Ch. 9: OTC Products

Question 1

FED OTC label language should be written in a fashion that a ___ can easily understand how to use the medication

Answer 1

layperson

Question 2

FED What are the 7 general categories that must be contained on an OTC drug label in order for it to not be considered misbranded

Answer 2

1) Principal display panel
2) Statement of identity (drug name, pharm category, intended action)
3) “Drug facts” panel
4) Directions for use
5) Net quantity of contents
6) Expiration date (on both inner and outer package)
7) Name/address of manufacturer, packer, or distributor

Question 3

FED The statement of identity on an OTC drug should appear on which part of the label

Answer 3

the principal display panel

Question 4

FED The statement of identity on an OTC drug label should contain what info

Answer 4

Drug name, general pharmacological category or principal inteded action (guaifenesin, expectorant)

Question 5

FED T/F The “Drug Facts” label on an OTC product is an FDA-approved label

Answer 5

True

Question 6

FED What are the 8 categories that need to be on a drug facts panel on an OTC drug

Answer 6

1) Active ingredient
2) Purpose
3) Uses
4) Warnings
5) Directions
6) Other information
7) Inactive ingredients
8) Contact information… question, questions or comments?

Question 7

FED On an OTC drug label, what order should the inactive ingredients be put into

Answer 7

alphabetical order…. not the order that they occur in from most to least

Question 8

FED What are the 4 electrolytes that need to be on an OTC product at what thresholds

Answer 8

Calcium 20 and up
Magnesium 8 and up
Potassium 5 and up
Sodium 5 and up
*all are INCLUDING that number

Question 9

FED If a product contains warnings for both calcium and sodium restricted diets, how should they be listed on the label
A) By whichever one has a greater amount
B) Alphabetically

Answer 9

Alphabetically…. so “ask doctor before use if you are on a calcium or sodium restricted diet”

Question 10

FED What are the thresholds for each of the 4 electrolytes where the amount per daily dose, if exceeded, needs to have the statement “ask doctor before use if you have a ___-restricted diet”

Answer 10

Calcium 3.2 grams
Magnesium 600 mg
Potassium 975 mg
Sodium 140 mg
*These do NOT include the values.... so the statement needs to be there if it is OVER this amount, such as 141, but not if its 140

Question 11

FED What are the amounts for sodium free, very low sodium, and low sodium on OTC labels

Answer 11

Sodium free = 5 or fewer
Very low sodium = 35 or fewer
Low sodium = 140 or fewer

Question 12

FED What are the generic names of the two FDA approved EC tabs

Answer 12

levonorgestrel, ulipristal

Question 13

FED The two FDA approved EC tabs can be taken up to how long after unprotected sex

Answer 13

levonorgestrel = 72 hours, but can recommend up to 120 hours as an RPh

ulipristal = 120 hours

Question 14

FED What is the most effective form of EC

Answer 14

The copper IUD, which reduces pregnancy risk by more than 99%, and can be inserted within 5 days after unprotected sex

Question 15

FED The combat meth act applies to which 4 drugs

Answer 15

pseudoephedrine, ephedrine, phenylpropanolamine, norpseudoephedrine

Question 16

FED The pseudoephedrine and ephedrine transaction log book should be kept where

Answer 16

Behind the counter or in a locked cabinet

Question 17

FED What is the exception where you can purchase pseudoephdrine without having to record the sale in the logbook

Answer 17

purchasing a single-dose package of pseudoephedrine, which contains a max of 60mg (two 30mg tabs)

Question 18

FED What are the daily and monthly pseudoephedrine/ephedrine limits

Answer 18

3.6 grams/day
9 grams/30 day period
7.5 grams/30 day period for mail order

Question 19

FED All pharmacies that sell ephedrine/sudafed products must “self-certify” that they are trained int he sales regulations for these drugs with:
A) The FDA
B) The DEA
C) The state BOP
D) The Attorney General of the United States

Answer 19

D I guess… I just made the others up tho, I’m not sure if maybe you also have to register w other places or not…. pg 162

Question 20

FED The DEA requires that the logbook be kept in a secure location for how long

Answer 20

at least 2 years

Question 21

FED T/F Dextromethorphan is only scheduled according to the CSA if the product exceeds a dose of 50mg per dose

Answer 21

False, dxm is not currently scheduled under the controlled substances act, but the DEA has indicated that dxm may become a scheduled drug in the future

Question 22

FED T/F Federal law requires each state to have a set syringe exchange program (SEP) or syringe service program (SSP) in place

Answer 22

False, these are not regulated by federal law…. they are legislated at the state and local levels