federal laws

FDCA

Food, Drug, and Cosmetic Act 1938

Durham-Humphrey Amendment

rx & OTC 1951

Kefauver-Harris Amendment

safe and effective, GMPs, rx ads 1962

DQSA

Drug Quality and Security Act 2013

DSCSA

Drug Supply Chain Security Act 2013

PPPA

Poison Prevention Packaging Act of 1970

DEA 106

Used to report lost or stolen controlled substances. (required when 5% of yearly product sold is missing - ie 50 tablets from a 1000 yearly supply)

DEA 224

register pharmacy as dispenser

DEA 224a

renewal of registration (every 3 years)

DEA 41 form

broken or spilled CS

DEA 222 form

ordering C-2s

PDMA

Prescription Drug Marketing Act of 1987, samples, 2nd marketing act

SAMHSA

Substance Abuse and Mental Health Services Administration X#

ADE

adverse drug event

DBA

Doing Business As

ISO

International Organization for Standardization

DSC

DRUG SUPPLY CHAIN