4 Written Questions
4 Multiple Choice Questions
- "Hatch-Waxman Act"
est modern system of generic drugs
manuf of generic drugs can seek FDA approval for generic versions of drugs whose patent protection is set to expire
- "Controlled Substances Act of 1970"
Established five "classes" or schedules for controlled substances (6 in MA)
- Ensure patient confidentiality and privacy
Give patients the right to review medical records
Est requirement of patient consent for transfer of medical records
Defines protected health info (PHI) - info that may identify a patient, info created or received by the pharmacy, info related to the patients health; mental or physical; past, present, or future
- Increased necessity of pharm techs
Focused on federal funding for Medicare and Medicaid
Mandated that pharmacists perform drug utilizaton reviews (DUR) and offer counseling to patients
3 True/False Questions
Drug Listing Act 1972 → intended to stimulate development of drugs for rare diseases affecting 200,000 or fewer
Kefauver-Harris Amendment 1962 → "Prescription Drug Amendment"
Required Rx to bear the legend "Caution: Federal law prohibits dispensing without a prescription"
Later: "Rx only"
Pure Food and Drug Act 1906 → intended to stimulate development of drugs for rare diseases affecting 200,000 or fewer