Legal and regulatory considerations for self-care Flashcards
Why was the Food, Drug and Cosmetic Act of 1938 developed?
The elixir of sulfanilamide tragedy proved a need for testing proving drug was proven safe before marketing and selling. The drug needed to have adequate directions for used and warnings
What was the durham-humphrey amendment of 1951?
Not all drugs could meet adequate directions for use so drugs were separate into 2 classes(legend and non-legend)
Non-legend drugs were OTC drugs and their label must meet adequate directions for use
How were OTC drugs created?
They have been proven to have a wide margin of safety
The FDA can authorize the switch from Rx to OTC thru numerous routes such as manufacturer request or the OTC drug review process
What is the benefit of switching from RX-OTC
It saves the healthcare billions of dollars every year
What are the implications of being classified as a drug?
Subjection to regulations such as label and labeling requirements(ALL text has to be approved by FDA)
What is required to appear on an OTC drug label?
Name of the product
Name and address of mfg/packager/distributor
Net contents of package
Cautions and warnings
NDC number
Directions for use
Drug facts
What is required on the drug facts section?
Active ingredients, including amount in each dosage unit
Purpose of med
Uses/indications
Warnings
Instructions for use
Inactive ingredients
Number to call for questions
T or F: All OTC drug products for retail sale must be packaged in a tamper evident package
True with the exception of dermatological, dentifrice, insulin or lozenge products
What is tamper evident packaging?
It is packaging having one or more indicators or barriers to entry. If breached or missing, can reasonably be expected to provide visible evidence to consumers tampering has occurred
How are dietary supplements regulated?
They are not regulated as drugs. No criteria for safety data. No clinical trials
What must appear on the label/labeling of dietary supplements
Health claim with FDA approval
Nutrient claim with FDA approval
Structure-function claim
