Chapter 3

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
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
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)
Conscientious Objection
- •Refers to whether a pharmacist has a right to refused to dispense prescriptions he or she has a moral or religious
- objection.
Collaborative Practice Agreements

Authority granted to pharmacists in most states

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Chapter 3

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Chapter 3

Updated

10/2/2012, 2:34:32 PM

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