What is the 1938 Federal Food, Drug and Cosmetic Act?
Misbranding and mislabeling
What is the 1951 Durham-Humphrey Amendment?
Distinction between legend drugs and otc drugs
What is the 1970 Poison Prevention Packaging Act?
Made sure all manufacturers and pharmacies to place medications with childproof caps and packaging
What is the 1983 Orphan Drug Act?
Encourages companies to develop drugs for rare diseases by providing research assistance, grants and
cost incentives
What is 1990 Omnibus Budget Reconciliation Act (OBRA)?
Pharmacist must offer to counsel a patient
What is the 1996 Health Insurance Portability and Accountability Act (HIPAA)?
To protect patients health information
What is the maximum amount for pseudoephedrine to be sold ?
3.6 g in a day
9 g per 30 days retail
,7.5 g per 30 days by mail order
How is pseudoephedrine stored ?
Behind the counter and locked in a cabinet
Pseudoephedrine documentation is kept in ? And if used what identification must be provided?
Kept in a log book and must provide:
Records of all information must be kept for at least 2 years.
Drug name
Drug strength
Drug amount
Date/time of sale
Customer's name
Customer's address
Customer's signature
Define what the FDA does ?
enforce the guidelines for manufacturers to Ensures all medications are pure, safe and effective.
What does the DEA enforce?
Controlled Substances Act investigates and prosecutes violators of controlled substance laws.
How many refills are permitted on class 2 substances ?
Zero need a new prescription every time
,Class III-V can be refilled how many times ?
Maximum of times or within 6 months from the original
Class 5 can be refilled how many times?
As often as prescribed
Scheduled 3-5 can be refilled how many times ?
One time basis
What scheduled drug must be locked away or refrigerated?
Schedule 2
What is the name of the program on which patients can return unused controlled substances?
Take back program
Define form 106
Report of theft
Define form 41
Destruction due to damage
, Define define form 222
Order scheduled 2 drugs
What is a boxed warning?
Type of warning on medications that carry high risks
What does the Occupational Safety and Health Administration (OSHA) do?
Ensures a safe workplace for employees
What does the Joint Commission do?
sets standards for accrediting health care facilties tans surveying every 3 years
Common drugs for bipolar disorder ?
Lithium
Rispirdal
Zyprexa
Geodon
the suffix -pril indicates what drug class?
ACE inhibitors
The suffix -faxine and -etine indicates what drug class ?