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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
Author
Anonymous
ID
174986
Card Set
Chapter 3
Description
Chapter 3
Updated
10/2/2012, 2:34:32 PM
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