POP Law Quiz 3
Requests to reclassify a Rx-only drug product to an OTC product may occur only by which 4 possible ways?
- By submitting a full NDA to the FDA requesting status change
- By the FDA granting an exemption if it deems that Rx-only status is unnecessary for the protection of public health
- By filing a supplement to the NDA
- By recommendation from the Nonprescription Drug Advisory Committee
Insufficient data available to permit final classification describes which OTC ingredient category?
Generally recognized as safe and effective (GRASE) for claimed therapeutic indication describes which OTC ingredient category?
Which law places health foods, food supplements, and herbal products in to a class different from Rx and OTC products?
What main 3 things did DSHEA do?
- Products to be marketed without proven efficacy
- Products currently on the market do not have be proven safe
- The USP published “Manufacturing Practices for Dietary Supplements
Not generally recognized as safe and effective or having unacceptable indications describes which OTC ingredient category?
According to DSHEA, who's responsibility was it to prove if a product is unsafe?
Who has to challenge the product after it has gone to market if evidence comes forth that the product is ineffective for its labeled use?
FDA or FTC
The final product is known as what?
A vitamin, mineral, herb or botanical, amino acid, or other dietary substance used to supplement the diet is referred to as a what?
An excipient or substance used to manufacture a DS is known as a what?
Most requirements fall on whom with respect to testing and record-keeping of DS?
True or False: GMP guidelines outline required tests that must be performed to verify identity, strength, purity, etc
False; do not outline
Records involving manufacturing a DS must be kept for how long?
- 1 year past the expiration date
- or 2 years beyond the date of distribution of the last batch
Violations of GMP rules results in the DS being considered what?
Who has published monographs for some botanicals that appear to have therapeutic efficacy?
True or False: Herbal product must have an FDA approved use of USP DI Panel recognized use
The monographs for herbal products outline at what 3 things?
- the portion of the plant used
- its botanical characteristics
- appropriate assays procedures for ingredients
The monographs for herbals do not describe what?
Dietary Supplements/Herbals with monographs include:
- Cranberry liquid preps
- Gingko biloba
- Milk Thistle
- St. John’s wort
- Saw Palmetto
What describes the relationship between a food, food component or DS ingredient AND reducing the risk of a disease or health-related condition?
What increases risk of bleeding (can be an ADR of a DS)?
What describes how a product may affect the organs or systems of the body AND it cannot mention any specific disease?
These decrease drug concentrations:
What describes the relative amount of a nutrient or DS in a product?
These Increase drug concentrations:
Labels of herbals and DS must contain standard common names listed in Herbs of Commerce, published by the who?
American Herbal Products Association
If the product does not have a standard common name, the manufacturer must include the herb’s what on the label?
When did the FDA ban the sale of all ephedra (used for asthma) containing dietary supplements?
The Ephedra ban does not apply to what products?
- prescription drug products
- non-prescription drug products
- conventional foods (herbal teas)
- products used for “Traditional Chinese Medicine”
List the 4 main resources for DS:
- Natural Medicines Comprehensive Database(PubMed)
- Office of Dietary Supplements (NIH)
- The Consumer Lab
- The U.S. Pharmacopeia (USP)
Incorrect or damaged composition of the product is referred to as what?
Incorrect or damage to the product label is referred to as what?
Articles 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 are known as what?
True or False: Cosmetics do not require pre-marketing approval by the FDA
Cosmetics do not have to meet GMP requirements, but are obligated to be manufactured under what?
Any product (cosmetic) not manufactured under sanitary conditions will be considered what?
Which law does not require cosmetics to be tested for safety?
FDCA of 1938
Any product (cosmetic) posing a safety risk will be considered what?
Any product (cosmetic) containing an unapproved color additive will be considered what?
List some examples of cosmetics:
- skin moisturizers
- cleansing shampoos
- permanent waves
- hair colors
Regulation of cosmetic advertising and labeling falls under the jurisdiction of the whom?
Cosmetic product labels must contain names of each ingredient listed in what?
descending order of predominance
What cosmetics may be listed by name?
- flavoring oils
Which cosmetics must be accepted for cosmetic use?
Ingredient names listed on cosmetic labels must match the generic name listed in at least 1 of what 2 resources?
- CTFA Cosmetic Ingredient Dictionary
–CTFA is a book compiled by whom that contains many ingredients commonly used in cosmetics?
Cosmetic, Toiletry, and Fragrance Association (CFTA)
Can a product be both a cosmetic and a drug?
List examples of products that can be a cosmetic and a drug:
- Anti-dandruff shampoo
- fluoridated toothpaste
- medicated mouthwash
- moisturizers and makeup with sun-protection claims
- essential oils with therapeutic claims
What are the 5 common ADRs and SE of a DS?
- Anticoagulation properties
- Enzyme inducers
- Enzyme inhibitors
- Affect electrolyte level
- Potentially hepatotoxic