EXAM 3 OTC Legal Considerations

Question 1

How does the FDA manage to oversee the massive amount of OTC products?

Answer 1

categorize by pharmacologic category

-> majority of OTC products are made from about 200 active ingredients

200 products that comprise most of the OTC combos

Question 2

How is an OTC product approved as safe and effective before being marketed and sold?

Answer 2

1. FDA appoints an advisory panel to review OTC products by class
2. published in the federal register to allow the e public to comment
3. active ingredients that are recognized as safe and effective are published in a monograph -> then may be marketed

Question 3

What are the 3 categories of active ingredients?

Answer 3

Category I:
ingredients are GRASE (generally recognized as safe and effective) and NOT misbranded
Ex: titanium oxide, zinc oxide

Category II:
risks outweigh the benefits of current data
Ex: PABA, trolamine salicylate

Category III: (can still be on the market)
ingredients for which available data are insufficient for classification
Ex: octocrylene, dioxybenzone, sulisobenzone

Question 4

What are the factors that make a drug an OTC product?
***
!!!

Answer 4

-the patient has to be able to self-diagnose
-self-treat
-self-monitor/manage

Labeling has to be
-easy to read
-easy to understand
-of minimum size font

Question 5

What must be on the label of an OTC product?

Answer 5

-the identity of the product: name of the drug, statement of the general pharmacological category of the drug

-Name and address of manufacturer
-Net quantity of contents of the package
-Cautions and warnings
-Adequate directions for use
-Drugs Facts panel

Question 6

What must be in the Drug Facts Panel?
***
!!!

Answer 6

-active ingredient
-purpose

-use (indication)
-warnings
-direction
-other pertinent information/miscellaneous: storage etc.
-inactive ingredients
-contact of the manufacturer (if there are Questions?)

Question 7

Professional OTC labeling
***

Answer 7

-Additional labeling specifically for healthcare professionals
-FDA doesn’t allow it on OTC labeling
-does not contain adequate direction of use

-OTC products used for the specific condition that was diagnosed by the doctor (not self-treated anymore -> doesn’t meet the criteria of OTC)

-pharmacist should not provide it to patients unless requested

Question 8

Can pharmacists recommend OTC drugs to patients for conditions or dosages not listed on the label?

Answer 8

Yes, but it may increase the pharmacist’s risk
of civil liability if the patient was harmed

Question 9

Who regulates the Nonprescription Drug Advertising?

Answer 9

Federal Trade Commission

Question 10

Companies are required to submit information for approval before marketing OTC products. T/F

Answer 10

False.

they can put the product on the market and they correct the branding or take the product back if something is worng

Question 11

If a company puts a claim on the label they have to provide evidence to support the claim.

Answer 11

True.

Question 12

Authorities of the Federal Trade Commission

Answer 12

-Issue cease and desist (tell them to take the product back)

-Require companies to issue corrective advertising

-Require advertisers to provide affirmative disclosures to qualify certain statements, half-truths, or disclose adverse consequences

Question 13

What are the 3 ways to switch from Rx to OTC based on the Durham Humphrey Amendment?
***

Answer 13

-the manufacturer requests the switch by submitting a NDA (new drug application) or SNDA (supplemental new drug application) - MOST OFTEN

-the manufacturer or other parties (anyone) can request through a citizen petition

-FDA may add or amend an OTC monograph