PTCB Domain 2: Federal Requirements Welcome to your PTCB Domain 2: Federal Requirements 1. PTCB: Federal Requirements What section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires drug manufacturers to provide proof of safety and effectiveness before marketing a new drug? A. Section 351 B. Section 502 C. Section 505 D. Section 801 None 2. PTCB: Federal Requirements Under the Drug Quality and Security Act (DQSA) which title outlines the requirements for compounding pharmacies to register as outsourcing facilities? A. Title I B. Title II C. Title III D. Title IV None 3. PTCB: Federal Requirements Which DEA form is used by pharmacies to report the theft or significant loss of controlled substances? A. DEA Form 41 B. DEA Form 106 C. DEA Form 222 D. DEA Form 224 None 4. PTCB: Federal Requirements The Poison Prevention Packaging Act (PPPA) requires child-resistant packaging for most prescription drugs. Which of the following is an exception to this rule? A. Nitroglycerin tablets B. Oral contraceptives C. Antidepressants D. Antibiotics None 5. PTCB: Federal Requirements According to the Ryan Haight Online Pharmacy Consumer Protection Act, which activity is explicitly prohibited? A. Dispensing controlled substances prescribed by a telemedicine practitioner B. Dispensing controlled substances without a valid prescription C. Advertising controlled substances online D. Offering online consultations for a fee None 6. PTCB: Federal Requirements Under which circumstances can a pharmacy process electronic prescriptions for controlled substances (EPCS)? A. Only if the prescription is for a Schedule II drug B. If the pharmacy's software meets DEA's EPCS standards C. Only if the prescriber uses a digital signature D. If the patient specifically requests an electronic prescription None 7. PTCB: Federal Requirements What is the required action for a pharmacy when a prescription drug is found to be adulterated or misbranded after being dispensed? A. Report to the DEA within 24 hours B. Conduct a recall within the pharmacy C. Notify the FDA immediately D. Remove the product from shelves and notify the supplier None 8. PTCB: Federal Requirements The Controlled Substances Act (CSA) classifies drugs into how many schedules based on their potential for abuse and medical use? A. Three B. Four C. Five D. Six None 9. PTCB: Federal Requirements What is the maximum amount of pseudoephedrine that an individual can purchase within a 30-day period under the Combat Methamphetamine Epidemic Act of 2005? A. 3.6 grams B. 9 grams C. 30 grams D. 60 grams None 10. PTCB: Federal Requirements Which act requires electronic health record systems to be interoperable and prohibits blocking patient health information? A. Health Insurance Portability and Accountability Act (HIPAA) B. Drug Quality and Security Act (DQSA) C. 21st Century Cures Act D. Patient Protection and Affordable Care Act None 11. PTCB: Federal Requirements Under the Federal Food, Drug, and Cosmetic Act, which type of drug labeling is most strictly regulated due to potential risks? A. Over-the-counter 'OTC' drug labeling B. Prescription drug labeling C. Dietary supplement labeling D. Cosmetic product labeling None 12. PTCB: Federal Requirements What specific provision does the Anabolic Steroid Control Act of 1990 add to the Controlled Substances Act 'CSA'? A. Classifies anabolic steroids as Schedule III controlled substances B. Requires a prescription for all anabolic steroid purchases C. Allows the importation of anabolic steroids for personal use D. Mandates special labeling for anabolic steroid prescriptions None 13. PTCB: Federal Requirements Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which provision directly impacts pharmacies? A. Establishment of Medicare Part D B. Introduction of Health Savings Accounts (HSAs) C. Provision for electronic prescribing D. All of the above None 14. PTCB: Federal Requirements Which DEA form is used for the transfer of Schedule II controlled substances between pharmacies? A. DEA Form 41 B. DEA Form 106 C. DEA Form 222 D. DEA Form 224 None 15. PTCB: Federal Requirements What requirement is outlined by the Secure and Responsible Drug Disposal Act of 2010 for pharmacies participating in take-back programs? A. Pharmacies must charge a fee for disposal B. Pharmacies must have a DEA registration to collect controlled substances C. Pharmacies cannot accept Schedule II drugs D. Pharmacies must provide mail-back programs only None 16. PTCB: Federal Requirements Which of the following is a requirement under the Federal Anti-Tampering Act? A. All over-the-counter 'OTC' medications must be in child-resistant packaging B. OTC medications must have tamper-evident packaging C. Prescription drugs must include a detailed drug monograph D. Dietary supplements are required to have safety seals None 17. PTCB: Federal Requirements What does the Orphan Drug Act of 1983 encourage? A. The development of drugs for rare diseases B. The fast-tracking of generic drug approvals C. The increase of prescription drug advertisements D. The reduction of drug prices through competition None 18. PTCB: Federal Requirements According to the FDA's Risk Evaluation and Mitigation Strategies (REMS) program, which type of medication often requires a REMS to ensure safe use? A. Antibiotics B. Over-the-counter pain relievers C. Drugs with potential for serious adverse effects D. Vitamin supplements None 19. PTCB: Federal Requirements Under the Hatch-Waxman Act, how many years of marketing exclusivity is granted to the first generic drug applicant who successfully challenges a patent? A. 180 days B. 1 year C. 3 years D. 5 years None 20. PTCB: Federal Requirements What is the primary focus of the Drug Supply Chain Security Act 'DSCSA' of 2013? A. To promote bioequivalence testing for generic drugs B. To establish a system for tracing prescription drug distribution in the United States C. To encourage the development of biosimilars D. To reduce prescription drug costs for consumers None 1 out of 20 Time is Up! Time's up
