2 Flashcards
Define A controlled substance?
Is a generally a drug or chemical whose manufacture, possession,or use are regulated by a government
What does DEA stands for
?
Drug Enforcement Administration
What does CSA stands for
?
US drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated.
What DEA responsible for?
responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act (CSA)
What are the dangers of inadequate control of drugs and medications?
The possibility of inappropriate use, adverse
reactions, and interactions with other drugs
Before…………, U.S. federal law made no difference between drugs that can and cannot be purchased without a prescription from a physician.
1952
In which year the law “Did not require drugs be labeled but required that drug labels not contain false information about the drugs’ strength and purity” was enforced?
Pure Food and Drug Act of 1906
Created the FDA
2. Required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing
Food, Drug, and Cosmetic (FDC) Act of 1938
Schedule 1
For research only
Example: heroine
Dispensing severely restricted
Example: morphine
Schedule 2
Prescriptions can be refilled up to 5 times in 6 months
3 and 4
Prescriptions for Schedule ………substances must be hand-signed by the prescriber except in emergencies
2
A pharmacist has the right to refuse to fill a prescription for a controlled substance
Ø in legitimate concern that a prescription was not written in good faith
Ø if forgery is suspected
• independent scientific organization
• official quality standards for prescription drugs, OTC drugs, and dietary supplements
The United States Pharmacopeia (USP)
The National Association of Boards of Pharmacy (NABP)
• professional standards for pharmacists
