Law Exam 1 - Lecture 5 (Packaging)

Question 1

special packaging

Answer 1

-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

Question 2

-child resistant means ___% of children or less can open after 10 minutes
-at least ___% of adults can open after 10 minutes

Answer 2

20%, 90%

Question 3

drugs for _____ _____ require special packaging

Answer 3

oral administration
(OTC or prescription)

Question 4

a product may be misbranded if not dispensed in ____

Answer 4

CRC (child resistant container)

Question 5

waivers for CRC are allowed prescription by prescription (by _____ or _____)
or
blanket waivers (by _____ only)

Answer 5

patient or prescriber
patient

Question 6

Notable CPSC exemptions

Answer 6

sublingual nitroglycerin
oral contraceptives in mnemonic packages
steroid dose packs
some oral powder formulations
unit-dose potassium

Question 7

Class 1 recall

Answer 7

drug product may cause serious adverse health consequences including death (pharmacies notify patients who received recalled drugs)

Question 8

Class 2 recall

Answer 8

Drug may cause temporary or reversible effects, but the probability of serious health consequences is remote

Question 9

Class 3 recall

Answer 9

drug product is unlikely to cause serious adverse health consequences

Question 10

drug recall vs seizure

Answer 10

drug recall done by company (voluntary)
drug seizure done by agency (often FDA or DEA, not voluntary)

Question 11

Federal Anti-Tampering Act does what?

Answer 11

makes tampering a federal crime (1983)

Question 12

Do OTCs require tamper evident packaging?

Answer 12

Yes, FDA requires it

Question 13

label definition

Answer 13

any printed, written or graphic material on the product

Question 14

Labeling definition

Answer 14

all labels and written, printed or graphic material on the container, container wrapper, or accompanying the product

Question 15

is a label part of the labeling?

Answer 15

yes

Question 16

If a drug on a shelf does not have a Package insert (PI), it is _______

Answer 16

misbranded

Question 17

3 sections on labelling that relates to reproduction

Answer 17

pregnancy
lactation
females and males of reproductive potential

Question 18

PI vs PPI

Answer 18

package insert vs patient package insert
-must give PPI to patient with their prescription

Question 19

If PPI is not dispensed to patient with prescription, it is considered _______

Answer 19

misbranding

Question 20

only drugs requiring PPIs

Answer 20

oral contraceptives and estrogens

Question 21

failure to dispense a MedGuide with a required drug is ______

Answer 21

misbranding

Question 22

MedGuides are required when one or more of the following exist:

Answer 22

1. labeling could help prevent adverse effects
2. serious risks of use exist which pts should be made aware of
3. pt adherence to directions is crucial to drug effectiveness

Question 23

Risk Evaluation and Mitigation Strategy (REMS) ____ be required by FDA as part of drug labeling

Answer 23

can

Question 24

4 REMS types

Answer 24

Pt Friendly Labeling
Communication Plans
Elements To Assure Safe Use (ETASU)
Implementation System

Question 25

OTC labeling require a ____ ____ section which includes: active ingredients purpose uses warnings directions inactive ingredients other info

Answer 25

drug facts

Question 26

3500 and 3500B are used for what?

Answer 26

health professionals (3500) and patients (3500B) can use these to report serious adverse events associated with drug or FDA covered products

Question 27

in 2007 a law was passed saying pharmacies must provide patients with what so they can report adverse events?

Answer 27

a toll free number