Legal Lecture Flashcards
(32 cards)
What did the pure food and drug act do?
Drugs had to meet the standards for strength, quality, and purity claimed by the manufacturer
- Did not have to be safe or effective
What did the Federal Food, Drug, and Cosmetic Act do?
Drugs must be safe
What did the Durham-Humphrey Amendment do?
Drugs classified as either prescription or non-prescription
What did Kefauver-Harris Amendment do?
All new drugs must be safe and effective
- Development of the FDA and NDA
What is the FDA?
Responsible for enforcing the provisions of the FDC Act
- Reviewing over-the-counters products (1972)
- Responsible for labeling of OTC products
- Decides whether prescription drugs can be switched to non-prescription status
What are OTC monographs?
Approved by the FDA for ingredients that are "GRASE" Established for each class of drugs Lists acceptable ingredients, dose, formulations and labeling
When can a manufacturer market a new product without FDA approval?
If ingredients are covered in a previous OTC monograph
What are the labeling requirements of OTC products?
Standardized content and format required by the FDA
“Drug Facts” box
- active ingredient
- uses
- warnings, directions and inactive ingredients
Expiration date
Define misbranded
Product that lacks active ingredients, uses, warnings, directions, and inactive ingredients
Exceptions of expiration dates include?
Stable for more than 3 years that do not have a dose limits
What are some package requirements?
Tamper-evident packaging is required
Nonprescription drugs must have a barrier
Packaging must state the mechanism
Patients should be educated to look for them
How can prescriptions switch to OTC?
Through the nonprescription drug review process
Manufacturer submits a supplemental NDA
Manufacturer or third party petitions the FDA
No exact standards
What does the Federal Trade Commission do?
Regulates advertising of nonprescription drugs
- Has to be honest and not deceiving (1970’s)
What are the code of guidelines for advertisements?
Urge customers to read and follow directions
No unsubstantiated claims
No curative suggestions
Point out uses and benefits
No unproven claims against competing products
What happens with product recalls?
Utilized when a product is ID as a potential risk to the public
What are the methods of action for product recalls?
If misbranded, adulterated or not approved the FDA can seize the product
Court injunction preventing further distribution
Ask the manufacturer to recall the product
What is a class I recall?
Dangerous or defective products that pose serious health risks or death
What is a class II recall?
May cause a temporary health risk or slight risk of serious problem
What is a class III recall?
Unlikely to cause a problem but violate FDA labeling or manufacturing regulation
Who regulates dietary supplements?
Dietary Supplement Health and Education Act of 1994
- Allows the FDA to regulate under the Center for Food Safety and Applied Nutrition
- Exempt from purity and potency standards
- Clinical trails are not required
- Only has to prove it is safe
What did the Dietary Supplements and Non-Prescription Drug Consumer Protection Act do?
Requires manufacturers to report to the FDA any serious adverse event reports from the consumer
What are Good Manufacturing Practices?
No adulterants
No impurities
Limits on the presence of bacteria, pesticides, heavy metals
Labeling requriements
Required by DSHEA in 2007
What must the label contain for dietary supplements?
Name of the product Word supplement Net quantity Manufacturers name and place of business Directions "Supplement Facts" label
What are dietary supplements not allowed to do?
Make claims that the product will diagnose, cure, mitigate, prevent or treat a disease
