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Pharmacy Law SS

laws for pharmacy NHA

TermDefinition
Pure Food and Drug Act (1906) (PFDA) Prohibited the interstate transportation or sale of adulterated or misbranded medications and food
Federal Food, Drug, and Cosmetic Act (1938) (FFDCA) Enacted to ensure that all medications are pure and safe Created the FDA
Durham- Humphrey Amendment (1951) Requires all products to have adequate directions for use unless they contain the federal legend " Caution: Federal law prohibits dispensing without a prescription." or "Rx only"
Kefauver- Harris Amendment ( 1962) Enacted to ensure all medications are pure, safe, and effective
Comprehensive Drug Abuse Prevention and Control Act (1970) or Controlled Substance Act (CSA)/ (CDAPCA) Regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration (DEA) Created the DEA
Poison Prevention Packaging Act (1970) (PPPA) Requires most prescriptions for oral use to be dispensed in child-resistant containers unless the patient or prescribers request otherwise
Drug Listing Act (1972) (DLA) All medications are assigned a specific 11- digit number known as the National Drug Code (NDC) First 5- manufacturer Next 4- medication product Last 2- package size
Orphan Drug Act (1983) (ODA) Provided an incentive for drug manufacturers to develop medications for the treatment, diagnosis, or prevention of rare diseases
Omnibus Budget Reconciliation Act (1990) (OBRA) Requires pharmacists to keep patient profiles and records of all medications used by medicaid patients. Also required them to offer counseling
Consolidated Omnibus Budget Reconciliation Act (COBRA) Gives workers and their families who lose their health benefits the right to choose to continue group health benefits provided by their group health plan for limited periods of time under certain circumstances
Anabolic Steroid Act ( 1990) (ASA) Classified anabolic steroids as Schedule III controlled substances
Medicare Modernization Act (2003) (MMA) Provides voluntary prescription medication benefits to Medicare beneficiaries (Medicare Part D)
Combat Methamphetamine Epidemic Act (2005) (CMEA) Created a new category of products called Schedule Listed Chemical Products (SLCP) and placed limits on daily and monthly sales Includes: ephedrine, PSEUDOEPHEDRINE, or phenylpropanolamine
Drug Supply Chain Security Act (2013) (DSCSA) Created a system to identify and trace prescription medications as they are distributed throughout the US Enables well organized medication recalls.
The Comprehensive Addiction and Recovery Act (CARA, 2016) Response to the growing opioid epidemic in the US. It covers 6 key areas that include: Prevention, Treatment, Recovery, Criminal Justice Reform, and Overdose Reversal Allows for partial refills within 30 days.
Created by: RGVCPharmily
 

 



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