Lecture 1 - Prescription Writing Flashcards
What part of the government regulates the production and use of drugs?
FDA
What are the two most basic categories of drugs?
OTC + Prescription
When is a DEA number required?
Scheduled drugs
What doesn’t the FDA regulate when it comes to drugs?
Botanicals + Supplements
What is the subdivision of the FDA that regulates drugs for animals specifically?
Center for Veterinary medicine (CVM)
What are the four big things in regards to drugs that CVM regulate?
Drug safety + effectiveness
Animal feed safety + manufacturing
Food additives
What three things can a new drug have in order to be approved?
Approved new animal drug application
Abbreviated NADA
Conditional approval
What are the regulations for use of investigational drugs?
Can be shipped interstate for use only by experts to investigate it’s safety + effectiveness
What is a big difference about the regulation of animal supplements compared to human supplements?
CVM/FDA will regulate food supplements as “food” or “animal drugs” while human supplements have no regulation by the FDA
What is the DEA a part of?
Department of justice
What is the act involving Scheduled drugs that the DEA enforces?
Controlled Substance Act
What are the levels of scheduled drugs?
5 levels
What MUST you have in order to prescribe a scheduled drug?
DEA number
What is the definition of a prescription drug?
Required by state/federal law to be dispensed by licensed medical practitioner
What must be stated on the label of an RX drug? (a statement)
RX only
Federal law prohibits dispensing w/o a RX