Reading 2 Flashcards
1
Q
What is the legal definition of a DRUG?
A
- 1) article/supplement recognized in the official compendium
- 2) intended for use in diagnosis, cure, mitigation, treatment etc.
- 3) intended to affect structure or body
- 4) use within 1), 2), 3)
2
Q
What is the definition of Official Compendium?
A
- it is the USP, NF, & HPUS and they provide standard for products or for practice
3
Q
What does the United States Pharmacopeia [USP] contain?
A
- Monographs, definitions, descriptions, and standards for all aspects of a drug [strength, quality, purity, packaging…]
- Also sterile and non-sterile
4
Q
What does the USP-NF contain?
A
- They develop/publish standards for drug substances, products, exciptants, supplements
5
Q
What does the HPUS conatain?
A
- Standard over homeopathy products [drugs that aren’t treated like USP-NF]
6
Q
What is the definiation of a Prescription Drug?
A
- Drug that is NOT safe [maybe toxic, harmful] unless under supervision of practitioner
Refers to Section 21; new drug section
7
Q
What is something that is a must to have on a prescription drug label?
A
- “Rx Only”;
- “Prescription Only”;
- “Caution: Federal law prohibits dispensing without prescription”
8
Q
What is the definiation of a Over-The-Counter Drug?
A
- Oppisite of Rx; Drugs that are safe and effective WITHOUT supervision of prescriber
9
Q
What is the definiation of a Behind-The-Counter Drug?
A
- Drugs that usually require a Rx BUT can be sold without one
- Pseudoephedrine
10
Q
What is the definition of an Orphan Drug?
A
- Drug intended for use in rare diseases [<200,000 people]
11
Q
What is the definiation of a Dietary Supplement?
A
- A product to “supplement” the diet that has one or more; vitamins, minerals, herbs, amino acids…
- NOT DRUGS [really classified as food; Reading 6]
12
Q
What is the definition of a New Drug?
A
- Drug NOT seen as safe and effective in dosage form picked OR
- Drug IS seen as safe and effective BUT not been used in dosage form
13
Q
What is a Grandfathered Drug?
A
- Drug that was made before 1938 and was still on the market in 1962 [Digoxin, Codeine, Phenobarbital]
- Assumed safe and effective b/c longevity
14
Q
What is the definition of DESI?
A
- Drug made between 1938 and 1962
- Assumed safe NOT effective [effectiviness wasn’t required]
- Had to prove EFFECTIVINESS to keep selling
15
Q
What is the definition of New Drug Appilication [NDA]?
A
- Application sent to FDA after clinical trails/data is all collected over that new drug = want approval
