PTCB Exam 2024 Federal Requirements

PTCB Exam 2024 Federal Requirements The State Board of Pharmacy ️establish state specific pharmacy laws and regulations The FDA ️The agency that is responsible for determining if a food or drug is safe and effective enough to be sold to the public. The DEA ️The agency that enforces the federal Controlled Substance Act (CSA) and classified drugs as controlled substances. OSHA ️The agency in the Department of Labor to maintain a safe and healthy work environment Federal Trade Commission (FTC) ️a federal agency established in 1914 to investigate and stop unfair business practices (advertising) Vitamins and herbal supplements are classified as ️Food substances Poison Prevention Packaging Act of 1970 (PPPA) ️• Designed to reduce the risk of children ingesting dangerous substances. • Required locking caps on most prescriptions Omnibus Budget Reconciliation Act of 1990 (OBRA '90) ️requires pharmacist to perform DURs and offer counsel to Medicaid patients (Try to remember the phrase "Oh... Bruh!" Like something is wrong and you need to call your friend to answer or fix something) HIPPA ️-Health Insurance Portability and Accountability Act of 1996 -protects the privacy and security of patient medical records and information Federal Food, Drug, and Cosmetic Act (FFDCA) ️a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. Schedule I Controlled Substances ️A HIGH ABUSE POTENTIAL AND "NO ACCEPTED MEDICAL USE" Schedule II Controlled Substances ️High abuse potential leading to: - SEVERE physical dependence - SEVERE psychological dependence Schedule III Controlled Substances ️Abuse potential leading to: - MODERATE or LOW physical dependence - HIGH psychological dependence Schedule IV Controlled Substances ️Mild abuse potentials leading to: -Mild physical/psychological dependence Schedule V Controlled Substances ️Substances in this schedule have a low potential for abuse-consist primarily of preparations containing limited quantities of certain narcotics. Federal Controlled Substances Act (CSA) ️Establishes a "closed system" of inventory and accounting for distribution of controlled substances 5 Schedules (I, II, III, IV, V) - based on likelihood of abuse Listed chemicals (precursors to controlled substances) Schedule I (C-I) Drugs ️GHB, heroin, LSD, marijuana, MDMA Schedule II (C-II) Drugs ️Some Opioids, Stimulants, Depressants, Hallucinogens