PHA 372 Law Quiz 3
What are the 4 ways a request to reclassify a Rx drug to an OTC product?
- Submit full NDA to FDA requesting status change
- FDA can grant exemption if it deems Rx-only status unnecessary for protection of public health
- Filing a supplement to NDA
- Recommendation from Nonprescription Drug Advisory Committee
OTC ingredients are classified into one of _______ categories
Which OTC ingredient category is generally recognized as safe and effective (GRASE) for claimed therapeutic indication?
Which OTC ingredient category is not generally recognized as safe and effective or having unacceptable indications?
Which OTC ingredient category has insufficient data available to permit final classification?
________ places health foods, food supplements, and herbal products into a class different from Rx and OTC products.
Dietary Supplement Health Education Act (DSHEA)
Examples of products included in DSHEA
- Amino Acids
- Dietary Supplements
What did DSHEA do?
- Products to be marketed w/o proven efficacy
- Products currently on the market do not have to be proven safe
- USP published "Manufacturing Practices for Dietary Supplements"
Who may challenge a DSHEA product after it has gone to market and when would they do so?
FDA or FTC; if evidence comes forth that the product is ineffective for its labeled use
Who's responsibility is it to prove DSHEA products unsafe?
Dietary supplement is defined as
The final product
Dietary ingredient is defined as
Vitamin, mineral, herb, or botanical, amino acid, or other dietary substance used to supplement the diet.
Non-dietary ingredient is defined as
An excipient or substance used to manufacture a DS
When manufacturing DS, most requirements fall on the _______________ with respect to testing and record-keeping
True/False: For DS, GMP guidelines outline required tests that must be performed to verify identity, strength, purity, etc.
True/False: For DS, manufacturers may test every batch of finished product OR subsets of finished batches.
True/False: DS manufacturers establish their own written procedures
How long must procedural records for DS manufacturers be kept?
1 year after exp date (if there is one) OR 2 year past date of distribution of the last batch
Violations of GMP rules results in DS being considered ___________
____________ has published monographs for some botanicals that appear to have therapeutic efficacy
Describes the portion of the plant used, its botanical characteristics and appropriate assay procedures for ingredients.
True/False: Monographs describe therapeutic use for botanicals
Herbal product must have an FDA approved use of _______________
USP DI Panel recognized use
DS/Herbals with monograph examples
- Milk thistle
- Saw Palmetto
Cranberry liquid preps
St. John's Wort
What are the 3 types of claims DS manufacturers can make?
- Health Claim
- Nutrient content claim
- Structure/Fxn claim
Describes relationship b/w food, food component, or DS ingredient AND reducing risk of a disease or health-related condition
Describes the relative amount of a nutrient or DS in a product
Nutrient content claim
Describes how a product may affect the organs / systems of the body AND it cannot mention any specific disease
What are some common ADRs and SE of DS?
- Anticoagulation properties -- Increase risk of bleeding
- Enzyme inducers -- Decrease drug concentrations
- Enzyme inhibitors -- Increase drug concentrations
- Affect electrolyte levels
- Potentially hepatotoxic
Herbal and DS labels must contain what kind of names listed in Herbs of Commerce, published by the American Herbal Products Association
Standard common names
What should a manufacturer do if the herbal/DS product does not have a standard common name to include on the label?
Include the herb's Latin name on the label
True/False: Claimes about structure/fxn must be truthful and not misleading.
True/False: Herbal/DS products may make claims that the product will diagnose, cure, treat, or prevent a disease
In 2004, the FDA banned the sale of all ________ (used for asthma) containing DS bc the use presented an unreasonable risk of illness/injury.
What did the 2004 ban on Ephedra by the FDA not apply to?
- Prescription/non prescription products
- Conventional foods (herbal teas)
- Products used for "Traditional Chinese Medicine"
- (Product labels cannot have an indication that the product is a DS)
Resources for DS include:
- Natural Medicines Comprehensive Database (PubMed)
- Office of Dietary Supplements (NIH)
- The Consumer Lab
- The US Pharmacopeia (USP)
Adulteration involves ___________ of the product
Misbranding involves ________ of the product
Atricles to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
Do cosmetics require premarket approval by the FDA?
Cosmetics do not have to meet GMP requirements, but are obligated to be manufactured under ____________ conditions
If a cosmetic is not manufactured under sanitary conditions, it is considered ______________
True/False: FDCA of 1938 required cosmetics to be tested for safety.
Any cosmetic product posing a safety risk will be considered ___________
Any cosmetic product containing an unapproved color additive will be considered ____________
Regulation of cosmetic advertising and labeling falls under the jurisdiction of ____________
True/False: Cosmetic product labels must contain names of each ingredient listed in ascending order of predominance.
Perfumes and flavoring oils in cosmetics may be listed by _______
Ingredient names listed on cosmetic labels must match the generic name listed int eh USP/NF or ___________
CTFA Cosmetic Ingredient Dictionary
Can a product be both a cosmetic and a drug?
What is the basis for distinction between cosmetics and drugs?
Claims made for the product