EXCPT Pharmacy Laws and Regulations Graded A+

EXCPT Pharmacy Laws and Regulations Graded A+ Pure Food and Drug Act of 1906 ️Prohibits interstate transportation or sale of adulterated or misbranded food and drugs Occupational Safety and Health Act of 1970 (OSHA) ️To assure safe and healthful working conditions for working men and women Durham-Humphrey Amendment ️Requires the label "caution: federal law prohibits dispensing without prescription" Made distinction between legend and no legend drugs Food, Drug & Cosmetic Act ️Legalized the FDA Required all controlled substances to be labeled with "Warning: may be habit forming" and prohibited misbranding Harrison Narcotic Act ️Prevented the sale of opium without a prescription Kefauver-Harris Amendment ️Attempts to ensure the safety and effectiveness of all new drugs Poison Prevention Package Act ️Requires childproof caps Orphan Drug Act ️Allowed some Companies to bypass some time requirements and costs of testing a new drug for orphan diseases Comprehension Drug Abuse Prevention & Control Act ️DEA formed Control drugs can be addictive and are placed in one of 5 categories Omnibus Budget Reconciliation Act ️Pharmacist must offer to counsel all patients who receive new drugs Medical Device Amendments of 1976 ️Called for all devices to be divided into classes (3), with varying amounts of control required in each one Federal Anti-Tampering Act of 1983 ️Made tampering with, or adulterating OTC and cosmetic products a federal criminal offense Drug Price Competition and Patent-Term Restoration Act of 1984 ️Streamlines the process for granting approval of generic drugs. Anabolic Steroids Control Act of 1990 ️To apply penalties to the distribution of anabolic steroids Dietary Supplement Health and Education Act of 1994 ️Herbal products and dietary supplements must be labeled as dietary supplements and identify all ingredients and quantities of the ingredient on the label Food and Drug Administration Modernization Act of 1997 ️Must have Rx on the label Medicare Modernization Act of 2003 ️Drug discount card available to low-income medicare patients. Combat Methamphetamine Epidemic Act of 2005 ️Only a licensed pharmacist or technician may dispense, sell, or distribute pseudoephedrine Patient Protection and Affordable Care Act of 2010 ️Allows young adults to stay on their parents' private health insurance policies until they turn 26 years old and thousands of adults will be able to buy affordable coverage HIPAA ️Patient privacy Drug Addiction Treatment Act ️Permits prescription of controlled substances to addicts for detoxification Combat Methamphentamine ️Pseudoephedrine must be sold behind the counter iPledge Program ️Requirements for dispensing isotretinoin (accutane) FDA ️Food & Drug Administration Ensures the safety & effectiveness of meds MedWatch ️Program of the FDA to report any adverse reactions to meds Form 41 ️authorization to destroy damaged, outdated, or unwanted controlled substances {this form can be used once a year} Form 222 ️needed to order or transfer C-II substances Form 224 ️needed to dispense controlled substances {must be renewed every 3 years}