Law Exam 1 - Lecture 5 (Packaging) Flashcards
special packaging
-targeted at kids under 5yo
-not difficult for normal adults to open
-most kids under 5 should struggle to open and those that can open it will be prevented from obtaining a toxic amount in a reasonable time
-child resistant means ___% of children or less can open after 10 minutes
-at least ___% of adults can open after 10 minutes
20%, 90%
drugs for _____ _____ require special packaging
oral administration
(OTC or prescription)
a product may be misbranded if not dispensed in ____
CRC (child resistant container)
waivers for CRC are allowed prescription by prescription (by _____ or _____)
or
blanket waivers (by _____ only)
patient or prescriber
patient
Notable CPSC exemptions
sublingual nitroglycerin
oral contraceptives in mnemonic packages
steroid dose packs
some oral powder formulations
unit-dose potassium
Class 1 recall
drug product may cause serious adverse health consequences including death (pharmacies notify patients who received recalled drugs)
Class 2 recall
Drug may cause temporary or reversible effects, but the probability of serious health consequences is remote
Class 3 recall
drug product is unlikely to cause serious adverse health consequences
drug recall vs seizure
drug recall done by company (voluntary)
drug seizure done by agency (often FDA or DEA, not voluntary)
Federal Anti-Tampering Act does what?
makes tampering a federal crime (1983)
Do OTCs require tamper evident packaging?
Yes, FDA requires it
label definition
any printed, written or graphic material on the product
Labeling definition
all labels and written, printed or graphic material on the container, container wrapper, or accompanying the product
is a label part of the labeling?
yes
If a drug on a shelf does not have a Package insert (PI), it is _______
misbranded
3 sections on labelling that relates to reproduction
pregnancy
lactation
females and males of reproductive potential
PI vs PPI
package insert vs patient package insert
-must give PPI to patient with their prescription
If PPI is not dispensed to patient with prescription, it is considered _______
misbranding
only drugs requiring PPIs
oral contraceptives and estrogens
failure to dispense a MedGuide with a required drug is ______
misbranding
MedGuides are required when one or more of the following exist:
- labeling could help prevent adverse effects
- serious risks of use exist which pts should be made aware of
- pt adherence to directions is crucial to drug effectiveness
Risk Evaluation and Mitigation Strategy (REMS) ____ be required by FDA as part of drug labeling
can
4 REMS types
Pt Friendly Labeling
Communication Plans
Elements To Assure Safe Use (ETASU)
Implementation System
OTC labeling require a ____ ____ section which includes:
active ingredients
purpose
uses
warnings
directions
inactive ingredients
other info
drug facts
3500 and 3500B are used for what?
health professionals (3500) and patients (3500B) can use these to report serious adverse events associated with drug or FDA covered products
in 2007 a law was passed saying pharmacies must provide patients with what so they can report adverse events?
a toll free number
