PTCB - Pharmacy Laws Exam Questions and Answers 100% Pass

PTCB - Pharmacy Laws Exam Questions and Answers 100% Pass Pure food and drugs act of 1906 - Answer- prohibit the interstate transportation or sale of adulterated or misbranded food or drugs What does Adulterated mean? - Answer- Consists of any filthy, decomposed, putrid susbtance Perpared, packed, or help under unsanitary conditions Perpared in containers composed of any poisonous or deleterious substance Containing unsafe color additives Recognized in an official compendium but differing in strength, quality, or purity of the drugs What does Misbranding mean? - Answer- False labeling No label Label lacks Name, place of business of the manufacturer/packer/distributor, lack accurate quantity of contents. No Warning if the product is habit forming No labeled direction for use and no warning against certain pathological conditions Products that are dangerous to health under the labeled dosage No ingredient/alcohol content if have alcohol Failed to bear the established name of the drug Durham-Humphrey Act of 1951 - Answer- Amendment of FDCA 1938 Require all products to have adequate directions for use Don't need to have adequate directions for use if the drug/products must be dispense with a prescription (not over-the-counter) Separated drugs into Legend and Nonlegend (over the counter) Allows verbal prescriptions over the phone Allows refills to be called in from a doctors' office Food, Drugs, and Cosmetic Act of 1938 (FDCA) - Answer- Created the US Food and Drug Administration (FDA) Required all new drug applications be filed with the FDA Clearly defined Adulteration and misbranding Kefauver-Harris Amendment of 1962 - Answer- Requires all medication in the US to be pure, safe, and effective Comprehensive drugs abuse prevention and control act of 1970 - Answer- Established "Controlled substance" rating Created the Drug Enforcement Agency (DEA) Separated the controlled substance into 5 Schedule based on potential for abuse and accepted medical use in the US Prescription monitoring programs. the federal National All Schedules Prescription Electronic Reporting Act in 2005 - Answer- The Act establish an electronic system for practitioner monitoring of the dispensing of controlled substances in SCH 2, 3, 4. The act would require specific information to be reported. But the act was never enacted at the federal level. But many states have enacted similar legislation