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Fed. Drug Law Dispensing

Terms in this set (31)

Prescription Drug Amendment / specified the minimum information that a dispensed prescription label must contain
What did the D-H amendment do?
federal law left it up to the states to determine who may prescribe independently or in collaborative practice
What did D-H do for prescriptive authority issues?
Pharmacists or prescriber (left up to state jurisdiction) - i.e. from D-H
amendment
Who has authority to dispense prescription drugs?
D-H amendment: refers to creating a class of drugs which can only be sold from the pharmacy (OTC products such as Humilin and Novolin)
What created the third class of drugs?
Banned the sale, trade, or purchase of prescription drug samples (NOBODY can sell them) / also prohibits community pharmacies from RECEIVING or DISPENSING SAMPLES
What did the Prescription Drug Marketing Act of 1987 do?
defined as a unit of drug not intended to be sold and intended to promote the sale of da drug
What is a drug sample?
FDA no allows U.S. citizens to obtain non-FDA approved medications from another country
PDMA generally prohibits reimportation of prescription drugs in attempt to prevent counterfeiting...But what?
addressed issue with meningitis outbreak / Created Title 1 and Title 2
What was the Drug Quality and Security Act of 2013?
/ Protects "Traditional Community Pharmacy Compounding" and created "Outsourcing Facilities" (Mass producing compounds)
What is Title 1: Compounding Quality Act
taking two or more ingredients and combining them into a dosage form of a drug, exclusive of compounding by a drug manufacturer, distributor, or packer (AKA - not reconstituting amoxicillin)
What is "compounding"?
Traditional Pharmacy Compounding
503A is what?
for a specific patient, based on a prescription (OK to compound in anticipation of receiving prescriptions, in limited quantities)
Traditional compounding is for what?
non-sterile drugs
USP 795 is for what?
Sterile Drugs
USP 797 is for what?
Hazardous drugs
USP 800 is for what?
5% / unless the State signs an MOU with the FDA - then they don't have the 5% restriction
May not distribute compounded products out of state in quantities that exceed _______ of the total prescription orders dispensed or distributed by such pharmacy. Unless what?
1. complies with USP or NF
2. On FDA approved Drugs list
3. On 503A bulk list
Pharmacies may use a bulk drug substance to compound if :
1. FDA new drug approval
2. Federal labeling requirements (labeled according to state law)
3. Current good manufacturing practices
Compounds from traditional compounding pharmacies are exempt from what?
voluntarily register each year / Defined as a facility that compounds sterile drugs
503B Outsourcing facilities are "non-traditional compounding." how do they register? what do they do?
pharmacy / pharmacist / good manufacturing practices under the FDA / "Track and Trace"
Outsourcing facilities are not required to be a licensed _________, but they have to have a licensed _________ present. Also unlike "traditional", outsourcing facilities are subject to ________. They also have to use approved substances but are exempt from ______
use drugs that aren't approved, safe, or copy a commercially available product
Anyone who compounds cannot do what?
. Pharmacies may only dispense compounds to a prescription
. W/o a prescription makes you an outsourcing facility and you must register
. Hospitals generally do not have to register as an outgoing facility
What are the Key Requirements of the Drug Quality and Security Act of 2013?
Track and Trace / FDA must be notified within 24 HOURS and documentation MUST be kept for 6 YEARS * / otherwise if its for product returns or intracompany distribution then you do not have to send tracking info
Title 2: Drug Supply Chain Security Act involves the _____________ program, which will be effective by 2023. If an illegitimate product is discovered then what must happen?***
with all estrogen containing drugs and oral contraceptives /
. Community: given to patient with each container
Institutional: same as community, or with first dose and every 30 days thereafter
Package Insert: when is it required and in what settings?
Consumer Medication Information: drug leaflets / patient information materials provided with prescriptions (developed by private sector)
What are CMI's?
patient information materials for drugs posing a serious and significant concern to public health (REMS for certain meds) - Responsibility of dispenser and manufacturer
What are Medication Guides?
No later then the expiration date on the manufacturer's container or 1 year from drug being dispensed *WHICHEVER IS EARLIER*
What is an appropriate BUD? according to USP
under the FDCA
Off-label prescribing and dispensing is legal under what?
Therapeutic equivalence (2 letter system / 2nd letter determines dosage form
. A - means equivalent to brand product and can interchange
. B - not therapeutically equivalent
Orange book determines what?
. Pharmacists must dispense ORAL prescription drugs in child-resistant container (unless otherwise documented by patient)
. Sublingual nitroglycerin and chewable isosorbide dinitrate should always be packaged in a non-child resistant container
.OTC drugs must have to be in child-resistant container
Some things that the Poison Prevention Packing Act did?
a container is made of glass or threaded plastic and given new closure top / otherwise use a new bottle
A container may not be reused unless what?
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