Chapter 3

  1. Durham-Humphrey Amendment
    • •Establishes criteria for distinguishing prescription drugs from OTC drugs
    • •Legally establishes oral prescriptions and refills
    • •The Amendment did not contemplate electronic prescriptions, other federal and state laws permit them
    • •Exempts the pharmacy label on dispensed drugs from §502 except for certain provisions pg 116
    • •Rx label must contain Specifies the minimum information pg 117
    • Expiration or beyond use dating on dispensed Rx label not required by the Amendment, but required pursuant to
    • state laws and USP standards
  2. Three method for Switching Prescription Drugs to OTC
    • •SNDA – product specific switch
    • •Petition- product specific switch
    • •Adding or amending modifying an OTC drug monograph- affects all products in the class 
  3. Third Class of Drugs (Behind the Counter Drug Classification Formerly)
    • •Refers to creating a class of drugs which can only be sold from the pharmacy department
    • - more dangerous drugs are being switched ex plan b (Emergency Contraception)
  4. Conscientious Objection
    • •Refers to whether a pharmacist has a right to refused to dispense prescriptions he or she has a moral or religious
    • objection.
  5. Collaborative Practice Agreements
    Authority granted to pharmacists in most states
Card Set
Chapter 3
Chapter 3