Pharmacy Laws and Regulations Flashcards
Pure Food and Drug ACT 1906 (PFDA)
- prohibited interstate commerce of misbranding and adulterated drugs, food and drinks.
- primary focus: purity
- DID NOT require manufacturers labels to list active ingredients, directions for use or warnings and safety concerns
Federal Food, Drugs and Cosmetics Act of 1938 (FFDCA)
- in response to the shortfalls of the PFDA
- deaths of 100 people due to an elixir component
- pre-marketing approval of all drugs
- the labeling should include the:: direction to use, warning, and safety concerns
What are some of the misbranding criteria?
- the product is misrepresented
- does not comply with color additives provisions set-fourth by the FDA
- the product is dangerous when used “ in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling”
- the label fails to include the “ name and the place of business manufacturers, packers, or distributor and accurate statement of the quantity of the contents in terms of weight, measures, or numerical account”
What results to a product being adulterated?
if the product does not meet the standards or quality, strength and purity
The Comprehensive Drug Abuse Prevention and Control Act of 1970 is also known as?
- AKA. Control substance act
The Control Substance Act, requires what?
registration, record keeping and rules regarding dispensing of controlled drugs, the substances are placed into five categories
Schedule 1
have a high potential for misuse, they are not legally accepted in the united states.
Schedule 2
high potential for abuse, can lead to severe psychological or physical dependence, are accepted in the US
LSD and Heroin are what type of scheduled drugs
Schedule 1
Oxycodone, amphetamine and hydrocodone are what type of scheduled drugs?
Schedule 2
These types of schedule drugs lead to moderate or low physical dependence and or high physiological dependence
Schedule 3
codeine and buprenorphine are what type of scheduled drugs ?`
schedule 3
the potential for abuse is less than that of schedule 3 is considered what?
Schedule 4
What are the examples of schedule 4 drugs?
alpram and dizepam
What scheduled drugs contain narcotics?
cough medication, no more than 200mg of codeine per 100ml
when opening up a new pharmacy, what should be obtained?
DEA 224 Form
For how long is the registration for DEA 224 Form valid?
3years, and should be kept at an accessible place for inspections
how can the registration be renewed?
by submitting the DEA 224a Form, this needs to be done 60 days prior to the expiration date.
how are schedule 2 medication ordered?
DEA 222 Form, it is triplicate form that must be handwritten or typed. Minimum of 10 items must be placed to order.
Copy 1 : (top) retained by the supplier
Copy 2 : (middle) forwarded to the DEA
Copy 3 : ( bottom) received by the purchaser
DEA 222 form, how long is it valid for?
60 days
The red C indicates what?
to note the presence of a controlled substance in the schedule 3,4,5 drugs
The schedule 2 drug inventory should be kept separate? yes or no
yes
which scheduled drugs should be manually counted?
Schedule 2
DEA numbers are required on what?
all controlled substances
what should the first letters of the DEA number be?
A B E M
what must be signed by the prescriber?
schedule 3 and 4
What is the NPI number used for?
to process pharmacy claims, they are found on the prescription or the prescribers profile.
which schedule drugs cannot be refilled?
Schedule 2
Schedule 3,4 can be refilled up to ____ times within _____months
5 times, 6 months
the total quantity dispensed meeting the total quantity prescribed is for what?
Schedule 3 drugs for partial refills
If the pharmacy cannot supply the full quantity written for an emergency oral prescription what should be done?
must note the quantity at the front of the prescription, and the remaining must be supplied within 72 hours, and the physician should be notified.
