Exam 1 Flashcards
Law/statute
Law that comes from a body of elected officials
Ex: US code (USC), Indiana Code (IC)
Rule/regulation
Rule having the force of law issued by an administrative agency (non-elected officials in area)
Ex: FDA, DEA, CFR, BOP, Indiana administrative code (IAC)
Format of United States Code citations?
Title number, US Code abbreviation, section number (subsection)
Ex: 21 USC 353(b)(1)(A)
Format of Code of Federal Regulations citations?
Title number, CFR, section number (subsection)
Ex: 21 CFR 1306.04(a)
Format of Indiana Code citations?
IC, title - article - chapter (or rule) - section
Ex: IC 25-26-13-15(a)
Format of Indiana Administrative Code citations?
Title number, IAC, article - chapter - section
Ex: 856 IAC 1-3.1-11(b)(1)
Drug
1) article recognized in official compendium or supplement of official compendium AND
2) intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal AND
3) intended to affect structure or function of body of man or animal AND
4) intended for use as component of any article specified above [not inactive ingredients]
What are the official compendia?
US pharmacopeia, national formulary, (now USP-NF) and HPUS
Cosmetic
1) article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to human body AND
2) articles intended for use as component (except soap)
True or false: the terms drug and cosmetic are mutually exclusive
FALSE, article can be both drug and cosmetic (dandruff shampoo)
Prescription drug
Intended for use by man which
A) because of toxicity or potential for harm, method of use, or collateral measures necessary to use, is not safe for use except under supervision of practitioner OR
B) limited by an approved application under section 355 for use under supervision (new drug)
*MUST have “Rx only” on label
OTC/nonprescription drug
Drug that is safe and effective for use without a prescriber’s supervision for certain conditions
- doesn’t need supervision
- *can be OTC for one indication, Rx for another
BTC drug
Unofficial class, generally drugs sold only by pharmacist
Ex: C-V drugs sold OTC
Controlled substance
Drug that has depend liability and/or potential for abuse
Orphan drug
for condition that
Affects <200,000 people in US
OR
Affects >200,000 but cost of development will not be recovered from sales in US
*Drug NEVER loses orphan drug status, even if found to be useful for other things
Dietary supplement
product (other than tobacco) intended to supplement diet that contains one or more of following:
vitamin, mineral, herb, botanical, amino acid, dietary supplement
OR concentrate/metabolite/extract/combination of any of above ingredients
New drug
NOT generally recognized as safe and effective or is recognized but not been used in the conditions/dosage form for sufficient time.
aka, unapproved drug
New drug application
NDA = what is sent to FDA after clinical trials/data are collected
Investigational new drug
IND is application that you submit to FDA to START clinical trials on new drug
abbreviated new drug application
ANDA is used by generic manufacturers to prove bioequivalence and proof of CGMP
Pre-‘38 drugs
assumed safe/effective by longevity.
Ex: thyroid, morphine, codeine, nitro
DESI drugs
Assumed safe, but had to prove efficacy
Established/generic name
applicable official name designated pursuant to section 358 OR official title in compendium OR common/usual name
Label
THING on a container
written, printed, or graphic matter upon the immediate container of any article