B C. 503A D. 503B

17. Although registration as a compounding outsourcing facility is optional, many businesses can be expected to opt for registration. Why would a business opt to register when registration is not required?

A. Professional ethics of the pharmacist B. Their customers will insist on purchasing only from registered compounding outsourcing facilities C. There are no real requirements that must be met by a registered compounding outsourcing facility D. Traditional manufacturers will complain if compounding outsourcing facilities have not registered

18. Under federal law, the label of a drug compounded within a compounding outsourcing facility must include which of the following statements:

A. “Warning: Compounded drugs are unsafe” B. “Warning: Compounded drugs are unsafe and ineffective” C. “This is a compounded drug” D. “Caution: This drug may cause cancer”

19. Compounding outsourcing facilities are subject to regulation by what agency?

A. The FDA, but not the state licensing board B. The state licensing board, but not the FDA C. Both the FDA and the state licensing board D. Neither the FDA nor the state licensing board