OTC Exam 1 - Law Flashcards
1906 pure food and drug act
prohibited adulteration and misbranding; the reason ineffective cure-alls were taken off the market
1914 harrison narcotic act
- required rx only status for opium and other narcotics (previously OTC)
- this was hard to enforce
1938 Food, Drug, and Cosmetic Act (FDCA)
Mandated food, drug, and cosmetic safety
Duram-humphrey amendment
Established rx vs OTC categories and the labeling requirements for each
Requirements for a drug to be OTC
- low potential for abuse and misuse
- benefits of being OTC must outweigh risks
- state law may make it rx only
Snake oil
Term used to describe “worthless pseudo-medical” remedies that were promoted as cures for various illnesses
A ____ medication may be used without medical supervision
Nonprescription
No HCP is needed for ____ and ____ use of OTC
Safe and effective
How can a state make a drug’s access more strict
By making a product that is considered OTC under federal law into a prescription only product under state law
Outcome of the Duram-Humphrey Amendment of 1951
- made a clear distinction between OTC and rx drugs
- named 3 conditions that would make a drug rx only
- determined labeling requirements for each
What are the 3 conditions that would make a drug rx only
- habit forming
- considered unsafe for use except under expert supervision due to toxicity concerns
- rx only drugs had to undergo a new drug application w/ FDA
Before the durahm-humphrey amendment the ___ decided what would be rx or OTC
Manufacturer
Kefauver-harris drug amendment of 1962
- required proven efficacy of marketed products (including OTC)
- both rx and OTC must be manufactured using current good manufacturing practices (cGMPs)
- FTC regulates advertising of OTC drugs
In ____ the FDA created the OTC review process
1972
OTC review process divided products into ___ according to therapeutic effect and active ingredients
Categories
What was the first rx to OTC switch
Diphenhydramine and hydrocortisone
Category 1
Generally recognized as safe and effective (GRASE)
Category 2
Not GRASE
Category 3
Insufficient evidence to prove safety and/or efficacy
3 phases of the nonprescription drug review process
- Advance notice of proposed rulemaking
- Tentative final monograph
- Final monograph
(At The Fair)
NDA
FDA reviews safety and efficacy of the product as a whole
Monograph
FDA reviews safety and efficacy of the individual ingredient
Can an OTC monograph be changed
Yes
Poison Prevention Packaging Act (1970)
Requires drugs and specific household substances to be in child resistant packaging
Drug Listing Act (1972)
- Established NDCs
- each drug is required to register w/ the FDA
Federal Anti-Tampering Act (1982)
- Makes it a crime to tamper w/ OTC products
- Requires tamper resistant features on OTC medications
Food and Drug Modernization Act (1997)
Expanded FDA authority over OTC drugs and established inactive ingredient labeling requirements
Exempt items from the federal anti-tampering act
Topicals
Toothpaste
Lozenges
Insulin
(T/F): pharmacists may recommend OTC drugs for a condition or a dosage NOT listed on the label
True
Who makes the decision on an OTC switch
FDA
Dual status
- Some OTC meds are also available as rx
- certain dosages, dosage forms, or indications deemed safe OTC
Who regulates advertising of nonprescription meds, devices, and dietary supplements
FTC
Who regulates nonprescription drug labeling
FDA
