Lose Controlled
The word specifically meaning opium containing substance
What is Narcotic?
They enforce the Controlled Substances Act
Prompted by the sulfanilamide tragedy, this act addresses safety but not efficacy
This phase of human trials is performed in healthy individuals to evaluate safety
What is Phase I?
This amount of sodium requires a warning on the product label
What is 140mg?
The schedule containing benzodiazepines and tramadol
What is Schedule IV?
They enforce the USP regulations
Who is the state BOPs?
Also known as the Wiley-Heyburn Act, this act prohibits misbranding and adulteration
What is the Pure Food and Drug Act?
This type of application is filed after the IND and clinical trial phases are complete
What is NDA?
This type of drug is found in the purple book
What is a biosimilar?
The Anabolic Steroids Control Act moved anabolic steroids into this schedule
What is Schedule III?
They regulate nonprescription drug advertising
Who is the FTC?
This amendment authorized refills and oral prescriptions
What is the Durham-Humphrey amendment?
This type of chemical classification is considered more important
What is Type 1?
Mississippi law requires prescriptions to be kept for this amount of time
What is 6 years?
If a substance switches schedules, a drug company has this many days until the new symbol must be on containers
What is 180 days?
They administer the Poison Prevention Packaging Act
Who is the CPSC?
This is another name for the Drug Price Competition and Patent Term Restoration Act
What is the Waxman-Hatch Amendment?
What item is not considered part of the FDA approved labeling?
What is the Consumer Medication Information (CMI)?
Media fill tests must be performed on high risk compounding personnel this often
What is biannually?
These two drugs are Schedule III in MS, but not scheduled federally
What are Sudafed and Fioricet?
They administer Safety Data Sheets
Who is OSHA?
This act not only added fast track drug approval, but also incentivized pediatric and off-label use studies
What is FDAMA?
Orphan drug applies if the disease targeted affects less than this many Americans
What is 200,000?
Safety Data Sheets must be kept on file for this amount of time
What is 30 years?