Pharmacy Laws and Regulations

Question 1

Pure Food and Drug ACT 1906 (PFDA)

Answer 1

• 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

Question 2

Federal Food, Drugs and Cosmetics Act of 1938 (FFDCA)

Answer 2

• 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

Question 3

What are some of the misbranding criteria?

Answer 3

• 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”

Question 4

What results to a product being adulterated?

Answer 4

if the product does not meet the standards or quality, strength and purity

Question 5

The Comprehensive Drug Abuse Prevention and Control Act of 1970 is also known as?

Answer 5

• AKA. Control substance act

Question 6

The Control Substance Act, requires what?

Answer 6

registration, record keeping and rules regarding dispensing of controlled drugs, the substances are placed into five categories

Question 7

Schedule 1

Answer 7

have a high potential for misuse, they are not legally accepted in the united states.

Question 8

Schedule 2

Answer 8

high potential for abuse, can lead to severe psychological or physical dependence, are accepted in the US

Question 9

LSD and Heroin are what type of scheduled drugs

Answer 9

Schedule 1

Question 10

Oxycodone, amphetamine and hydrocodone are what type of scheduled drugs?

Answer 10

Schedule 2

Question 11

These types of schedule drugs lead to moderate or low physical dependence and or high physiological dependence

Answer 11

Schedule 3

Question 12

codeine and buprenorphine are what type of scheduled drugs ?`

Answer 12

schedule 3

Question 13

the potential for abuse is less than that of schedule 3 is considered what?

Answer 13

Schedule 4

Question 14

What are the examples of schedule 4 drugs?

Answer 14

alpram and dizepam

Question 15

What scheduled drugs contain narcotics?

Answer 15

cough medication, no more than 200mg of codeine per 100ml

Question 16

when opening up a new pharmacy, what should be obtained?

Answer 16

DEA 224 Form

Question 17

For how long is the registration for DEA 224 Form valid?

Answer 17

3years, and should be kept at an accessible place for inspections

Question 18

how can the registration be renewed?

Answer 18

by submitting the DEA 224a Form, this needs to be done 60 days prior to the expiration date.

Question 19

how are schedule 2 medication ordered?

Answer 19

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

Question 20

DEA 222 form, how long is it valid for?

Answer 20

60 days

Question 21

The red C indicates what?

Answer 21

to note the presence of a controlled substance in the schedule 3,4,5 drugs

Question 22

The schedule 2 drug inventory should be kept separate? yes or no

Answer 22

yes

Question 23

which scheduled drugs should be manually counted?

Answer 23

Schedule 2

Question 24

DEA numbers are required on what?

Answer 24

all controlled substances

Question 25

what should the first letters of the DEA number be?

Answer 25

A B E M

Question 26

what must be signed by the prescriber?

Answer 26

schedule 3 and 4

Question 27

What is the NPI number used for?

Answer 27

to process pharmacy claims, they are found on the prescription or the prescribers profile.

Question 28

which schedule drugs cannot be refilled?

Answer 28

Schedule 2

Question 29

Schedule 3,4 can be refilled up to ____ times within _____months

Answer 29

5 times, 6 months

Question 30

the total quantity dispensed meeting the total quantity prescribed is for what?

Answer 30

Schedule 3 drugs for partial refills

Question 31

If the pharmacy cannot supply the full quantity written for an emergency oral prescription what should be done?

Answer 31

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.