Week 9, Lecture 1 Flashcards
Unless its a controlled substance this is a state law thing in terms of prescription refill as to how long prescriptions are good for
Most states have adopted the ________year rule for when prescriptions are refilled unless its a controlled substance thats where you have the limitations of the 6 month and thats federal so states have to follow that unless they get more strict
one year
FDA decides whether its a food, dietary supplement, cosmetic, a medical device
There’s a alot of medical devices that have drugs in them so is it a device or a drug and if it is a drug fda decides whether or not its a prescription this is NOT left to the states
Prior to 1951 manufacturers decided whether there product needed prescription and they would put it right on the package if it did
Exam question
Durham-Humphrey Amendement of 1951
Established criteria for distinguishing __________ from _______
Legally established oral prescriptions and refills
Exempts the pharmacy label on dispensed drugs from §502 except for certain provisions (Section 502 requirements are requirements regarding what has to be on the manufactured product by the manufacturer)
Specifies the ___________ that a dispensed Rx
label must contain
Expiration or beyond use dating on dispensed Rx label
required pursuant to state laws and USP standards (whose standard did they use for whats the expiration date you can put on the expiration date you put on something that you repackaged? ___________
State standardized prescription labels
prescription drugs from OTC drugs
minimum information
USP
Durham-Humphrey Amendment Established ________as the federal agency that decides whether or not it requies a prescription or not (this is not left to the states; its the FDA making this law prior to this it was left to the manufacturers to decide
FDA
Prescription Drug Dispensing Label Federal Requirements
Must not be ________or misleading
Must not be an ___________drug
Must not be use anther drug’s name
Packaging and labeling must conform to compendial standards
Packaged and labeled appropriated based on its deterioration. (if its a product like nitroglycerin sublingual tablets has to be in a special container;can’t put it in any container you find)
Conforms to the Poision Prevention Packaging Act
(Has to deal with child safety lids)
false
imitation
USP is NOT a federal agency they are not government agency its an independent organization
1 year from the date your dispensing or the actual expiration date of the product if its less than that if there’s only six months left on the product you can’t put 1 year on the dispensing label
package inserts dont go to patients they are directed at the prescriber and the dispenser they are on the package from the manufacturer; they are not intended to be dispensed to the pt they are not patient package inserts
Black box warnings don’t appear on patient package inserts;only on package inserts
The feds when it comes to a label on a dispense product not the manufacturer’s label they don’t say a whole lot nd they don’t establish alot of criteria they leave that to the states
One year prescription refill is forcing everyone to see their physician once a year
Prescription Drug Dispensing Label “Usual State” Requirements
Name/initials of dispensing ____________
Name/address of __________
Name/address of patient
Directions of use
drug’s name, strength, and quantity
Name of _______________/distributor
Expiration date of the drug (feds only said anything about and that is when repackage you have to use compendia stanards which is 1 year or the expiration date of the product your dispensing is less than one year)
pharmacist
pharmacy
Manufacturer
