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Pharmacy Laws

Domain 2: Laws, Subsection A: Laws and Regulations

QuestionAnswer
Pure Food and Drug Act Prevents inaccurately labels and adulterated drugs.
Durham-Humphrey Amendment Required labeling in original medication bottle. Caution: Federal law prohibits dispensing without a prescription. RX Only.
Food Drug, and Cosmetic Act Defined adulteration and misbranding as illegal. Required drug companies to include package inserts.
Kefauver-Harris Amendment Ensures drugs are pure, safe and effective.
Controlled Substance Act Regulates manufacturing, distribution, prescribing and dispensing of controlled substances through the DEA. Created the Five-level Schedule (CI-CV)
Drug Listing Act A unique number assigned to every drug. (labeler, product, package size)
Poison Prevention Packaging Act Required manufacturers and pharmacies to place all oral medications in containers with childproof caps or packaging.
Omnibus Budget Reconciliation Act Pharmacies must keep patient profiles. Pharmacists must offer counseling to CMS patients.
Anabolic Steroid Act Medications abused by athletes became CIIIs.
Medicare Modernization Act Provided voluntary prescription benefits (Part D).
Combat Methamphetamine Epidemic Act Made pseudoephedrine now sold behind the counter. Created restrictions for access and purchase amounts.
Health Insurance Portability and Accountability Act Established the principle of Protected Health Information (PHI)
Food and Drug Administration Enforces the guidelines for manufacturers to ensure safety and effectiveness of medications
MedWatch FDA program that allows consumers and health care professionals to report any discrepancies or adverse reactions to medications
Class 1 Recall Deals with products that could cause serious harm or prove fatal
Class 2 Recall Deals with Products found to cause temporary health problems
Class 3 Recall Products have minor defect or other condition that would not harm the patient
Drug Enforcement Agency Prevent illegal distribution and misuse of controlled substances. Enforces the nation's federal drug laws.
Created by: ceferinoibarra
 

 



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