Reading 2 Flashcards
What is the legal definition of a DRUG?
- 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)
What is the definition of Official Compendium?
- it is the USP, NF, & HPUS and they provide standard for products or for practice
What does the United States Pharmacopeia [USP] contain?
- Monographs, definitions, descriptions, and standards for all aspects of a drug [strength, quality, purity, packaging…]
- Also sterile and non-sterile
What does the USP-NF contain?
- They develop/publish standards for drug substances, products, exciptants, supplements
What does the HPUS conatain?
- Standard over homeopathy products [drugs that aren’t treated like USP-NF]
What is the definiation of a Prescription Drug?
- Drug that is NOT safe [maybe toxic, harmful] unless under supervision of practitioner
Refers to Section 21; new drug section
What is something that is a must to have on a prescription drug label?
- “Rx Only”;
- “Prescription Only”;
- “Caution: Federal law prohibits dispensing without prescription”
What is the definiation of a Over-The-Counter Drug?
- Oppisite of Rx; Drugs that are safe and effective WITHOUT supervision of prescriber
What is the definiation of a Behind-The-Counter Drug?
- Drugs that usually require a Rx BUT can be sold without one
- Pseudoephedrine
What is the definition of an Orphan Drug?
- Drug intended for use in rare diseases [<200,000 people]
What is the definiation of a Dietary Supplement?
- A product to “supplement” the diet that has one or more; vitamins, minerals, herbs, amino acids…
- NOT DRUGS [really classified as food; Reading 6]
What is the definition of a New Drug?
- 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
What is a Grandfathered Drug?
- Drug that was made before 1938 and was still on the market in 1962 [Digoxin, Codeine, Phenobarbital]
- Assumed safe and effective b/c longevity
What is the definition of DESI?
- Drug made between 1938 and 1962
- Assumed safe NOT effective [effectiviness wasn’t required]
- Had to prove EFFECTIVINESS to keep selling
What is the definition of New Drug Appilication [NDA]?
- Application sent to FDA after clinical trails/data is all collected over that new drug = want approval
What is the definition of Investigational New Drug Application [IND]?
- Application to FDA to exempt NDA requirements
What is the definition of Abbreviated New Drug Application?
- Used by generic manufacturers to show bioequivalance
No need for NDA since they are copying NDA-approved drug
What is the definition of Brand Name?
- Name given by the manufacturer
What is the definition of Generic Name?
- Established name in the law
What is the definition of Label in pharmacy law?
- Any printed, written, graphic material on a product container
What is the definition of Labeling in pharmacy law?
- ALL LABELS and written, printed, graphic material on the container, wrapper, or accompanying product.
What is the definition of Special Packaging?
- Packaging that is made difficult to open for childern 5 years and younger
- Adults SHOULD be able to open
- Kids under 5 MIGHT be able to get it but it stops them getting in a reasonable time
What is the definition of Pharmaceutical Equivalents?
- Products with same active ingredents, dosage forms, and strength
- May differ by; look, mechanism, expiration, labeling…
What is the definition of Theraputic Equivalent?
- Pharmaceutical Equivalents that have the same clinical and safety profile
What is the definition of Person in pharmacy law?
- Includes; individuals, partnership, corpoeration, association
