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Excpt 2

Laws & Regulations

National /State pharmacy associations establish... professional standards, which do not have the force of law; nevertheless, a court of law can use these standards as evidence as to whether a pharmacist or technician followed standard practice
Federal & State Laws: sometimes address the same topic related to pharmacy practice, if so, the more stringent of the two laws takes precedence
State laws specific to pharmacy governs... how pharmacists & techs practice pharmacy within the states.
State Board Pharmacy can... revoke, suspend, or place probation licensees on pharmacists/techs
Activities that constitute Misconduct... dosage calculation errors, mislabeling, failure to identify expired medications, nonadherence to controlled substance regulations, keeping inaccurate or insufficient records, dispensing wrong medication, and breaching patient confidentiality
Federal laws oversee... the development, manufacturing, marketing, and distribution of medications.
FDA Food & Drug Association
FDA: The largest and most impactful federal regulatory agency. This agency supervises the development, testing, purity, safety, and effectiveness of prescription and OTC medications. This agency must approve medications before pharmacies sell them in the US.
Medication dispensed with patient package inserts/MedGuides are... potentially dangerous/require very specific self-administration procedures
FDA requires retail pharmacies to provide a patient package Insert to every patient who receives medications with a _______ _____/______ ________ Black Box/Boxed Warning
MedWatch An FDA reporting system, through which manufacturers, health care professionals, and consumers can report defects, adverse reactions, or any other errors related to medications/medical products.
Food, Drug, and Cosmetic Act (1938) was passed as a supplement, requiring manufacturers to show a medicine was safe, required appropriate warnings for medicine; formulized the FDA as a brunch of Govt, under the U.S Department of Health & Human Services; determined legend & OTC drugs
PHI Protected Health Information
Created by: shinyyang
 

 



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