OTC
What classifies OTC or nonprescription status
What is safe for use without a physician supervision, conditions suitable for self-diagnosis, and adequate written directions for self use
What does FAERS means
FDA Adverse Event Reporting System
What are the four exemptions from tamper resistant packaging act?
What is Lozenges, Insulin, Dermatology, and Dentifrice
True or False: You can request to reclassify legend status to OTC
What is True
Products must have detailed usage and warning information (Drug facts) section FDA requires:
What is
Active ingredient / per dosage unit
Uses - purpose for medication / treatment
Warnings: side effects, when to contact MD; when not to use product:
Pregnancy; out of children reach
Inactive ingredients
purpose
Directions
Storage
Certain ingredients and amounts
Reporting voluntary for who and mandatory for who
What is voluntary for HCPs and consumers and mandatory for manufactures
What are examples of Lozenges
Category 1
Generally recognized as safe and effective (GRASE) for the claimed therapeutic indication
If any of the product information is missing it is...
What is Misbranded
Special OTC labeling Sodium Content
If product contains >140 mg daily dose must include "Ask your doctor before use if you have a sodium restricted diet
What are examples of Insulin
What is Novolog, humalog,
Category 2
Not generally recognized as safe and effective or having unacceptable indications
True or false: An OTC label has to contain what to do if overdose occurs
What is True
What are the special OTC labeling electrolytes?
What is Calcium, Magnesium, Potassium, and Sodium
What are examples of Dermatology products
What is Hydrocortisone cream 1%, antifungal cream
Category 3
Insufficient data available to permit final classification
What is
Warnings - "As With any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product
Contains aspirin(oral or rectal) _ "It is especially important not to use this product during the last three months of pregnancy unless specifically directed to do so by a doctor
True or False: Tamper resistant packaging act changed to Tamper evident packaging in 1998?
What is True
What are examples of Dentifrice products?
What is Colgate, Crest, toothpaste, fluoride
What are the 4 ways to reclassify legend status to OTC
What is a full NDA requesting OTC, FDA may grant exemption if it deems prescription status is unnecessary for the protection of the public health, Supplement to the NDA may be filed - safety information and lack of history adverse events. Nonprescription Drug Advisory committee may recommend a particular ingredient to be converted to nonprescription status