Federal Regulation of Medications - Dispensing Flashcards
What does the Durham-Humphrey Amendment do?
Legally establishes refills and oral prescriptions. Establishes criteria for distinguishing Rx vs. OTC drugs
Does the Durham-Humphrey Amendment include electronic prescriptions?
NO
What is the legal concern with oral prescriptions from Durham-Humphrey?
Responsibility of the pharmacist to get the prescription correct
What does the Durham-Humphrey Amendment 2 do?
Specifies the MINIMUM information that a dispense prescription label must contain
What are the components that are the MINIMUM on every dispensed prescription label?
- Name/Address of DISPENSER
- Serial number and DATE of prescription filling
- Name of PRESCRIBER
- Name of PATIENT
- DIRECTIONS for use and cautionary statements
Where do number of refills and name of drug fall under for requirements on a label?
STATE laws that require ADDITIONAL information compared to Durham-Humphrey
Where does the regulation fall under for expiration or beyond use dating on dispensed Rxs?
STATE laws, guided by USP
What is a consideration for prescription refill related to Durham-Humphrey?
Authorization of refill comes from TRANSMITTAL authority
Who has prescriptive authority based on Durham-Humphrey?
Federal law leaves it up to the STATES to determine who may prescribe independently or through collaborative practice
As a pharmacist what you need to know about a prescriber?
A scope of their practice and if the medications they are prescribing makes sense
Does Durham-Humphrey dispensing standards apply to prescribers?
FDA believes NO
What are the three ways in which the transition of Prescription Drugs switch to OTC?
- Supplemental NDA
- Other Party Manufacturer
- FDA adds or amends OTC drug monograph
What is a Citizen Petition?
A product-specific switch from Rx to OTC done by another manufacturer
When the FDA adds/amend OTC drug monographs, what happens to the Rx to OTC?
It affects all products in the class
What is the Nonprescription Under Conditions of Safe Use?
Refers to creating a class of drugs that can only be sold from the pharmacy department
What is a Conscientious Objection?
Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists
Courts have held that a pharmacist CANNOT obstruct a patient’s legal right to receive medications but?
But the STATE regulations requires pharmacists to dispense violate first amendment rights
Is off-label prescribing and dispensing legal under the FDCA?
YES
What do courts require for off label use?
Evidence OF the standard the care, not the actual standard of care
Pharmacy compounding is allowed in what situations?
PATIENT SPECIFIC needs
What is the FDA 1992 Compliance Policy Guide CPG?
Published over concern that some pharmacies were crossing the line from compounding to manufacturing and compounding improperly
What is the FDAMA 503A 1997?
Canceled the CPG
Defined compounding and delineated nine conditions that might cross the line from compounding to manufacturing
What was the big act of the FDAMA 503A 1997?
Stripped FDA of authority to consider compounded drugs as new drugs
What are the NINE Conditions of the FDAMA 503A 1997?
- Individual patient by prescription
- Limited quantities ‘pre-made’ in anticipation of Rx
- Cannot copy commercially available product
- Compounded in compliance with USP standards for compounding
- Compounded with bulk ingredients manufactured by entity registered with FDA
- All ingredients comply with USP Standards
- No drugs from DFA List of withdrawn/removed agents due to safety/efficacy concerns
- No FDA regulated products with difficulty compounding
- Not more than 5% of total sales unless a memorandum of understanding MOU between state and FDA
