Pharmacy Law and Regulations - PTCB Test Prep
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Pharmacy Law and Regulations

Welcome to your Pharmacy Law and Regulations

1. Which of the following pieces of legislation placed prescription drug advertising under FDA supervision and required drug manufacturers to register and permit inspections of their manufacturing sites?
2. Which legislation was responsible for banning the reimportation of a drug into the US by anyone except the manufacturer?
3. Enacted in 1990, the Anabolic Steroids Control Act classified anabolic steroids as what controlled substance schedule?
4. Which of the following medicines is a Schedule IV controlled substance?
5. Which of the following organizations is responsible for implementing legislation relating to controlled substances?
6. In the following NDC number of ramipril, what do the final two digits refer to: 00431-4007-01?
7. Which of these organizations is designed to establish state-specific pharmacy laws and regulations?
8. Pharmacies must notify their local DEA office, in writing, within how long after discovering that controlled substances have been stolen?
9. Material Safety Data Sheets (MSDS) were an important consequence of which piece of legislation?
10. All of these DEA registrant types fall under the Narcotic Treatment Program classification except which?
11. Which of the following USP chapters sets standards for non-sterile compounded formulations as well as providing guidance on how to manufacture compounded products?
12. Upon receiving a formal request for pharmacy records, how long does the pharmacy have to deliver the requested data?
13. Which of the following laws established the protocol that drugs are identified and reported using the NDC?
14. The Orphan Drug Act is involved in the manufacture of drugs that affect which of the following?
15. Which of these drugs is classified as a Schedule II controlled substance?
16. Which of the following terms refers to drugs that are made less pure than those manufactured in licensed premises?
17. Which of the following was passed in direct response to the sulfanilamide disaster that killed more than 100 people?
18. Which of the following pieces of legislation is divided into privacy regulations, security regulations, and transaction standards?
19. How often must pharmacy personnel, who compound low to medium-risk level sterile products, be evaluated on their aseptic technique?
20. Medical malpractice or negligence most accurately falls under which of these legal frameworks?
21. Data on the generic equivalence of drugs can be found in what book?
22. Which of the following laws, enacted in 1990, requires pharmacies that fill orders for Medicaid patients to obtain, record, and maintain basic patient information?
23. Which of the following activities is the pharmacy technician not mandated to do?
24. The iPLEDGE program is a REMS that restricts the use of which of the following drugs?
25. Which of the following USP chapters sets standards for hazardous drug handling for patients, healthcare workers, and the environment?
26. Which piece of legislation was passed to offer financial incentives for pharmaceutical companies to manufacture medicines for the treatment of rare diseases and conditions?
27. Which of the following organizations is responsible for accrediting and certifying healthcare organizations in the United States?
28. Enacted in 2005, the Combat Methamphetamine Epidemic Act regulates the sale of OTC products that contain any of the following drugs except which?
29. Generic drugs may be substituted for branded equivalents if which of the following conditions is met?
30. Which of these drugs is classified as a Schedule III controlled substance?
31. Which of these laws compels pharmacists to conduct a drug utilization review, DUR?
32. Which part of the NDC code is a reference to “product code”?
33. Which of the following laws was passed that ensures medicines were in developed in a child protected form?
34. What does the second letter of a DEA number represent?
35. According to law, all pharmacies must contain a copy of which of the following books?
36. According to federal legislation, how frequently should pharmacies complete an inventory of controlled substances?
37. Which of the following drugs comes with a Risk Evaluations and Mitigation Strategies (REMS)?
38. Which of the following pieces of legislation was passed that allowed verbal prescriptions to be taken over the phone?
39. What is the maximum number of prescription refills permitted for Schedule III-IV substances?
40. Here is an NDC number: 00471-4550-02 – what does the first five digits represent?
41. A physician by the name of Dr. John Courtney will have a DEA number that follows which of these formats?Assume that the prescriber's DEA number is valid.
42. Where a DEA number is registered using a business address rather than a person’s name, what number is used to represent that fact?
43. Lomotil or cough preparations with codeine fall into which of the following scheduled of controlled substances?
44. Which of the following DEA forms is used when ordering Schedule II medicines?
45. What part of Medicare covers prescription drugs?
46. What piece of legislation prohibited selling prescription drugs to patients who did not have a prescription for that drug?
47. Upon being signed by the prescriber, a prescription for a Schedule II controlled substance must be filled within what period?
48. Which of the following drugs is exempt from the packaging conditions set out in the Poison Prevention Packaging Act, 1970?
49. A registrant registered under the Suboxone/Subutex Prescribing Program has which of these letters commencing their DEA number?
50. According to federal standard requirements, which of the following details is not mandated to appear on the medicine label of a single unit package of an individual dose?
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